3(Seattle/Secretary)4 For IEC use only

® 2010-10-03

INTERNATIONAL ELECTROTECHNICAL COMMISSION

TECHNICAL COMMITTEE 3: INFORMATION STRUCTURES, DOCUMENTATION AND GRAPHICAL SYMBOLS Maintenance Team 21: MAINTENANCE OF IEC 62079

Report on IEC TC 3 MT 21 Activities

1 Organization Convenors: Mrs Gabriela Fleischer (DE) Mr Naoki Tokuda (JP) Members: Mr Sumio Araki (JP) Mr Thomas Borglin (SE) Mr Kai Bohn (DE) Mr Michael Fritz (DE) Mr Gordon Hayward (GB) Mr Hiroaki Ikeda (JP) Ms Junko KANAMARU (JP) Mr John Perry (GB) Mr Sven Radhe (ISO) Mr Arto Sirviö (FI) Mr Karl-Anker Thorn (DK) Mr Sven Ingolf Garnæs Ring (DK) Mr Roland Schmeling (DE)

2 Status of IEC 82079.

The 2nd CD of IEC 82079 was circulated with closing 2010-03-05. The circulation resulted in a big number of comments which required essential changes of the draft. TC 3 Chairman and Secretary decided that a third draft should be circulated.

The 3rd CD was circulated with closing date 2010-08-13. Also this circulation resulted in a big number of comments (for one thing because comments from ISO TC 10 on 2nd CD by mistake was not reported to the 2nd CD but to the 3rd). A preliminary compilation of comments was circulated 2010-09-17.

MT 21 considered all comments in a meeting in September and prepared a draft intended to be circulated as CDV. The final compilation of comments has been completed but could not be circulated before the TC 3 plenary meeting in Seattle. The draft CC also including the draft CDV is attached to this report.

3 Plans and recommendations The compilation of comments shall be circulated as soon as possible after the TC 3 plenary meeting. MT 21 proposes to circulate the CDV for voting by 2011-01-15.

Sven-Anders Lejdeby TC 3 Secretary

® Registered trademark of the International Electrotechnical Commission 3/1022A/CC

COMPILATION OF COMMENTS ON COMMITTEE DRAFT ®

Project number: Reference number of the CD IEC 82079-1 3/1000/CD IEC/TC or SC Date of circulation TC 3 2010-10-xx Title of the TC or SC: Information structures, documentation and graphical symbols

Title of the committee draft: IEC 82079-1: Preparation of instructions for use – Structuring, content and presentation - Part 1: General principles and detailed requirements

The above-mentioned document was distributed to National Committees with a request that comments be submitted

Report of comments

See printout attached

Comments received – see annex1 NOTE: This compilation of comments is the finally revised version of 3/1022/CC with the date of circulation 2010-09-10. For information a preliminary draft of the coming CDV have been attached to this circulation..

DECISION OF THE CHAIRMAN (in cooperation with the secretariat)

a A revised committee draft will be distributed as a committee draft for vote (CDV) by (date) 2011-01-15

b A revised committee draft will be distributed for comment by (date) ......

c The committee draft and comments will be discussed at the next meeting (date) ......

NOTE 1 In the case of a proposal a or b made by the chairman, P-members objecting to such a proposal shall inform the Central Office with copy to the secretary in writing within 2 months of the circulation of this compilation (see ISO/IEC Directives, Part 1, 2.5.3). NOTE 2 The above decision is preliminary, since the discussion of implementation of comments is not completed. Final decision will be announced in a revised CC. Eventually objections from P-members should refer to the final proposal.

Name or signature of the Secretary Name or signature of the Chairman

Sven-Anders Lejdeby Hans Brückner

1 To be collated on FormComments and annexed

FORM CC (IEC) ® Registered trademark of the International Electrotechnical Commission 2009-01-09 Report of Comments on CD - Document 3/1000/CD

Project: IEC 82079-1 Ed.1: Preparation of instructions for use - Structuring, content and presentation - Part 1: general principles and detailed requirements

Circulation Date: 2010-05-14 Closing Date: 2010-08-13

Country Status Received Comments Australia O - - Austria P - - Belgium O 2010-07-19 N Bulgaria O - - China P 2010-08-12 Y Czech Republic P 2010-08-12 N Denmark P 2010-08-13 Y Finland P 2010-06-14 Y France P - - Germany P 2010-08-13 Y Hungary P - - India O - - Israel O - - Italy P 2010-07-07 N Japan P - - Korea (Rep. of) O 2010-08-13 N Malaysia O - - Netherlands P 2010-08-09 N Norway P 2010-08-13 Y Pakistan P 2010-08-12 N Poland O - - Portugal P 2010-08-13 N Romania P - - Russian Fed. P 2010-08-13 N Serbia P - - Singapore O - - Slovenia O 2010-07-09 N South Africa O - - Spain P - - Sweden P - - Ukraine O - - United Kingdom P 2010-07-14 Y

P-members O-members Total Y : comment received 6 0 6 N : no comments 6 3 9 - : no response 8 9 17

P-members with no response: Austria, France, Hungary, Japan, Romania, Serbia, Spain, Sweden

1

Date Document Project Nr. 3/1000/CD IEC 82079-/Ed 1

National Line Clause/ Paragraph Type COMMENTS Proposed change OBSERVATIONS OF THE SECRETARIAT Committee number Subclause Figure/ of comment on each comment submitted Table (General/ Technical/Editorial) NO1 The Norwegian national committee Noted provide the following answers to the questions raised in document 3/954/DC. DE 02 General editorial It appears that often multiple blanks have Search for multiple blanks between words Accepted. been used in the text and replace them by a single blank. DE 03 General editorial Incorrect cross reference, e. g. 6.2.5 and Check cross references. Accepted. 6.8.3 and check-list (Annexes B and C). DE 04 General technical Definition of supplier introduces in the Add to the definition: “and related Accepted. and note terms like vendor, distributor, documentation.” 3.45 retailer, agency which are not used in the Add to the existing note: “authorised text of the standard but the term representative” "authorized representative" is missing Check if “supplier” can be used The use of all terms like producer, everywhere in the document. manufacturer, integrator, ect. should be The definitions for manufacturer, checked Do we need all of them have to producer and integrator are to be deleted. be repeated in the text for several time? DK 01 Forewor T Annex B is changed to an informative Annex B, C ... are for information only Accepted. d Annex DE- FOREW ANN. C ge Check list for communication Annexes A, B and C are normative. Not accepted because Annexes B 01_ISO ORD effectiveness should have the and C are recommendations which same normative status as check list for may not be applicable to every compliance and comments. Both check situation covered by instructions for lists are equally necessary for the use. assessment of instructions for use. (cf. A.3) DE- FOREW Next par ed Add for. preparing successive drafts, in order to Already incorporated in 3/1000/CD 02_ISO ORD improve them for the principal target groups of the GB1 Forewor Para 2 Te This states that "Annexes A and B are Amend to read "Annex A is normative, Accepted. d normative...." This is not correct, Annex Annexes B,C, D and E are for information Page 7 B is informative. only."

1 National Line Clause/ Paragraph Type COMMENTS Proposed change OBSERVATIONS OF THE SECRETARIAT Committee number Subclause Figure/ of comment on each comment submitted Table (General/ Technical/Editorial) DE 01 Forewor 2nd technical Last sentence the term "target group of The sentence should read as follows: Accepted d paragrap the standard is misleading. “They are addressed primarily to experts The text is combined with the Page 7 h engaged in the evaluation of instructions previous paragraph. for use but will also be helpful to writers of instructions for use who may wish to use the checklists while preparing successive drafts, in order to improve them for the principal target groups of the standard. (Delete part of the sentence behind the comma) NO2 1 1st para T We do not appreciate a list of Convert the list of examples of products Not accepted because they clarify examples directly given in the to a note. the coverage of this international normative text of the scope. The list standard. of examples of products should be presented as a note. NO3 1 2nd para T We do not appreciate a list of Convert the list of examples of parties to Not accepted because they clarify examples directly given in the a note. the coverage of this international normative text of the scope. The list standard. of examples of parties should be presented as a note. DE 05 1 3 editorial Sentence 3: “The amount … does only Modify phrase as follows: Partly accepted. refer to the complexity of products. It has “Among other considerations, the amount The text is changed to improve to be pointed out that the amount of the of documentation required, depends on English. documentation in particular the amount the complexity of a particular product and of the instructions for use is also the skills of the users”. reflected by the abilities of the user. DE 07 1 last para editorial Terminology inconsistent (“This Replace “This part of international Not accepted and reference to self standard … this standard … This part of standard” by “This standard”. shall be in line with the rule. international standard …”). Therefore it reads “This part of the International Standard…”. This will be implemented in the whole document. JP- 1 Last te We do not think to need “guidance of “It provides guidance on how such Not accepted because the last 01_ISO sentence usage” in the scope. instructions for sentence is not completely state the use are to be prepared” should be coverage of this part of the changed to International Standard and covered NOTE of Scope. by the first paragraph. Therefore, the last sentence was deleted.

2 National Line Clause/ Paragraph Type COMMENTS Proposed change OBSERVATIONS OF THE SECRETARIAT Committee number Subclause Figure/ of comment on each comment submitted Table (General/ Technical/Editorial) DE 06 1 and para 1 editorial Font size inconsistent. Correct the formatting. Accepted. 3.16 para 2 GB2 1 Scope Para 1 Ed Because IEC are leading on this After paragraph 1 add "Note - The term Accepted in principle. standard there is likely to be a mistaken "product" covers consumer, professional, MT 21 is consensus to reword the assumption in some quarters that it electromechanical and mechanical proposed note as follows: relates only to electromechanical products". NOTE The term "product" as products. defined in 3.34 relates to consumer,

Therefore, for the avoidance of doubt it is non-consumer, electric, electronic, suggested that suitable note be added to electromechanical, mechanical and the Scope. other products. NO4 2 We note that in definitions provided, Write used terms in definitions in italic Accepted. (Pendent) other terms defined in the document are written in bold. In other publications of TC3 (see IEC 61082-, IEC 81346-1), such used terms are written in italic. We prefer the latter method to be used. DE 08 2 editorial The normative references are not Write titles in italics Accepted. correctly presented in accordance with the directives (titles in italics) DE 09 2 list editorial ISO_ 12100-1 is mentioned but not the Add the list with a reference to ISO Accepted in principle. ISO 12100-2 standard which does 12100-2. The new normative reference is “ISO include in section 6 a detailed description 12100 (all parts), Safety of of the documents for the use of machinery – Basic concepts, general machinery. principles for design”. GB3 2 ISO/DIS Te This standard will shortly be issued as Amend reference accordingly. Accepted. Normativ 7010 FDIS. e referenc es DE 10 3 – technical “use” is not defined; “use” could be Add a new definition for “use”: “In the Accepted in principle. misinterpreted by only operating the international standard “use” means any The definition is reworded as product. activity that the user may perform with or follows: on the product in the whole product life any activity that the user may cycle” perform with or on the product during its whole life cycle. DE 11 3.1 editorial Change "design" to designed" Replace "design" by "designed" Not accepted because the term “accessible design” is taken from ISO/IEC Guide 71.

3 National Line Clause/ Paragraph Type COMMENTS Proposed change OBSERVATIONS OF THE SECRETARIAT Committee number Subclause Figure/ of comment on each comment submitted Table (General/ Technical/Editorial) DE- 3.1 te It is necessary to distinguish the two basic safety notes Already covered in 3CD. 03_ISO New methods of safety and warning notes Compilation of comments on definition because many technicians use to mix non-contextual notes to be observed through the whole product life cycle 3/984/CD, i.e. 3/997/CC introduces After 3.1 them up the new definitions for "safety note" and "warning messages".

JP- 3.1 Definitio te Sentence “including older persons and Delete the sentence “including older Accepted. 02_ISO n persons with persons and disabilities” is included in the word persons with disabilities”. “potential user”. DK 02 3.4 E We are missing the reference to 3.7 in Make this reference Accepted. IEC 81346-1 DE- 3.7 te It is necessary to distinguish the two contextual warning messages Already covered in 3CD. 04_ISO New methods of safety and warning notes messages given before a possibly risky Compilation of comments on definition because many technicians use to mix 3/984/CD, i.e. 3/997/CC introduces after 3.7 them up. work step has to be taken, even redundantly if necessary, resulting from the new definitions for "safety note" the product risk assessment and "warning messages".

GB4 3.8 Consum Ed The Note includes a reference to "skilled Change font to Italic. Accepted. Terms er. person". This is defined at 3.41 and and Note should therefore be in Italic script in 3.8. definition s DE 29 3.9 Modify definition: product to be acquired Accepted in principle. or used by a consumer Reworded as follows: product available to, intended for or likely to be used by consumers DE 31 3.9 2nd para editorial Singular instead of plural (last word Write “used by consumers”. Accepted. “consumer”). See the observations on DE 29. GB5 3.9 consume Ed Missing indefinite article. Add "a" before "consumer". Already covered by the observation r product on DE 29. DE 3 3.9 note editorial Change "design" to designed" Replace "design" by "designed" See the observations on DE 11. JP- 3.13 Definitio te Add “administration” as follows. Not accepted because the concept 03_ISO n collection and administration of of administration falls in the area of documents ….. . document management.

4 National Line Clause/ Paragraph Type COMMENTS Proposed change OBSERVATIONS OF THE SECRETARIAT Committee number Subclause Figure/ of comment on each comment submitted Table (General/ Technical/Editorial) DE 12 3.15 technical The definition of foreseeable misuse Modify the wording as follows: Accepted in principle. should be consistent with the usual “foreseeable misuse The term is changed to reasonably definition of foreseeable misuse e.g. the use of a product in a way not described in foreseeable misuse and the definition which is used in section 1.1.1., the instructions for use, which may result definition is changed as follows: Annex I of the EC Machinery Directive from readily predictable human 2006/42. behaviour.” use of a product in a way not described as intended use in the instructions for use, but which may result from readily predictable human behaviour. DK 03 3.16 E We are missing the “NOTE” the note text Make the note a NOTE Accepted is already there. It is a problem with fonts that have been corrected. DE- 3.16 te Add reasonably, as applied in relevant reasonably foreseeable misuse Accepted. 05_ISO legal regulations. See the observations on DE 12.

DE- 3.20 ed Since this standard demands Illustration Accepted in principle taking into 06_ISO New consistency of terms, it account the definition for graphic definition should serve as a good practice example common and consistent term for graphic image, picture, figure photograph, line image. Two terms “graphic image” after itself. and “illustration” are combined to 3.20 drawing produce the following definition: visually perceptible figure, such as graphical image, picture, figure, photograph, line drawing, etc., artificially created to transmit specific information, excluding graphical symbols Relevant terms have been changed as appropriate. DE 13 3.20 technical Term instruction material should be Delete definition and replace “instruction Accepted. avoided for consistency reasons. material” by “instructions for use” or by other defined concepts like “documents” within the entire document. DE 14 3.21 technical The producer (manufacturer?) is not the Modify phrase as follows: Accepted. solely person which may provide the “information provided by the supplier of a user with the instructions for use. Also product for the user …. the importer or the distributor of a product may provide the user the necessary information.

5 National Line Clause/ Paragraph Type COMMENTS Proposed change OBSERVATIONS OF THE SECRETARIAT Committee number Subclause Figure/ of comment on each comment submitted Table (General/ Technical/Editorial) DE 15 3.22 technical The term "user" has to be deleted Delete "user" in the note Not relevant. otherwise the user (for example the According DE 04, the definition is consumer) in the role of the integrator is deleted. responsible for requirements regarding instructions for use. FI 1 3.22 Technical Add reference to ISO 11161 where it is 3.22 integrator Not longer relevant. originally defined (see definition 3.10 in entity who designs, provides, According DE 04, the definition is ISO 11161) manufactures or assembles an deleted. integrated manufacturing system and Delete note because “user” is confusing is in charge of the safety strategy, Æ In IEC 82079-1 user is user of the product not integrator. including the protective measures, control interfaces and interconnections of the control system [3.10 of ISO 11161]

DE 16 3.23 technical Add "supplier, producer and their Replace terms by supplier only Accepted. authorized representative" to be consistent GB6 3.23 Intended Ed Clarify meaning. After "not listed" delete rest of sentence Accepted. use and insert "by the manufacturer/producer/integrator are excluded from the intended use of the product." DE- 3.24 ed Add of. ...from the structure and function of the The comment and the proposed 07_ISO product change were on 2CD. Text of definition of "intended use" was changed in 3CD. Therefore, they are not relevant. DE 17 3.26 editorial The note is obviously not finished. The XXX shall be replaced by the correct Not accepted expression because this expression is appropriate. See IEC 61355. DE 18 3.26 2nd para editorial Terminology inconsistent (“usage”). Replace “usage” by “use”, because “use” Accepted. is used throughout the whole document. GB7 3.26 manual Ed Correct wording. Change "usage" to "use". Accepted. DE 19 3.27 technical Definition is not relevant for the standard. Delete definition Accepted. GB8 3.27 manufact This is the only place in the document Replace “physical product” with “ a Not relevant because the definition urer where the term "physical products" product for which instructions for use are was deleted according to the appears. What is meant by 'physical' in required” observation on DE-19. this context?

6 National Line Clause/ Paragraph Type COMMENTS Proposed change OBSERVATIONS OF THE SECRETARIAT Committee number Subclause Figure/ of comment on each comment submitted Table (General/ Technical/Editorial) DE 20 3.28 editorial Change the plural of "tactile indicators" to Delete the "s" at the end of "indicators" Accepted. singular to be consistent with other terms DK 04 3.29 E A product is singular Change “their” to “its” Not relevant because the text has been changed. See GB9. DE 21 3.29 editorial Change "their" to "its" intended use" Replace "their" by "its" Not relevant because the text has been changed. See GB9. DE 22 3.29 2nd para editorial Wrong grammatical number of pronoun Replace “their” by “its”. Not relevant because the text has “their”, the connection is “product” not been changed. See GB9. “changes” GB9 3.29 modificat Ed Improve wording. Delete existing text and replace with: Accepted. ion "changes made to a product in order to alter its specified intended use". GB10 3.30 Organisa Ed The Note conveys no real information. Delete Note 1. Accepted. tion Note 1 DE 23 3.33 technical What is meant by “content”? Delete “and content” and replace in the Accepted. note "instruction material" by "related decantation" to be correct DE 24 3.34 technical Reuse the existing definition of product Replace by: intended or accomplished Accepted in principle. as defined in IEC 81346-1 definition 3.6 result of labor, or of a natural or artificial The definition is changed as follows: process intended or accomplished result of Add a Note: In the context of this labour, or of a natural or artificial standard instructions for use are seen as process, which could be a good or a part of the product delivery, not as part of the product itself. service. Note Instructions for use are seen as a part of product delivery. GB11 3.35 Product Ed The Note merely states the obvious and Delete Note. Accepted. safety provides no additional information. label Note GB12 3.36 repair Ed The term "item" appears to refer to a Delete "an item" and insert "a product". Accepted. physical object but is generally used in the document to refer to abstract concepts or information.

7 National Line Clause/ Paragraph Type COMMENTS Proposed change OBSERVATIONS OF THE SECRETARIAT Committee number Subclause Figure/ of comment on each comment submitted Table (General/ Technical/Editorial) DE 25 3.38 editorial Last part of the sentence sounds odd. Write “… to give users awareness of safe Accepted in principle. practices.” The definition is changed as follows: safety related information that is collected or grouped in a document or section of a document in a meaningful organizational system to explain safety measures, raise safety awareness and provide a basis for safety related training of users DE- 3.38 te Term is needed for a consistent safety residual risk Accepted in principle, 08_ISO New strategy. but essence of the definition is definition risk remaining after each step of the three step integration of safety: immanently effectively added as an extension to after 4.2. 3.38 safe construction, protection devices, safety instructions GB13 3.38 Safety Ed Improve wording. After "section of a document" delete rest Accepted. note of text and insert "to explain safety measures, raise safety awareness, or provide safety-related training of users where appropriate. DE- 3.39 te Term is needed for a consistent safety risk assessment Not accepted because the meaning 09_ISO New strategy: necessary to put safe products of the term “risk assessment” definition in the market. overall process comprising a risk analysis depends on the domain and is not and a risk evaluation after possible to define it in the context of 3.39 [ISO 12100-1:2003, definition 3.13] this International Standard. DE- 3.42 ed operation = bold print (for consistent risks and to avoid hazards which Not relevant because the text of 10_ISO presentation) operation or maintenance of a product definition "skilled person" is different can create in 3CD.

DE 26 3.43 technical Why are stakeholders only interested in Delete definition “stakeholder” (3.43). See Accepted. risks? The only use of the term also 4.1.4 (last paragrph) where “stakeholder” in the document is in stakeholder can be replaced by “users chapter 4.1.4 where the term is used in and target groups”. the more general meaning of customer or owner or user. Definition not relevant for this standard

8 National Line Clause/ Paragraph Type COMMENTS Proposed change OBSERVATIONS OF THE SECRETARIAT Committee number Subclause Figure/ of comment on each comment submitted Table (General/ Technical/Editorial) JP- 3.43 Definitio te “requirements” Word “requirements” should be changed Comments and proposed change 04_ISO n to “design requirements”. are on 3.43 of 2CD. Definition is not only for design requirements but also for other requirements. Therefore MT 21 suggests to remove the term and definition in the revised text.

DE 27 3.44 editorial Use plural form for "operation" Change "operation" to "operations" Accepted. DK 05 3.46 E Examples do not fit in a definition Make examples as a note Accepted in principle. Definition is changed as follows: group of persons for which instructions for use are intended. DE 28 3.47 technical The definition of "url" is not need delete and explain in 5.8.6. Accepted in principle but no explanation is added to 5.8.6. because URL is a common term. DE- 3.47 te Term is needed for a consistent safety unskilled person Not accepted. 11_ISO New strategy Comments and proposed change clause individual with no or little education, training and experience to enable him or are on 3.47 of 2CD. after The definition proposed is not 3.47 her to perceive risks and to avoid hazards which operation or maintenance of a adequate and creating product can create; layman comprehensive definition will be too complex to deal with all possible circumstances.

DK 06 3.49 E The definition has to be consistent with Make the choice: Accepted. the text in 4.2 and 5.4.1 Warning message, or Warning message is chosen. Warning notes GB14 3.49 Warning Ed Improve wording. Line 1: delete "against" and insert Accepted. message "about". Delete "the" and insert "them".

Line 2: Delete "hazard". Delete "are" and insert "should be". After "instructions" insert "for use". DE 32 4 and general Guides are matters related to References to Guides should be omitted. Not accepted because if Guide is further standardization and are not a reference referenced normatively, e.g. in 4.1.5, documen for the target groups of this standard. reference to the Guide should not be tgeneral (seeISO/IEC Directives Part 2 Definition omitted. 3.8)

9 National Line Clause/ Paragraph Type COMMENTS Proposed change OBSERVATIONS OF THE SECRETARIAT Committee number Subclause Figure/ of comment on each comment submitted Table (General/ Technical/Editorial) DE- 4.1.1 ed Improve wording of: The level of description and details of Comments and proposed change 12_ISO "It is important that the level of information shall be adapted to the are on 4.1.1 of 2CD. description and details of knowledge of target group(s). Based on The text was changed in 3CD. information is adapted to the knowledge ascertained needs of the target group, the The comment is not relevant of target group(s). Based on ascertained instructions for use shall ensure the anymore. needs of the target group, the instruction completeness of relevant information in a for use shall ensure the completeness of sufficient level of description. The new text is as follows: relevant information in a sufficient level The level of description and details of description." of information shall be adapted to the knowledge of target group(s), Instructions for use shall ensure the completeness of relevant information at a sufficient level of description based on the ascertained needs of the target group. DE 33 4.1.2 Change header: Instructions for use are Not accepted because seeing part of the product delivery instructions for use as a part of product insures that the two are considered as whole and not separate entities.

