Government of Romania
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UNOFFICIAL TRANSLATION
GOVERNMENT OF ROMANIA
DECISION No 88 / 2003
on radio equipment and telecommunications terminal equipment and the mutual recognition of their conformity
On the basis of the provisions of Article 107 of the Constitution of Romania and of the Article 5, paragraph (2), of Law No 608/2001 concerning the conformity assessment of the products,
The Government of Romania has adopted this Decision:
CHAPTER I - General Aspects
Article 1. - The present Decision establishes the regulatory regime for free circulation, placing on the market, and putting into service in Romanian territory of radio equipment and telecommunications terminal equipment as well as the regime of their conformity assessment and marking. Article 2. - Without prejudice to applicable legislation, the present Decision applies to apparatus defined in Article 5, letter a), which: a) includes, as an integral part or as an accessory, a medical device and an active implantable medical device, within the meaning of the Law No 176/2000 on medical devices; b) constitutes a component or a separate technical unit of a vehicle, within the meaning of Order No 1938/2001 of the Minister of the Public Works, Transports and Housing, for the approval of Regulations on the technical conditions the vehicles are supposed to perform in order to receive the acceptance of rolling on the public roads of Romania-RNTR 2- release 2002. Article 3. - The present decision shall not apply to equipment listed in Annex I. Article 4. - The present decision shall not apply to apparatus exclusively used for activities concerning public security, defence, State security (including the economic well-being of the State in the case of activities pertaining to State security matters) and the activities of the State in the area of criminal law. Article 5. - For the purpose of the present decision the following definitions shall apply: a) apparatus: means any equipment that is either radio equipment or telecommunications terminal equipment or both; b) electronic communications network: means transmission systems and, where applicable, switching or routing equipment and other resources which permit the conveyance of signals by wire, by radio, by optical or by other electromagnetic means, including satellite networks, fixed (circuit- and packet-switched, including Internet) and mobile terrestrial networks, electricity cable systems, to the extent that they are used for the purpose of transmitting signals, networks used for radio and television broadcasting, and cable television networks, irrespective of the type of information conveyed; c) public communications network: means an electronic communications network used wholly or mainly for the provision of publicly available electronic communications services; d) telecommunications terminal equipment: means a product enabling communication or a relevant component thereof which is intended to be connected directly or indirectly by any means whatsoever to interfaces of public communications networks;
1 e) radio equipment: means a product, or relevant component thereof, capable of communication by means of the emission and/or reception of radio waves utilising the spectrum allocated to terrestrial/space radiocommunication; f) radio waves: means electromagnetic waves of frequencies from 9 kHz to 3 000 GHz, propagated in space without artificial guide; g) interface means: (i) a network termination point, which is a physical connection point at which a user is provided with access to public communications network, and/or (ii) an air interface specifying the radio path between radio equipment and their technical specifications; h) equipment class: means a class identifying particular types of apparatus that under the present decision are considered similar and those interfaces for which the apparatus is designed. Apparatus may belong to more than one equipment class; i) technical construction file: means a file describing the apparatus and providing information and explanations as to how the applicable essential requirements have been implemented; j) harmonised standard: means a technical specification adopted by a recognised standards body under a mandate from the Commission in conformity with the applicable procedures, for the purpose of establishing a European requirement, compliance with which is not compulsory; k) harmful interference: means interference which endangers the functioning of a radio navigation service or of other safety services or which otherwise seriously degrades, obstructs or repeatedly interrupts a radiocommunications service operating in accordance with the applicable legislation. Article 6. - (1) The following essential requirements are applicable to all apparatus: a) the protection of the health and the safety of the user and any other person, including the objectives with respect to safety requirements contained in Government Decision No 567/2002 on insurance of the safety of the users of low voltage electric equipment, but with no voltage limit applying; b) the protection requirements with respect to electromagnetic compatibility contained in Government Decision No 1032/2001 on establishing the condition for the placing on the market and setting into function of the electric and electronic apparatus form the point of view of electromagnetic compatibility. (2) Radio equipment shall be so constructed that it effectively uses the spectrum allocated to terrestrial/space radio communication and orbital resources so as to avoid harmful interference. (3) Additional requirements may also apply to specific equipment classes or certain types of apparatus when a measure has been adopted by the European Commission determining that the apparatus shall be so constructed that: a) it interworks via networks with other apparatus and that it can be connected to interfaces of the appropriate type throughout the European Union and Romania; and/or that b) it does not harm the network or its functioning nor misuse network resources, thereby causing an unacceptable degradation of service; and/or that c) it incorporates safeguards to ensure that the personal data and privacy of the user and of the subscriber are protected; and/or that d) it supports certain features ensuring avoidance of fraud; and/or that e) it supports certain features ensuring access to emergency services; and/ or that f) it supports certain features in order to facilitate its use by users with a disability. (4) The additional requirements specified in paragraph (3) will be adopted by Order of Minister of Communications and Information Technology and published in the Official Gazette of Romania, Part I.
