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共享89 336 EEC.pdf 标准文件

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发表于 2009-10-30 15:46:34 | 显示全部楼层 |阅读模式

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  89/336/EEC
THE COUNCIL OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Economic Community, and in particular Article 100a thereof,
Having regard to the proposal from the Commission (1),
In cooperation with the European Parliament (2),
Having regard to the opinion of the Economic and Social Committee (3),

Whereas it is necessary to adopt measures with the aim of progressively establishing the internal market over a period expiring on 31 December 1992; whereas the internal market comprises an area without internal frontiers in which the free movement of goods, persons, services and capital is ensured;
Whereas Member States are responsible for providing adequate protection for radiocommunications and the devices, apparatus or systems whose performance may be degraded by electromagnetic disturbance produced by electrial and electronic apparatus against the degradation caused by such disturbances;
Whereas Member States are also responsible for ensuring that electric energy distribution networks are protected from electromagnetic disturbance with can affect them and, consequently, equipment fed by them;
Whereas Council Directive 86/361/EEC of 24 July 1986 on the initial stage of the recognition of type¾approval for telecommunications terminal equipment (4) covers in particular the signals emitted by such equipment when it is operating normally and the protection of public telecommunications networks from harm; whereas it is therefore still necessary to provide adequate protection for these networks, including the equipment connected to them, against temporary disturbances caused by signals of an accidental nature that may be emitted by this equipment;
Whereas in some Member States, mandatory provisions define in particular the permissible electromagnetic disturbance levels that this equipment is liable to cause and its degree of immunity to such signals; whereas these mandatory provisions do not necessarily lead to different protection levels from one Member State to another but do, by their disparity, hinder trade within the Community;
Whereas the national provisions ensuring such protection must be harmonized in order to guarantee the free movement of electrical and electronic apparatus without lowering existing and justified levels of protection in the Member States;
Whereas Community legislation as it stands at present provides that, notwithstanding one of the fundamental rules of the Community, namely the free movement of goods, barriers to intra¾Community trade resulting from disparities in national laws on the marketing of products have to be accepted in so far as those provisions may be recognized as necessary to satisfy essential requirements; whereas the harmonization of laws in the case in point must therefore be confined to those provisions needed to comply with the protection requirements relating to electromagnetic compatibility; whereas these requirements must replace the corresponding national provisions;
Whereas this Directive therefore defines only protection requirements relating to electromagnetic compatibility; whereas, to facilitate proof of conformity with these requirements, it is important to have harmonized standards at European level concerning electromagnetic compatibility, so that products complying with them may be assumed to comply with the protection requirements; whereas these standards harmonized at European level are drawn up by private bodies and must remain non¾binding texts; whereas for that purpose the European Committee for Electrotechnical Standardization (CENELEC) is recognized as the competent body in the field of this Directive for the adoption of harmonized standards in accordance with the general guidelines for cooperation between the Commission and the European Committee for Standardization (CEN) and CENELEC signed on 13 November 1984; whereas, for the purposes of this Directive, a harmonized standard is a technical specification (European standard or harmonization document) adopted by CENELEC upon a remit from the Commission in accordance with the provisions of Council Directive 83/189/EEC of 28 March 1983 laying down a procedure for the provision of information in the field of technical standards and regulations (5), as last amended by Directive 88/182/EEC (6), and pursuant to the abovementioned general guidelines;
Whereas, pending the adoption of harmonized standards for the purposes of this Directive, the free movement of goods should be facilitated by accepting, as a transitional measure, on a Community level, apparatus complying with the national standards adopted, in accordance with the Community inspection procedure ensuring that such national standards meet the protection objectives of this Directive;
Whereas the EC declaration of conformity concerning the apparatus constitutes a presumption of its conformity with this Directive; whereas this declaration must take the simplest possible form;
Whereas, for apparatus covered by Directive 86/361/EEC, in order to obtain efficient protection as regards electromagnetic compatibility, compliance with the provisions of this Directive should nevertheless be certified by marks or certificates of conformity issued by bodies notified by the Member States; whereas, to facilitate the mutual recognition of marks and certificates issued by these bodies, the criteria to be taken into consideration for appointing them should be harmonized;
Whereas it is nevertheless possible that equipment might disturb radiocommunications and telecommunications networks; whereas provision should therefore be made for a procedure to reduce this hazard;
Whereas this Directive applies to the appliances and equipment covered by Directives 76/889/EEC (7) and 76/890/EEC (8) which relate to the approximation of the laws of the Member States relating to radio interference caused by electrical household appliances, portable tools and similar equipment and to the suppression of radio interference with regard to fluorescent lighting luminaires fitted with starters;
whereas those Directive should therefore be repealed,
HAS ADOPTED THIS DIRECTIVE:

Article 1
For the purposes of this Directive:
1. apparatus means all electrical and electronic appliances together with equipment and installations containing electrical and/or electronic components.
2. electromagnetic disturbance means any electromagnetic phenomenon which may degrade the performance of a device, unit of equipment or system. An electromagnetic disturbance may be electromagnetic noise, an unwanted signal or a change in the propagation medium itself.
3. immunity means the ability of a device, unit of equipment or system to perform without degradation of quality in the presence of an electromagnetic disturbance.
4. electromagnetic compatibility means the ability of a device, unit of equipment or system to function satisfactorily in its electromagnetic environment without introducing intolerable electromagnetic disturbances to anything in that environment.
5. competent body means any body which meets the criteria listed in Annex II and is recognized as such.
6. EC type-examination certificate is a document in which a notified body referred to in Article 10 (6) certifies that the type of equipment examined complies with the provisions of this Directive which concern it.

Article 2
1. This Directive applies to apparatus liable to cause electromagnetic disturbance or the performance of which is liable to be affected by such disturbance.
It defines the protection requirements and inspection procedures relating thereto.
2. In so far as protection requirements specified in this Directive are harmonized, in the case of certain apparatus, by specific Directives, this Directive shall not apply or shall cease to apply with regard to such apparatus or protection requirements upon the entry into force of those specific Directives.
3. Radio equipment used by radio amateurs within the meaning of Article 1, definition 53, of the radio regulations in the International Telecommunications Convention, shall be excluded from the scope of this Directive, unless the apparatus is available commercially.

Article 3
Member States shall take all appropriate measures to ensure that apparatus as referred to in Article 2 may be placed on the market or taken into service only if it complies with the requirements laid down by this Directive when it is properly installed and maintained and when it is used for the purposes for which it is intended.

Article 4
The apparatus referred to in Article 2 shall be so constructed that:
(a) the electromagnetic disturbance it generates does not exceed a level allowing radio and telecommunications equipment and other apparatus to operate as intended;
(b) the apparatus has an adequate level of intrinsic immunity of electromagnetic disturbance to enable it to operate as intended.
The principal protection requirements are set out in Annex III.

Article 5
Member States shall not impede for reasons relating to electromagnetic compatibility the placing on the market and the taking into service on their territory of apparatus covered by this Directive which satisfies the requirements thereof.

Article 6
1. The requirements of this Directive shall not prevent the application in any Member State of the following special measures:
(a) measures with regard to the taking into service and use of the apparatus taken for a specific site in order to overcome an existing or predicted electromagnetic compatibility problem;
(b) measures with regard to the installation of the apparatus taken in order to protect the public telecommunications networks or receiving or transmitting stations used for safety purposes.
2. Without prejudice to Directive 83/189/EEC, Member States shall inform the Commission and the other Member States of the special measures taken pursuant to paragraph 1.
3. Special measures that have been recognized as justified shall be contained in an appropriate notice made by the Commission in the Official Journal of the European Communities.