DE 34 4.1.2 1st sentence: A product shall be delivered Not accepted because DE 33 is not together with instructions for use… accepted. NO5 4.1.2 1st para, T “are and depends” does not provide a Reword to read: Accepted. last sent. requirement, but indicates a statement of facts. We disagree to provide a The way in which third party document statement of facts on this issue as this is are integrated shall be based on not true in all cases. The statement customer requirements and user needs. should be made as a requirement. DE 35 4.1.2 2nd editorial Replace "it" by "they" because it refers to In addition they should … Accepted. clause "the instructions for use" 2nd sentence GB15 4.1.2 Para 1 Ed Improve wording. Delete "In case that" and insert "Where". Accepted. Line 2

10 National Line Clause/ Paragraph Type COMMENTS Proposed change OBSERVATIONS OF THE SECRETARIAT Committee number Subclause Figure/ of comment on each comment submitted Table (General/ Technical/Editorial) DE- 4.1.3 Replace shall by may. It depends on the modifications), and may be provided as a Comments and proposed change 13_ISO variety of conditions due to the number part of instructions for use. (See also are on 4.1.3 of 2CD. of distribution channels. Clause 5.) The new text is in 4.1.4 of 3CD. (cf. Note 1 of par. 5.10.3) Accepted in principle. The text is changed as follows: and shall be provided together with instructions for use. DE 37 4.1.3 1st editorial Replace "All information regarding by "all Delete "regarding" insert "in" Accepted. sentence information in" GB16 4.1.3 Line 1 Ed Improve wording. Delete "Regarding" and insert "included Not accepted. in". See the observation on DE 37. DE 36 4.1.3 sentence technical This sentence will result in a possible Modify sentence as follows: Accepted in principle. 1 misunderstanding regarding the meaning “….as advertising or packaging and For improvement, the text is of “warranty”. The “warranty” does not World Wide Web based information; the changed as follows: include any information which might be information has also to be consistent with “as advertising or packaging, any relevant for the instructions. The the legal requirements which may result warranty and World Wide Web instructions for use have to be consistent from any warranty stipulations.” to the stipulations of the “warranty”. based information, and the information has also to be consistent with the legal requirements which may result from any warranty stipulations”. DE 38 4.1.4 technical To be consistent with clause 5.2 Start sentence with “If applicable … Withdrawn by DE. See also clause 5.2 DE 44 4.1.4 technical It is clearly understood that this Replace header by : Information provided Accepted in principle. document is about instructions for use, with the sale of products 4.1.4 is split into two subclauses, so the headers shall be short and focus each with the appropriate heading. on the issue dealt with in the relevant clause ; see also 4.1.5 DE 42 4.1.4 2nd para technical The intention of this sentence is unclear. Replace the existing text by: As Accepted in principle It appears that due to different guarantee issues may be different The text is improved as follows: requirements in different countries the depending on countries or sales It may be appropriate to put the issue of guarantee shall be provided in channels, they may be presented in product guarantee into a separate different documents or not separate documents. document especially when the terms vary between different sales channels or countries.

11 National Line Clause/ Paragraph Type COMMENTS Proposed change OBSERVATIONS OF THE SECRETARIAT Committee number Subclause Figure/ of comment on each comment submitted Table (General/ Technical/Editorial) DE 39 4.1.4 Last technical To be more precise replace Replace text and delete 3.43 Accepted. clause "stakeholders or the general public" by "users and target groups" because the new information is intended to be used by them. If the term "stakeholder" is replaced the definition 3.43 "stakeholder" should be deleted because the term is used only once DE 40 4.1.4 last para technical Why are stakeholders only interested in Replace “the stakeholders or the general Accepted. risks? The only use of the term public” in 4.1.4 by “anyone interested”. “stakeholder” in the document is in chapter 4.1.4 where the term is used in the more general meaning of customer or owner or user. GB17 4.1.4 Line 1 Ed Correct word. Delete "tterms" and insert "the terms". Accepted. GB18 4.1.4 Page 16 Ed Improve wording. Delete "questions" and insert Accepted. Line 1 "information". DE 43 4.1.4 para 1, editorial Spelling mistake “tterms”. Delete one t. Not relevant. See GB17. first sentence DE 45 4.1.5 technical A guide not appropriate to be referenced. Delete this subclause Not accepted because it is not sector Security content is sector specific. No specific and if Guide is referenced sector specific content should be in this normatively, e.g. in 4.1.5, reference standard to the Guide should not be omitted. DE 46 4.1.5 para 1 editorial Double full stop. Delete one full stop. Accepted. DE 47 4.2 3rd bullet technical The term "warning note" is not correct. Replace "safety and warning notes" by Accepted. Change to a broader term Insert "safety "safety related information" related information" delete "safety and warning notes". DE 49 4.2 note technical Wording will effect misunderstanding. Modify wording as follows: Accepted in principle. “As a matter of principle, the supplier has The text is improved as follows: an obligation to include such warnings As a matter of principle, the supplier due to the applicable product liability law. has an obligation to include such safety-related information, in fact it is a legal requirement in most countries. DE 48 4.2 para 1 technical Instructions are not limited to “protect” Write “They shall provide information to Accepted. the user and the product itself but also avoid any unacceptable risk for the user other persons and goods. or other persons, damage to the product itself or other goods, malfunction …”.

12 National Line Clause/ Paragraph Type COMMENTS Proposed change OBSERVATIONS OF THE SECRETARIAT Committee number Subclause Figure/ of comment on each comment submitted Table (General/ Technical/Editorial) DE 50 4.3 last sent. technical The target groups shall be defined at the Modify term; use defined instead of Accepted. beginning of the content and not be identified. identified. DE 51 4.6 editorial For ease of reading the clause within the Not accepted because the standard Guide 71 should be added, to which the should be as simple as possible. reference is made. There are several appropriate clauses in the guide. GB20 4.6.1 First Te Need to clarify meaning. Explain the meaning of "ambient Noted. It is impossible to explain bullet conditions". therefore the bullet is deleted.

DE 52 4.6.1 Last editorial To be consistent with Guide 71 Insert "to address the needs of" delete Accepted. bullet "design" GB19 4.6.1 Line 1 Ed Improve meaning. Delete "elements". Accepted.

Delete "considered" and insert "taken into account".. GB21 4.6.1 Para 2 Ed The intention of this paragraph seems to Delete paragraph. Accepted. be to link the items listed as bullet points with the material in the following sub clauses. However, there appears to be no connection between them - i.e. the sub clause headings bear no relationship to the bulleted items. The paragraph is therefore meaningless. JP- 4.6.1, ed Marking ● Marking “●“ shall be changed to a), b), Noted. 05_ISO 4.6.2, c) … . The method of itemization was and reviewed to be consistent in the other whole document. DE 53 4.6.1. bullet 3 technical Which requirements are similar to the Delete “or similar”. Accepted. legal requirements? The term “similar requirements” is useless. DK 07 4.6.2 E (see 4.6.3 below) (see also 4.6.3) Accepted.

13 National Line Clause/ Paragraph Type COMMENTS Proposed change OBSERVATIONS OF THE SECRETARIAT Committee number Subclause Figure/ of comment on each comment submitted Table (General/ Technical/Editorial) DE 55 4.6.2 editorial For better understanding Rearrange the text Accepted. Rearranged as follows: Instructions for use shall be given in one or more of the following locations as appropriate (see also 4.6.3): • inside the packaging together with the product; • on or within the product itself; • on the packaging, but not only on the packaging; • on the World Wide Web sites provided by suppliers: see 4.6.5, 5.6 and 6.2.1, but not only on the World Wide Web; Where instructions for use are complex, it is helpful that certain important messages are additionally given or displayed on the product, for example by means of short reference or reminder cards, stickers, illustrations or labels. DE 54 4.6.2 a) editorial To be more specific Start with "as a separate document" Accepted in principle as shown in the observation on DE 55.

DE 56 4.6.2 bullet e) editorial For better understanding Stored in the product and made visible or Not accepted because the clause is accessible from the outside only about location. See the observation on DE 55. DE 57 4.6.2 c/d editorial Bad formatting of second sentences of Use line break instead of return so that Accepted in principle as shown in list items c and d. the list will not seem broken/discontinued. the observation on DE 55.

DE 59 4.6.3 editorial Delete "(GUI"" it is not needed because it Delete the abbreviation “GUI” Not accepted to keep consistency. is not used in the text DE 58 4.6.3 Note 1 technical Note 1 is referring to 4.6.2 but it is in Delete Note 1 Accepted. contradiction with the recommendations in 4.6.2 GB22 4.6.3 Page 18 Ed Instructions on products are only useful if At end of first sentence add "provided Noted but the comment is not Para 3 they are legible and comprehensible. they are clearly legible." applicable because the note was Note deleted. See the observation on DE 58.

14 National Line Clause/ Paragraph Type COMMENTS Proposed change OBSERVATIONS OF THE SECRETARIAT Committee number Subclause Figure/ of comment on each comment submitted Table (General/ Technical/Editorial) DK 08 4.6.4 1. para T We talk about a requirement Change “should” to “shall” Accepted in principle. and But the text is changed as follows: 1. bullit Instructions for use given on the product shall remain legible throughout the expected life of the product. Instructions for use given on packaging or in materials accompanying the product (such as leaflets, manuals, data media, etc.) shall be produced in durable form. They shall be designed and made so as to survive frequent use during the expected life of the product in the environment where the product is intended to be used. DE 60 4.6.4 1st bullet technical Important requirement Replace "should" by "shall" and replace Accepted in principle. “lifecycle” by “use” See the observation on DK 08. GB23 4.6.4 Line 1 Ed Improve meaning. Delete "application" and insert "use". Accepted. DK 09 4.6.5 1. para T The first requirement demand the next Change “should” to “shall” Accepted. DE 61 4.6.5 2nd editorial To improve understanding/wording Delete "needs to be kept" Accepted. clause DK 10 4.6.6 2. para T Are we here talking about permission or Maybe change “might” to “can” Not accepted because the text is possibility changed as follows: Warning messages for foreseeable exceptional situations shall be assigned only to those nodes in the structure to which they are relevant.

15 National Line Clause/ Paragraph Type COMMENTS Proposed change OBSERVATIONS OF THE SECRETARIAT Committee number Subclause Figure/ of comment on each comment submitted Table (General/ Technical/Editorial) GB24 4.6.6 Para 1 Ed Improve wording. At beginning of line delete "if" and insert Accepted in principle Line 1 "When". The text is changed as follows: Where an electronic guidance Delete "applied" and insert "provided". system is provided, it shall allow a

user to navigate through the Delete "such system" and insert "it". structure of the system so that the users at any time know where they are in the structure. Users shall be able anytime to view on-screen the system structure, together with its nodes and associated information. The user shall be able to collapse or to expand the system structure as required. Warning messages for foreseeable exceptional situations shall be assigned only to those nodes in the structure to which they are relevant. GB25 4.6.6 Para 1 Ed Clarify meaning. Delete sentence and insert "Users shall Accepted in principle Second be able at any time to view on-screen the The text is changed as observed on sentence system structure, together with its nodes GB 24. and associated information." GB26 4.6.6 Para 1 Ed Improve wording. Delete sentence and insert "The user Accepted in principle Third shall be able to collapse or expand the The text is changed as observed on sentence system structure as required." GB 24. DE- 4.7.1.1 te Add product illustration to support the shall comprise the information: product Accepted in principle. 14_ISO recognition of the correct instructions for illustration, product name, product type, Reworded as follows: use. manufacturer, The first page of documentation shall include the information: product name, product type, supplier, document designation. If applicable, product illustration should be provided. DK 11 4.7.1.1 2. para E A International standard is an very useful Change ... shall indicate that the product Noted option, but not a requirement is ... he text is changed as follows: to Where the product is in conformity ... shall indicate whether or not the with a recognized standard, this shall product is ... be clearly indicated. DE 62 4.7.1.1 2nd technical According to 3.5 Replace "conformance" by "conformity" Accepted. clause 16 National Line Clause/ Paragraph Type COMMENTS Proposed change OBSERVATIONS OF THE SECRETARIAT Committee number Subclause Figure/ of comment on each comment submitted Table (General/ Technical/Editorial) DK 12 4.7.1.1 3. para T We are talking about "Instructions for Delete the paragraph or write: Accepted in principle and reworded use" not the whole documentation. The first page of Instructions for use as follows: shall ... An introduction to instructions for use shall include: the product name and type, the supplier, and document designation. GB27 4.7.1.1 Para 3 Ed Improve wording. Delete "the information:" and insert "the" Accepted. before "product name". DE 63 4.7.1.2 2nd technical The proposed way is not very helpfu Modify 1st sentence: “There are different Accepted. Paragrap ways to organize information, for h) example …” Modify b) 2nd sentence to : “… highlighted using for example, sub- headings, different colors, …” GB30 4.7.1.2 b) Ed Improve wording of first sentence. Delete first two sentences, insert the Accepted in principle. Line 1 following: "Information on all product Incorporated in revised text. variants is included in one common section and information relevant only to specific variants is visually distinguished– for example by use of highlighting, colour, font type etc " GB32 4.7.1.2 Line 1 Ed Complete wording. At end of line 1 insert "a". Accepted. GB28 4.7.1.2 Para 1 Ed Improve wording at end of line 4. Delete "unambiguous" and insert "clearly Accepted. Line 4 specified". GB29 4.7.1.2 Para 3 Ed Improve wording. Delete "in case" and insert "Where". Accepted. Line 1 Delete "for" and insert "covers". GB33 4.7.1.4 First Ed The second sentence states the Delete the first sentence. Not accepted however the clause sentence requirement. The first sentence is reworded. . therefore unnecessary (and slightly confusing). DE 64 4.7.1.5 Bullets editorial Notation of list to be corrected Modify to: Not accepted because this is an a) the use of re-chargeable batteries, example of headings. and b) the use of non-chargeable batteries.

17 National Line Clause/ Paragraph Type COMMENTS Proposed change OBSERVATIONS OF THE SECRETARIAT Committee number Subclause Figure/ of comment on each comment submitted Table (General/ Technical/Editorial) JP- 4.7.1.5 L2 te Quantities shall be expressed in SI units Add a NOTE as follows. Comments and proposed change 06_ISO and units outside the SI recognized by NOTE Quantities should be expressed by are on 4.7.1.5 of 2CD. The new CIPM as having to be retained, and for units outside the SI recognized by CIPM subclause in 3CD is 4.7.1.4. special cases some of their combination as having to be retained, and for special Not accepted because the with SI units. cases some of their combination with SI paragraph has been amended to units. commodity use of both SI units and non-SI units. GB34 4.7.1.5 Line 1 Ed Correct wording. At end of line deleted "d" from Accepted. "separated". DE- 4.7.1.7 ed Add the missing plural-s. The instructions for use should also Comments and proposed change 15_ISO contain the name and... are on 4.7.1.7 of 2CD The new subclause in 3CD is 4.7.1.6. The text is already changed accommodating the proposed change. Not longer relevant GB31 4.7.2 Para 3 Ed Add reference to Annex E Add "(See also Annex E)" to end of Accepted. paragraph. DE 65 4.7.2.2 1st editorial For consistency Delete "special" insert "particular" before Accepted in principle. sentence "needs" Improved text reads: 2nd Replace "Particular target groups" by Where products are intended to be sentence "Target groups with particular needs" used by target groups with particular needs, instructions for use shall take them into account. Target groups with particular needs include,… GB35 4.7.2.2 Line 2 Ed Improve wording. After "any special needs" insert "they may Already covered by the observation have". on DE 65. GB36 4.7.2.3 Heading Ed Improve wording. Delete "Understandable" and insert Accepted. "Comprehensible". GB37 4.7.2.3 Line 1 Ed Improve wording. Delete "easily understandable" and insert Accepted. "comprehensible". DE- 4.7.2.4 ed Improve wording. The signals should easily be Not accepted. 16_ISO recognizable and understandable by the English is not good. target groups DE 66 4.7.2.4 editorial Change order shift note to the end of the Change to: Accepted but the text is combined to clause The signals should be easily recognised the first paragraph. and understood by the target group. Note…. DE 67 4.7.2.4 Last editorial Spelling error Modify to …recognized… Not accepted because British sentence English should be used.

18 National Line Clause/ Paragraph Type COMMENTS Proposed change OBSERVATIONS OF THE SECRETARIAT Committee number Subclause Figure/ of comment on each comment submitted Table (General/ Technical/Editorial) GB38 4.7.2.4 Line 1 Ed Improve wording. Delete "Meaning" and insert "The Accepted. meanings". GB39 4.7.2.5 Line 2 Ed Correct wording. Delete "these" and insert "it". Accepted. DE 68 4.7.3.1 technical The clause starting with "If a single Delete sentence "If a single…" Accepted with changes "only if" is graphical image can serve…" is Add sentence: “A single graphical image replaced with "provided." confusing in relation to the clause above may serve for more than one language starting with "Where instructions for use only if the image is perceived together are given …" with the text in every language, and the image does not contain language specific elements.” DE 69 4.7.3.1 5th para editorial Spelling error Correct to: If a single graphical image can Accepted. serve multiple language variants … DE 72 4.7.3.1 last para editorial Missing dash in “language independent Replace by “language-independent Accepted. means” means” GB40 4.7.3.1 Para 2 Ed Correct wording. Delete "in" and insert "on". Accepted. Bullet a) Line 2 GB41 4.7.3.1 Para 3 Ed .Paragraph 3 is intended to refer to Accepted images used to identify a language (e.g. In para 3, delete from “they shall..” to end a flag or vehicle plate letters) of sentence. Insert “they shall be distinguishable by colour coding and/or by commencing with a graphical imagel widely associated with each language – e.g. a flag or country identification letters.” DE 70 4.7.3.1 para 5 editorial Why “any relevant graphical image”. Replace “any relevant …” by “a Noted but text is changed. Wrong full stop after “example”. relevant …”. Replace full stop after See the observation on GB41 “example” by a comma. DE 71 4.7.3.1 para 7 editorial Conflict or misunderstanding with Clarify what is meant, e. g. fold-out page. Not accepted. preceding paragraph. DE 74 4.7.3.2 editorial For consistency with the heading change Graphical symbols including safety signs Accepted. order of words in the 1st sentence and product safety signs… DK 13 4.7.3.2 1. para T The first requirement demand the next Change “should” to “shall” Accepted DE 73 4.7.3.2 2nd technical Make requirement consistent with 5.14.6 Replace “should” by “shall”: Safety signs Accepted. sentence and graphical symbols used on the product or within the instructions for use which are neither readily understandable nor unambiguous shall be explained. DE 75 4.7.3.2 Last editorial For consistency with the 1st bullet Which are internationally acceptable Accepted. bullet replace "may be" by "are" GB42 4.7.3.2 Para 1 Ed Improve wording (use correct term) and Delete "understandable" and insert Accepted. Line 2 consistency. "comprehensible".

19 National Line Clause/ Paragraph Type COMMENTS Proposed change OBSERVATIONS OF THE SECRETARIAT Committee number Subclause Figure/ of comment on each comment submitted Table (General/ Technical/Editorial) DE 79 4.7.3.3 technical This clause makes a statement Add new paragraph after new 1st Accepted in principle. concerning the qualification of paragraph “The original and …”: The text is reworded and included as translators. For logical reasons, there For the creation of the source documents, new clause “4.2 Quality of should also be a statement about the technical writers or specialists shall be communication.” qualification of authors who write the responsible source documents. • who have acquired advanced The statement in this clause should be competences in technical amended with a new Annexe F – communication (see Annexe F) Competencies required for technical communication experts • who are familiar with the product, the application, the service or the subject matter • who know the process chain in the creation of information • who are able to apply specialized tools for the structured content creation process DE 80 4.7.3.3 technical First sentence is divided in two parts. Write after the added new paragraph on Not accepted. Also one important skill is missing. source documents: “Where instructions First 3 bullets are already covered, for use are translated from the original last bullet is not relevant. language into others, expert translators or specialists shall be responsible for the translation including checking and proofreading. Expert translators or specialists are persons • who have basic competences in technical communication; • who are familiar with the subject area; • who are fluent in the original languages, preferably native speakers in the target language; • who are skilled in using the relevant editing tools; DE 81 4.7.3.3 2nd para technical “Colloquial expressions … should be Shift the whole paragraph to a new Accepted in principle. avoided” is a statement that deals rather clause under 6.x.y “Quality of the original See the observation on DE 79. with recognized communication and the translated instructions for use principles than with translation.

20 National Line Clause/ Paragraph Type COMMENTS Proposed change OBSERVATIONS OF THE SECRETARIAT Committee number Subclause Figure/ of comment on each comment submitted Table (General/ Technical/Editorial) DE 78 4.7.3.3 last para technical Regarding the logical structure of the Put paragraph in first place Not accepted argumentation this paragraph should be But the text is reworded as: put in first place in this clause. The translated instructions for use should be edited by qualified persons specializing in writing and translating for the target groups. DE 82 4.7.3.3 Last technical Delete "original and" clause is referring Accepted. sentence only to the quality of translation GB43 4.7.3.3 Para 1 Ed Punctuation. Add full stop after "target language". Accepted. Third bullet CN 1 5 Proposed to Chapter 5, after the Echoes the standard title, term extension of the original s content to be a separate chapter Noted. Chapter 5,6 CN 2 5 5.x electrical and electronic Response to green design and Not accepted equipment instructions for use low-carbon, and then add because proposal is relevant for For electrical and electronic electrical and electronic products documentation but not for products, specifications should specifications of pollution control instructions for use (therefore out of provide RoHS (Restriction of (RoHS) requirements scope). Hazardous Substance) related content: ——Packaging of the product itself or the period specified product's environmental identity. ——Toxic and hazardous substances to provide products (Pb, Hg, Cd, Cr6 +, PBB, PBDE) content description. DE 83 5.1 general technical Consideration of the target group should Add: “The information to be given Accepted. be emphasized right at the beginning of depends on the target group(s) and the chapter 5 (like it is done e.g. in 5.9.1). tasks that they are intended or allowed to perform throughout the lifetime of the product.” DE- 5.2 ed Incorrect wording: "notes on reasonably • notes on intended use and Accepted. 17_ISO foreseeable use and misuse" reasonably foreseeable misuse;

21 National Line Clause/ Paragraph Type COMMENTS Proposed change OBSERVATIONS OF THE SECRETARIAT Committee number Subclause Figure/ of comment on each comment submitted Table (General/ Technical/Editorial) DE 98 5.2 editorial For clarity replace "it" by "the instructions Furthermore the instructions for use…. Accepted in principle but instructions for use" in the sentence starting with for use is replaced by "the "Furthermore… specification or description of the product." DE- 5.2 te Add missing requirements. • list of trouble-shooting Not accepted. 18_ISO • service addresses Requirements are covered in clause • notes for guarantee 5 and listed bullets are not relevant • sources of supply for for identification. consumables and spare parts • information about disposal DE 99 5.2 last but editorial The “reasonably foreseeable use” is a Change the wording to…notes on the Accepted in principle. one misleading expression and is not intended use and any foreseeable See the observation on DE-17_ISO. bullet consistent with the terms and definitions misuse. DE 100 5.2 last editorial Misunderstanding wording. Replace “to show the product… the Accepted. clause standard” by “to show that the product complies with particular requirements of these product standards.” GB44 5.2 Para 1 Ed Punctuation. Add colon after "the product by". Accepted. Line 2 GB45 5.2 Para 1 Ed Add missing word. Before "supplier's" insert "the". Accepted. Second bullet GB46 5.2 Para 1 Ed Missing space. Insert space in "webaddresses". Accepted. Third bullet GB47 5.2 Para 2 Ed Improve wording. Insert "intended" before "user". Accepted. Seventh bullet DE 101 5.3 1st para technical The intention of that clause is not clearly Change to: When a supplier does not Accepted in principle and reworded: expressed, as it does not precisely allow to modify the product, this shall be Where a supplier does not allow for transmit the consequences of modifying clearly stated in the instructions for use a product to be modified this shall be a product. The actual text allows too including warnings about possible clearly stated in the instructions for many juridical interpretations. consequences caused by a modification. use including information about possible consequences caused by a modification.