CHAPTER II - Notification and publication of interface specifications
2 Article 7. - (1) Operators of public telecommunications networks shall provide the Ministry of Communications and Information Technology with accurate and adequate technical specifications of all interfaces offered by them before the services provided through such interfaces are made publicly available. (2) For the purposes of the previous paragraph, the specifications should include: a) sufficient details of technical interface specifications to permit the design of telecommunications terminal equipment capable of using all services provided through the corresponding interface; b) all the information necessary to allow manufacturers to carry out relevant tests to check the essential requirements applicable to telecommunications terminal equipment. (3) The Ministry of Communications and Information Technology is responsible for ensuring publication by electronic means of the technical specifications of the interfaces referred to in paragraph (1), after their reception from the operators of public telecommunications networks. Article 8. - The operators of public communications network are obliged to provide the information specified in Article 7, paragraphs (1) and (2), whenever so requested by interested parties. Article 9. - The operators of public communications network are obliged to provide the Ministry of Communications and Information Technology with any change of the technical specifications of the interfaces, under the terms of the Article 7, for their publishing by electronic means.
CHAPTER III - Placing on the market
Article 10. - The apparatus is placed on the market only if it complies with the appropriate essential requirements identified in Article 6 and the other relevant provisions of this Decision when it is properly installed and maintained and used for its intended purpose. Article 11. - Manufacturer of apparatus or person responsible for placing such apparatus on the market are obliged to: a) provide all information for the user on the intended use of the apparatus, written in Romanian, and in other languages of international circulation, too; b) supply the user with a declaration of conformity to the essential requirements, written in Romanian, together with the apparatus. Article 12. - For the purposes of the Article 11, letter a), the packaging and instructions for use of radio equipment should expressly: a) contain an indication as to whether the radio equipment is intended to be used in Romania; b) alert the user, when appropriate, to any possible restrictions or requirements for authorisation of the use of such radio equipment. Article 13. - (1) In the case of radio equipment using frequency bands whose use is not harmonised throughout the European Union and Romania the manufacturer or his authorised representative established within the European Union or Romania or the person responsible for placing the equipment on the market shall notify the Inspectorate General for Communications and Information Technology in writing of the intention to place such radio equipment on the market. (2) The notification specified in paragraph (1), should be provided not less than four weeks before the date it is intended to place such radio equipment on the market and in particular must contain: a) information on its radio characteristics, in particular its frequency bands, channel spacing, type of modulation and RF power; b) where appropriate, the identification number of the notified body or bodies contacted for the purposes of the provisions specified in Annex IV or V. (3) The notification procedure and content will be adopted by an Order of the Minister of Communications and Information Technology and published in the Official Gazette of Romania, Part I.
3 (4) The Inspectorate General for Communications and Information Technology is responsible for evaluating the information supplied, and may at any time place conditions on the putting into service of radio equipment in the situations specified in Article 17. The apparatus whose putting into services may be restricted are listed in Annex VIII. (5) The Inspectorate General for Communications and Information Technology shall periodically update the list of the apparatus specified in Annex VIII according as the usage of frequency bands are harmonised in the European Union and Romania. Article 14. - For the purposes of the provisions of Article 11, letter a), telecommunications terminal equipment must prominently display information that makes it possible to identify the public communications network interfaces to which the equipment is intended to be connected. Article 15. - In the situations referred to in Article 6, paragraph (3), and in the event of apparatus that has already been placed on the market, the apparatus may be maintained in the market for the period indicated in the regulations specified in Article 6, paragraph (4).
CHAPTER IV - Putting into service and right to connect
Article 16. - Apparatus shall be allowed to be put into service for its intended use provided that it complies with the suitable essential requirements specified in Article 6 and any other relevant provisions of this Decision. Article 17. - Not withstanding Article 16, and without prejudice to conditions attached to authorisations for the provision of the service using radio equipment, the Inspectorate General for Communications and Information Technology may restrict the putting into service of radio equipment only for reasons related to the effective and appropriate use of the radio spectrum, avoidance of harmful interference or matters relating to public health. Article 18. - Without prejudice to Article 19, operators of public communications networks shall not refuse to connect telecommunications terminal equipment to appropriate interfaces on technical grounds, where that equipment complies with the essential requirements specified in Article 6. Article 19. - (1) The Ministry of Communications and Information Technology may authorise a public network operator to refuse connection, disconnect apparatus that has complied with the suitable essential requirements or withdraw it from service, when it considers that such apparatus: a) causes serious damage to a network; b) causes harmful interference; c) harms the network or its functioning. (2) Authorisation by Ministry of Communications and Information Technology should be preceded by a duly reasoned request by the operator, accompanied by a set of general elements to be defined by Ministry of Communications and Information Technology, including the following: a) proof of confirmation of the situations specified in the paragraph (1); b) proof of the conformity assessment of the apparatus and its compliance with the essential requirements; c) reference to the harmonised standards or other standards which have been applied as well as others to be defined by Ministry of Communications and Information Technology in secondary legislation, published in the Official Gazette of Romania, Part I; d) clarifications and additional elements from the operator, where applicable. (3) The Ministry of Communications and Information Technology shall inform the operator on the said decision, within no longer 30 days, specifying the reasons for adopting it. Article 20. - (1) In duly proven emergency situations the operator may disconnect apparatus without prior authorisation from the Ministry of Communications and Information Technology, provided that both of the following conditions are complied with: a) if the protection of the network requires the apparatus to be disconnected without delay; b) if the user can be offered an alternative solution without any delay or cost.