Article 7
1. Member States shall presume compliance with the protection requirements referred to in Article 4 in the case of apparatus which is in conformity;
(a) with the relevant national standards transposing the harmonized standards, the reference numbers of which have been published in the Official Journal of the European Communities. Member States shall publish the reference numbers of such national standards;
(b) or with the relevant national standards referred to in paragraph 2 in so far as, in the areas covered by such standards, no harmonized standards exist.
2. Member States shall communicate to the Commission the texts of their national standards, as referred to in paragraph 1 (b), which they regard as complying with the protection requirements referred to in Article 4. The Commission shall forward such texts forthwith to the other Member States. In accordance with the procedure provided for in Article 8 (2), it shall notify the Member States of those national standards in respect of which there is a presumption of conformity with the protection requirements referred to in Article 4.
Member States shall publish the reference numbers of those standards. The Commission shall also publish them in the Official Journal of the European Communities.
3. Member States shall accept that where the manufacturer has not applied, or has applied only in part, the standards referred to in paragraph 1, or where no such standards exist, apparatus shall be regarded as satisfying the protection requirements has been certified by the means of attestation provided for in Article 10 (2).

Article 8
1. Where a Member State or the Commission considers that the harmonized standards referred to in Article 7 (1) (a) do not entirely satisfy the requirements referred to in Article 4, the Member State concerned or the Commission shall bring the matter before the Standing Committee set up by Directive 83/189/EEC, hereinafter referred to as the Committee, giving the reasons therefor. The Committee shall deliver an opinion without delay.
Upon receipt of the Committees opinion, the Commission shall inform the Member States as soon as possible whether or not it is necessary to withdraw in whole or in part those standards from the publications referred to in Article 7 (1) (a).
2. After receipt of the communication referred to in Article 7 (2), the Commission shall consult the Committee. Upon receipt of the latters opinion, the Commission shall inform the Member States as soon as possible whether or not the national standard in question shall enjoy the presumption of conformity and, if so, that the references thereof shall be published nationally.
If the Commission or a Member State considers that a national standard no longer satisfies the necessary conditions for presumption of compliance with the protection requirements referred to in Article 4, the Commission shall consult the Committee, which shall give its opinion without delay. Upon receipt of the latters opinion, the Commission shall inform the Member States as soon as possible whether or not the standard in question shall continue to enjoy a presumption of conformity and, if not, that it must be withdrawn in whole or in part from the publications referred to in Article 7 (2).

Article 9
1. Where a Member State ascertains that apparatus accompanied by one of the means of attestation provided for in Article 10 does not comply with the protection requirements referred to in Article 4, it shall take all appropriate measures to withdraw the apparatus from the market, prohibit its placing on the market or restrict its free movement.
The Member State concerned shall immediately inform the Commission of any such measure, indicating the reasons for its decision and, in particular, whether non-compliance is due to:
(a) failure to satisfy the protection requirements referred to in Article 4, where the apparatus does not meet the standards referred to in Article 7 (1);
(b) incorrect application of the standards referred to in Article 7 (1);
(c) shortcomings in the standards referred to in Article 7 (1) themselves.
2. The Commission shall consult the parties concerned as soon as possible. If the Commission finds, after such consultations, that the action is justified, it shall forthwith so inform the Member State that took the action and the other Member States.
Where the decision referred to in paragraph 1 is attributed to shortcomings in the standards, the Commission, after consulting the parties, shall bring the matter before the Committee within two months if the Member State which has taken the measures intends to uphold them, and shall initiate the procedures referred to in Article 8.
3. Where apparatus which does not comply is accompanied by one of the means of attestation referred to in Article 10, the competent Member State shall take appropriate action against the author of the attestation and shall inform the Commission and the other Member States thereof.
4. The Commission shall ensure that the Member States are kept informed of the progress and outcome of this procedure.