22 National Line Clause/ Paragraph Type COMMENTS Proposed change OBSERVATIONS OF THE SECRETARIAT Committee number Subclause Figure/ of comment on each comment submitted Table (General/ Technical/Editorial) DE 102 5.3 2nd para editorial Make 2 sentences to avoid Change to “When a producer allows Accepted. misunderstanding users to modify a product, the instructions for use shall describe permissible (and non-permissible) modifications. The instructions for use shall clearly describe and illustrate how to undertake permissible modifications (or direct the user to a source of relevant information), so as to allow the user to modify the product correctly and to ensure continuing safe and efficient use.” DE- 5.4.1 te Add basic and contextual to easily There are two types of safety-related Already covered in 3CD. 19_ISO distinguish the two types more clearly. information, basic safety notes and Compilation of comments on contextual warning messages. 3/984/CD, i.e. 3/997/CC introduces the new definitions for "safety note" and "warning messages." DE 103 5.4.1 technical Meaning unclear: Why shall safety- Replace “several” by “all” Accepted in principle. related information refer always to The text was changed. See GB 49. several phases of the life cycle and not only to one phase of the life cycle? DE 104 5.4.1 Last editorial For ease of reading the clause within the Not accepted because the standard sentence Guide 14 should be added, to which the should be as simple as possible. reference is made. There are several appropriate clauses in the guide. GB48 5.4.1 Para 1 Ed Improve wording. Delete "distinguished" and "separately Accepted. identified". GB49 5.4.1 Para 2 Ed Improve wording. Delete "refer to several" and insert "relate Accepted. to the various".

GB50 5.4.1 Para 2 Ed The text after "product" does not scan Delete all text after "product" and add full Accepted. and is unnecessary. stop. GB51 5.4.1 Para 3 Ed Redundant word. Delete "aspects" and add comma after Accepted. Line 1 "following". GB52 5.4.1 Para 3 Ed Improve wording. Delete "applicable" and insert "any Accepted. Second necessary". Insert a comma after "tools". bullet Line 2 GB53 5.4.1 Para 3 Ed Improve wording. Delete "When failing" and insert "which Accepted. Sixth may result from failure". bullet Line 1

23 National Line Clause/ Paragraph Type COMMENTS Proposed change OBSERVATIONS OF THE SECRETARIAT Committee number Subclause Figure/ of comment on each comment submitted Table (General/ Technical/Editorial) GB54 5.4.1 Para 3 Ed Redundancy of meaning. Delete either "immediately" or "without Accepted. Sixth being pointed out". bullet Line 2 DK 14 5.4.1 The last T This important requirement: Should have its own paragraph and Accepted. para Restrictions concerning the use should ... change “should” to “shall” DE- 5.4.2 te cf. 5.4.1 5.4.2 Basic safety notes Already covered in 3CD. 20_ISO Compilation of comments on 3/984/CD, i.e. 3/997/CC introduces the new definitions for "safety note" and "warning messages." DE- 5.4.2 te "They shall be visually highlighted." They shall be made conspicuous. Sentence deleted in 3CD. 21_ISO There are more means to make a warning message conspicuous than highlighting. DE- 5.4.3 te cf. 5.4.1 5.4.3 Contextual warning messages Already covered in 3CD. 22_ISO Compilation of comments on 3/984/CD, i.e. 3/997/CC introduces the new definitions for "safety note" and "warning messages." DE- 5.4.3 te Add sentence "Cross references in warning messages Not accepted. 23_ISO should be avoided." Cross references in warning messages are required. GB55 5.4.4 First Ed The meaning is unclear. Delete from “each single component Accepted in principle and the text is sentence …“ to end of sentence and replace with reworded as follows: “…each component that the manufacturer Safety-related information shall be may despatch separately. “ " provided with each component. Where an assembly of components might produce additional potential hazards, the relevant safety-related information shall be only provided at the relevant level of assembly. DE 105 5.4.4 Last technical To be deleted; IEC 62023 has nothing to Delete the reference to IEC 62023 Accepted. sentence do with the previous statements GB56 5.4.4 Second Ed Improve wording. Delete "In that case that" and insert Accepted. sentence "Where". .

24 National Line Clause/ Paragraph Type COMMENTS Proposed change OBSERVATIONS OF THE SECRETARIAT Committee number Subclause Figure/ of comment on each comment submitted Table (General/ Technical/Editorial) DK 15 5.7.1 1. para T Important requirement with more items of Change Accepted. attention Instructions for use should ... To If applicable instructions for use shall ... DK 16 5.7.2 1. para T The first requirement demand the next Change Accepted. ... should include: To ... shall if relevant include: DE 106 5.7.2 3rd bullet editorial Improve wording for "a checklist of items Replace “item” by “inventory” Not accepted. included in the package" Meaning of checklist of items is more precise in this context. DE- 5.8.1 ed Replace normal by intended for The user shall be provided with Not accepted. Term "normal 24_ISO consistency of wording. information regarding intended and safe operation" is correct. operation... DE- 5.8.1 ed Replace abnormal operation by ...as well as reasonably foreseeable Not accepted. 25_ISO reasonably foreseeable misuse for misuse of products. The term "abnormal operation" is consistency of wording. correct. .DE- 5.8.2 te "means of emergency stopping;" Correct • means of emergency stop or In 3CD the bullet point is deleted. 26_ISO wording acc. to emergency switching off; IEC 60204-1! DK 17 5.8.2 1. para T Important requirement with more items of Change Accepted. attention ... should contain the following: To ... shall if relevant contain the following: DE 107 5.8.2 Last two editorial The last two bullets will be combined by - recommendations for waste removal , Accepted. bullets the term and and - identification and correction of malfunctions. GB57 5.8.2 Line 1 Ed Improve meaning. Delete "contain" and insert "cover". Accepted.

At end of line add ", where applicable". DE 108 5.8.3 Last two editorial The last two bullets will be combined by - - instructions on how to manage fault Accepted. bullets the term and situations, and - Information regarding whether the system… DE 109 5.8.4 First editorial Spelling error Correct to recognizable Not accepted because deleted sentence according to GB 58. GB58 5.8.4 Para 1 Ed Delete unnecessary word. Delete "Recognisable" and begin Accepted. Line 1 "indications" with an initial upper case letter.

25 National Line Clause/ Paragraph Type COMMENTS Proposed change OBSERVATIONS OF THE SECRETARIAT Committee number Subclause Figure/ of comment on each comment submitted Table (General/ Technical/Editorial) GB59 5.8.4 Para 2 Ed Improve wording. Delete "understandable" and insert Accepted. Line 2 "comprehensible". GB60 5.8.4 Para 3 Ed Improve clarity and use correct term - i.e. Delete sentence and replace with: Accepted. 'medical devices'.. "Appropriate warnings shall be provided where use of the product in question might affect electrically controlled medical devices, such as heart pacemakers."

DE- 5.8.5 te "modes and means for emergency stop;" • modes and means for Not accepted. 27_ISO cf. 5.8.2 emergency stop or emergency Used term is sufficient, reason to switching off; replace is missing.

GB62 5.8.5 Fifth Ed Improve wording. Delete "possibly associated with the" and Accepted. bullet insert "that may result from". (page 27) Line 1/2 GB61 5.8.5 Line 1 Ed Improve wording. Delete line and insert: "Where applicable, Accepted. information on the following shall be provided:" DE 110 5.8.5 Page 27 editorial "information about" is not needed Delete "information about" Accepted. (4th bullet) DE 111 5.8.6 2nd line editorial The change of terminology is confusing, Consistent terminology shall be used. Accepted in principle. "the instruction leaflet" is not needed Delete “instruction leaflet and/or” Necessary rewording in 5.8.6, 5.8.7, because it is a subcategory of 5.9.2 and 5.9.3 has been done. Instructions for use DE 112 5.8.6 Header editorial Harmonize the common parts of the Modify header of 5.8.7 to: Fault diagnosis Accepted in principle. and headers of 5.8.6 and 5.8.7 and repair for skilled persons Necessary rewording in 5.8.6, 5.8.7, 5.08.7 5.9.2 and 5.9.3 has been done. DK 18 5.8.7 1. para T Important requirement with more items of Change Accepted in principle. attention ... should be provided: Necessary rewording in 5.8.6, 5.8.7, To 5.9.2 and 5.9.3 has been done. ... shall if relevant be provided: GB63 5.8.7 Fourth Ed Improve wording. Delete "rationally" and insert "efficiently". Accepted in principle. bullet Necessary rewording in 5.8.6, 5.8.7, 5.9.2 and 5.9.3 has been done. GB64 5.8.7 Sixth Ed Delete redundant word. After the semi-colon delete "and". Accepted in principle. bullet Necessary rewording in 5.8.6, 5.8.7, 5.9.2 and 5.9.3 has been done.

26 National Line Clause/ Paragraph Type COMMENTS Proposed change OBSERVATIONS OF THE SECRETARIAT Committee number Subclause Figure/ of comment on each comment submitted Table (General/ Technical/Editorial) DE- 5.9.2 ed For the sake of consistency, replace ...list of possible operations with Accepted in principle. 28_ISO graphic images by illustrations. appropriate graphic images illustrations Necessary rewording in 5.8.6, 5.8.7, 5.9.2 and 5.9.3 has been done. DE 113 5.9.2 editorial For consistency Delete "Product" in the heading of 5.9.2 Accepted in principle. with 5.9 and Delete "user" insert "non-skilled person" Necessary rewording in 5.8.6, 5.8.7, with the heading of 5.9.2 in the text 5.9.2 and 5.9.3 has been done. DK 19 5.9.2 4. and 5. T Important requirements Change 4 times Accepted in principle. para “should” to “shall” Necessary rewording in 5.8.6, 5.8.7, 5.9.2 and 5.9.3 has been done. DE 115 5.9.2 Header editorial Harmonize the common parts of the Modify header of 5.9.2 to: Product Accepted in principle. headers of 5.9.2 and 5.9.3 maintenance and troubleshooting by non- Necessary rewording in 5.8.6, 5.8.7, skilled persons 5.9.2 and 5.9.3 has been done. DE 114 5.9.2 Last editorial "how" is not needed Delete "how" Accepted in principle. clause Necessary rewording in 5.8.6, 5.8.7, 5.9.2 and 5.9.3 has been done. DE 117 5.9.3 technical 1. sentence is partly redundant to 5.9.1. Shift "-preferably as separate documents Accepted. or at least as separate clauses" to 5.9.1 Start 5.9.3 with "Information on maintenance and troubleshooting should include" DK 20 5.9.3 1. para T Important requirement with more items of Change Accepted. attention ... should include: To ... shall if relevant include: GB65 5.9.3 Fifth and Ed Use consistent terminology. Both "fault Delete "fault finding" and insert Accepted in principle. sixth finding" and "troubleshooting" are used in "troubleshooting" in bullets five and six. Necessary rewording in 5.8.6, 5.8.7, bullets the body of the document (twice and six 5.9.2 and 5.9.3 has been done. times respectively). As "troubleshooting" is used more frequently it is suggested that it be the preferred term. DE 116 5.9.3 Header editorial Harmonize the common parts of the Modify header of 5.9.3 to: Product Accepted in principle. headers of 5.9.2 and 5.9.3 maintenance and troubleshooting by Necessary rewording in 5.8.6, 5.8.7, skilled persons 5.9.2 and 5.9.3 has been done. DE 84 5.10.2 Text editorial Apply identical font Accepted. DK 21 5.10.3 1. para T Important requirement with more items of Change “should” to “shall” Accepted. attention DE 85 5.10.3 1st bullet editorial "if applicable" is not needed. Delete Accepted. DE 86 5.10.3 1st bullet editorial 2nd "in the form used" not needed delete Accepted. DE 87 5.12 title technical Ambiguous title New title: “Information on repair of Accepted. products and on replacement of parts” 27 National Line Clause/ Paragraph Type COMMENTS Proposed change OBSERVATIONS OF THE SECRETARIAT Committee number Subclause Figure/ of comment on each comment submitted Table (General/ Technical/Editorial) DE 88 5.12.1 editorial For consistency e.g. with 5.9 Change heading to "Information on repair Accepted. of products and replacement of parts for non-skilled persons" DE 89 5.12.2 editorial For consistency e.g. with 5.9 Change heading to "Information on repair Accepted. and replacement of parts for skilled persons" DE 90 5.12.2 last lines technical Information setting up a suitably Delete the last two lines Accepted. equipped workshop staffed with skilled persons should not be part of an instruction for use. That could be a complete separated service. DK 22 5.12.2 Last T A requirement Change Accepted. para If required ...should ... to If required ... shall ... DE- 5.13.2 ed Rearrange order of words Where relevant, the instructions for use Accepted in principle and reworded 29_ISO shall state that disassembly by as: consumers is prohibited. Where appropriate, instructions for use shall include information, separately or in combination, on disassembly of the product and/or handling of any waste materials with due regard to safety and environmental considerations. DE 91 5.13.2 2nd editorial "separately or in combination" is Delete Accepted. clause irrelevant DE 92 5.14.1 editorial Clause is also relevant for other Replace "Manuals" by "Instructions for Accepted. instructions for use not only for manuals use" GB66 5.14.1 Para 2 Ed Improve wording. Delete "contained" and insert "it Accepted. Line 1 contains". GB67 5.14.1 Para 2 Ed The text refers to complexity of Delete "and the level of structuring shall Accepted. Lines 3/4 structuring. However, complexity is not be over complex." subjective: what is overly complex for one type of user could well be acceptable for others. GB68 5.14.1 Para 3 Ed The term "sets" is used here for the only Delete "sets" and insert "instructions for Accepted. time in the body of the document (apart use". from in Table 2 in the context of character sets) and is not explained. It should be replaced with "instructions for use". DE 93 5.14.1 Text editorial Apply identical font Accepted. 28 National Line Clause/ Paragraph Type COMMENTS Proposed change OBSERVATIONS OF THE SECRETARIAT Committee number Subclause Figure/ of comment on each comment submitted Table (General/ Technical/Editorial) DE- 5.14.2 te Add sentence. They should be concise and, if possible, Not accepted. 30_ISO in active voice. The qualifier "if possible" might be interpreted as requiring use of passive voice verbs in tables of contents entries. Since tables of contents entries often lack verbs, such a requirement would not be appropriate. DE 94 5.14.4 editorial Make 2 sentences to improve If instructions for use are lengthy and Accepted. understandability complex, an index of keywords presented in alphabetical order should be included. The index shall be referenced in the table of contents. DE 96 5.14.5 editorial To specify wording Replace "to have empirical tests" by "to Accepted. conduct empirical tests" DE- 5.14.5 te Delete: "are not readily understandable Graphical symbols and tactile dots Accepted in principle and reworded 31_ISO 5.14.6 or not unambiguous, they ". They shall (Braille) shall be defined. as: be defined in any case, because users Graphical and tactile symbols and will find a great variety of meanings for tactile dots shall be listed and symbols in instructions for use of explained. different manufacturers. DE 95 5.14.5 3nd technical The aspect of consistency within the Insert after “whether”: "within the Accepted in principle and reworded clause instructions for use is missing instructions for use," as: Consistent terminology shall be used in the instructions for use themselves on the product itself, on the packaging, or in accompanying material such as manuals. DE 97 5.14.8 technical This clause may be misinterpreted due to Modify heading to: “Explanation of user Accepted in principle. its dual interpretation. controls and indicators” Header adapted to be consistent and Clause 5.14.8 is a sub-clause of 5.14 Modify text to: “Instructions for use shall "If applicable" is kept. dealing with the structural layout of the contain a description of the user controls instruction for use. and indicators applicable to the relevant The intention of this requirement is component.” inadequately expressed in this context. DE- 6.1.1 1st par ed 1st par.: Apply consistency in wording. ...the user (at each step) to a graphic Accepted. 32_ISO image an illustration... DE 120 6.1.1 2nd editorial In the brackets the term "instructions for delete Accepted. clause use" is wrong DE 119 6.1.1 3rd editorial Wrong wording change Change "procedural instructions for use" Accepted. clause to "procedural instructions"

29 National Line Clause/ Paragraph Type COMMENTS Proposed change OBSERVATIONS OF THE SECRETARIAT Committee number Subclause Figure/ of comment on each comment submitted Table (General/ Technical/Editorial) DE 118 6.1.1 3rd para technical Text difficult to understand and to Modify to : For procedural instructions for Accepted. translate, add commas. use, preconditions for the sequence of necessary steps… DE- 6.1.1 5th par. ed Apply consistency in wording. T he use of graphical images... Accepted. 33_ISO illustrations...... meaningful balance of text and graphical images illustrations is recommended. GB69 6.1.1 Para 2 Ed Improve wording. Deleted "separated and distinguishable" Accepted. Line 3 and insert "separately identified". GB70 6.1.1 Para 5 Ed "Logical" is generally used to describe Delete "logical" and insert "correct". Accepted. Line 1 concepts rather than actions. DE- 6.1.10 ed ISO 9241 consists of several parts. ...ergonomic requirements as stated in Accepted. 36_ISO ISO 9241 series. GB76 6.1.10 Para 3 Ed Improve wording. Delete "amounts of". Accepted. Line 1 Delete "is not useful to keep" and insert "are not helpful in holding". DE- 6.1.12 te add sentence. The assessment criteria are: Accepted. 37_ISO • wording acc. to editorial style guide • correct spelling and punctuation • correct grammar • consistency of terms DE 121 6.1.3 technical Some terms are missing in the list Add to the list: Not accepted. • technical data; Proposed items are no text • maintenance plan; functions. • trouble shooting; GB72 6.1.3 9th bullet Es “Hint” has a slightly different meaning in Replace “hint” with “suggestions and Accepted. English to German, that usually does not options” or “prompts and reminders” suit standards requirements. “Hints and tips” would be clearer but is colloquial. GB71 6.1.3 Fourth Ed "Prerequisite" is being used in an Not accepted. bullet antiquated way in this context. Replace "Prerequisite" with “tools Prerequisite is the term text function required and preparations to be made” – and should be kept. [or just “preparations”] DE- 6.1.4 te Add sentences. Cross references should be avoided. Accepted in principle and reworded 34_ISO Readers use to read a specific chapter. "Cross references shall be kept to a There they should find all information they minimum." need in this specific situation.

30 National Line Clause/ Paragraph Type COMMENTS Proposed change OBSERVATIONS OF THE SECRETARIAT Committee number Subclause Figure/ of comment on each comment submitted Table (General/ Technical/Editorial) GB73 6.1.4 Para 1 Ed The standard deals with instructions for Delete "In instructions for use," and begin Accepted. Line 1 use so there is no need to repeat the "terminology" with "T". term unnecessarily. GB74 6.1.4 Para 2 Ed The standard deals with instructions for Delete "in instructions for use". Accepted. Line 1 use so there is no need to repeat the term unnecessarily. GB75 6.1.5 Last Ed Deciding whether information is Delete sentence. Accepted. sentence necessary or unnecessary can only be a subjective judgement and cannot be address in this standard. DE 122 6.1.6 technical First 2 sentences are more relevant in Shift to 6.1.5"The sentence structure Accepted. 6.1.5 should be simple. Sentences should be short and shall be grammatically correct." DE 123 6.1.7 note editorial Replace "instructions for use" by "in table Accepted. 1" DE 124 6.1.7 Table 1 editorial Correction required Modify to: Fit 3A fuses only Not accepted. No grammatical improvement. DE 125 6.1.7 table 1 editorial Why do all sentences in the first column Delete “to” and write “Use the active Accepted. start with “to”? voice …”, “Be assertive …” and so on. DE- 6.1.8 ed In the middle of the table, replace keep Use, maintain, avoid Accepted. 35_ISO by maintain, because this is the usual term. DE- 6.2.1 te Add new par. between 2nd and 3rd par. The best possible legibility is achieved Accepted in principle and reworded 38_ISO when optimizing the relation of the four variables: • type font • type size • number of characters each line (appr. 70) • line spacing (min. 120 % of type size)

GB78 6.2.1 Col 7 Ed In some rows, column 7 is subdivided. Graphical symbols including safety Accepted. Table 2 The heading needs to explain this signs symbols | safety generally | signs subdivision GB79 6.2.1 footnote Ed There is only one general warning sign – Replace “signs” with “sign” Accepted. Table 2 the yellow triangle containing “!”

31 National Line Clause/ Paragraph Type COMMENTS Proposed change OBSERVATIONS OF THE SECRETARIAT Committee number Subclause Figure/ of comment on each comment submitted Table (General/ Technical/Editorial) GB77 6.2.1 Para 3 Ed Improve wording. Delete "in cases" and begin "where" with Accepted. Line 1 "W".

Delete "any of the". JP- 6.2.1 Table 2 ed What is “__” ? “__” shall be changed to Kanji character, Already changed in 3CD. 07_ISO Bottom “_” is Katakana character, and “_” is for examples, “__”, “___”, etc. . of Hiragana character, these are not Kanji “__” means products, and “___” means middle character. explanation /instruction text book. column DE 126 6.2.1 table 2 editorial Division of last column into 2 subcolumns Explain the division of the last column, Accepted. is not explained and not understandable. e.g. by a respective division of the table See observation on GB 78. head. GB80 6.2.3 Line 1 Ed Delete unnecessary words. Delete "on more parameters" and insert Accepted. "and specifications". DE- 6.2.4 te Add criteria. ...make effective use of white space Accepted in principle and reworded 39_ISO (appr. 25 % of page). The editorial style (text in brackets deleted) because guide should be followed. certain amount of white space cannot be specified generally.

DE 127 6.2.4 2nd technical To simplify and shorten the text change Change to Not accepted but text reworded. clause text, refer to 6.13 and delete bullets. "The layout shall support the differentiation among the various text functions. Such text functions are listed in 6.1.3." GB81 6.2.4 Para 2 Ed Will many people responsible for writing Noted instructions understand this? The answer is yes. GB82 6.2.4 Para 2 Ed " The bullets simply repeat the list in Not accepted but text reworded. 6.1.3 After “..intensions” insert “..as listed in 6.1.3” . Delete the rest of the paragraph and the bullets DE- 6.2.5 ed Re-arrange bracket. against a possible disadvantage in 40_ISO contrast and (therefore) legibility, Accepted in principle and reworded to: The advantages in terms of durability and production of incorporating instructions for use in the material of the product should be weighed against the disadvantages of loss of contrast and legibility. DE 129 6.2.5 editorial Change reference to 6.8.4 Accepted. 32 National Line Clause/ Paragraph Type COMMENTS Proposed change OBSERVATIONS OF THE SECRETARIAT Committee number Subclause Figure/ of comment on each comment submitted Table (General/ Technical/Editorial) DE 130 6.2.5 editorial For consistency Replace "warning notices" by warning Accepted. messages" DE 128 6.2.5 3rd editorial Grammar Change to Accepted in principle and reworded clause Use plural: "possible disadvantages" "possible disadvantages in contrast (and to: therefore) in legibility The advantages in terms of durability and production of incorporating instructions for use in the material of the product should be weighed against the disadvantages of loss of contrast and legibility. DE- 6.3 ed Replace graphical images by 6.3 Graphical images Illustrations, Accepted. 41_ISO illustrations. photographs and supporting text [in the whole clause 6] DE- 6.3.1 ed Replace graphical images by are most informative. Information in Accepted. 42_ISO illustrations. illustrations should be [in the whole clause 6] DE 131 6.3.1 2nd editorial Make 2 sentences to simplify Graphical symbols should be designed Not accepted. clause for immediate recognition at a distance. Graphical images should be composed to focus attention on important details and should be self-explanatory.