4 (2) The operator must immediately inform the Ministry of Communications and Information Technology, presenting proof of the urgency of procedures and verification of the conditions specified in the paragraph (1). (3) The Ministry of Communications and Information Technology, after analysis of the documentation presented by the operator, shall decide whether the operator should reconnect the apparatus, or maintain the decision to disconnect the apparatus. CHAPTER V - Conformity assessment
Article 21. - The conformity assessment procedures identified in Article 23, paragraph (2), Articles 24, 25, 26 shall be used to demonstrate the compliance of the apparatus with all the relevant essential requirements identified in Article 6. Article 22. - (1) Apparatus is presumed to conform with the applicable essential requirements identified in Article 6 if it meets the relevant harmonised standards or parts thereof which cover these essential requirements, and whose reference numbers have been published in the Official Journal of the European Communities. (2) The list of Romanian standards which have adopted relevant harmonised standards is approved by an order of the Minister of Communications and Information Technology and published in the Official Gazette of Romania, Part I, within 60 days after the date of the publication of the present decision. The list of standards is updated in due course. Article 23. - (1) The presumption identified in Article 22, paragraph (1) does not preclude the need for conformity assessment with essential requirements, under the terms of the present decision. (2) At the choice of the manufacturer, compliance of the apparatus with the essential requirements identified in Article 6, paragraph (1), letter a) and b) may be demonstrated using the procedures specified in Government Decision No 567/2002 and Government Decision No 1032/2001 respectively, where the apparatus is within the scope of those Government Decisions, as an alternative to the procedures identified in Article 24, 25, 26. (3) The Romanian standards which have been published in the Official Gazette of Romania, Part I, in accordance with provisions of Government Decision No 567/2002 and Government Decision no 1032/2001, and which adopted the standards whose references have been published in the Official Journal of the European Communities, may be used as the basis for a presumption of conformity with the essential requirements referred to Article 6, paragraph (1), letters a) and b). (4) The common technical regulations whose references have been published in the Official Journal of the European Communities and which have been transposed as national regulations may be used as the basis for a presumption of conformity with the other relevant essential requirements referred to in Article 6. Article 24. - Telecommunications terminal equipment which does not make use of the spectrum allocated to terrestrial/space radio communication and receiving parts of radio equipment shall be subject to the procedures described in any one of Annexes II, IV or V at the choice of the manufacturer. Article 25. - Where a manufacturer has applied the harmonised standards referred to in Article 22, paragraph (1), radio equipment not within the scope of Article 24 shall be subject to the procedures described in any one of Annexes III, IV or V at the choice of the manufacturer. Article 26. - Where a manufacturer has not applied or has only applied in part the harmonised standards referred to in Article 22, paragraph (1), radio equipment not within the scope of Article 24 shall be subject to the procedures described in either of Annexes IV or V at the choice of the manufacturer. Article 27. - Records and correspondence relating to the conformity assessment procedures referred to in Article 23, paragraph (2), Articles 24, 25, 26 shall be in Romanian or English language.
CHAPTER VI - CE conformity marking and inscriptions
5 Article 28. - (1) Apparatus complying with all relevant essential requirements shall bear the CE conformity marking referred to in Annex VII. (2) CE conformity marking shall be affixed under the responsibility of the manufacturer, his authorised representative within the European Community or Romania, or the person responsible for placing the apparatus on the market. (3) Where the conformity assessment procedure is carried out in accordance with Annexes III, IV or V, marking shall be accompanied by the identification number of all notified bodies involved. Article 29. - (1) The marking of radio equipment shall in addition be accompanied by the equipment class identifier where such identifier has been assigned. The class identifier is specified in Annex VII. (2) In the case of radio equipment, the mark shall also include a user information item that the apparatus uses frequency bands whose use has not been harmonised throughout the European Union and Romania. Article 30. - (1) The CE conformity marking affixed, as laid down in Articles 28 and 29 shall be legible, indelible affixed visible on the apparatus, or on the respective characteristics plate, as well as on the packaging and on the instructions manual that accompanies the apparatus. (2) The affixing of markings on apparatus that are likely to mislead third parties as to the meaning or form of the CE marking, specified in Annex VII, is prohibited. (3) Any other marking may be affixed to the equipment provided that the visibility and legibility of the CE marking is not thereby reduced. Article 31. - Apparatus shall be identified by the manufacturer by means of type, batch and/or serial numbers and by the name of the manufacturer or the person responsible for placing the apparatus on the market. Article 32. - (1) Where the apparatus is subject to other specific regulations which concern other aspects, transposed on the basis of European Directives and also provide for the affixing of the CE marking, the latter shall indicate that such apparatus also fulfils the provisions of those other regulations. (2) However, should one or more of those specific regulations allow the manufacturer, during a transitional period, to choose which arrangements to apply, the CE marking shall indicate that the apparatus fulfils the provisions only of those regulations applied by the manufacturer. The documentation, information and instructions manuals, which accompany the apparatus, should include a version in Romanian language and contain express indication of those specific regulations with which the apparatus is in conformity. Article 33. - At trade fairs, exhibitions, demonstrations, etc., is allowed the display of apparatus which does not comply with this Decision, provided that a visible sign clearly indicates that such apparatus may not be marketed or put into service until it has been made to comply.