Article 10
1. In the case of apparatus for which the manufacturer has applied the standards referred to in Article 7 (1), the conformity of apparatus with this Directive shall be certified by an EC declaration of conformity issued by the manufacturer or his authorized representative established within the Community. The declaration shall be held at the disposal of the competent authority for ten years following the placing of the apparatus on the market.
The manufacturer or his authorized representative established within the Community shall also affix the EC conformity mark to the apparatus or else to the packaging, instructions for use or guarantee certificate.
Where neither the manufacturer nor his authorized representative is established within the Community, the above obligation to keep the EC declaration of conformity available shall be the responsibility of the person who places the apparatus on the Community market.
The provisions governing the EC declaration and the EC mark are set out in Annex I.
2. In the case of apparatus for which the manufacturer has not applied, or has applied only in part, the standards referred to in Article 7 (1) or failing such standards, the manufacturer or his authorized representative established within the Community shall hold at the disposal of the relevant competent authorities, as soon as the apparatus is placed on the market, a technical construction file. This file shall describe the apparatus, set out the procedures used to ensure conformity of the apparatus with the protection requirements referred to in Article 4 and include a technical report or certificate, one or other obtained from a competent body.
The file shall be held at the disposal of the competent authorities for ten years following the placing of the apparatus on the market.
Where neither the manufacturer nor his authorized representative is established within the Community, this obligation to keep a technical file available shall be the responsibility of the person who places the apparatus on the Community market.
The conformity of apparatus with that described in the technical file shall be certified in accordance with the procedure laid down in paragraph 1.
Member States shall presume, subject to the provisions of this paragraph, that such apparatus meets the protection requirements referred to in Article 4.
3. Where the standards referred to in Article 7 (1) are not yet in existence, and without prejudice to the provisions of paragraph 2 of this Article, the apparatus concerned may, on a transitional basis until 31 December 1992 at the latest, continue to be governed by the national arrangements in force on the date of adoption of this Directive, subject to the compatibility of such arrangements with the provisions of the Treaty.
4. Conformity of apparatus covered by Article 2 (2) of Directive 86/361/EEC with the provisions of this Directive shall be certified in accordance with the procedure laid down in paragraph 1 once the manufacturer or his authorized representative established within the Community has obtained an EC type-examination certificate concerning this apparatus issued by one of the notified bodies referred to in paragraph 6 of this Article.
5. The conformity of apparatus designed for the transmission of radiocommunications, as defined in the International Telecommunication Union Convention, with the provisions of this Directive shall be certified in accordance with the procedure laid down in paragraph 1 once the manufacturer or his authorized representative established within the Community has obtained an EC type-examination certificate concerning this apparatus issued by one of the notified bodies referred to in paragraph 6 below.
This provision shall not apply to the above apparatus where it is designed and intended exclusively for radio amateurs within the meaning of Article 2 (3).
6. Each Member State shall notify the Commission and the other Member States of the competent authorities referred to in this Article and of the bodies responsible for issuing the EC type-examination certificates referred to in paragraphs 4 and 5. The Commission shall publish a list of those authorities and bodies, for information purposes, in the Official Journal of the European Communities and shall ensure that the list is updated.
Such notification shall state whether those bodies are competent for all apparatus covered by this Directive or whether their responsibility is limited to certain specific areas.
Member States shall apply the criteria listed in Annex II for the assessment of the bodies to be notified.
Bodies which comply with the assessment criteria fixed by the relevant harmonized standards shall be presumed to comply with the aforementioned criteria.
A Member State which has notified a body must withdraw approval if it finds that the body no longer meets the criteria listed in Annex II. It shall forthwith inform the Commission and the other Member States thereof.

Article 11
Directive 76/889/EEC and Directive 76/890/EEC shall be repealed as from 1 January 1992.

Article 12
1. By 1 July 1991, Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive. They shall inform the Commission thereof.
They shall apply these provisions as from 1 January 1992.
2. Member States shall communicate to the Commission the texts of the provisions of national law which they adopt in the field covered by this Directive.
Article 13
This Directive is addressed to the Member States.
Done at Brussels, 3 May 1989.
For the Council
The President
P. SOLBES
(1) OJ No C 322, 2. 12. 1987, p. 4.
(2) OJ No C 262, 10. 10. 1988, p. 82 and OJ No C 69, 20. 3. 1989, p. 72.
(3) OJ No C 134, 24. 5. 1988, p. 2.
(4) OJ No L 217, 5. 8. 1986, p. 21.
(5) OJ No L 109, 26. 4. 1983, p. 8.
(6) OJ No L 81, 26. 3. 1988, p. 75.
(7) OJ No L 336, 4. 12. 1976, p. 1.
(8) OJ No L 336, 4. 12. 1976, p. 22.