DE 132 6.3.1 3rd editorial Wording: is "comprehensible" right or is Not Accepted. clause "clearly visible" more appropriate? “comprehensible” is correct Last sentence GB83 6.3.1 Para 1 Ed Clarify meaning and word usage. Delete "be complementary and the Accepted and reworded. Line 3 information of the illustrations comprehensible." and insert "complement information presented in other forms. Both graphical images and illustrations should be comprehensible." GB84 6.3.1 Para 2 Ed Add reference to safety signs. After "In contrast to" insert "safety signs Accepted. Line 1 and". DE 133 6.3.4 3rd technical Heading doesn't fit with the 3rd clause Shift 3rd clause to the right place, e.g. Accepted with the following changes: clause Reference to 4.7.3.1 doesn't fit either section 4.6.4 “Durability ...” 1st sentence reworded and moved Reference to 4.6? to 6.3.1 2nd sentence moved to 4.6.4.

33 National Line Clause/ Paragraph Type COMMENTS Proposed change OBSERVATIONS OF THE SECRETARIAT Committee number Subclause Figure/ of comment on each comment submitted Table (General/ Technical/Editorial) DE 134 6.6 2nd technical To specify in accordance to IEC 61355 add in the 2nd sentence after “document Accepted. sentence kinds”: "for plants, systems and equipment" AU- 6.6 Page 39 te The existing paragraph does not justify Add the following paragraph after the Accepted in principle 01_ISO or explain the reasons for the existing paragraph. intention and additional text is added requirement of suitably qualified people. Wherever qualified persons are required, in 5.4.1. This may lead to confusion and safety the text shall state that this is an absolute and operations issues. requirement for safety and / or technical reasons and that no other people shall operate or maintain the machines. The qualifications and skills required of the people concerned, in order to carry out the desired operations and maintenance, are to be clearly stated in the instruction manual or other written documents relevant to the machines concerned. GB85 6.7.1 Para 5 Ed It is not clear whether "in accordance Delete "If, in accordance with applicable Accepted. (Page with applicable legal regulations" refers legal regulations," and insert "Where". 40) to the form of the electronic media that may be used or that electronic-only Suggest the legal point is clarified and instructions should only be used if this is included as a Note. “Note: Legal legally permissible. regulations may require printed instructions to accompany some products.” DE 135 6.7.2 2nd technical The last phrase "and increase the delete Accepted. bullet knowledge transfer rate as compared with other medias" because it is unnecessary GB86 6.7.2 Para 1 Ed The phrase "however, shall not be Delete 2nd sentence and insert “However Accepted. Line 3 overwhelming for the user." can only be care should be taken that users are not an aspiration and any such assessment overwhelmed by the duration, information could only be subjective. Therefore, density or 'shall' is not appropriate. complexity of electronic sequences.” GB87 6.8.1 First Ed Include reference to safety signs. After "(see 6.10)," insert "safety signs Accepted. bullet. and". Line 2 DE 136 6.8.3 list technical Add as 6th bullet point; this improves Add: “state the probable consequences of Accepted consistency with chapter 5.4 not avoiding the hazard without playing MT 21 changed term “warning” to down the consequences “ “warning messages.” DE- 6.9.2 ed Keep the wording consistent. 6.9.2 Making graphic images Accepted. 43_ISO illustrations conspicuous Graphic images Illustrations for safety-related issues shall be emphasized... 34 National Line Clause/ Paragraph Type COMMENTS Proposed change OBSERVATIONS OF THE SECRETARIAT Committee number Subclause Figure/ of comment on each comment submitted Table (General/ Technical/Editorial) DE 137 6.9.2 technical Meaning of the 2nd sentence is unclear Replace by: “Therefore, information shall Accepted. not be presented by the use of colour only; colour is an additional means for the presentation of instructions for use and for the improvement of understanding.” DE- 6.9.3 ed Improve wording of 6th bullet par. • provide clear guidance on what how to Already covered in 3CD. 44_ISO avoid the See 6.8.3. hazard; DE- 6.9.3 ed Correct grammar of 7th bullet par. ...illustrations and provided the user with Not relevant. In 3CD, The text is 45_ISO a... changed as in 6.8.3. DK 23 6.9.3 1. para T Important requirement Change “should” to “shall” Accepted. GB88 6.9.3 Line 1 Ed Line 1: delete "consideration" and insert Accepted. "care". After "select" insert "contrasting".

Line 2: delete "also" and insert "even". DE- 6.9.6 te Add condition, because the use of When alerting users by using signal Accepted in principle 46_ISO hierarchical signal words is not words in a hierarchical manner, ... The text is reworded as in 6.8.6. mandatory. DE- 7 ed In the whole clause 7, replace user, users Accepted. 47_ISO consumer/s by user/s. DE- 7.1 ed Delete first be. ...judgements. This check list may be also In 3CD,,the text is already changed. 49_ISO be used as a guide to... DE 138 7.1 2nd technical Replace "(some or all) consumers by Replace "(some or all) consumers by "the Not accepted. clause "the target group(s)" because it is more target group(s)" See the observation on DE-47_ISO. specific and some information in Annex B is not intended for consumers DE- 7.1 3rd par. ed Replace qualitively by qualitatively ...could neither be achieved nor be In 3CD, the text is already changed. 48_ISO Replace is by it. measured qualitatively, and so in practice assessment is it must... DE- 7.1 4th par. ed Delete sentence. Importance cannot be a For a particular product, certain Accepted. 50_ISO criterion, because instructions for use requirements may be designated contain only necessary information -- no important or very important. more and no less. GB89 7.1 Para 3 Ed Delete unnecessary word. Delete "communication". Accepted. GB90 7.1 Para 3 Ed Whilst the effectiveness of instructions Delete "and influencing their behaviour". Accepted. Lines 2/3 for use in communicating information can insert “and predicting their effectiveness be measured it does not follow that even in influencing user behaviour.” the best will always influence the behaviour of users. There are many examples of comprehensible instructions and safety signs and symbols being ignored. 35 National Line Clause/ Paragraph Type COMMENTS Proposed change OBSERVATIONS OF THE SECRETARIAT Committee number Subclause Figure/ of comment on each comment submitted Table (General/ Technical/Editorial) GB91 7.1 Para 3 Ed Space. Close up space between "effective" and Accepted. Lin 6 the comma. DE 139 7.2 3nd technical What is meant by "sample" ? Accepted and explained: sample bullet replaced by product sample. DE- 7.2 Note ed Improve wording. and/or there may need to be internal Accepted. 51_ISO evaluations and revisions ...and/or there may be need for internal evaluations and revisions... DK 24 A.3 3. para E Annex B is informative Change MT 21 discussed the proposed ... shall be carried out using ... change and concluded that the text to will be changed to “should be carried ... shall be carried out preferable using … out using…” DK 25 A.3 4. para T Annex C is also informative but Change Not accepted ... should be carried out using ... because of consistency between 3rd to and 4th paragraphs in A3. No ... shall be carried out preferable using … change.

DE 141 Annex A A.2 technical Replace "product" by "instructions for Accepted. 2nd use" bullet GB92 Annex A A.3 Ed Correct word. Delete "instruction" and insert Accepted. Para 2 "instructional". Line 2 GB93 Annex A A.3 Ed Missing initial capital letters. Begin both "annex B" and "annex C" with Accepted. Paras 3 "A". and 4 DE 142 Annex B 2.8 editorial Delete "for example" Accepted. DE- Annex B Footnote te Add footnote to table heading. 1) In order to assess instructions for use, Not accepted. 52_ISO this check list may be downloaded and MT21 appreciates the proposal but distributed free of charge at for practical problems to organize. http://www.[din, dke, iec, iso/...].htm GB94 Annex B Heading Ed Orphaned from text it applies to Move to top of next page Accepted. item 4 DE 143 Annex B 3.7 technical Replace the term "qualified people" by Accepted. 3.7 "skilled persons" DE- B.3.7 ed Replace qualified people by skilled skilled persons Accepted. 53_ISO persons (consistency). DE 144 Annex B 6.3 technical Replace the term "qualified people" by Accepted. 6.3 "skilled persons"

36 National Line Clause/ Paragraph Type COMMENTS Proposed change OBSERVATIONS OF THE SECRETARIAT Committee number Subclause Figure/ of comment on each comment submitted Table (General/ Technical/Editorial) DE 145 Annex B 7. technical In the 62079:2001 the following Discuss in MT21 and introduce respective Not accepted: 7. information is listed additionally: statements in 2nd edition. Information is already covered in "7.1 General safety regulations Annex B. summarized at the beginning of the instruction material 7.2 Recognized technical regulations have been observed 7.3 Clear guidance on what to do and what to avoid is provided" DE- B.7.4 ed Replace useful life by life cycle. life cycle Not accepted. 54_ISO Text is corrected as written in draft CDV (attached) DE- Annex C te Check list for communication Normative Not accepted. 55_ISO effectiveness should have the same See the observation on DE-01_ISO. normative status as check list for compliance and comments. Both check lists are equally necessary for the assessment of instructions for use. (cf. A.3) DE- Annex C 02 te Line length and line space are missing. Add "line length and line space". Accepted. 58_ISO DE- Annex C 02 te White space is missing. Add "white space used". Not accepted because certain 59_ISO amount of white space cannot be specified generally. DE- Annex C 04 te Replace consumer (consistency). Each language version checked by a Accepted in principle and reworded 60_ISO native speaking user and/or expert for as: comprehensibility and absence of Each language version checked by a linguistic errors native speaker for comprehensibility and absence of linguistic errors DE 146 Annex C 4. technical Replace "consumer" by "expert" or Accepted in principle and reworded. "translator" or "person of the target group" See the observations on DE 60_ISO. GB96 Annec C Heading Orphaned from text it applies to Move to top of next page Accepted. item 5 DE- Annex C 06 ed Replace any by and. for any new symbols and non-registered Not accepted 61_ISO symbols Reworded see GB 98. DE- Annex C Footnote te Add footnote to table heading. 1) In order to assess instructions for use, Not accepted. 56_ISO this check list may be downloaded and MT21 appreciates the proposal but distributed free of charge at for practical problems to organize http://www.[din, dke, iec, iso/...].htm not accepted.

37 National Line Clause/ Paragraph Type COMMENTS Proposed change OBSERVATIONS OF THE SECRETARIAT Committee number Subclause Figure/ of comment on each comment submitted Table (General/ Technical/Editorial) DE- Annex C new 01 te Add new no. 1. Before we know the 01 Target group/s Accepted. 57_ISO target group (kind of users), we cannot assess the comprehensibility of a • Target group/s specified document. • Instructions for use adequately Renumber the following Nos. presented for target group/s • Conventions: How to read this document

GB95 Annex C Para 1 Ed Unnecessary word. Delete "with". Accepted.. Line 4 GB97 Annex C Table Ed Use correct term. Delete "recognizable" and insert Accepted. Item 6 "comprehensible" First bullet GB98 Annex C Table Ed Delete unnecessary text. At end of line delete "any non-registered Accepted. Item 6 symbols". Third bullet GB99 Annex D D.1 Ed Improve wording. Delete "Annex gives" and insert "This Accepted. Line 1 Annex provides". GB100 Annex D D.2 Ed Improve wording. Delete brackets around "(instructions for Accepted. Lines 1 use)". and 2 Delete "impose major restrictions on" and insert "can affect".

Delete "received by" and insert "provided for". GB105 Annex D D.2 Ed Correct wording. Delete "documentation" and insert Accepted. Para 2 "document". First bullet GB106 Annex D D.2 Ed Word spacing is out of keeping with rest Correct word spacing and delete "to" at Accepted to delete "to" but word Para 2 of document. end of line. spacing is correct. Sixth bullet Unnecessary word at end of line. Line 1 GB107 Annex D D.2 Ed Rogue capital letter. Begin "Compliance" with "c". Accepted. Para 2 Seventh bullet

38 National Line Clause/ Paragraph Type COMMENTS Proposed change OBSERVATIONS OF THE SECRETARIAT Committee number Subclause Figure/ of comment on each comment submitted Table (General/ Technical/Editorial) GB101 Annex D D.2 a) Ed Word spacing is out of keeping with rest Correct word spacing. Not accepted Line 1 of document. (word spacing is correct). GB102 Annex D D.2 a) Ed Unwanted bracket. Delete second bracket after "see section Accepted. Third 5)" bullet Line 2 GB103 Annex D D.2 a) Ed If information is to be presented on the Delete "can" and insert "should". Accepted. Third product then space for this should be bullet allowed for at the design stage. Line 1 GB104 Annex D D.2 a) Ed Unnecessary plural and incorrect Make "products" singular. Accepted. Third punctuation. Bullet Delete full stop at end and insert semi- Line 2 colon.

GB108 Annex D D.3 Ed Word spacing is out of keeping with rest Correct word spacing. Not accepted Lines 1 of document. Unnecessary word at end (word spacing is already correct). and 2 of line.

Note: rogue word spacing appears in some other places so whole document requires checking. GB109 Annex D D.3 Ed Improve wording. At end of line delete "each individual" and Accepted. Line 1 insert "all possible" and make "requirement" [line 2] plural. GB110 Annex D D.3 a) Ed Phrase "means of implementing Delete ", means of implementing Accepted. First instructions for use within the product" instructions for use within the product" bullet does not make sense. and place full stop after "cycle". Lines 4 and 5 GB111 Annex D D.3 a) Ed Improve wording. Delete "are known by" and insert "will be Accepted. Third known to". bullet Line 2 GB112 Annex D D.3 d) Ed Missing plural. Make "device" [after safety] plural. Accepted. Para 2 Line 4 GB113 Annex D D.3 d) Ed Improve wording. Delete "defects" and insert Accepted. Para 3 "shortcomings". Line 1

39 National Line Clause/ Paragraph Type COMMENTS Proposed change OBSERVATIONS OF THE SECRETARIAT Committee number Subclause Figure/ of comment on each comment submitted Table (General/ Technical/Editorial) GB114 Annex D D.3 e) Ed Incomplete phrase. At end of line add "for use". Accepted. Para 1 Line 2 GB115 Annex D D.3 j) Ed Correct English. Delete "utilizable" and insert "usable". Accepted. Line 1 DE- Annex D i) te Supply an example for required Appropriate standards for translation Accepted. 62_ISO standard. services should be taken into account (e.g. EN 15038). AU- Annex D Page 54 te The existing text does not cover the After the last paragraph insert the Accepted in principle and reworded 02_ISO Section situation where only qualified and following paragraph. as: d) experienced persons should use or assemble or disassemble the product. Wherever qualified persons are required, Wherever skilled persons are This would be a requirement for safety the text shall state that this is an absolute required, the text shall state that and operational reasons. requirement for safety and / or technical this is an absolute requirement reasons and that no other people shall for safety and/or technical assemble, operate, maintain or reasons and that no other people disassemble the machines or item. The shall assemble, operate, maintain qualifications and skills required of the or disassemble the machines or people concerned, are to be clearly stated in the instruction manual or other item. The qualifications and skills written documents relevant. required of the people concerned, are to be clearly stated in the instructions for use.

DE 147 Annex D D.2 technical Replace "users" by "producers" Not accepted but reworded. D.2 1st sentence DE 148 Annex D D.3 technical Add "for use" after instructions Accepted. D.3 12. bullet DE 149 Annex D D.3 technical Add "for use" after instructions Accepted. D.3 8. bullet DE 150 Annex D D.3 technical Add "for use" after instructions Accepted. D.3 e) 1st sentence DE 151 Annex D D.3 technical Add "for use" after instructions Accepted and reworded. D.3 f) 3rd clause DE 152 Annex D D.3 technical Add "for use" after instructions Accepted. D.3 h) DE 153 Annex D D.3 technical Add "for use" after instructions Accepted. D.3 j)

40 National Line Clause/ Paragraph Type COMMENTS Proposed change OBSERVATIONS OF THE SECRETARIAT Committee number Subclause Figure/ of comment on each comment submitted Table (General/ Technical/Editorial) DE 154 Annex E E.2.1 technical Add "for use" after instructions in the 3rd Accepted. E.2.1 and 4th column,in the row "scope/objectives" DE 155 Annex E E.2.2 technical Replace "representation" by Accepted. E.2.2 ""representativeness" DE 157 Annex E E.2.3 editorial Change order of words "assessment Accepted. E.2.3 Cons development" to development of assessment DE 156 Annex E E.2.3 technical Add "for use" after instructions Accepted. E.2.3 pros DE 158 Annex E E.2.5 editorial Add "those of" after "with" Accepted. E.2.5 Pros DE- Annex F te Add Annex F as attached to this Annex F... ((see attached proposal)) Not accepted. 63_ISO (new) document. MT 21 appreciates effort and result The idea is helpful for another part or revision of the standard. But at this stage of the standard it is too late to introduce new and extensive material. DE 140 8 Annex technical Add new Annexe G – Competencies Not accepted. G required for technical communication There is not yet common basis for experts education of technical writers at least in Europe and Japan. The approach is not rejected generally but it is seen as too early to put it in an International standard.

DE 159 Annex G technical Add a new Annex G (informative), see Not accepted. proposal below See the observation on DE 140.

41 Annex F (informative)

Example of a table of contents of instructions for use F.1 General

This annex gives guidance on the selection and sequential arrangement of information in technical instructions in a user manual. This user manual may include all instructions for handling a product from its delivery to its disposal.

F.2 Restrictions to be observed

An example cannot give comprehensive information covering each individual requirement. Therefore each heading listed here has to be checked against the appropriate requirement depending on complexity, risk, legal issues, etc. Nevertheless, this example might fulfil user needs for guidance on a standard layout for manuals.

F.3 Table of contents (example) 1 Identification 1.1 Product brand and type designation 1.2 Product version/release N° (software)/edition of document 1.3 Producer, supplier, distributor name and address 1.4 Declaration of conformance to product standards 1.5 Manual guide: definitions, description of symbols, print conventions 2 Specification of the product 2.1 General functions and range of applications, intended use 2.2 List of control units 2.3 Dimensions and weight (for transport purposes) 2.4 Supply data for power, gas, water and other consumables 2.5 Energy consumption, conditions 2.6 Emission of noise, waste, etc. conditions 2.7 Type of protection, IP code (for example, protected against waterdripping vertically) 2.8 Environmental conditions and limits for operation and storage 3 Basic safety information, summary (personal protection, unintended use) 4 Preparing the product for use 4.1 Transport and storage 4.2 Safety precautions before use 4.3 Unpacking, checking scope of delivery 42 4.4 Disposal of packaging material 4.5 Preparatory work before installation 4.6 Installing and assembling, work places 4.7 Storing and protecting when out of use 4.8 Repackaging for transport 4.9 Information assignment (users, operators, service experts) 4.10 Location of instructions 5 Operating instructions 5.1 Safe operating/functioning 5.2 Normal intended function (manual, automated operation) 5.3 Secondary functions (for example, material handling) 5.4 Exceptional functions/situations 5.5 Signals to be observed 5.6 Personal protection 5.7 Optional modules, extras 5.8 Quick reference instructions 5.9 Disposal of waste materials 5.10 Measures in the case of emergency 6 Maintenance 6.1 Safety precautions 6.2 Maintenance and cleaning by users 6.3 Maintenance and cleaning by qualified people 6.4 Trouble-shooting, fault diagnosis, and repair 7 Optional modules and extras, specifications 8 Service and repair by service agent 8.1 Service cycles for safe operating 8.2 Addresses of service agents 8.3 Repackaging for further transport 9 List of spare parts and consumables 10 Taking product out of operation, dismantling, disposal

If applicable:

Instructions for use, delivered by suppliers of components EC declaration of conformity Glossary Index

43 Annexe G (informative)

Competencies required for the preparation of instructions for use

G.1 Core competencies

• Communication principles Social, psychological and linguistic aspects of communication; communication models; oral and written communication; how information is perceived and processed • Understanding and using tools Knowledge of relevant and available tools. Hardware components and their interfaces; operating systems; basic principles of systematic use of software; overview on common software in technical documentation: word processing, image processing, publishing tools, data management tools • The regulatory framework for Technical Communication Knowledge of laws, directives, national and international standards; where to get information about these • Project and process management How to write specifications; needs analyses, goals definitions, project planning, project monitoring and evaluation, controlling, steering processes, budget planning, basic principles of business administration • Information gathering How to obtain information; interview techniques; use of the internet and databases; questionnaires; research methodology and techniques • Documentation planning and information development Draft a documentation plan; define scope and objective; define target groups; define information to be transmitted and adequate means to transmit the information; define tools to be used; define standards • Usability Target group analyses; needs analyses; usability test designing; data collection and analysis – both quantitative and qualitative; document testing methods • Structuring information Use structuring methods and techniques (e.g. "mind mapping", "card sorting"); apply structuring principles in accordance to information types and target groups • Standardisation techniques Overview of different techniques such as information mapping, instructional design, style guides; application of standardised structures using software (e.g. templates, XML-schema, SGML-DTDs) • Professional writing How to describe complex technical matters in a simple and concise way; text analyses, text types, writing processes, writing techniques, stylistics; use of consistent terminology

• Editing Substantive editing, style editing, copy editing and proof-reading of printed text and online text • Visual communication Basic principles of visual analysis; graphic design; visualisation of technical and abstract contents; basic principles of digital image processing; integration in DTP; understanding of the principles of combining text and visual elements • Layout and typography Typographical elements, concepts and styles; visual structure for different output media (print or screen); relation text-image; basic knowledge of DTP; use and creation of templates

44

G.2 Specialist competencies

• Quality management Basic principles of process-oriented quality management systems; how to define quality criteria for technical documentation in conformity with national and international quality standards; how to organise a feedback control loop; quality assurance; usability testing • Production and publishing of technical documentation Different output media; production processes and techniques (typesetting, print, processing, finishing); production budget planning • Localisation and internationalisation Basic principles of intercultural communication; understanding of the requirements of the translation and localization process; understanding the basic principles of translation memory use; management of localisation projects • Terminology Basic principles of terminology theory; mono-, bi- and multi-lingual terminology; understanding of existing terminology resources; controlled language, create and administrate terminology data bases; terminology management tools; create glossaries • Indexing and abstracting Write effective index entries; evaluate and edit an index; embed index markers in documents; design of controlled vocabularies for indexing and searching; computer-assisted techniques; how to write an abstract; application to multimedia and hypermedia • Databases The use of data bases in technical documentation; basic principles of data modelling; structured query language (SQL) • XML and Single Source Publishing XML/SGML user skills; how to create a DTD; which software can be used to process data in conformity with SGML; publishing SGML-data; XML-based web applications • Online help Basic principles (topics, levels of help, data bases, structuring principles, display issues); create and integrate topics; create and administrate help systems • Designing digital media Overview of different media (sound, video, interactions); digital formats; media processing software; design, process and integrate multimedia elements

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CONTENTS

Page

1 Scope ...... 7 2 Normative references ...... 7 3 Terms and definitions ...... 8 4 Principles ...... 13 4.1 Provision of instructions for use ...... 13 4.1.1 General ...... 13 4.1.2 Instructions for use are part of the product ...... 13 4.1.3 Consistency of information ...... 14 4.1.4 Product warranty ...... 14 4.1.5 Information provided after sale of products ...... 14 4.1.6 Security aspects ...... 14 4.2 Quality of communication ...... 14 4.3 Minimizing risks ...... 14 4.4 Target group(s) ...... 15 4.5 Special precautions ...... 15 4.6 Short-life products ...... 15 4.7 Considerations as to the nature of instructions for use ...... 15 4.7.1 General ...... 15 4.7.2 Location ...... 16 4.7.3 Means of communication and media ...... 16 4.7.4 Durability ...... 16 4.7.5 Availability ...... 17 4.7.6 Electronic guidance systems ...... 17 4.7.7 User training ...... 17 4.8 Creating instructions for use ...... 17 4.8.1 Conformity with the product ...... 17 4.8.2 Consideration of needs of target groups ...... 19 4.8.3 Languages ...... 19 5 Content of instructions for use ...... 21 5.1 General ...... 21 5.2 Identification and specification of the product ...... 21 5.3 Modification of products ...... 21 5.4 Safety-related information ...... 22 5.4.1 General ...... 22 5.4.2 Safety notes ...... 23 5.4.3 Warning messages ...... 23 5.4.4 Safety-related information for industrial plants ...... 23 5.5 Product compliance ...... 23 5.6 Importance of retaining instructions for use ...... 23 5.7 Preparing products for use ...... 24 5.7.1 Transportation and storage ...... 24 5.7.2 Installation ...... 24 5.7.3 Commissioning ...... 24