CHAPTER VII - Notified bodies and surveillance authorities
Article 34. - (1) The procedure on national designation and notification of notified bodies to carry out relevant tasks in relation to perform the assessment of conformity of products for radio equipment and telecommunications terminal equipment are adopted in accordance with the legislation in force through the Order of the Minister of Communications and Information Technology, in accordance with the criteria provisioned in Annex VI. (2) The Ministry of Communications and Information Technology is responsible for designating the notified bodies, which shall carry out relevant tasks, referred to in Annex III, IV and V. (3) Before the entering into force of the Protocol to the Europe Agreements on Conformity Assessment and Acceptance of Industrial Products (PECA) or Romania’s accession to European Union the notified bodies will be called approved certification bodies. The Ministry of Communications and Information Technology shall publish and shall periodically update the list including the approved certification bodies, approved through the Order of the Minister of
6 Communications and Information Technology. The list shall be published in the Official Gazette of Romania, Part I. After the transition period Romania notifies the approved certification bodies to the Commission, according to the special provisions foreseen in the PECA or in the directives, these become notified bodies and should be included in the list of notified bodies of the Official Journal of the European Communities. Article 35. - (1) The Ministry of Communications and Information Technology is competent authority for market surveillance in the field of the radio equipment and telecommunications terminal equipment for the purpose to ensure that the provisions of the present Decision are complied. (2) The Inspectorate General for Communications and Information Technology is responsible to exercise the control and surveillance activities on the market of the radio equipment and telecommunications terminal equipment. (3) Finding and punishment of the contravention in the case of the apparatus intended for consumers, as natural persons, may be performed by the National Authority for Consumer Protection. Article 36. - (1) The control and surveillance activities referred to the Article 35, paragraphs (2) and (3), planned or under notification of the anyone interested person, are exercised by inspection staff special empowered to fulfil this tasks. The inspection staff shall have to: a) get free access, whenever is necessary, under the applicable legal provisions, to the premises where the manufacturers or his authorised representatives established in Romania, the importers, the dealers, operators of communications networks and other users of the apparatus, as well as the persons which assemble, hold, install, connect or maintain the apparatus, develop works which constitute the object of the provisions of this Decision; b) request and retain any document and any necessary information for the inspection purposes to ensure that the provisions of the present Decision are complied; c) seal, retain and request the performance of tests on the apparatus for which exist grounds to suppose that the provisions of the present Decision are uncomplied; d) take any other necessary measures in given situation, under the applicable legal provisions. (2) The manufacturer or his authorised representative established within the European Union or Romania or the person responsible for placing the equipment on the market must hold and present, by request of the inspection staff, the documents certifying that the provisions of the present Decision are complied; (3) The inspection staff is bound to: a) not disclose the information gained in carrying out its tasks; b) keep confidentiality regarding the sources of information connected with the complaints and intimations received. Article 37. - (1) The Inspectorate General for Communications and Information Technology may undertake, at any time, suitable tests in order to check the conformity of apparatus with the applicable essential requirements, contained in declaration of conformity. (2) The costs resulting from carrying out tests on apparatus performed under the terms of the paragraph (1), will be met by the Inspectorate General for Communications and Information Technology. (3) Unless such apparatus is found to fail to conform with the applicable essential requirements, in which case the costs resulting from carrying out tests of apparatus performed under the terms of the paragraph (1), will be met by the manufacturer, his legal representative or the person responsible for placing the apparatus on the market. If any of these persons is not identifiable, the holder of the apparatus will meet these costs. Article 38. - (1) Where the Ministry of Communications and Information Technology ascertains that apparatus within the scope of the present Decision does not comply with the requirements of this Decision, it shall take all appropriate measures to withdraw the apparatus from the market or from service, prohibit its placing on the market or putting into service or restrict its free movement.
7 (2) The Ministry of Communications and Information Technology may prohibit or restrict the placing on the market or require the withdrawal from the market of radio equipment, including types of radio equipment, which has caused or which it reasonably considers will cause harmful interference, including interference with existing or planned services on frequency bands referred in the National Table of Frequency Bands Allocations. (3) In the event that the Ministry of Communications and Information Technology takes a decision in accordance with the provisions of the paragraphs (1) or (2), it shall specify the reasons for adopting them and whether non-compliance is due to: a) incorrect application of the harmonised standards referred to in Article 22; b) shortcomings in the harmonised standards referred to in Article 22; c) failure to satisfy the requirements referred to in Article 6, where the apparatus does not meet the harmonised standards referred to in Article 22; d) the causes associated to harmful interference
CHAPTER VIII – Contravention and sanctions
Article 39. - The following deeds are considered contravention and are punished as follows: a) infringement upon the provisions of Articles 8, 10, 11, Article 13, paragraph (1) and (2); Article 16, Article 32, paragraph (1), fine from 50000000 ROL to 100000000 ROL, as well as withdrawing from the market or from service of the apparatus, prohibiting its placing on the market or putting into service, according to Article 38; b) infringement upon the provisions of Articles 14, 24, 28, 29, 30, 31, Article 32, paragraph (2), Article 33, fine from 25000000 ROL to 50000000 ROL, as well as withdrawing from the market or from service of the apparatus, prohibiting its placing on the market or putting into service, according to Article 38; c) if the person who affixed the marking, infringing upon Articles 28, 29 and 30 paragraph (2), is not identifiable, appropriate action may be taken against the holder of the apparatus at the time when non-compliance was discovered, applying the provisions specified in letter b); d) infringement upon the provisions of Annex II, points 5 and 7, Annex III, point 5, Annex IV, points 2 and 6, Annex V, points 14, 15, 19 and 24, fine from 25000000 ROL to 50000000 ROL, as well as prohibiting placing on the market of the apparatus or its putting into service until to the deadline for non-conformity elimination, settled by inspection staff, according to Article 36, paragraph (1), together with the manufacturer, his legal representative or the importer, as the case may be; e) infringement upon the provisions of Article 7, paragraphs (1) and (2), Article 9, Article 18, Article 20, paragraphs (2), fine from 50000000 ROL to 100000000 ROL. f) Infringement upon the provisions of the Article 43, fine from 50000000 ROL to 100000000 ROL and the seizure of the apparatus withdrawn from the market or from service. Article 40. - (1) The finding of contravention provided in Article 39 and the applications of the sanctions shall be performed by the inspection staff of the Inspectorate General for Communications and Information Technology, special empowered to fulfil this tasks, under notification of the anyone interested person or ex officio. (2) The finding of contravention provided in Article 39, letters a), b), d) and the applications of the adequate sanctions, in the case of the apparatus intended for consumers, as natural persons, shall be performed also by the inspection staff of the National Authority for Consumer Protection, special empowered to fulfil this tasks, under notification of the anyone interested person or ex officio. Article 41. - The contravention provided in Article 39 are under the provisions of the Government Ordinance No 2/2001 regarding legal regime of the contravention, approved with adjustments by the Law No 180/2002, with the subsequent amendments, and excepting Articles 28 and 29 of this ordinance.