ANNEX I
1. EC declaration of conformity
The EC declaration of conformity must contain the following:
- description of the apparatus to which it refers,
- reference to the specifications under which conformity is declared, and, where appropriate, to the national measures implemented to ensure the conformity of the apparatus with the provisions of the Directive,
- identification of the signatory empowered to bind the manufacturer or his authorized representative,
- where appropriate, reference to the EC type-examination certificate issued by a notified body.
2. EC conformity mark
- The EC conformity mark shall consist of the letters CE as set out below and the figures of the year in which the mark was affixed.
- This mark should, where appropriate, be accompanied by the distinctive letters used by the notified body issuing the EC type-examination certificate.
- Where apparatus is the subject of other Directives providing for the EC conformity mark, the affixing of the EC mark shall also indicate conformity with the relevant requirements of those other Directives.


ANNEX II
Criteria for the assessment of the bodies to be notified
The bodies designated by the Member States must fulfil the following minimum conditions:
1. availability of personnel and of the necessary means and equipment;
2. technical competence and professional integrity of personnel;
3. independence, in carrying out the tests, preparing the reports, issuing the certificates and performing the verification function provided for in this Directive, of staff and technical personnel in relation to all circles, groups or persons directly or indirectly concerned with the product in question;
4. maintenance of professional secrecy by personnel;
5. possession of civil liability insurance unless such liability is covered by the State under national law.
Fulfilment of the conditions under points 1 and 2 shall be verified at intervals by the competent authorities of the Member States.
ANNEX III
Illustrative list of the principal protection requirements
The maximum electromagnetic disturbance generated by the apparatus shall be such as not to hinder the use of in particular the following apparatus:
(a) domestic radio and television receivers
(b) industrial manufacturing equipment