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5.8 Operation of products ...... 24 5.8.1 General ...... 24 5.8.2 Normal operation ...... 24 5.8.3 Additional information for automatic and remotely controlled products ...... 25 5.8.4 Indications of faults and warning device signals ...... 25 5.8.5 Exceptional/emergency situations ...... 25 5.8.6 Troubleshooting and repair for non-skilled persons ...... 26 5.8.7 Troubleshooting and repair for skilled persons ...... 26 5.9 Maintenance ...... 26 5.9.1 General ...... 26 5.9.2 Product maintenance by non-skilled persons ...... 26 5.9.3 Product maintenance by skilled persons ...... 27 5.9.4 Planned maintenance of industrial plants ...... 27 5.10 Supplied accessories, consumables and spare parts ...... 27 5.10.1 Accessories ...... 27 5.10.2 Consumables ...... 27 5.10.3 Spare/replacement parts ...... 28 5.11 Information on special tools, equipment and materials ...... 28 5.12 Information on repair of products and replacement of parts ...... 28 5.12.1 Information on repair of products and replacement of parts for non- skilled persons ...... 28 5.12.2 Information on repair of products and replacement of parts for skilled persons ...... 29 5.13 Information required when the product is no longer needed ...... 29 5.13.1 General ...... 29 5.13.2 Disassembly ...... 29 5.13.3 Recycling ...... 29 5.13.4 Disposal ...... 29 5.14 Structure ...... 29 5.14.1 General ...... 29 5.14.2 Page numbering ...... 30 5.14.3 Table of contents ...... 30 5.14.4 Index ...... 30 5.14.5 Technical terms, acronyms and abbreviations ...... 30 5.14.6 Graphical and tactile symbols and tactile dots ...... 30 5.14.7 Presentational conventions ...... 30 5.14.8 User controls and indicators ...... 30 6 Presentation of instructions for use ...... 30 6.1 Comprehensibility ...... 30 6.1.1 Recognized communication principles ...... 30 6.1.2 Style guide...... 31 6.1.3 Structure ...... 31 6.1.4 Consistent terminology ...... 32 6.1.5 Simple and brief ...... 32 6.1.6 One sentence, one command ...... 32 6.1.7 Rules for simple wording ...... 32 6.1.8 Standardized signs and graphical symbols...... 33 6.1.9 Ergonomic principles ...... 33

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6.1.10 Keeping the attention of the readers ...... 33 6.1.11 Proof reading ...... 33 6.2 Legibility ...... 33 6.2.1 Text font sizes and graphical symbol heights ...... 33 6.2.2 Maximum brightness contrast ...... 36 6.2.3 Legibility standards ...... 36 6.2.4 Layout ...... 36 6.2.5 Instructions for use on surfaces of products or packaging ...... 36 6.3 Illustrations and supporting text ...... 36 6.3.1 Quality ...... 36 6.3.2 Following a sequence of operations ...... 37 6.3.3 Illustration with captions ...... 37 6.3.4 One illustration, one item of information ...... 37 6.4 Graphical symbols, including safety signs ...... 37 6.4.1 Graphical symbols for use on equipment, including safety signs ...... 37 6.4.2 Explanation of graphical symbols ...... 37 6.4.3 Graphical symbols for diagrams ...... 37 6.4.4 Minimum sizes of graphical symbols ...... 37 6.5 Use of tables ...... 37 6.6 Use of appropriate document types ...... 38 6.7 Use of electronic media ...... 38 6.7.1 General ...... 38 6.7.2 Didactic Requirements ...... 39 6.7.3 Requirements for downloadable instructions for use...... 39 6.7.4 Requirements for user interaction ...... 40 6.8 Making safety-related information prominent and conspicuous ...... 40 6.8.1 Making text conspicuous ...... 40 6.8.2 Making illustrations conspicuous ...... 40 6.8.3 Design of warning messages ...... 40 6.8.4 Permanence and visibility ...... 41 6.8.5 Making warning messages prominent ...... 41 6.8.6 Signal words ...... 41 6.9 Colours ...... 41 6.9.1 Consistency ...... 41 6.9.2 Colour perception considerations ...... 41 6.9.3 Photocopying/printing considerations ...... 41 7 Evaluation of conformance to this part of the International Standard ...... 42 7.1 Claiming conformance to this part of the International Standard ...... 42 7.2 Documentary evidence of evaluation ...... 42 Annex A (Normative) Evaluation of instructions for use ...... 44 A.1 General ...... 44 A.2 Choice of methodologies for evaluation ...... 44 A.2.1 Desk research by experts ...... 44 A.2.2 Empirical evaluation by potential users ...... 44 Annex B (Informative) Checklist for conformity and comments ...... 45 Annex C (Informative) Checklist for communication effectiveness ...... 48 Annex D (Informative) Planning the preparation of instructions for use ...... 51

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D.1 General ...... 51 D.2 Restrictions on planning the preparation ...... 51 D.3 Planning preparation in detail (example) ...... 52 Annex E (Informative) Empirical methods supporting the preparation of instructions for use...... 56 E.1 General ...... 56 E.2 Methods ...... 56 E.2.1 Opinion polls ...... 56 E.2.2 Usability-Testing ...... 57 E.2.3 Self Assessments and Checklists ...... 57 E.2.4 Expertise, Expert reviews and Certification ...... 57 E.2.5 Findings from independent award or merit schemes ...... 58 E.2.6 Feedback from Complaints Management, Hotlines and Service information...... 58 Bibliography ...... 59

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INTERNATIONAL ELECTROTECHNICAL COMMISSION

______

PREPARATION OF INSTRUCTIONS FOR USE – STRUCTURING, CONTENT AND PRESENTATION:

Part 1: General principles and detailed requirements

FOREWORD

1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising all national electrotechnical committees (IEC National Committees). The object of IEC is to promote international co-operation on all questions concerning standardization in the electrical and electronic fields. To this end and in addition to other activities, IEC publishes International Standards, Technical Specifications, Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested in the subject dealt with may participate in this preparatory work. International, governmental and non- governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely with the International Organization for Standardization (ISO) in accordance with conditions determined by agreement between the two organizations. 2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international consensus of opinion on the relevant subjects since each technical committee has representation from all interested IEC National Committees. 3) IEC Publications have the form of recommendations for international use and are accepted by IEC National Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any misinterpretation by any end user. 4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications transparently to the maximum extent possible in their national and regional publications. Any divergence between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in the latter. 5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any services carried out by independent certification bodies. 6) All users should ensure that they have the latest edition of this publication. 7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and members of its technical committees and IEC National Committees for any personal injury, property damage or other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC Publications. 8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is indispensable for the correct application of this publication. 9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of patent rights. IEC shall not be held responsible for identifying any or all such patent rights.

International Standard IEC 82079-1 has been prepared by IEC technical committee 3: Information structures, documentation and graphical symbols in liaison with ISO technical committee 10: “Technical product documentation, and ISO Committee on consumer policy (COPOLCO).”

This part of the International Standard replaces IEC 62079 (2001).

The text of this part of the International Standard is based on the following documents:

FDIS Report on voting XX/XX/FDIS XX/XX/RVD

82079-1 Ed.1 © IEC:2009 – 6 – 82079-1 Ed.1 © CEI:2009

Full information on the voting for the approval of this part of the International Standard can be found in the report on voting indicated in the above table.

Annex A is normative, and Annexes B, C, D and E are for information only. The Annexes are addressed primarily to experts engaged in the evaluation of instructions for use but will also be helpful to writers of instructions for use who may wish to use the checklists while preparing successive drafts.

This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.

The committee has decided that the contents of this publication will remain unchanged until the maintenance result date1) indicated on the IEC web site under "http://webstore.iec.ch" in the data related to the specific publication. At this date, the publication will be

• reconfirmed, • withdrawn, • replaced by a revised edition, or • amended.

————————— 1) The National Committees are requested to note that for this publication the maintenance result date is ....

82079-1 Ed.1 © IEC:2009 – 7 – 82079-1 Ed.1 © CEI:2009

PREPARATION OF INSTRUCTIONS FOR USE – STRUCTURING, CONTENT AND PRESENTATION:

Part 1: General principles and detailed requirements

1 Scope

This part of the International Standard provides general principles and detailed requirements for the design and formulation of all types of instructions for use that will be necessary or helpful for users of products of all kinds ranging from a tin of paint to large or highly complex products, such as large industrial machinery, turnkey based plants or buildings.

NOTE The term "product" as defined in 3.29 relates to consumer, non-consumer, electrical, electronic, electromechanical, mechanical and other products.

This part of the International Standard is intended for all parties involved in the preparation of instructions for use, for example:

• suppliers technical writers, technical illustrators, software designers, translators or other people engaged in the work of conceiving and drafting such instructions for use;

This part of the International Standard does not specify a fixed amount of documentation that has to be delivered with a product. This is obviously not possible because this part of the International Standard is applicable to all kinds of products. The amount of documentation required, will depend on the nature of the product, its complexity and the skills of the users.

2 Normative references

The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.

IEC 60073:2002, Basic and safety principles for man-machine interface, marking and identification – Coding principles for indication devices and actuators IEC 60204-1, Safety of machinery – Electrical equipment of machines – Part 1: General requirements IEC 60417, Graphical symbols for use on equipment IEC 60529, Degrees of protection provided by enclosures IEC 60617, Graphical symbols for diagrams IEC 60848, GRAFCET specification language for sequential function charts IEC 61082-1:2006, Preparation of documents used in electrotechnology – Part 1: Rules IEC 81346-1, Industrial systems, installations and equipment and industrial products – Structuring principles and reference designations – Part 1: Basic rules IEC 61310-1, Safety of machinery – Indication, marking and actuation – Part 1: Requirements for visual, acoustic and tactile signals IEC 61355-1:2008, Classification and designation of documents for plants, systems and equipment – Part 1: Rules and classification tables IEC/FDIS 62507-1, Requirements for identification systems enabling unambiguous information interchange – Part 1: Principles and methods

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IEC/PAS 62569-1:2009, Generic specification of information on products – Part 1: Principles and methods IEC 80416-1, Basic principles for graphical symbols for use on equipment – Part 1: Creation of symbol originals for registration ISO/IEC 80000 (all parts), Quality and units ISO 3864 (all parts), Graphical symbol – Safety colours and safety signs ISO 7000, Graphical symbols for use on equipment – Index and synopsis ISO 7010, Graphical symbols – Safety colours and safety signs – Registered safety signs ISO 7731:2003, Ergonomics – Danger signals for public and work areas – Auditory danger signals ISO 9000:2005, Quality management systems – Fundamentals and vocabulary ISO 9186 (all parts), Graphical symbols – Test methods ISO 9241 (all parts), Ergonomics of human-system interaction ISO 10628, Flow diagrams for process plants – General rules ISO 11429:1996, Ergonomics – System of auditory and visual danger and information signals ISO 11683, Packaging – Tactile warnings of danger – Requirements ISO 12100 (all parts), Safety of machinery – Basic concepts, general principles for design ISO 14617 (all parts), Graphical symbols for diagrams ISO 15006:2004, Road vehicles – Ergonomic aspects of transport information and control systems – Specifications and compliance procedures for in-vehicle auditory presentation ISO/TR 16352:2005, Road vehicles – Ergonomic aspects of in-vehicle presentation for transport information and control systems – Warning systems ISO/IEC Guide 14:2003, Purchase information on goods and services intended for consumers ISO/IEC Guide 37, Instructions for use of products by consumers ISO/IEC Guide 51:1999, Safety aspects – Guidelines for their inclusion in standards ISO/IEC Guide 71:2001, Guidelines for standards developers to address the needs of older persons and persons with disabilities ISO/IEC Guide 73:2002, Risk management – Vocabulary – Guidelines for use in standards ISO/IEC Guide 74:2004, Graphical symbols – Technical guidelines for the consideration of consumers' needs ISO/IEC Guide 81:---, Guidelines for the inclusion of security aspects in standards

3 Terms and definitions

For the purpose of this International Standard, the following definitions apply.

3.1 accessible design product product which is designed to maximize the number of potential users

3.2 Braille writing system using a series of two dimensional patterns of raised dots to be read with the fingers

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3.3 commissioning procedures prior, or related, to the handing over of a product ready for putting into service, including final acceptance testing, the handing over of all documentation relevant to the use of the product and, if necessary, instructing personnel

3.4 component product used as a constituent in an assembled product, system or plant

[3.7 of IEC 81346-1]

3.5 conformity fulfillment of specified requirements

NOTE The term “conformance” is synonymous but deprecated.

3.6 consequence outcome of an occurrence of a particular set of circumstances

NOTE 1 There can be more than one consequence from one event.

NOTE 2 Consequences can range from positive to negative. However, consequences are always negative for safety aspects.

NOTE 3 Consequences can be expressed qualitatively or quantitatively.

[3.1.2 of ISO/IEC Guide 73]

3.7 consumable any part or material that is necessary for continued use or maintenance of the product

3.8 consumer individual member of the general public, purchasing or using products, property or services, for private purposes

NOTE For the purpose of the requirements of this part of the International Standard, a “consumer” is assumed not to be a skilled person.

3.9 consumer product product available to, intended for or likely to be used by consumers

NOTE Consumer products include accessible design products.

3.10 customer individual or organization that purchases or receives a product

NOTE 1 Examples are consumer, client, end-user, retailer, beneficiary and purchaser.

NOTE 2 The term "customer" includes but has a broader meaning than “consumer”. [3.3.5 of ISO 9000, modified]

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3.11 display device provided as part of a product for the purpose of visually or tangibly presenting text or graphics

3.12 document fixed and structured amount of information intended for human perception that can be managed and interchanged as a unit between users and systems

[3.1.2 of IEC 61082-1]

3.13 documentation collection of documents related to a given subject

[3.1.4 of IEC 61082-1]

3.14 equipment associated assemblies intended to achieve a defined final objective

3.15 graphical symbol visual perceptible figure with a particular meaning used to transmit information independently of language

[3.1 of IEC 80416-1]

3.16 harm physical injury or damage to the health of people or damage to property or the environment

[3.3 of ISO/IEC Guide 51]

3.17 hazard potential source of harm

[3.5 of ISO/IEC Guide 51]

3.18 illustration visually perceptible figure, such as graphical image, picture, figure, photograph, line drawing, etc., artificially created to transmit specific information, excluding graphical symbols

3.19 instructions for use information provided by the supplier of a product to the user, containing all the necessary provisions to convey the actions to be performed for the safe and efficient use of the product

NOTE Instructions for use of a single product comprise one or more documents. [2.8 of ISO/IEC Guide 14]

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3.20 intended use exhaustive range of functions or foreseen applications defined and designed by the supplier for the product

Note 1 Functions or applications not listed by the supplier are excluded from the intended use of the product.

Note 2 Modification of the product which is possible to be done by a skilled person leading to additional or modified functions or applications are excluded of the intended use.

3.21 label item, attached to a product, which displays information related to one or more characteristic(s) of the product

[2.9 of ISO/IEC Guide 14]

3.22 maintenance actions intended to retain a product in or restore it to, a useful and safe condition in which it can perform the intended use

3.23 manual document containing information for the use of a product

NOTE IEC 61355-D00014 defines the document type “XXX Manual”.

3.24 marking logo, inscription, graphical symbol, pictogram, tactile indicator, warning sign on the product to identify its type or to give directive

NOTE Marking may also include short textual messages. [2.4 of ISO/IEC Guide 14, modified]

3.25 modification changes made to a product in order to alter its specified intended use

3.26 organization group of individuals and facilities with an arrangement of responsibilities, authorities and relationships

EXAMPLES company, corporation, firm, enterprise, institution, charity, sole trader, association, or parts or combination thereof

NOTE An organization can be public or private. [3.3.1 of ISO 9000, modified]

3.27 personal protective equipment any device or appliance designed to be worn or held by an individual for protection against one or more health and safety hazards

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3.28 plant assembly of different systems on a specific site

[IEC 61355-1]

3.29 product intended or accomplished result of labour, or of a natural or artificial process, which could be a good or service

Note Instructions for use are seen as a part of a product.

3.30 product safety label label on a product that informs the observer of one or more potential hazards and describes the safety precautions and/or actions required to avoid the hazard(s)

3.31 reasonably foreseeable misuse use of a product in a way not described as intended use in the instructions for use, but which may result from readily predictable human behaviour

[3.14 of ISO/IEC Guide 51, modified]

3.32 repair part of corrective maintenance in which actions are performed on a product including replacement of worn-out parts and reworking of defective or damaged parts or functions

3.33 risk combination of the probability of occurrence of harm and the severity of that harm

[3.2 of ISO/IEC Guide 51]

3.34 safety note safety-related information that is collected or grouped in a document or section of a document in a meaningful organizational system to explain safety measures, raise safety awareness and provide a basis for safety related training of users

3.35 safety sign sign which gives a general safety message, obtained by a combination of colour and geometric shape and which, by the addition of a graphical symbol, gives a particular safety message

[ISO 7010]

3.36 service result of activities between a supplier and a customer, and the internal activities carried out by the supplier to meet the requirements of the customer

[2.2 of ISO/IEC Guide 14, modified]

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3.37 skilled person individual with relevant technical education, training and/or experience enabling him or her to perceive risks and to avoid hazards occurring during use of a product

[IEV 195-04-01 and 3.53 of IEC 60204-1, modified]

3.38 supplied accessory part packaged with the product (or as optional extra) that is necessary for certain operations or maintenance of the product

3.39 supplier individual or organization that provides products and related documentation

NOTE Examples of supplier are producer, manufacturer, integrator, vendor, distributor, retailer, agency, provider of information or their authorized representatives. [2.16 of ISO/IEC Guide 14 and 3.3.6 of ISO 9000, modified]

3.40 target group group of persons for which instructions for use are intended

3.41 use any activity that the user may perform with or on the product during its whole life cycle

3.42 user individual or organization that uses products

NOTE In this part of the International Standard, the term “user” means “end user” except when otherwise noted

3.43 warning message safety-related information that warns users about hazards and instructs on how to avoid them. Warning messages should be given within instructions for use related to tasks in which the hazards may occur

4 Principles

4.1 Provision of instructions for use

4.1.1 General

The level of description and details of information shall be adapted to the knowledge of target group(s), Instructions for use shall ensure the completeness of relevant information at a sufficient level of description based on the ascertained needs of the target group.

4.1.2 Instructions for use are part of the product

A product shall be accompanied by instructions for use which promote its intended use and contain all information that a user needs to know before using the product. Where instructions for use comprise more than one document, these shall be arranged in a meaningful and organized system and support navigation. The way in which third party documents are integrated shall be based on customer requirements and user needs.

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Instructions for use should reduce the risk of injury or illness to people or animals. In addition they should reduce the risks of damage, malfunction or inefficient operation of the product. Instructions for use cannot compensate for design deficiencies or missing safety systems (see ISO/IEC Guide 37).

4.1.3 Consistency of information

All information in instructions for use shall be consistent within itself and with all other information relating to the same product issued by the supplier, such as advertising or packaging, any warranty and World Wide Web based information, and the information has also to be consistent with the legal requirements which may result from any warranty stipulations. Consistent terminology shall be used in the instructions for use, on the product and its packaging, and in supplementary materials, all training and promotional materials including markings, labels and transport packaging.

4.1.4 Product warranty

The product warranty shall include all relevant terms and conditions (for example, date of expiry, service conditions, allowed modifications, availability of spare parts), and shall be provided together with instructions for use.

It may be appropriate to put the product warranty into a separate document especially when the terms vary between different sales channels or countries.

4.1.5 Information provided after sale of products

After the product has passed into the user’s possession, it can be helpful to provide, via World Wide Web sites or other means of communication to users and target groups, newly added or revised instructions for use, information about using the product, and other information that will be beneficial to the user.

4.1.6 Security aspects

Inclusion of security aspects shall be in accordance with ISO/IEC Guide 81.

4.2 Quality of communication

Expert writers or specialists shall be responsible for the preparation of instructions for use, including checking and proofreading, and:

• have advanced competencies in communication; • have solid competencies in the original language; • are familiar with the subject area; • know the process chain for the preparation of instructions for use and are competent in the application of the requirements of this part of the International Standard in the process chain.

Instructions for use should be contextually edited by qualified persons specialised in writing for the target groups.

4.3 Minimizing risks

Instructions for use are an integral part of the safe operation and maintenance of a product. They shall provide information to avoid any unacceptable risk for the user or other parties, damage to the product itself or other goods, malfunction or inefficient operation. They shall directly help to avoid reasonably foreseeable misuse, which may result in the generation of hazards, therefore:

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• risk assessment of use, i.e. the analysis of the process from risk analysis to risk evaluation, shall be undertaken by the supplier in accordance with ISO 12100 and/or IEC 60204-1 if applicable; • result of the risk assessment, that is remaining risk, shall be taken into account in the instructions for use as safety-related information in accordance with ISO/IEC Guide 51 and, any relevant standards for safety-related information; • reasonably foreseeable misuse and risks arising from the use of the product shall be covered.

See also 5.4.

NOTE As a matter of principle, the supplier has an obligation to include such safety-related information, in fact it is a legal requirement in most countries.

4.4 Target group(s)

When preparing instructions for use, the needs and capabilities of the intended target group of the product shall be addressed. Usually they will be the type of people likely to use the product, defined for example by age range, language, technical knowledge, or technical discipline. See also 4.8.2 and 4.8.3.

If instructions for use are directed to more than one target group (for example consumers and persons responsible for installation, repair or certain types of maintenance), those shall be separated and be adequately marked in a clear visible manner. The target groups shall be defined at the beginning of the content.

4.5 Special precautions

Attention should be drawn to the need for special protective measures, such as adult supervision or the wearing of special clothing, needed to protect users and bystanders.

Dangers to particularly vulnerable groups such as children, older persons and persons with disabilities (including, for example, users with heart pacemakers, or who suffer allergic reactions to specific chemicals or are sensitive to strobe lighting effects) should also be highlighted (see ISO/IEC Guide 37 and ISO/IEC Guide 71).

4.6 Short-life products

For products which have an intended limited life, for example, for safety reasons, quality or economic performance, information shall be provided about the year of manufacture, date of expiry and/or hours of operation.

4.7 Considerations as to the nature of instructions for use

4.7.1 General

With respect to the nature of instructions for use, the following shall be taken into account:

• writing style, for example. the use of discriminatory or offensive language; • legal requirements and standards; • the latest technology available for preparing instructions; • relevant international standards addressing the needs of older persons, persons with disabilities and accessibility. See ISO/IEC Guide 71.

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4.7.2 Location

Instructions for use shall be given in one or more of the following locations as appropriate:

• inside the packaging together with the product; • on or within the product itself; • on the packaging, but not only on the packaging; • on the World Wide Web sites provided by suppliers: see 4.7.5, 5.6 and 6.2.1, but not only on the World Wide Web.

Where instructions for use are complex, it is helpful that certain important messages are additionally given or displayed on the product, for example by means of short reference or reminder cards, stickers, illustrations or labels.

4.7.3 Means of communication and media

Means of communication and media shall be chosen as appropriate according to the environment and types of target groups (including child users, older users and users with disabilities). The decision about the media shall ensure that the target groups can have permanent easy access to all information necessary during use under foreseeable circumstances, especially for safety, intended use, installation, getting started, commissioning, putting into service, troubleshooting, maintenance and disposal.