8 Article 42. - (1) In the case of finding the contravention and the applications of the sanctions provided in Article 39, letters a) or b), the inspection body shall inform, in writing, the Ministry of Communications and Information Technology, within 3 days. (2) The Ministry of Communications and Information Technology shall confirm the applied sanction and to notify confirmation of this sanction to the manufacturer, his legal representative or the importer of the apparatus, as the case may be. (3) The Ministry of Communications and Information Technology must publish in the Official Gazette of Romania, Part I, the notification of decision of withdrawing from the market or from service of non-conformable apparatus, of prohibiting its placing on the market or putting into service. The notification also may be published in national daily or speciality magazine, depending on the type of radio equipment or telecommunications terminal equipment. Article 43. - The manufacturer, his legal representative or the importer of the apparatus, as the case may be, must require to the Inspectorate General for Communications and Information Technology the inventorying and sealing of the withdrawn apparatus, within 60 days from the notification of decision to withdraw from the market or from service the type of non-conformable apparatus, provided to Article 39, letters a) and b).
CHAPTER IX – Transitory provisions
Article 44. - Until the signing of the Protocol to the Europe Agreements on Conformity Assessment and Acceptance of Industrial Products (PECA), if the conformity assessment of one apparatus intended to national market involve the participation of one notified body designated according to Article 34, the manufacturer or his legal representative must apply national conformity marking CS. The pattern of the CS marking is specified in Annex VII. Having entered into force of the Protocol to the Europe Agreements on Conformity Assessment and Acceptance of Industrial Products (PECA), the apparatus will bear only the CE conformity marking in accordance with the provisions of the chapter VI of this Decision. Article 45. - Radio equipment and telecommunications terminal equipment may be placed on the market and put into service according to the authorisation documents provided by the Order of the Minister of Communications and Information Technology No 259/2002, on the designation of the Inspectorate General for Communications and Information Technology to issue the type approval for the radio equipment and telecommunications terminal equipment and the import purchase agreement for the radio equipment, if they were placed on the market for the first time before the present Decision entered into force but only until to the date of repeal of the Order No 259/2002, in accordance with the provisions of Article 48, paragraph (2).
CHAPTER X – Final provisions
Article 46. - (1) This Decision is not a specific regulation within the meaning of Article 1, paragraph (2) of Government Decision No 1032/2001 on establishing the conditions for placing on the market and putting into service of the electric and electronic apparatus from the point of view of electromagnetic compatibility. The provisions of Government Decision No 1032/2001, shall not apply to apparatus falling within the scope of this Decision, with the exception of the protection requirements in Article 3, paragraph (1) and Annex 1 and the conformity assessment procedure in Article 5, paragraph (2), letters a) and b) to Government Decision No 1032/2001. (2) The provisions of Government Decision No 567/2002 on insurance of the safety of the users of low voltage electric equipment shall not apply to apparatus falling within the scope of this Decision, with the exceptions of the objectives with respect to safety requirements in Article 2, paragraph (1) and Annex 2 and the conformity assessment procedure in Annex 5 to Government Decision No 567/2002. Article 47. - The Annexes I-VIII are part of the present Decision.
9 Article 48. - (1) The present Decision shall enter into force within three months from the date of its publication in the Official Gazette of Romania, Part I, except of the provisions of Article 22, paragraph (2) and of Article 34, which enter into force at the date of publishing of this decision. (2) As from the day of entry into force of the present Decision, the Order of the Minister of Communications and Information Technology No 259/2002, published in the Official Gazette of Romania, Part I, No 788 of October 30, 2002, must be repealed. Article 49. – The present Decision transposes Directive 1999/5/EC of the European Parliament and of the Council on radio equipment and telecommunications terminal equipment and the mutual recognition of their conformity.
PRIME-MINSTER
ADRIAN NASTASE
10 Annex I
EQUIPMENT NOT COVERED BY THIS DECISION AS REFERRED TO IN ARTICLE 3
1. Radio equipment used by radio amateurs within Article 1, definition 53, of the International Telecommunications Union (ITU) radio regulations, unless the equipment is available commercially. 2. Kits of components to be assembled by radio amateurs and commercial equipment modified by and for the use of radio amateurs are not regarded as commercially available equipment. 3. Equipment falling within the scope of the Order of Minister of the Transports No216/2000 on marine equipment. 4. Cabling and wiring. 5. Receive only radio equipment intended to be used solely for the reception of sound and TV broadcasting services. 6. Products, appliances and components in the field of civil aviation, transposed by the Orders of Minister of the Transports No 247/1999 and No 785/2000 and Order of Minister of the Public Works, Transports and Housing No 44/2002. 7. Air-traffic-management equipment and systems.