(c) mobile radio equipment
(d) mobile radio and commercial radiotelephone equipment
(e) medical and scientific apparatus
(f) information technology equipment
(g) domestic appliances and household electronic equipment
(h) aeronautical and marine radio apparatus
(i) educational electronic equipment
(j) telecommunications networks and apparatus
(k) radio and television broadcast transmitters
(l) lights and fluorescent lamps.
Apparatus, and especially the apparatus referred to in (a) to (l), should be constructed in such a way that it has an adequate level of electromagnetic immunity in the usual electromagnetic compatibility environment where the apparatus is intended to work so as to allow its unhindered operation taking into account the levels of disturbance generated by apparatus complying with the standards laid down in Article 7.
The information required to enable use in accordance with the intended purpose of the apparatus must be contained in the instructions accompanying the apparatus.
 楼主| 发表于 2009-10-30 15:47:14 | 显示全部楼层
欧盟电磁兼容指令89/336/EEC中文版
欧盟电磁兼容指令89/336/EEC中文版
关于统一各成员国有关电磁兼容法律的指令
本指令经由理事会指令92/31/EEC (1992年4月28日)和93/68/EEC(1993年7月22日)修改[1]。
欧洲共同体理事会
考虑到建立欧洲经济共同体的条约,特别是其第100a条,
考虑到委员会提案,
在与欧洲议会的合作下,考虑到经济与社会委员会意见,鉴于有必要采取措施,以期能在1992年12月31日之前,逐步建立一个内部市场;鉴于该内部市场是一个无内部边界的区域,在此区域内可以保证货物、人员、服务及资金的自由流通;
鉴于各成员国应负责对可能受到电器和电子仪器产生的电磁干扰而减损其功能的无线电讯及其装置、设备或系统提供充分保护,以抵抗电磁干扰造成的功能减损;
鉴于各成员国还应负责保护供电网络及接受其供电的设备免受电磁干扰;
鉴于1986年7月24日理事会关于电讯终端设备型式批准认可的初级阶段第86/361/EEC号指令,特别包括当上述设备正常运行时发出的各种讯号和保护公用电讯网免受损害;
鉴于仍有必要对这些网络,包括与其相连的设备提供充分的保护,以抵抗这种设备因异常信号造成的短暂性干扰;
鉴于某些成员国特别强制性规定了此种设备造成电磁干扰的允许水平及其对这种讯号的抗干扰度;鉴于这些强制性规定不一定导致了成员国之间采取的保护水平互不相同,但他们之间的差异,妨碍了在欧共体内的贸易;
所以,为了保证电气和电子仪器设备的自由流通而又不降低各成员国现有的合理的保护水准,必须协调与保证此种保护水平有关的国家规定:
鉴于欧共体现行法规规定,尽管欧共体的基本原则之一叫做货物的自由流通,但也不得不接受由于各国关于产品投放市场的法律存在差别、因而造成在欧共体内的贸易障碍这个事实,只要那些规定对于满足基本要求是必要的;鉴于法律的协调必须限于符合有关电磁相容性的保护要求所必需的那些规定,这些要求必须取代相应的国家规定:
鉴于本指令只规定有关电磁相容性的保护要求,为了便于证实符合上述要求,需要有欧洲级水平的有关电磁相容性的协调标准。这样,符合协调标准的产品也就被推定为是符合各项保护要求,欧洲协调标准是由非官方机构制定的,并且必须是没有约束力的文本;鉴于为此目的,欧洲电工标准化委员会(CENELEC)是根据1984年11月13日委员会与欧洲标准化委员会(CEN)的和(CENELEC)签定的关于委员会与该两机构之间合作总导则被承认作为在本指令领域制订协调标准的主管机构;鉴于本指令所称“协调标准”是指由(CENELEC)基于委员会按照88/182/EEC号指令最新修订的1983年3月28日第83/189/EEC号理事会“关于技术标准和法规领域的信息传送程序的规定的指令”提交的任务并遵照上述总导则正式制订的技术规范(欧洲标准或协调文件);
鉴于在上述协调标准通过以前,作为过渡措施,可以接受符合已采用国家标准的仪器设备,以促进货物的自由流通,但作为欧共体水平的仪器设备要按欧共体的检验程序检验,并保证上述国家标准符合本指令的保护目的;