In most cases, such as for consumer products, a printed version of the instructions for use is necessary. Supplying instructions for use only in electronic format is not permissible in many cases, such as for compliance with legal requirements.

The following are examples of possible means of communication and media: a) Means of communication 1) graphical symbols; 2) text, video (including auxiliary means such as audio and subtitles when appropriate), speech; 3) Braille, large text, tactile figures, signs or other visible hand gestures; 4) in supplementary documentation (for example, leaflet, manual or information provided by Braille) or electronic-documentation (for example built-in manual, recorded media, or in World Wide Web). b) Medium 1) accessing information via Web sites; 2) accessing information via appropriate tools using for example Radio Frequency Identification Devices (RFID); 3) leaflets with text and illustrations; 4) manuals for users and maintenance staff; 5) a graphical user interface (GUI).

4.7.4 Durability

Instructions for use given on the product shall remain legible throughout the expected life of the product.

Instructions for use given on packaging or in materials accompanying the product (such as leaflets, manuals, data media, etc.) shall be produced in durable form. They shall be designed and made so as to survive frequent use during the expected life of the product in the environment where the product is intended to be used. It should be taken into consideration

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4.7.5 Availability

Instructions for use shall be marked KEEP FOR FUTURE REFERENCE or its equivalent unless it is clear that there will be no circumstances in which they will be required during the product's operational life. The supplier of the product shall keep replacement copies of all such instructions for use available throughout the expected life of the product. For each consumer product instructions for use should in addition be made available and easily found on the World Wide Web (see 5.6 and 6.2.1).

Since packaging is often impermanent and destroyed in the unpacking process, the instructions for use which need to be kept for future reference should not be placed on the packaging only. Where this cannot be avoided (for example, for practical reasons), the advice to keep them for future reference shall be clearly indicated. If only a part of the packaging contains instructions for use, that part should be easily detachable from the rest of the packaging and have an appropriate form and size for being stored.

4.7.6 Electronic guidance systems

Where an electronic guidance system is provided, it shall allow a user to navigate through the structure of the system so that the users at any time know where they are in the structure. Users shall at any time be able to view on-screen the system structure, together with its nodes and associated information. The user shall be able to collapse or to expand the system structure as required.

Warning messages for foreseeable exceptional situations shall be assigned only to those nodes in the structure to which they are relevant.

4.7.7 User training

Where user training is required, this shall be specified in the instructions for use and, where appropriate also in the supply contract. However, user training courses cannot be a substitute for instructions for use but only complement them. User training courses should be provided where the instructions for use alone cannot fulfill the general requirements given in 4.1.1 because of the complexity of the product or the necessity for more comprehensive user information, or if a sufficient knowledge on behalf of the user cannot be expected.

4.8 Creating instructions for use

4.8.1 Conformity with the product

4.8.1.1 Relationship between instructions for use and the product

Instructions for use shall unambiguously relate to the supplied product, therefore they shall contain the information related to identification with which the product is marked. This shall as a minimum comprise name and address of the supplier, designation of series or type and, if applicable, serial number.

Where the product is in conformity with a recognized standard, this shall be clearly indicated. For identification requirements see IEC 62507-1. See also 5.2.

An introduction to instructions for use shall include: the product name and type, the supplier, and document designation. If applicable, a product illustration should be provided.

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4.8.1.2 Variants of one product

If more than one product variant is addressed by a set of instructions for use, the identifier of a specific variant shall be clearly recognizable in the instructions for use and on the product to ensure unambiguous identification. The relationship between content and operational features of different product variants shall be unambiguous.

Where a single document covers multiple variants of one product, there are different ways to organize information, for example: a) Each product variant has its own sections. Common parts are repeated in each product variant section. In this solution the amount of pages is large, but from the user’s point of view it is easy to read (all content is applicable for the particular product variant) and the risk for misinterpretation is low. Identification of the applicable product variant is highlighted for example in footer or header of each page (see 5.2). b) All product variants have one common section. Product variant specific information is highlighted using for example, sub-headings, different colours, This solution is compact, but special care needs to be taken when implementing and verifying instructions for use.

If option b) is used the result should be verified using empirical evaluation because there is a higher risk of misinterpretation.

4.8.1.3 Information on installation and maintenance

The parts of instructions for use dealing with installation and maintenance shall include as a minimum addresses of the supplier and authorized service centres for the product. The following information should be included as far as applicable: technical data, notes on warranties, trouble-shooting, a list of consumables and information about disposal.

4.8.1.4 Units of measurement

Quantities should normally be expressed in SI units (international system of units of measurement) or in derived SI units (see ISO/IEC 80000). However, quantities expressed in instructions for use shall comply with those units of measurement used on the product. Where non-SI units of measurements are used for the product, SI equivalents should be provided.

4.8.1.5 Optional modules and extras

Instructions for use concerning optional modules or extras should be kept clearly separate from common instructions for use and from instructions for use for other modules or extras (for example by using separate sections, headings, etc.) so that users are not confused by irrelevant information.

Where a product offers, for example, both the ability to charge re-chargeable batteries in the battery compartment or to use non-rechargeable batteries, the instructions for use should include paragraphs under separate headings for: a) the use of re-chargeable batteries; b) the use of non-rechargeable batteries.

4.8.1.6 Special tools, equipment, material

Instructions for use should include information for interconnecting accessories and other equipment including indication of suitable accessories, detachable parts and any special materials, as far as appropriate. The instructions for use should also contain the name and address of suppliers from whom special tools, materials, etc. and technical assistance can be obtained.

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If necessary, information on repackaging should be provided for replacement, repair, reworking, refilling, etc.

4.8.2 Consideration of needs of target groups

4.8.2.1 Analyses of target groups

Consideration of the needs of target groups shall be based on analyses as set out in 4.4. For consumer products empirical tests are recommended. See also Annex E.

4.8.2.2 Target groups with particular needs

Where products are intended to be used by target groups with particular needs, instructions for use shall take them into account. Target groups with particular needs include, for example, older persons, children or other persons unable to use the product safely without supervision, persons with disabilities, adults supervising children and persons who are functionally illiterate.

4.8.2.3 Comprehensible terminology

Instructions for use shall be comprehensible by the general public unless the product is intended for use by a specific target group with specialist knowledge. Where the use of technical terms and expressions is unavoidable, their meanings shall be explained.

4.8.2.4 Meanings of signals

The meanings of signals, such as flashing indicators, colour changes or audible signals, shall be explained so that they are easily recognised and understood by the target group.

NOTE Examples of signal signs are found in IEC 60073, ISO 7731, ISO 11429, ISO 15006 and ISO/TR 16352.

4.8.2.5 Supplementary information

Where supplementary information is provided, either for particular target groups or for a specific purpose, it shall clearly be indicated on the first page of the instructions for use.

4.8.3 Languages

4.8.3.1 General

Instructions for use shall be supplied in the official language(s) of the country of sale in accordance with the local or regional legal requirements.

Selection of the additional language(s) of instructions for use should take into account the following: a) Tourists, ethnic minorities and cross-border internet buyers are likely to be a significant (and increasing) proportion of customers of many products on the markets of many countries. b) A large number of target groups (for example, migrants and refugees) are non-native speakers of the official language(s) of the country they live in. They therefore will find themselves using products whose instructions for use are not written in a language they adequately understand.

Where instructions for use are given in several languages, they shall be distinguishable by colour coding and/or by commencing with an illustration widely associated with each language – for example a flag or country identification letters. In order to facilitate ease of use, instructions for use in different languages should be provided separately.

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Where illustrations need explanatory texts, they shall be placed adjacent to one another so that they are perceived together (see also 6.3.4).

A single illustration may serve for more than one language provided the illustration is perceived together with the text in every language and the illustration does not contain language specific elements.

In addition, important operation and safety precautions can be conveyed by language- independent means such as safety signs and graphical symbols and self-explanatory illustrations.

4.8.3.2 Graphical symbols, including safety signs and product safety labels

Graphical symbols, including safety signs and product labels shall be easily recognizable and comprehensible by the target group. Safety signs and graphical symbols used on the product or within the instructions for use which are neither readily comprehensible nor unambiguous shall be explained.

Because of the limited space generally available, placing instructions for use on a product may present problems in relation to languages, especially when the country where the instructions for use will be used has more than one official language. These problems can be solved by use of:

• safety signs, product safety labels and graphical symbols (see 6.4) which are comprehensible; • alpha-numeric codes, with an explanation of the meaning; • certain words or abbreviations (for example STOP, MAX./MIN.) which are internationally acceptable.

NOTE 1 ISO 7010, IEC 60417 and ISO 7000 provide internationally standardized safety signs and graphical symbols.

NOTE 2 The ISO 9186 series of standards provides procedures for testing the comprehensibility of graphical symbols including safety signs.

4.8.3.3 Quality of translations

Where instructions for use are translated from the original language into others, expert translators or specialists shall be responsible for the translation including checking and proofreading, and;

• have basic competences in communication; • are familiar with the subject area; • are fluent in the original and target languages, preferably native speakers in the target language.

Colloquial expressions and untypical regional variations of names and product features should be avoided.

The translated instructions for use should be edited by qualified persons specializing in writing and translating for the target groups.

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5 Content of instructions for use

5.1 General

The functionality of products shall be described and users questions such as WHERE? WHO? WHAT? WHEN? HOW? WHY? should be anticipated and appropriate answers provided.

The information to be given depends on the target group(s) and the tasks that they are intended or allowed to perform throughout the life of the product.

5.2 Identification and specification of the product

The specification or description of the product shall enable the user to identify the product itself and find the identifying information on the product by:

• product identification number, serial number, model and/or type, see IEC 62507-1; • name/identifying information of the supplier together with the supplier’s contact details such as easily accessible telephone numbers, fax numbers, and any other possible means of communication; • name, address, phone numbers, fax numbers, e-mail and web addresses of providers of special tools, material, etc. and technical assistance.

Furthermore, the specification or description of the product shall provide a general overview on requirements, performance and features, and provide the following information as far as applicable:

• complete measurements, for example, mass, volumetric capacity, and performance; • information regarding energy consumption and input voltage, insulation category (in case of insulation category II marking with graphical symbol IEC 60417-5172, in case of insulation category III marking with graphical symbol IEC 60417-5180) and IP Code defined in IEC 60529; • energy efficiency rating; • requirements for gas supply (for example, type, pressure), water supply and other relevant information on items such as cleaning agents, lubricants, and fuses (for example, type, rated value and characteristics); • emitted noise level, waste discharge rate, etc. under specified circumstances; • electromagnetic compatibility; • description of the type of intended user (and, especially in the case of accessible design products, a clear statement of any special precautions that should be followed by the user (see ISO/IEC Guide 71)); • standards to which the product complies; • notes on reasonably foreseeable use and misuse.

For principles and methods for detailed specification of products, see IEC/PAS 62569-1.

Some product standards may require the use of particular marking or labelling on the product and/or associated instructions for use in order to show the product complies with particular requirements of these product standards.

5.3 Modification of products

Where a supplier does not allow for a product to be modified this shall be clearly stated in the instructions for use including information about possible consequences caused by a modification.

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Where applicable it should be clearly stated that any modification of the product by the user is not recommended and any consequences will not be covered by support services or product warranties.

When a supplier allows users to modify a product, the instructions for use shall describe permissible (and non-permissible) modifications. Instructions for use shall clearly describe and illustrate how to undertake permissible modifications (or direct the user to a source of relevant information), so as to allow the user to modify the product correctly and to ensure continuing safe and efficient use.

5.4 Safety-related information

5.4.1 General

There are three types of safety-related information which should be separately identified:

• safety notes; • warning messages; • product safety labels.

Note ISO 3864-2 defines product safety labels.

Safety-related information shall relate to the various phases of the life of the product.

Safety-related information shall include the following, if applicable:

• intended use of the product, the main function/purpose and scope of application and the essential safety principles to be observed; • limits of application regarding, for example, place, time, environment and type of application, materials and additives, any necessary tools, as well as climatic conditions for operation and storage, such as temperature and humidity, explosive atmosphere, outdoor operation; • clear and prominent information about personal protective equipment (for example, clothing, protective goggles) that is necessary to use the product safely; • protective features that need to be installed or activated by users; • potential hazards or precautions for specific groups of persons of which users shall be aware and which would not be immediately obvious without being pointed out; • potential health consequences which may result from failure to observe precautions or avoid hazards if the risk or severity would not be immediately obvious; • description of the user type, for example, skilled persons, or ordinary persons older than 18 years; • information regarding restrictions on the personnel who are permitted to use the product together with any special skills required; • specific indications that products are no longer safe to use, for example, due to wear, ageing or damage; • information regarding safe disposal; • explanation of graphical symbols used in safety-related information (see ISO 7000, ISO 7010, IEC 60417); • restrictions and/or recommendations for safe use, for example, use in dry environments, or not to be used in bathrooms or other humid environments; • signal words and/or graphical symbols; • warning messages on hazards; • warning messages on reasonably foreseeable misuse;

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• warning messages on radiation, including any sealed hazard, for example, laser according to IEC 60825-1, microwave, ultraviolet, infrared and lethal voltages.

Information about personal protective equipment should additionally be given on the packaging and/or on the product itself.

Restrictions concerning the use of the product shall be given clearly in the instructions for use, for example in specifications and in commercial brochures at the point of sale (see also ISO/IEC Guide 14).

NOTE Product-related standards and legal regulations may contain additional requirements.

5.4.2 Safety notes

Safety notes shall be presented in a meaningful organizational system. They shall be provided in a separate clause or section at the beginning of the instructions for use. This clause or section shall be clearly identifiable and shall have a heading which emphasizes the importance of the content.

Safety notes shall as a minimum provide directions on the safe use of products, indicate potential hazards and how to avoid such hazards, and state the probable consequences of not avoiding them.

5.4.3 Warning messages

Warning messages shall be given in the context in which a danger may occur. They shall indicate potential hazards and state possible consequences if not avoided.

Warning messages shall be concise. They shall not contain complete procedures, but complement the procedures described elsewhere in the instructions for use. Information about avoiding the hazards shall be included. However, if the information about avoiding the hazard is clearly understood by the intended target groups, it may be omitted in the warning message itself.

5.4.4 Safety-related information for industrial plants

Safety-related information shall be provided with each component. Where an assembly of components might produce additional potential hazards, the relevant safety-related information shall be only provided at the relevant level of assembly. When integrating components to higher assemblies, safety-related information should be provided only at that level of aggregation where they occur.

5.5 Product compliance

Where applicable, instructions for use shall include information about legal and other requirements applicable to the product.

5.6 Importance of retaining instructions for use

The user's attention shall be drawn to the importance of retaining instructions for use for the life of the product by means of a statement such as

IMPORTANT READ CAREFULLY BEFORE USE KEEP FOR FUTURE REFERENCE.

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Replacement copies of all such instructions for use should be made available from the supplier on demand (for example, from the web site), throughout the expected life of the product.

5.7 Preparing products for use

5.7.1 Transportation and storage

If applicable instructions for use shall include information for the protection of the product and the safety of persons during transportation and storage, for example:

• dimensions, mass, and centre of gravity; • methods of lifting, handling and transportation that are ergonomically efficient and will prevent damaging impacts (for example, by indicating gripping points and lock-down screws); and • storage requirements with associated ambient conditions (for example, humidity, laying flat, avoiding direct sunlight); • storage of the product after use; • methods for securing the product against unexpected shocks.

5.7.2 Installation

For products which require installation, instructions for use shall if relevant include:

• methods for the removal of transport and packaging restraints, and equipment transit clamps; • procedures for unpacking (provided on the outside of the packaging) and for the removal and safe disposal of any protective and preservative packaging; • a checklist of items included in the package; • minimum space needed for use, maintenance and repair; • a layout plan; • interconnection diagram and/or table; • conditions for assembly and mounting; and • methods, precautions and legal requirements for connecting the product to power and water supplies, drainage and other auxiliary supplies.

5.7.3 Commissioning

The instructions for use shall include all the information necessary for the commissioning of the product prior to its handing over in working order to the user.

5.8 Operation of products

5.8.1 General

The user shall be provided with information regarding normal and safe operation as well as abnormal operation of the product.

5.8.2 Normal operation

Instructions for use shall if relevant cover the following:

• information related to the operational environment; • information on any manual operating techniques; • information about local/remote operation and how to switch between the two;

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• information regarding vibration for portable hand-held and hand-guided machinery if necessary; • means of starting/stopping the product's operation; • any initiating operations, checks, adjustments or conditioning required prior to each occasion of normal use; • illustrations that clarify or reinforce understanding of the main functions and safety precautions; • recommendations for waste removal; and • identification and correction of malfunctions.

5.8.3 Additional information for automatic and remotely controlled products

User guidance systems shall provide the user in an on-line mode with additional information on the operational state of the products. For example:

• full information about normal operation; • an indication that the system has automatically switched to safe operation mode before a hazardous situation has been reached; • the current state of operation so that the user is made aware of this automatically guided function; • what to do when the control system itself has failed; • instructions on how to manage fault situations; and • information regarding whether the system is in manual, local or automatic mode.

NOTE For software documentation for user guidance systems, refer to IEC 61506.

5.8.4 Indications of faults and warning device signals

Recognisable indications of normal and abnormal operation and the recognition of signals from any warning devices shall be explained in instruction media that can be referred to without operation of the product itself.

Any signals or displays intended to indicate impending risk of damage or imminent danger shall be readily comprehensible and unambiguous.

Appropriate warnings shall be provided where use of the product in question might affect electrically controlled medical devices, such as heart pacemakers.

Advice shall be given to enable users to recognize any medical symptoms or adverse medical reactions that might arise from the use of the product and to understand what corrective actions or treatment to implement.

5.8.5 Exceptional/emergency situations

Where applicable, information on the following shall be provided:

• sequence of actions to be taken in the case of an unexpected interruption of power, cooling, etc; • fault indication and its location, and restarting after an intervention; • in the case of possible fire, which type of fire-fighting equipment to be used; • information about foreseeable emissions or leakages of substances with associated warnings of the nature of any hazard including precautions to avoid harm and, if possible, by which means the effects may be countered and the normal state of operation regained;

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• first aid treatments recommended for any foreseeable acute medical conditions that may result from the use of the product, for example, toxic shock, epileptic fit or burns, and advice on subsequent professional medical treatment to be sought.

5.8.6 Troubleshooting and repair for non-skilled persons

If the user of the product can perform troubleshooting and repair tasks without risk of harm to him/herself, other people or safety of the product, the instructions for use shall provide a checklist of possible faults (or ‘frequently-asked-questions - ‘FAQs’). This checklist or the FAQs including appropriate illustrations shall give a clear indication of those faults which the user can attempt to repair. Directions for repairing faults should be limited to those tasks that a non-technical user could reasonably be expected to undertake.

Telephone and URL or e-mail contact details, for communicating a complaint or customer service query, should be provided in instruction media that can be referred to without operation of the product itself. A list of the locations and contact details of the supplier in the country or countries in which it is marketed shall accompany the product or be available on the supplier’s website.

5.8.7 Troubleshooting and repair for skilled persons

The following information shall if relevant be provided:

• list of indications for fault identification and its location; • list of indications of normal operation; • descriptions of built-in diagnostic systems to aid fault detection, when applicable; • drawings and diagrams enabling the troubleshooting task to be done effectively; • directions for noting malfunctions of equipment, noting abnormal symptoms and indications, and recording operation of alarms and trips; • directions for starting standby or alternative systems, and for shutting-down and isolating malfunctioning units; • repairs and adjustments; • aids for troubleshooting procedures, such as functionally identified maintenance system (FIMS), fault step diagnosis (FSD), fault step and algorithms, or, in complex systems, fault trees and computer-based fault diagnosis. • clear definition of troubleshooting and repair tasks that should not be attempted by the user, together with instructions on how to contact the supplier or others from whom technical assistance may be obtained; and • name, address, accessible telephone numbers, fax numbers, and any other means of communication of the supplier or others from whom technical assistance can be obtained.

5.9 Maintenance

5.9.1 General

Separate information shall be provided for maintenance that can be performed by skilled and non-skilled persons - preferably as separate documents or at least as separate clauses.

5.9.2 Product maintenance by non-skilled persons

If the user of the product can perform maintenance tasks without harm to the user, other people, or the product, the instructions for use shall include specific descriptions of these tasks and their nature and frequency.

Instructions for use shall provide a list of possible maintenance tasks with appropriate illustrations as required to allow users to perform the tasks accurately and without difficulty.

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When certain maintenance tasks need to be performed more frequently than others, everyday maintenance tasks shall be distinguished from periodic (short-term and long-term) maintenance and inspection activities.

Materials and tools used for cleaning, for example, appropriate chemical substances, cleaning cloths and brushes, shall also be specified. Risks arising from the use of inappropriate materials and tools shall be clearly specified.

When there are maintenance tasks that should not be attempted by the user, those tasks shall be clearly identified and the user shall be instructed how to contact the supplier or others from whom technical assistance may be obtained.

5.9.3 Product maintenance by skilled persons

Information on maintenance for skilled persons shall be provided separately from the information provided to non-skilled persons – preferably as separate documents or at least as separate clauses. Such information shall include:

• the nature and frequency of inspections; • safety precautions and warnings for maintenance carried out on running or live equipment; • drawings and diagrams enabling the maintenance task to be done effectively; • regular checking of warning devices; • details of cleaning methods. Where there is a possibility of an incorrect cleaning or decontamination process or the use of wrong cleaning materials that causes an immediate safety hazard or problems resulting from corrosion or weakening of structural parts of a product this shall specifically be mentioned; • maintenance schedules and, if necessary, master schedules which incorporate details of all tasks required to be carried out at regular intervals; • the name, address, accessible telephone numbers, fax numbers, and any other means of communicating with the supplier or others from whom technical assistance can be obtained.

5.9.4 Planned maintenance of industrial plants

An overall maintenance and service plan for an industrial plant shall be drawn up by combining the maintenance and service plans for all key components.

5.10 Supplied accessories, consumables and spare parts

5.10.1 Accessories

The following information, as required for each accessory, should be supplied in instructions for use:

• name, part number and whether basic or optional; • illustrations to allow the user to identify the accessory and where to attach it; • description of its function and purpose.

5.10.2 Consumables

Where consumables are required, the following information shall be provided in the instructions for use:

• description and recommended quantity of consumables, the official model name or part number, any common commercial name (and, for materials, generic name);

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• typical replacement frequency (in time or volume of usage); • an illustration that allows the user to identify the consumables; • an illustration to show the position of, or the access to, the consumables (in an exploded view if clearer); • information for removal and replacement or refilling; • information about disposal of removed consumables.

5.10.3 Spare/replacement parts

A list of replacement parts purchasable as spares shall be provided. The following information should, as appropriate, be provided for each part, together with an indication of the level of skill required to replace the part without causing potential hazards:

• its name, identification and serial numbers in the form used on the product and in commercial transactions; • the supplier's part/type and version numbers as well as the name, reference and version numbers for branded parts, if different from the above; • an illustration of the part and its position, preferably in exploded view; • sources of supply as well as alternative sources of supply for spare parts; • parts for which there is a refurbishing service available provided by the supplier or a service provider; • an identification in accordance with IEC 81346 of components of complex products; • an identification in accordance with IEC 81346 of locations where a specific spare part can be used as replacement; • the year of manufacture or the year of expiry for the spare/replacement parts availability if not given in a separate document; • information about disposal of removed spare/replacement part.

5.11 Information on special tools, equipment and materials

Information on any special tools, items, or equipment required to deal with special conditions, but not used in normal operation, shall normally not be provided to non-skilled persons. Such information shall be provided only to skilled persons.

The information shall include descriptions of interconnections with accessories and other equipment, including indication of suitable accessories, detachable parts, and any special materials that may be used.

Methods to repackage shall be provided, if necessary, for replacing, repairing, reworking, and refilling the product.

Consumables, cleaning material, lubricant products and repair kits shall be identified, if appropriate.