11 Annex II
CONFORMITY ASSESSMENT PROCEDURE REFERRED TO IN ARTICLE 24 Module A (internal production control)
1. This Annex describes the procedure whereby the manufacturer or his authorised representative established in the European Union or Romania, ensures and declares that the products concerned satisfy the applicable requirements. 2. The manufacturer must establish the technical documentation, which must enable the conformity of the product with the essential requirements to be assessed, and must cover the design, manufacture and operation of the product. 3. For the purposes of the previous point, the technical information should contain: a) a general description of the product; b) conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.; c) descriptions and explanations necessary for the understanding of said drawings and schemes and the operation of the product; d) a list of the harmonised standards applied in full or in part, and descriptions and explanations of the solutions adopted to meet the applicable essential requirements of present Decision where such standards have not been applied or do not exist; e) results of design calculations made, examinations carried out, etc.; f) test reports. 4. The manufacturer must take all measures necessary in order that the manufacturing process ensures compliance of the manufactured products with the technical documentation referred to in points 2 and 3 and with applicable requirements of this Decision. 5. The manufacturer or his authorised representative established in the European Union or Romania must keep the technical documentation for surveillance purposes, for a period ending at least 10 years after the last product has been manufactured. 6. Where neither the manufacturer nor his authorised representative is established in the European Union or Romania, the obligation to keep the technical documentation available is the responsibility of the person who places the product on the market. 7. The manufacturer or his authorised representative when established in the European Union or Romania must affix the CE mark to each equipment and draw up a written declaration of conformity, keeping a copy of this declaration together with the technical documentation.
12 Annex III
CONFORMITY ASSESSMENT PROCEDURE REFERRED TO IN ARTICLE 25 (Internal production control plus specific apparatus tests)
This Annex consists of Annex II, plus the following supplementary requirements: 1. For each type of apparatus, all essential radio test suites must be carried out by the manufacturer or on his behalf. 2. The identification of the test suites that are considered to be essential is the responsibility of a notified body chosen by the manufacturer except where the test suites are defined in the harmonised standards. 3. In the determination of the test suites to be carried out, the notified body must take due account of previous decisions made by notified bodies acting together. 4. The manufacturer, his authorised representative or importer, in any case established in the European Union or Romania must: a) declare that these tests have been carried out; b) declare that the apparatus complies with the essential requirements; c) affix the notified body's identification number during the manufacturing process. When the essential radio test suites are defined in the harmonised standards is not still necessary to apply the notified body's identification number to the apparatus.
13 Annex IV
CONFORMITY ASSESSMENT PROCEDURE REFERRED TO IN ARTICLE 26 (Technical construction file)
This Annex consists of Annex III plus the following supplementary requirements: 1. The manufacturer must establish a technical construction file composed of the following elements: a) the technical documentation described in point 3 of Annex II; b) declaration of conformity to specific radio test suites described in point 3 of Annex III. 2. The manufacturer, his authorised representative established in the European Union or Romania, or the person responsible for placing the apparatus on the market, must present the file to one or more notified bodies. 3. Whenever the technical construction file is presented to more than one notified body, the entities identified in point 3 must inform each of the notified bodies of others who have received the file. 4. The notified body must review the technical construction file and within a maximum of four weeks of receipt of the file may either: a) Issue an opinion to the manufacturer, his authorised representative established in the European Union or Romania , or the person responsible for placing the apparatus on the market that it has not been properly demonstrated that the requirements of the present Decision have been met, and must inform the other notified bodies who have received the file accordingly; or, b) Issue an opinion to the entities identified in the letter a) that the file proves compliance with the requirements established by the present Decision. 5. After confirmation of either of the previous two possibilities, the apparatus may be placed on the market, without prejudice to Article 13, paragraph (1) and Article 20. 6. The manufacturer or his authorised representative established in the European Union or Romania, or the person responsible for placing the apparatus on the market must keep the technical construction file for a period ending at least 10 years after the last apparatus has been manufactured at the disposal of the relevant national authorities for inspection.
