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Blank IEC Form 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.
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