5.12 Information on repair of products and replacement of parts

5.12.1 Information on repair of products and replacement of parts for non-skilled persons

Information on repairing and replacing parts for consumers shall be provided if this can be undertaken without risk of harm to consumers, other people or the safe use of the product.

When the supplier permits consumers to replace parts themselves, the following information shall be provided to consumers:

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• the source of replacement parts; • the method of repair or replacement; and • the method for testing after the repair or replacement, if any test is required.

When the supplier does not permit consumers to replace parts themselves, information about the service agent(s) to contact shall be provided.

5.12.2 Information on repair of products and replacement of parts for skilled persons

Information on repairing and replacing parts shall be provided for skilled persons:

• to repair the equipment and/or to replace parts; • to carry out tests that have to be performed after replacing a part.

5.13 Information required when the product is no longer needed

5.13.1 General

Instructions for use shall contain information relating to handling, reuse, recycling or disposal of the product after it is no longer needed.

5.13.2 Disassembly

Disassembly by the consumer shall only be permitted where this does not create a hazard.

Where appropriate, instructions for use shall include information, separately or in combination, on disassembly of the product and/or handling of any waste materials with due regard to safety and environmental considerations.

5.13.3 Recycling

Where specific procedures are necessary for recycling of the product or its components, these shall be specified in accordance with the appropriate legal requirements and/or standards.

5.13.4 Disposal

Any applicable standards for disposal processing should be clearly indicated.

Instructions for use shall convey important information to the user about aspects relating to waste disposal and environmental considerations.

If the product contains any hazardous substance, or if any hazardous substance is supplied together with the product, the necessary information on its constituents and the correct disposal procedure shall be given with due regard to safety and legal requirements.

5.14 Structure

5.14.1 General

Instructions for use that are lengthy or complex shall be clearly divided into convenient parts, and shall have a regular format. Requirements for individual parts should be specified in relevant product standards or in technical documentation within an industry sector taking account of the provisions of this part of International Standard.

Depending on the purpose of the instructions for use and the amount of information they contain, some of the subclauses in Clause 5 of this part of the International Standard may be omitted. The structure of chapters, sections, and topics shall be internally consistent.

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For instructions for use comprising multiple manuals, the information on the front covers and/or spines shall make it easy to distinguish one manual from another.

5.14.2 Page numbering

If instructions for use comprise more than two (printed) pages, the pages shall be numbered as n of m where n is the actual page number and m is the total number of pages.

5.14.3 Table of contents

Instructions for use that exceed four pages shall have a table of contents.

Headings appearing in the table of contents shall be the same as those used in the text.

5.14.4 Index

If instructions for use are lengthy and complex, an index of keywords presented in alphabetical order should be included. The index shall be referenced in the table of contents.

5.14.5 Technical terms, acronyms and abbreviations

Unavoidable technical terms, acronyms and abbreviations not readily comprehensible by the intended target group shall be listed and explained.

For consumer products it is useful to conduct empirical tests if it is doubtful whether technical terms are generally understood by the target group. A glossary is recommended when technical terms are often used in the instructions for use.

Consistent terminology shall be used in the instructions for use themselves on the product itself, on the packaging, or in accompanying material such as manuals.

5.14.6 Graphical and tactile symbols and tactile dots

Graphical and tactile symbols and tactile dots shall be listed and explained.

5.14.7 Presentational conventions

Presentational conventions used in instructions for use shall be listed and explained, for example the use of a specific typeface for actions to be carried out by the user.

5.14.8 User controls and indicators

If applicable, instructions for use shall contain a description of the user controls and indicators applicable to the relevant component.

6 Presentation of instructions for use

6.1 Comprehensibility

6.1.1 Recognized communication principles

Within each section of instructions for use, the learning process demanded of the user should, as far possible, be broken down into a series of small steps. Building understanding in a continuous sequence may be reinforced by numbering operational steps and/or by referring the user (at each step) to an illustration representing each action visually or its effect schematically. Each step should provide a single action.

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The function and meaning of information (for example, the description of the product or information about troubleshooting) should be readily identifiable and different types of information should be separately identified.

For procedural instructions, preconditions for the sequence of necessary steps shall be given before the sequence of operation.

Where possible (and particularly for assembly) the user should be led to read a single instructional step, then perform it, appreciate the effect, then read the next step.

Accepted methods for structuring should be used which support the correct use of the product ("what" should be done with the product and "how", in correct order). General aspects should be described in an overview chapter, specific aspects in the relevant context.

The use of illustrations increases comprehensibility of instructions for use. An effective balance of text and illustrations is recommended. Illustrations shall be provided with a unique number to which reference can be made in the text.

6.1.2 Style guide

An editorial style guide should be established and followed through the entire instructions for use covering, for example:

• writing style (see Table 1); • wording; • terms (consistency); • way to address the readers; and • design of text and page layout including selection of typeface and font size (see Table 2).

6.1.3 Structure

The wording should fit the structure which supports the various text functions. Such text functions are for example:

• subject (heading); • description; • goal; • prerequisite; • condition; • action; • result; • warning; • prompt and reminder; • example; • caption (addressing a figure or a table).

The use of a consistent structuring method is recommended.

Instructions for use should cover basic or normal functions first, and other functions later.

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Headings shall be numbered, short and easy to understand. As a structuring element, they shall serve as a guide as the user reads through the instructions for use, and shall help the user to locate the required information.

6.1.4 Consistent terminology

Terminology shall be used consistently according to an editorial style guide thus enhancing comprehensibility.

Consistent terminology shall be used in the instructions for use themselves, on the packaging, in other collateral materials and on the product itself.

6.1.5 Simple and brief

Information shall be as simple and as brief as possible, and shall be expressed in consistent terms and units. The sentence structure should be simple. Sentences should be short and shall be grammatically correct.

Cross references shall be kept to a minimum.

6.1.6 One sentence, one command

One sentence shall contain one command only, or at most a small number of closely related commands.

6.1.7 Rules for simple wording

The text of instructions for use shall be written in simple, clear, direct phrases within short sentences, thus following the principle “One expression, one simple meaning”. The logical structure of the text shall be clear.

Abbreviations and acronyms shall be avoided unless it can be assumed that they will be familiar to the intended users or the terms are explained when they first appear in the instructions for use.

The examples in Table 1 should be observed independent of the language used.

Note Translators of this part of the International Standard may substitute examples of effective wording in Table 1 in the language into which translation is being made.

Table 1 – Writing style examples

Recommendation Preferred Not preferred Use the active voice of verbs rather than the passive Turn off power Be sure that the power has been disconnected Be assertive in using commands rather than weaker Do not remove tabs The tabs should not be forms removed Phrase directions around action verbs rather than Use, maintain, avoid Utilization, maintenance, abstract nouns avoidance Speak directly to users rather than saying what they Pull black lever towards Users will pull the black lever might do you away from the machine Avoid double negatives There will always be There will never be any some leakage. leakage. Fit only 3 A fuses Fit no fuses other than 3 A Avoid easily confused words (particularly with Flammable contents Inflammable contents prefixes that look and sound alike) High(/low) sensitivity Hyper(/hypo) sensitivity

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6.1.8 Standardized signs and graphical symbols

Where appropriate, the use of standardized safety signs in ISO 7010 or graphical symbols for use on equipment in IEC 60417 and ISO 7000 shall be considered in order to convey important messages such as warnings.

6.1.9 Ergonomic principles

Instructions for use presented using electronic media, for example, on-line or on-screen documentation, shall fulfil ergonomic requirements as stated in ISO 9241 series.

6.1.10 Keeping the attention of the readers

If the readers find expressions that irritate them, they will be distracted from processing the information. At worst they may discontinue reading or disregard the whole text.

Disrespectful, prejudiced or patronising expressions, assumptions or stereotypes should be avoided, for example, those relating to older people, users with particular disabilities, gender- role stereotypes or assumptions about family/household structures.

Excessive warnings are not helpful in holding the attention of the readers. As far as possible warnings should be phrased so that they relate to events or errors users can foresee. For example instead of “Do not immerse toaster in water” advise “Keep internal parts dry when cleaning.”

Marketing and advertising messages (for example, unnecessarily repeating or emphasising brand names) shall not intrude into instructions for use.

Necessary statements in legal terms for example statements relating to liability shall be clearly distinguished from and kept separate within instructions for use. They shall be written in a way that allows the users to follow the meaning and intent of these statements.

6.1.11 Proof reading

Instructions for use shall be proof-read by persons other than the writer or translator, preferably a native speaker, with knowledge of the product in question.

The assessment criteria are:

• wording according to editorial style guide; • correct spelling and punctuation; • correct grammar; • consistency of terms.

6.2 Legibility

6.2.1 Text font sizes and graphical symbol heights

Text fonts and graphical symbols used for information integrated in the product, of printed material and of computerized information shall be as clear and as large as practicable to ensure the best possible legibility for all users, including older users and users with visual impairment.

Recommended minimum text font sizes and graphical symbol heights are listed in Table 2.

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The best possible legibility is achieved when optimizing the relation of at least four variables including: type font, type size, number of characters per line (approximately 70 in Latin characters) and line spacing (minimum 120 % of type size in Latin characters).

Measures used to create emphasis shall be considered carefully so as not to reduce legibility. Bold letters, underlining, and if applicable, upper case and italic letters may be used to emphasize single words and phrases, but not to emphasize whole paragraphs or sections.

Where instructions for use present any of the text in a font size smaller than 10 point, or the legibility is reduced by other factors, such as low contrast, the supplier shall provide a larger printed version upon request free of charge.

For the benefit of consumers who are visually impaired, suppliers should offer options of access to all information in large print versions, and alternative media, for example, audio files or plain text files which can be read using Braille.

Table 2 – Minimum recommended text font sizes and graphical symbol heights (to be continued)

NOTE The term "point" (abbreviated here to "pt") is a unit of measurement of type sizes and spacing. There are several kinds of standards. However, "DTP point" is adopted in this part of the International Standard which is 0.353 mm or 1/72 inches.

Product/ Location High Low contrast Complex Other remarks Graphical symbols instruction and role of contrast colours or character including safety document instruction dark text on white on black sets (for signs size light example background Kanji) Symbols Safety generally signs Instructions Critical on- 14 pt bold 16 pt bold for use product viewed markings BEFPR BEFPR from up to As required by 1 m 68.39l,0 6.83l,0_ standards/regulations distance on Consider using QGOC Otherwise according floor- large print fonts QGOC to viewing distance standing specially aeocld from which attention products developed to help aeocld needs to be attracted people with visual text 14 pt 16 pt or the symbol needs impairments to to be recognised. Manuals, Critical on- 14 pt bold read signs and single-fold product labels at 30 cm to Less than 15 mm leaflets, & markings BEFPR 100 cm height unlikely to be desk-top sufficient for critical products 68.39l,0 on-product markings QGOC aeocld Headings, 12 pt Serif fonts may be 5 mm min 10 mm warning used. height (or min phrases, BEFPR 14 pt) height decimals 68.39l,0 QGOC aeocld continuous 10 pt 12 pt Do not use graphical text symbols in continuous text

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Table 2 – Minimum recommended text font sizes and graphical symbol heights (continued)

Product/ Location High Low contrast Complex Other remarks Graphical symbols instruction and role of contrast colours or character including safety document instruction dark text on white on black sets (for signs size light example background Kanji) Hand-held Critical on- 12 pt 5 mm min 10 mm products & product height min multi-fold markings height instruction sheets Headings, 10 pt 12 pt Use only sans pref min 5 10 mm warning BEFPR BEFPR serif fonts at mm; min phrases, this level and height decimals 68.39l,0 68.39l,0 4mm/12 pt except*: QGOC below. if very QGOC_ simple aeocld aeocld_ continuous 9 pt ELECTRONIC, Do not use graphical text BEFPR AUDIO, OR symbols in continuous text 68.39l,0 LARGE PRINT QGOC 9 pt with MEDIA aeocld 150 % SHALL BE line Very small Markings, 8 pt pref min 5 10 mm Not advised spacing AVAILABLE products headings, BEFPR ON DEMAND mm; min and warning for text smaller height* 68.39l,0 than 12 pt 3 mm if packaging phrases, QGOC very (for decimals aeocld 電気 example, (for example from simple 規格 web site or point printable continuous 6 pt Do not use graphical surface < of sale) 2 text BEFPR symbols in 10 cm ) 68.39l,0 continuous text QGOC aeocld *except the general warning sign (ISO 7010-W001) accompanying text warning, which may be 5 mm minimum as a marking and 3 mm minimum in headings to text.

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6.2.2 Maximum brightness contrast

For printed or engraved instructions for use, the brightness contrast (ratio of reflectance of the bright part over reflectance of the dark part) shall be as high as possible.

Contrast requirements for text displayed on visual display terminals shall be in accordance with ISO 9241-300.

6.2.3 Legibility standards

National standards may contain detailed information and specifications relating to legibility, and especially on the relation between type size and reading distance. These should be consulted and considered when producing instructions for use.

6.2.4 Layout

The layout shall make it easy to distinguish the various elements of information. The text block should have appropriate proportions and make effective use of white space.

The layout shall facilitate differentiation between the various types of information to be communicated, for example:

• subject (heading); • description; • action; • warning.

6.2.5 Instructions for use on surfaces of products or packaging

The location of on-product instructions for use and the angle between their surface and the vertical plane shall be such that they can be easily read and understood by users from their position(s) during use of the product.

Instructions for use on packaging should be visible and legible when the package is in the upright position.

The advantages in terms of durability and production of incorporating instructions for use in the material of the product should be weighed against the disadvantages of loss of contrast and legibility. Incorporating instructions for use in the material of the product generally produces an inferior result to that of good quality printing (See also 6.8.4 on the permanence and visibility of warning messages).

6.3 Illustrations and supporting text

6.3.1 Quality

Attention shall be paid to quality and clarity of illustrations, and to choosing where photographs, line drawings or CAD-generated are most informative. Information in illustrations should complement information presented in other forms and be comprehensible. Illustrations should not be overloaded with information. Visual representations of complex or specific information need to be selective in what detail they show (for example. cross-sections, exploded views, conceptual diagrams and cartoon strips).

In contrast to graphical symbols and safety signs, which should be designed for immediate recognition at a distance, illustrations should be composed so as to focus attention on important details and to be self-explanatory. Illustrations should be chosen or designed individually for each purpose by a competent graphic artist or technical illustrator.

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Whenever appropriate, text and illustrations shall be used together, each supporting the other to make the instructions for use more comprehensible. Information in illustrations and supporting text should be identical and clear. A sequence of illustrations should be logical and comprehensible. Illustrations shall be comprehensible at the expected viewing distance.

In addition to the recommendations in 4.8.3.1, illustrations which fold out, may be placed on pages of the leaflet or manual, so that they can be seen adjacent to different pages of text at different times.

6.3.2 Following a sequence of operations

If a sequence of operations is being described, text and illustrations shall follow the same sequence. Illustrations shall be placed as close as possible to the text to which they relate, so that they can be viewed adjacent to the relevant text.

6.3.3 Illustration with captions

Illustrations should be supplemented with captions providing written details. There shall be a clear relationship between the illustration(s) and the caption text. The caption should be numbered for clear reference from the main text.

6.3.4 One illustration, one item of information

Illustrations should normally provide only information relevant to describing the related function. Illustrations or detailed part(s) of these should be repeated in the relevant part(s) of instructions for use as needed to assist the user. Information overload in illustrations shall be avoided.

However, where proliferation of illustrations would be cumbersome, several items of information may be presented in a single illustration if this will be easier to understand.

6.4 Graphical symbols, including safety signs

6.4.1 Graphical symbols for use on equipment, including safety signs

Graphical symbols shall comply with internationally recognized standards, for example ISO 7010, IEC 60417 and ISO 7000.

6.4.2 Explanation of graphical symbols

Graphical symbols, pictograms, markings and pictorial symbols placed on the product itself or in accompanying materials shall be explained in the instructions for use.

6.4.3 Graphical symbols for diagrams

Graphical symbols for diagrams shall comply with internationally recognized standards, for example IEC 60617 and ISO 14617.

6.4.4 Minimum sizes of graphical symbols

Minimum sizes for graphical symbols in different situations are listed in Table 2. They should be complied with unless smaller sizes are unavoidable because of the dimensions of the product.

6.5 Use of tables

Tables are frequently used in instructions for use in order to present the information to the user in a more convenient form. Tables shall be presented next to the relevant text.

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Tables are useful for different purposes, for example, for referencing and troubleshooting. They shall be set out clearly, informatively, presented in a consistent design and be repeated when necessary.

6.6 Use of appropriate document types

Instructions for use should use those document types which suit best the intended purpose. An overview of established document types is given in IEC 61355. Existing document types for plants, systems and equipment shall be used.

Examples:

• If a specific sequence of operations needs to be documented for a safe and correct use of a product, it is recommended that a flow chart is used. • If a specific safety function of a product needs to be documented, it is recommended that a circuit diagram is used and the related circuitry is highlighted.

6.7 Use of electronic media

6.7.1 General

Electronic media are any modes of communication that can be used to convey the contents of documentation in the form of on-screen displays and/or audibly. These include:

• audio sources; • video sources; • combined video and audio sources; • printable versions of documents which are made readable on-screen through a file exchange format in which the layout matches that of the printed version; • interactive multimedia applications that combine static elements, for example text, images, with dynamic elements, for example video, audio, animations, dynamic symbols, spoken language. They may operate at the same time and users can control them interactively; • on-line context sensitive help systems. These may contain elements of interactive multimedia applications as described above. Furthermore they can offer numerous access and search options; • web-based collaboration applications (like blogs and wikis) which support the creation of content by a virtual team or community.

Instructions for use delivered via electronic media shall take maximum advantage of the chosen media. However, like printed instructions for use, they shall be readily comprehensible by users and follow the requirements of this part of the International Standard (for example, concerning languages, legibility and illustrations).

Accessibility is an important consideration for instructions for use. Care shall be taken to ensure that all users can obtain the information they need. Electronic media should use a medium which would allow the addressing of the widest possible audience, but shall focus on the user, be easy to use and promote comprehension. For example, audio and video or multimedia DVDs should provide a range of sound tracks and sub-title options including a sign language feature for consumers with a hearing impairment and audio description for those with sight impairment.

The Internet potentially offers access to information for users with the greatest range of individual needs, but it is important that barriers to access are not inadvertently introduced by, for example, difficult methods of navigation or use of animations requiring special software. Therefore, when any part of the instructions for use or related information is made available on the Internet, both the presentation of it and all necessary navigation to it should conform to

82079-1 Ed.1 © IEC:2009 – 39 – 82079-1 Ed.1 © CEI:2009 the Web Content Accessibility Guidelines (WCAG) recommended by the World Wide Web Consortium (W3C®).

Where instructions for use are provided ONLY electronically (that is, with no print version available) this shall be clearly indicated at the point of sale and on the packaging, together with the media format and the type of player required to access the instructions for use (for example, personal computers, CD audio or DVD video players).

NOTE Legal regulations may require printed instructions to accompany some products.

6.7.2 Didactic Requirements

The didactic advantages of electronic media compared to print media should be fully utilized for the achievement of better communication results. However care should be taken that users are not overwhelmed by the duration, information density or complexity of electronic sequences.

Therefore:

• instructions in electronic media shall follow the order of activities that the user has to perform; • if complex processes are to be explained, for example, difficult maintenance and repair tasks, a sequence of suitable visual and auditory elements can facilitate the understanding of the user; • the requirement for conveying safety-related information in electronic media, particularly in multimedia applications, shall be the same as for printed media (see 6.8).

Animation sequences may enable the amount of other visual information to be reduced to the basic features needed. Animation sequences shall have synchronized spoken accompaniment or written text.

If advertising or promotional content is included in electronic media, it shall be kept clearly separate from the instructions for use, and viewing of such content shall not be required prior to viewing the instructions for use.

6.7.3 Requirements for downloadable instructions for use Instructions for use in electronic media shall be provided in a form that allows downloading and display without further changes on commonly used computer platforms. Therefore: • the web site shall allow the download of the electronic media at any time; • the web site shall provide either the software needed, or a link for download of the required viewing software.

Electronic media shall be conceived and executed in a manner that allows them to be displayed without further changes on commonly used computer platforms. Therefore:

• the method of distribution shall ensure the ability to access the electronic media from the computer platform at any time; • the computer platform shall be provided with software needed to permit viewing the electronic medium; • the supplier shall guarantee the availability of any proprietary viewer/player necessary to access instructions for use supplied on electronic media.

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6.7.4 Requirements for user interaction

Electronic media applications shall take advantage of dynamic navigation and presentation devices to facilitate rapid location, comprehension and, where appropriate, printing of necessary information. Therefore:

• electronic media applications shall provide a (preferably tree-like) navigation system that facilitates free user movement within the application, as well as access to all individual portions of the application. Points of reference shall facilitate constant user orientation, and make it possible to return to fixed starting points at any time; • appropriate navigation elements such as menus, buttons, hyperlinks, breadcrumbs and bookmarks shall be provided to enable user orientation and interaction with the system. Furthermore, so called hot spots, that is, areas for interaction, may serve as entry points for submenus; • especially for on-line help applications, but also for other advanced multimedia applications, access to topics may be realized using electronic search functions. The most important of these are tables of contents, keyword searches, full text searches, natural- language searches and catchword searches; • to maintain layout clarity for extensive sections of text, texts should be embedded behind clickable subheadings (hot spots). When required, the user can activate these and display or hide individual sections; • print functions may be provided with electronic printable versions of documents as well as on-line help applications. Printable versions shall adapt or exclude multi-media applications and dynamic web page elements that printed pages cannot represent; • how to use software shall, as far as possible, be integrated into the user interface. Where integration is not possible, for example, because of the extent of the information, access shall be directly available, for example, via a help button.

6.8 Making safety-related information prominent and conspicuous

6.8.1 Making text conspicuous

Safety related information shall be emphasized by use of larger and/or different type font or size (see 6.2.1), by use of colours (see 6.9), safety signs and graphical symbols (see 6.4) or other means of making it conspicuous.

6.8.2 Making illustrations conspicuous

Illustrations within safety-related information shall be emphasized by use of colours, shapes, positioning (see 6.3) or other means of making them conspicuous.

Packaging and containers with hazardous contents may require tactile danger warnings in accordance with ISO 11683 if there is a possibility that the contents will be mistakenly misused by people unable to see a visual warning.

6.8.3 Design of warning messages

Warning messages shall be designed consistently and shall be made conspicuous and prominent. In the formulation and design of warning notices, the following shall be taken into account in order to achieve maximum effectiveness:

• start with signal words (see 6.8.6); • limit the text and/or illustrations to the essentials; • make the location, content and style of the warning messages conspicuous in accordance with 6.2; • ensure that the warning messages is visible to the user and to any other people exposed to hazards, from their position during use (see also 6.2.5), and at the right time;

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• explain the nature of a hazard and, if appropriate, its causes; • provide clear guidance on how to avoid a particular hazard; • place warning messages as determined by the risk assessment. Warning messages repeated too frequently may reduce their effectiveness; • state the probable consequences of not avoiding the hazard without playing down the consequences.

6.8.4 Permanence and visibility

Warning messages for special hazards leading to an increased risk when the instructions for safe use have not been followed shall continue to be clearly visible to users during the life of the product. When colours are used in warning messages, discoloration and fading shall be taken into account.

6.8.5 Making warning messages prominent

Warning messages about hazards or restrictions on use (for example NOT SUITABLE FOR CHILDREN UNDER THREE YEARS OF AGE) are crucial for safety and shall be given prominence at least equal to other instructions in documents issued with the product.

6.8.6 Signal words

Warning messages shall always draw attention to themselves. If using signal words, the following shall be used as appropriate. These are set out in ISO 3864-2.

DANGER: the signal word that indicates a hazard with a high level of risk which, if not avoided, will result in death or serious injury,

WARNING: the signal word that indicates a hazard with a medium level of risk which, if not avoided, could result in death or serious injury, and

CAUTION: the signal word that indicates a hazard with a low level of risk which, if not avoided, could result in minor or moderate injury.