14 Annex V
CONFORMITY ASSESSMENT PROCEDURE REFERRED TO IN ARTICLE 24, 25 and 26 (Full quality assurance)
1. Full quality assurance is the procedure whereby the manufacturer who satisfies the provisions of point 2 ensures and declares that the products concerned satisfy the requirements of the present Decision that apply to them. 2. The manufacturer must affix the marks referred to in Article 28, Article 29 and Article 31 of the present Decision to each product and draw up a written declaration of conformity. 3. The manufacturer must operate an approved quality system for design, manufacture and final product inspection and testing as specified in points 4 to 17 and must be subject to surveillance as specified in points 18 to 23 of the present Annex. 4. For the purposes of the terms of the previous point, the manufacturer must lodge an application for assessment of his quality system with a notified body. 5. The application must include: a) all relevant information for the products envisaged; b) the quality system's documentation. 6. The quality system must ensure compliance of the products that are submitted to it with the essential requirements that apply to them. 7. All the elements, requirements and provisions adopted by the manufacturer must be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. 8. The quality system documentation referred to in the previous point must ensure a common understanding of the quality policies and procedures such as quality programmes, plans, manuals and records. This must contain in particular an adequate description of: a) the quality objectives and the organisational structure, responsibilities and powers of the management with regard to design and product quality; b) the technical specifications, including the harmonised standards and technical regulations as well as relevant test specifications that will be applied and, where the standards referred to in Article 22, paragraph (1) will not be applied in full, the means that will be used to ensure that the essential requirements of the present Decision that apply to the products will be met; c) the design control and design verification techniques, processes and systematic actions that will be used when designing the products pertaining to the product category covered; d) the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used; e) the examinations and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out, as well as the results of the tests carried out before manufacture where appropriate; f) the means by which it is ensured that the test and examination facilities respect the appropriate requirements for the performance of the necessary test; g) the quality records, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.; h) the means to monitor the achievement of the required design and product quality and the effective operation of the quality system. 9. The notified body must assess the quality system to determine whether it satisfies the requirements referred to in the previous point. 10. The notified body must presume compliance with the requirements specified in point 8 in respect of quality systems that implement the relevant harmonised standard. 11. The notified body must assess in particular whether the quality control system ensures conformity of the products with the requirements of the present Decision in the light of the relevant
15 documentation supplied in respect of points 5 and 8 of the present Annex, including, where relevant, test results supplied by the manufacturer. 12. For the purposes of the previous point, the auditing team must include an assessment visit to the manufacturer's premises, and must have at least one member experienced as an assessor in the product technology concerned. 13. The decision must be notified to the manufacturer. The notification must contain the conclusions of the examination and the reasoned assessment decision. 14. The manufacturer must undertake to fulfil the obligations arising out of the quality system as approved and to uphold it so that it remains adequate and efficient. 15. The manufacturer or his authorised representative must keep the notified body that has approved the quality system informed of any intended updating of the quality system. 16. The notified body must evaluate the modifications proposed under the terms of the previous point and decide whether the amended quality system will still satisfy the requirements referred to in point 8 of the present annex or whether a reassessment is required. 17. The decision by the notified body, under the terms of the previous point, including the conclusions of the examination and the reasoned assessment decision, must be notified to the manufacturer. 18. The purpose of surveillance to be carried out by notified bodies is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system. 19. The manufacturer must allow the notified body access for inspection purposes to the locations of design, manufacture, inspection and testing, and storage and must provide it with all necessary information, in particular: a) the quality system documentation; b) the quality records as foreseen by the design part of the quality system, such as results of analyses, calculations, tests, etc.; c) the quality records as foreseen by the manufacturing part of the quality system, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc. d) the manufacturer must permit visits to be made by the notified body to its premises without prior notice; 20. The notified body must carry out audits at reasonable intervals to make sure that the manufacturer maintains and applies the quality system. 21. For the purposes of the terms of the previous point, the notified body must provide an audit report to the manufacturer. 22. Additionally, the notified body may pay unexpected visits to the manufacturer. At the time of such visits, the notified body may carry out tests or have them carried out in order to check the proper functioning of the quality system where necessary; 23. The notified body must provide the manufacturer with a report of the visit made under the terms of the previous point and, if a test has been carried out, with a test report. 24. The manufacturer must, for a period ending at least 10 years after the last product has been manufactured, keep at the disposal of the national authorities for surveillance: a) the documentation referred to in point 5, letter b) of the present Annex; b) the updating of the quality system referred to in point 15 of the present Annex; c) the decisions and reports from the notified body that are referred to in points 17, 22 and 23 of the present Annex. 25. Each notified body must make available to the other notified bodies the relevant information concerning quality system approvals including reference to the product(s) concerned, issued and withdrawn.
16 Annex VI
MINIMUM CRITERIA TO BE TAKEN INTO ACCOUNT WHEN DESIGNATING NOTIFIED BODIES IN ACCORDANCE WITH ARTICLE 34
1. The notified body, its director and the staff responsible for carrying out the tasks for which the notified body has been designated must not be a designer, manufacturer, supplier or installer of radio equipment or telecommunications terminal equipment, or a network operator or a service provider, nor the authorised representative of any of such parties. They must be independent and not become directly involved in the design, construction, marketing or maintenance of radio equipment or telecommunications terminal equipment, nor represent the parties engaged in these activities. This does not preclude the possibility of exchanges of technical information between the manufacturer and the notified body. 2. The notified body and its staff must carry out the tasks for which the notified body has been designated with the highest degree of professional integrity and technical competence and must be free from all pressures and inducements, particularly financial, which might influence their judgement or the results of any inspection, especially from persons or groups of persons with an interest in such results. 3. The notified body must have at its disposal the necessary staff and facilities to enable it to perform properly the administrative and technical work associated with the tasks for which it has been designated. 4. The staff responsible for inspections must have: - sound technical and professional training; - satisfactory knowledge of the requirements of the tests or inspections that are carried out and adequate experience of such tests or inspections; - the ability to draw up the certificates, records and reports required to authenticate the performance of the inspections. 5. The impartiality of inspection staff must be guaranteed. Their remuneration must not depend on the number of tests or inspections carried out nor on the results of such inspections. 6. The notified body must take out liability insurance unless its liability is assumed by the state in accordance with national law. 7. The staff of the notified body is bound to observe professional secrecy with regard to all information gained in carrying out its tasks under this Decision.
17 Annex VII
CONFORMITY MARKING AND CLASS IDENTIFIER
A. CE Marking
1. The CE conformity marking must consist of the initials “CE” taking the following form:
If the CE marking is reduced or enlarged, the proportions given in the above graduated drawing must be respected. 2. The CE marking must have a height of at least 5 mm except where this is not possible on account of the nature of the apparatus. 3. The CE marking must be affixed to the product or to its data plate. Additionally it must be affixed to the packaging, if any, and to the accompanying documents. 4. The CE marking must be affixed visibly, legibly and indelibly.