The general warning sign as in ISO 3864-2 composed of an equilateral triangle surrounding an exclamation mark in specified safety colours as in ISO 3864 should precede the signal words DANGER, WARNING or CAUTION.

6.9 Colours

6.9.1 Consistency

The use of colours shall be consistent, in addition to being functional and systematic. Any safety signs in instructions for use shall conform to requirements, including colours, specified in the ISO 3864 series.

6.9.2 Colour perception considerations

It should be kept in mind, that a sizeable percentage of users have some form of colour- deficient vision. Therefore, information shall not be presented by the use of colour only; colour is an additional means for the presentation of instructions for use and for the improvement of understanding.

6.9.3 Photocopying/printing considerations

When selecting colours, care shall be taken to select contrasting colours which will remain distinct even after black and white photocopying or printing on a monochrome printer.

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7 Evaluation of conformance to this part of the International Standard

7.1 Claiming conformance to this part of the International Standard

Claims of conformity to this part of the International Standard shall be dependent upon the supplier maintaining the availability of evidence that the instructions for use (including safety information) have been evaluated either by expert desk research or by an empirical evaluation, for example, a usability test, following the requirements and guidance in Annexes A, B and C.

The checklist in Annex B lists types and items of information content that may (depending on the type of product) need to be supplied to some or all users by means of the instructions for use. Conformance could be indicated by items being ticked off one by one if they have been adequately covered.

The checklist in Annex C summarizes the criteria against which to evaluate the effectiveness of instructions for use in communicating the information to consumers and predicting their effectiveness in influencing user behaviour. For most products 100 % effectiveness of instructions for use can neither be achieved nor be measured qualitatively, and so in practice assessment shall be based on subjective judgements. The checklist may also be used as a guide to criticizing items in the instructions for use that are shown not to be effective, rather than just a list of criteria against which to award marks to the document as a whole. Constructive criticism needs to be very specific about the section in need of improvement and the reasons why it is not considered to be effective (and preferably how it could be revised to become effective).

Neither checklist should be assumed to be comprehensive for every type of product. They may need to be supplemented and/or amended in accordance with relevant product standards or (in the absence of such standards) in accordance with standards dealing with comparable products or functions, or in any other appropriate way.

Where a regime of independent certification of conformance is required (whether by legislation, product standards or contractual specification), independent certificates shall state:

• what documentary evidence (that is, research reports or evaluation reports) was submitted by the supplier after the instructions for use were assessed; • whether the evidence referred to the above bullet was based on expert desk research or empirical evaluation; • the name of the body or person who made these assessments.

7.2 Documentary evidence of evaluation

Research reports or evaluation reports shall state:

• what instructions for use and retail packaging were submitted for examination; • the language of the instructions for use which was assessed and approved in compliance with this part of the International Standard; • whether the product sample was supplied fully assembled or was assembled as part of the assessment of the instructions for use; • which aspects of the assessment were based on expert desk research and which on an empirical evaluation; • the name of the body or person(s) who made the assessment; • the name of the body or person(s) responsible for checking and verifying each translation.

No claim of compliance to this part of the International Standard shall be made unless the instructions for use have been evaluated by suitably qualified experts. These experts shall not

82079-1 Ed.1 © IEC:2009 – 43 – 82079-1 Ed.1 © CEI:2009 have been previously involved in the writing of the instructions for use or in the development, design, production or marketing for the product in question. See also Annex A.

NOTE Depending upon the complexity of the product and the extent to which safe and correct use depends on conveying information to the user, instructions for use may need to be evaluated during the development stage and/or there may be a need for internal evaluations and revisions of draft instructions for use to optimise them before they are submitted to a third party for evaluation.

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Annex A (Normative)

Evaluation of instructions for use

A.1 General

Instructions for use should be evaluated in accordance with the following criteria.

A.2 Choice of methodologies for evaluation

Depending upon the complexity of the product and the importance of conveying relevant information to the user in order to ensure safe and correct use, assessment should take the form of:

• desk research by experts outside the product development team; • interactive empirical evaluation of the instructions for use by a panel covering the range of potential users; • a combination of both.

A.2.1 Desk research by experts

Only suitable qualified experts who have no connection with any aspect of the design, production, or marketing of the product and its instructions for use may carry out assessment by desk research.

The actual product (and preferably packaging) shall be available to the researcher or independent evaluator, not just the instructional media.

Comprehensiveness checks should be carried out preferable using the checklist in Annex B.

Effectiveness checks should be carried out preferable using the checklist in Annex C.

It may be necessary for desk research to be supplemented by independent third-party checking; for example, where provision of information at the point of sale is a requirement.

The effectiveness of each translation shall be proofread and evaluated for comprehensibility and linguistic accuracy using the relevant criteria listed in the checklist in Annex C as a guide for comments.

A.2.2 Empirical evaluation by potential users

See Annex E for guidance on empirical methods.

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Annex B (Informative)

Checklist for conformity and comments

NOTE This checklist should not be considered to be comprehensive.

Relevant Items to be checked Compliance Comments clause 1. Identification 1.1 Brand and type designation 5.2 1.2 No. of model, version, type, subgroup 1.3 Expiry date 1.4 Up-to-date check / for example. date of publication of the handbook coverage of product modifications 1.5 Supplier or other information 5.2 1.6 Contact details. of supplier/service agency 5.2 1.7 Certification references 1.8 Requirements of specific product standards 5.2 1.9 Optional modules/extras 4.8 2. Technical specification of the product and its residual hazards 2.1 Functions and range of application 5.2 2.2 Safe and correct use; principal residual hazards, general warnings 5.4 about product or use 2.3 Dimensions — mass — capacity 5.2 2.4 Chemical composition 5.2 2.5 Performance data 5.2 2.6 Supply data for power, gas, water and other consumables (for 5.2 example. detergents, lubricants) 2.7 Energy consumption and methods of measurement used 5.2 2.8 Emission of noise, waste water, etc., with methods of 5.2 measurement used 2.9 Expected product life and intended disposal 2.1 Information on personal protection (for example. clothing) 5.4 0 2.1 Information on dangers to particular vulnerable groups (for 5.4 1 example. potential allergy or strobe effects) 3. Preparing the product for use 4.7 3.1 Safety precautions before installation 3.2 Unpacking 3.3 Safe disposal of packaging 3 4 Installation and assembly (for example. special tools, space for maintenance and repair) 3 5 Storage and protection during intervals in normal use 3.6 Repackaging to prevent damage in transport 3.7 Information on operations to be carried out only by skilled persons. Separation of this information from instructions for use to users. Comprehensiveness of instructions for use to qualified people

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Relevant Items to be checked Compliance Comments clause 4. Operation of products 5.8 — structure from basic to sophisticated operations/functions — meaningful separation between basic product and optional modules 4.1 Basic functions — Complete for correct intended use — Complete for safe intended use — Complete for reasonably foreseeable misuse — Conformity with minimum list in relevant product standard(s) 4.2 Secondary functions(identical to 4.1 above) 4.3 Optional modules and extras 4.4 Personal protection 4.5 Quick references — by reminder cards, stickers or labels — by reference to handbook, etc. 4.6 Disposal of waste products 5. Information needed by user Explanations of visible and audible signals 4.8.2.4 Distinctions between characteristics of normal and 5.8 faulty/dangerous operation Trouble-shooting advice (for example. in the form of Frequently 5.8 Asked Questions and fault detection procedures) – intelligible to consumers and paying due regard to safety 6. Maintenance and cleaning 5.9 6.1 Safety precautions (for example. personal protection, special tools) 6.2 Maintenance and cleaning by users 6.3 Maintenance and cleaning by skilled persons 6.4 Safety/deterioration checks during maintenance 7. Critical safety and health information 5.4 7.1 Safety warnings/cautions — correct locations (for example. to alert, remind, etc) z on product and/or z on packaging and/or z in accompanying material — if relevant, visibility at point of sale — correct use of terms — use of simple/standardized phrases — durability of warnings — conformity with requirements in relevant product standard(s) 7.2 Safety signals 7.3 Information on residual risk 7.4 Safe disposal of product at the end of its useful life 7.5 Environmental impacts of using the product

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Relevant Items to be checked Compliance Comments clause 8. Consistency in design of information and of whole ‘product’ offered 8.1 Integrated design of product and instructions for use - No compensation for design deficiencies 8.2 Consistent terminology on the product itself; on the packaging; in accompanying material, on Web site resources and in marketing media (see clauses 6.2 and 6.3) 8.3 Structure of text and graphics 6.1 — structure follows communication principles — meaningful headings used — unnecessary material excluded to avoid information overload (for example. sales promotion, extensive repetition, too many documents) 8.4 Location(s) and presentation of instructions for use 8.5 Numbered pages and/or paragraphs, with table of contents and/or index appropriate to length and complexity of text. Use of keywords

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Annex C (Informative)

Checklist for communication effectiveness

This list offers criteria for subjectively evaluating each individual item in the instructions for use being assessed – e.g. each on-product warning, each paragraph in leaflets and each graphic. It is only necessary to record comments on those items or sections considered to be in need of improvement. The evaluations should be listed giving the reasons why the item is not considered to be effective (and preferably how it could be altered to become effective).

Relevant Issues that may need to be addressed Evaluation Comments clause 1. Target groups Target group/s specified Instructions for use adequately presented for target Group/s Conventions: How to read this document 2. Location and medium Placement on product, on packaging or in accompanying media meets 4.7 needs of availability and durability Alerting function is appropriate to user’s needs (prominence/ visibility distance, etc ) Place in order or sequence with respect to other information following 6.1 communication principles Grouped under appropriate heading and found in index?? 3. Legibility of text 6.2 Clear typeface and adequate font size (depending on reading distance) Line length and line spacing Contrast with background Durability of legibility of on-product (or on-packaging) text

4. Wording and structure of text 6 Text/use of words — words and phrases not complicated or over-sophisticated — short phrases — one sentence-one command. Not too much information in one sentence — direct active voice and assertive commands Terms used for features and user actions — terms familiar to consumers used if possible — technical features and terms well explained — consistent use of terms Communication principles — encouraging quick reactions (for example. simple and easy information for an emergency) — setting out learning process for complex functions — answering the questions WHERE? WHO? WHAT? WHEN?

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Relevant Issues that may need to be addressed Evaluation Comments clause HOW? WHY?

5. Multiple language variants 4.8.3 Clear differentiation/ identification of languages Each language version checked by a native speaker for comprehensibility and absence of linguistic errors

6. Illustrations 6.3 Clarity of features and actions illustrated at intended viewing distance (lack of ambiguity; self-explanatory without text whenever possible) Sufficient number of illustrations for each one to provide clear and specific information Illustrations supported by clear and helpful captions Clear connections or cross-references between text and illustrations Can be viewed adjacent to relevant text when necessary

7. Use of graphical symbols 6.4 Adequate size to be comprehensible at intended viewing distance Standardized symbols used where possible (in standard colours) Standard design principles (for example. shape and colour) followed for any new symbols Each symbol clearly explained in text

Durability of on-product (or on-packaging) symbols

8. Tables, conceptual diagrams and flow charts 6.5,6.6 Provided and located where appropriate Clearly set out and informative Repeated where necessary

9. Use of colours 6.9 Functional Clear and easily distinguishable Consistent

10 Explanation of visual and audible signals 4.8.2.4 . Clarity of information provided to users Lights, sounds, text displays (or other indications) that may be given by the product at each stage are explained and referred to at each relevant point in the text 11 Instructions for use presented in audio, video or 6.7 . animated text Indicate whether supplementing or replacing instructions for use in text Follow structure and language of text except when this is unsuitable to medium Offer multi-lingual and text/audio options

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Relevant Issues that may need to be addressed Evaluation Comments clause

12 Durability 4.7 . Those items of instructions for use that need to be kept for reference or new users should be in media that offer adequate provision against loss or deterioration in expected (normal) life of product and discouragement of their disposal.

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Annex D (Informative)

Planning the preparation of instructions for use

D.1 General

This Annex provides guidance on planning the preparation of instructions for use. This guidance is based on an example of a plan that includes typical procedures for preparing instructions for use from conception to publication, and is composed of the three phases planning, development and optimisation.

D.2 Restrictions on planning the preparation

The time, resources and priority accorded to the preparation of instructions for use can affect the quality and effectiveness of the information provided for users (for example, if planning is not begun until the product is being manufactured, or the writers are untrained or evaluation is simply a rubber stamping exercise). It is the responsibility of Senior Management to arrange the resources, time plans and quality targets so as to enable the planning, preparation and delivery of effective instructions for use.

a) Senior Management should ensure that the development of instructions for use is considered in parallel with the development of product design and marketing, so that (for example):

• the choice of medium /media to be used to convey instructions for use is made early in the design process (see 4.7.3); • detailed lists of the specific content that will need to be included (instructions, warnings and user information – see section 5) can be compiled throughout the development of the product; • locations where on-product information will need to be presented should be allowed for in the exterior design and surface styling of the product and packaging (see 6.2.5); b) Senior Management should arrange availability (through combination of staff resources and access to external consultants) of all the skills and experience necessary to prepare instructions for use.

Depending on the product, these may include:

• technical document writing; • human error/ergonomics expertise; • graphic art creation; • design/creation of electronic instructional media; • thorough understanding of the product’s development and intended functions; • scientific/technical knowledge and experience necessary to analyse hazards and anticipate damage, wear and faults likely to develop during use; • legal compliance and product liability expertise; • technical translation competence for each language intended to be used.

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A writer who is initially unfamiliar with the product but familiar with the language needs of the target group will be in the best position to take into account the needs of first time users. c) Senior Management should decide (at an early stage) the method of evaluating the draft instructions for use and the agency or individuals who will undertake it, so that sufficient time can be planned for this without delaying production, packaging or meeting legal and contractual requirements.

D.3 Planning preparation in detail (example)

A single example cannot give comprehensive information covering all possible requirements, therefore each step listed here has to be checked against the appropriate requirement depending on complexity, risk, legal issues, etc. This example is for a fairly large scale and comprehensive project, it may nevertheless prove helpful to writers of instructions for simpler products by illustrating the range of processes that may need to be planned.

During the process of creating instructions for use several steps should be considered. The following describes steps which can help ensure that instructions for use are well thought out and provide users with the information they require. The steps described here are intended to be adapted and completed according to the requirements of the party responsible for the development of the instructions for use. a) Analyses, define general conditions

To meet all requirements and ensure that instructions for use are fit for purpose, relevant sources, such as legal requirements, contracts and standards should be investigated. This will provide the basis for the preparation of a list of requirements which the instructions for use shall satisfy. The following should be analysed:

• the product to which the instructions for use relate: aim and function of the product, similar products and their instructions for use, structure of the product, residual risks (from risk assessment), possible problems and troubleshooting, spare parts and options, compliance and conformity, product life; • the proposed market in which the product is going to be used: attributes of the market, channels of distribution of the product; • all legal and normative requirements for all markets, which have to be fulfilled. Usually the legal and normative documents which apply to the product will be known to the product developer; • the relevant target groups: Intended users of the instructions for use, and other persons who are going to be instructed in the use of the product in question.

After completing the above analyses a detailed list of requirements should be drawn up before beginning the preparation of documentation. b) Planning and project management

The development of instructions for use requires special project management and project communication. Tasks, responsibilities, authorization and milestones should clearly be defined. An editorial deadline may be helpful to ensure that all relevant information is provided in time. c) Conceptual design

Instructions for use should be developed on the basis of a well planned concept. A concept is needed to assure consistency and accessibility of the information.

Components of a conceptual design are, but are not restricted to:

• guidelines and definition of the intended information quality;

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• type and structure of the documents to give the user an optimal access to the information; • combination of more than one document, if applicable; • use of text, types of visualization and the coordination of text and visualization; • media concept; • media-specific layout and navigation; • information types (for example. action sequence, component description, screen description, maintenance plan, trouble shooting table, safety note, warning message) and their communication patterns (definition, structure, phrasing and authoring rules); • if the instructions for use are made up of information modules: description and types of modules; • way of using cross references and links; • single-source concept if applicable; • language and general text production rules; • terminology and its use in the instructions for use; • glossary and index, where terminology is of outstanding importance; • globalization and internationalization, preparation for translation and localization.

The concept should be defined and well explained with worked-out and tested examples in an in-house style guide. Especially if the instructions for use are to be produced by a team of technical writers and/or over a longer period of time, a style guide and corresponding training for the technical writers is necessary to assure quality and consistency. The style guide should be presented in a form which makes it easy to use during editing and writing.

Usually a concept is defined for a series of instructions for use. The concept itself should be periodically improved. d) Instructions for use as a part of a product

The development of instructions for use is an integral part of the development and construction of the product.

Especially with respect to safety, the developer of instructions for use should be involved in the risk assessment to make clear the limits of instructions for use, to work out the need for constructional safety, and to get an optimal interplay of the means of construction, for example, inherent safety, safety devices, safety equipment, user interface design, and information such as warning messages, safety notes, training, packaging.

All available sources of feedback from users should be searched for indications of shortcomings in instructions for use supplied with previous similar products, for example, customer complaints, service reports, analyses of causes of accidents and injuries, and reviews of products posted on the Internet.

Wherever skilled persons are required, the text shall state that this is an absolute requirement for safety and/or technical reasons and that no other people shall assemble, operate, maintain or disassemble the machines or item. The qualifications and skills required of the people concerned, are to be clearly stated in the instructions for use or other written documents relevant. e) Research

Research is a crucial factor in the development of instructions for use. If possible the product should be available for the technical writers to assure correct and adequate instructions for use.

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Research interviews should be well planned. Interviewed developers should have the necessary resources and enough time to give all information properly.

Product developers should have a duty to deliver information when the product is going to be changed. A proper change process should be put in place so that the instructions for use can be amended when necessary.

It should be made sure that results from surveillance (for example. complaint management, service, and publications) with effect on the instructions for use will be taken into account.

If existing information is going to be re-used this information should be identified. It should be made sure that the information for re-use is applicable. If necessary such information needs adoption. f) Content creation

Content should be created on the basis of the concept and the research. Chapters and sections should be planned in a table of contents. Every Chapter and section should be assigned to a single information type. Such a plan may serve as a basis for documentation made up of information modules.

Check lists and tools for authoring assistance are helpful to assure correct terminology, phrasing, structure and completeness of information. Authoring tools and editors should support authoring as good as possible.

Early quality control and user tests of draft versions should be performed to reveal and avoid failures at an early stage of the development of the instructions for use. g) Reviews and Quality control

Instructions for use should be carefully reviewed according to the requirements and the style guide by a person skilled in the area of technical communication or with at least 5 years experience in that area. Enough time should be scheduled for this reading and the following editing.

Reviews for technical correctness should be scheduled and performed.

If the requirements are not met by the instructions for use a decision about further editing is necessary. The intention of no failure should be aimed for. h) Quality assurance

Empirical evaluation (user testing) should show whether the instructions for use achieve the aim. User testing should be performed in the development of the whole product including the instructions for use. All improvements should be incorporated within the requirements, quality assurance and style guide to gain a continuous advancement in instructions for use quality. Change lists may be used to organize improvement. i) Translation

In most cases translation cannot be of higher quality than the source text. So a high quality and translation-adequacy of the source text is of paramount importance for the quality and safety of the translated text.

Translation projects should be well planned and managed, including a linguistic and a technical review by persons who have the necessary skills. Appropriate standards for translation services should be taken into account (for example EN 15038). j) Media production

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The produced (for example. printed) instructions for use should be usable for the expected life time of the product. Printed instructions for use should be printed on durable paper.

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Annex E (Informative)

Empirical methods supporting the preparation of instructions for use

E.1 General

A variety of empirical methods can be employed when preparing instructions for use:

• opinion polls (written interviews, oral interviews, focus groups); • usability testing; • self assessments and checklists; • expertise, expert reviews and certification; • independent award or merit schemes; • complaints management, hotlines and service information.

E.2 Methods

E.2.1 Opinion polls

Written Interviews Oral Interviews Focus groups

Scope / Objectives • Analysis of • Assessment/evaluation of • Identification of users' satisfaction documentation regarding needs handling of and working • Target group analysis with the instructions for use • Assessment/evaluation of the documentation • Identification of • Comparison of different regarding handling of and information about use; documents working with the for example why, instructions for use where, how often • Small tasks for appliances can be integrated • Comparison of different • Identification of users' documents/ documentation needs styles

Pros • Low-cost • Substantial avoidance of • Opposing opinions can be misunderstandings discussed • Geographically broad regarding the interpretation spread of target of the questions • The creative potential of the groups reachable group can create proposals • Interviewee can make for solutions • Determination of proposals for change frequency • Easy and practical • Background information and • Statistically explanations possible representative data

Cons • Limited integration of • Time consuming and • Pressure of the group can examples of the relatively expensive restrict expression and instructions for use narrow perspectives • Availability of interviewees • Only limited may be limited • No statistical explanations and representativeness background to the • Trained person as answers interviewer needed • Only qualitative results • Questionnaires should • Representativeness of be developed by results not always experts guaranteed

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E.2.2 Usability-Testing

Scope/Objectives:

• development of new instructions for use/documentation; • testing of instructions for use/documentation or comparison of different documents and • testing of comprehensibility and usability.

Pros:

+ reliable results about the usability of a documentation and + weak points are detectable quickly.

Cons

- special laboratory techniques are needed; - statistical representativeness of the results should be proven and - comparatively cost-intensive.

E.2.3 Self Assessments and Checklists

Scope/Objectives:

• assessment of quality according to technical criteria and • checklists according to standards.

Pros:

+ low-cost; + comparison of different instructions for use with the same criteria possible and + process and changes over time resp. steps for optimizing can be detected.

Cons:

- despite objective assessment criteria, subjective differences in assessment can not be excluded; - no information ascertainable about customers' wishes and requirements and - know-how needed for development of assessment.

E.2.4 Expertise, Expert reviews and Certification

Scope/Objectives:

• assessment of instructions for use according to defined criteria; • analysis of weak points and • arrangements regarding legal disputes.

Pros:

+ expert assessment; + variable range of test criteria; + identification of weak points and + certification of compliance with designated requirements.

Cons:

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- inability to ensure an objective assessment from a single expert; - comparatively high cost (of comprehensive expertise/certificates); - no compulsory requirement to incorporate suggestions for improvement, and - despite certificate, no release from liability.

E.2.5 Findings from independent award or merit schemes

Scope/Objectives:

• certification of high quality of a product according to generally accepted guidelines and • competition with other information products

Pros:

+ independent experts; + low-cost and + comparability of assessment results with those of other information products.

Cons:

- criteria checklist is not tailored to a particular question/problem and - does not necessarily reflect the customer's point of view regarding quality.

E.2.6 Feedback from Complaints Management, Hotlines and Service information

Scope/Objectives:

• ongoing improvement process; • optimization of request handling and • improvement of the information product.

Pros:

+ ongoing feedback; + information can be used for improvement of instructions for use and + hotline costs can be reduced.

Cons:

- no systematic evaluation according to defined criteria; - no quantitative evaluation regarding how common the problem is and - limited to negative responses due to so-called self-selection of participants.

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Bibliography

IEC 60073, Basic and safety principles for man-machine interface, marking and identification – Coding principles for indicators and actuators ISO 7731, Ergonomics – Danger signals for public and work areas – Auditory danger signals ISO 11429, Ergonomics – System of auditory and visual danger and information signals ISO 15006, Road vehicles – Ergonomic aspects of transport information and control systems - Specifications and compliance procedures for in-vehicle auditory presentation ISO/TR 16352, Road vehicles – Ergonomic aspects of in-vehicle presentation for transport information and control systems – Warning systems Web Content Accessibility Guidelines (WCAG) 2.0, B. Caldwell, M. Cooper, L. Reid, G. Vanderheiden, Editors, W3C Recommendation, 11 December 2008