B. Class identifier
1. Radio Equipment for which the restrictions are applied on the putting into service as foreseen in Article 17, or on the placing on the market as foreseen by Article 38, paragraph (2) of this Decision will constitute "Class 2". The following Equipment Class Identifier is assigned to equipment within this class and has the following form:
2. Class identifier must have the same height as initials “CE”.
18 C. CS Marking
1. The CS conformity marking consist of the initials “CS” taking the following form: C
NOTE: S - font: Times New Roman, size 36; - diameter of circle: 20 mm; In the case when “CS” marking is reduced or enlarged it is necessary to respect the proportions given in the above figure. 2. The “C” and “S” components of the CS marking must have the same vertical dimensions, but must not be less than 5 mm, except where this is not possible on account of the nature of the apparatus. 3. The CS marking must be affixed to the product or to its data plate. Additionally it must be affixed to the packaging, if any, and to the accompanying documents. 4. The CS marking must be affixed visibly, legibly and indelibly.
19 Annex VIII
CLASSES OF EQUIPMENT AND INDICATIVE AND NON-EXHAUSTIVE LIST OF EQUIPMENT OR SORTS OF EQUIPMENT
1. Radio equipment and telecommunications terminal equipment that can be placed on the market and be put into service without restrictions will constitute "Class 1". An equipment class identifier is not assigned for “Class 1 ” of equipment. 2. Radio Equipment for which it apply restrictions on the putting into service as foreseen in Article 17, or on the placing on the market as foreseen by Article 38, paragraph (2) of this Decision will constitute "Class 2". For “Class 2” equipment is assigned class identifier provided in Annex VII, letter B.
Class 1
(i) Terminal equipment attached to fixed networks and non-transmitting radio equipment: 1. ISDN (ISDN Basic Rate, ISDN Primary Rate, ISDN U, Broadband ISDN ATM); 2. PSTN (Analogue single line, Analogue multi-line (with/without DDI), equipment attached to Centrex interfaces or Virtual Private Networks); 3. Leased lines (2w and 4w analogue (baseband), 2w and 4w analogue (voiceband), Digital, SDH, optical); 4. Wired data equipment (X.21, X.25, Ethernet, token ring, token bus, TCP/IP, frame relay); 5. Wired interactive broadcast equipment (unswitched vision/sound, switched vision/sound); 6. Telex (single line equipment, multiple line equipment); 7. Receive-only radio equipment; 8. Other terminal equipment attached to fixed networks. (ii) Radio equipment, which transmits only under the control of a network: 9. GSM handsets, including GSM 900, GSM 1800, GSM 1900 (and when it appears GSM 450); 10. TFTS terminal equipment; 11. Land Mobile earth stations in the 1,5/1,6 GHz bands; 12. Land Mobile earth stations operating in the Ku-band; 13. TETRA end-user equipment (non-DMO); 14. Satellite Personal Communication earth stations operating in the 1,6/2,4 GHz bands; 15. Satellite Personal Communication earth stations operating in the 1,9/2,1 GHz bands; 16. Low data rate Land Mobile earth stations in the 1,5/1,6 GHz bands; 17. Other Radio equipment, which transmits only under the control of a network.
Radio transmitters, technically harmonised in the Community for which Member States do not constrain their putting into service: 18. DECT equipment
19. – 21. Non-specific Short Range Devices The use of these frequency bands is for Telemetry, Telecommand, Alarms, Data in general and other similar applications. Video applications are only included in "Class 1" for frequencies above 2.4 GHz.
20 Sub- Frequency Power Channel Duty Comments class Band spacing cycle 19. 40.665, 10 mW 10 kHz <100% Applications employing audio and 40.675, 40.685 erp voice signals are excluded from and 40.695 "Class 1" MHz 20. 433.050 - 10 mW - <10% Applications employing audio and 434.790 MHz erp voice signals are excluded from "Class 1" 21. 2446.5 - 2475 10 mW - <100% In the following frequency range: MHz eirp 2454 - 2475 MHz only indoor video applications are included in "Class 1"
22. Radio Local Area Networks (RLANs)
Sub- Frequency Power Channel Duty Comments class Band spacing cycle 22. 2446.5 – 2475 100 mW - <100% Only indoor applications are MHz eirp included in "Class 1".
23. -24. Inductive applications Inductive applications include for example car immobilisers, animal identification, alarm systems, cable detection, waste management, personal identification, wireless voice links, access control, proximity sensors, anti-theft systems including RF anti-theft induction systems, data transfer to handheld devices, automatic article identification, wireless control systems and automatic road tolling. Users should be aware that emissions from inductive applications could cause interference to nearby receivers of other radio services. Particular attention should also be paid to the more stringent protection requirements identified by the ITU for global distress and safety communications frequencies in the same or adjacent bands.
Sub- Frequency Field Channel Duty Comments class Band strength spacing cycle 23. 115 – 119 kHz 42 - <100% dBµA/m @10 m 24. 13.553 – 42 - <100% 13.567 MHz dBµA/m @10 m
21 Class 2
(iii) Other Radio Equipment:
1. VSATs in the C-band; 2. VSATs in the Ku-band; 3. Satellite News Gathering earth stations in the Ku-band; 4. TETRA Direct Mode of Operation; 5. TETRAPOL; 6. Private Mobile Radio; 7. Short Range Devices; 8. Microwave links; 9. Fixed radio links; 10. Broadcast transmitters; 11. Maritime radio equipment; 12. Infrastructure equipment (e.g. base stations); 13. Radio equipment, operating in amateur radio bands.
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