鉴于有关仪器设备的《EC合格声明书》可作为推定其符合本指令的根据,《EC合格声明书》必须采用尽可能简单的式样:
鉴于为使第86/361/EEC指令(已被91/263/EEC指令取代)所涵盖的仪器设备得到有关电磁相容性的有效保护,应以各成员国指定的注册认证机构发给的标志或合格证书来证明所述仪器设备符合本指令的有关规定,为了便于互相承认由上述机构发给的标志和证书,应协调指定他们作为注册认证机构的准则;
鉴于仪器设备可能对公共无线电通讯(Radio communications)和长途电讯(Telecommunications)网造成干扰,因此,应该作出减少此种公害的程序的规定;
鉴于本指令适用于第76/889/EEC号指令和第76/890/EEC号指令所涵盖的仪器和设备,该两项指令是“关于使各成员国有关家用电器、便携式工具和类似设备造成的无线电干扰(Radio interference)的法律趋于一致的指令”,以及“关于使带有起动器的月光照明装置的无线电干扰的抑制的法律趋于—致的指令”;鉴于该两项指令应因之而被废除。
鉴于89/336/EEC④指令规定了电磁兼容的完整协调方法[2];鉴于统一适用该指令就要求有协调标准;鉴于到该指令适用时也不会存在这些标准;
鉴于该指令未规定允许销售依照在该指令生效前仍然适用的国家法规生产的设备的适当过渡期;鉴于生产商必须有时间销售所有的库存设备;鉴于89/336/EEC应进行相应修订。
鉴于理事会已经依据理事会于1985年5月7日颁布的关于技术协调和标准的新方法的决议④的原则,通过了一系列用于消除技术性贸易壁垒的指令;鉴于这些指令规定加贴CE标志;鉴于,因此,为了简化共同体立法并使其更具一致性,这些不同的规定应由统一的法规取代,尤其对于可能涉及数个指令的产品[3];
鉴于,在1989年6月15日颁布的认证和测试的全球方法的通告中,理事会建议拟定关于采用单一图案的“CE”标志的通用规则;鉴于,在1989年12月21日颁布的符合性评估的全球方法的决议中,理事会将作为采用一致方法(例如关于使用“CE”标志)作为指导原则;
鉴于必须适用的新方法的两个基本要素,因而成为基本要求和符合性评估程序;鉴于有关加贴和使用“CE”标志的规定的协调要求对现有的指令进行细致的修订,以达到与新标准的一致性;
兹通过本指令: 第1条本指令所用名词定义:
1.“仪器设备”(Apparatus)是指所有的电器.电子仪表及装有电器元件或(和)电子元件的装置和设备。
2.“电磁干扰”是指任何足以减损仪器、器械、机器设备或装置的部件的功能的任何电磁观象,电磁干扰也可以是电磁嗓音、无用的讯号或在传播介质自身中的一种变化。
3.“抗扰性”是指在电磁干扰存在的情况下,机器设备或装置的部件能正常运行不会降低质量的性能。
4.“电磁相容性”是指仪表.器械.机器设备或装置的部件在电磁环境里能良好运行,并对任何事物都不会造成不能容忍的电磁干扰的性能。
5.“权能机构”(Competent Body – CB机构)是指符合附件Ⅱ所列准则并经按此准则认可的任何机构。
6.《EC型式试验证书》是指由第10(5)条提到的注册认证机构(Notified Body—NB机构)证明经试验的设备的型式符合本指令有关规定的一种文件。
第2条1. 本指令适用于容易产生电磁干扰或其性能易受电磁干扰的仪器设备。
本指令对上述仪器设备规定了保护要求和检验程序。
2. 本指令规定的保护要求,对于某些仪器来说,要由专门指令来协调,在专门指令生效后,本指令不适用于或停止适用于上述仪器或保护要求。
3. 国际电讯公约(International Telecommunication Convention)无线电条例第1条定义,5.3所指的无线电业余爱好者使用的无线电设备不包括在本指令范围内,除非该仪器设备供商业销售。
第3条
各成员国应采取一切适当措施确保第2条中提到的仪器设备,只要它加附第10条规定的CE标志,表明其符合本指令的全部规定包括符合第10条规定的合格评定程序,当它被正确地安装和维修,并按其预定用途使用时,就可以投放市场或投入使用[4]。
第4条
第2条所指仪器设备的构造应按如下要求,使:
(a) 仪器设备所产生的电磁干扰不能超过无线电通讯设备和长途电信设备,以及其它仪器设备按规定用途正常运行的允许水平;
(b) 仪器设备对电磁干扰具有足够的内在的抗干扰水平,使其能按预定条件正常运行。
主要的保护要求列于附录Ⅲ。
第5条
各成员国不得以电磁相容性为理由,阻碍满足本指令要求的仪器设备在本国境内投放市场和投入使用。
第6条
1. 本指令的要求不妨碍任何成员国采取以下特殊措施;
(a) 为了克服现有的或可预知的电磁相容性问题而在特定地点就仪器设备的服务和使用所采取的措施;
(b) 为了保护公共电讯网、接收站或发射站的安全使用,就仪器设备的安装所采取的措施。
2. 在不损害第83/189/EEC号指令的情况下,有关成员国应将按本条第1款所采取的特殊措施通知委员会和其它成员国。
3. 已被公认为正确的特殊措施,应由委员会列入一个适当的通告中,在欧共体官方公报上公布。
第7条
1. .如果仪器设备符合下列情况,各成员国应推定为符合第4条所规定的保护要求:
(a) 符合已转换为协调标准的有关国家,其标准号已公布在欧共体官方公报上。各成员国应公布相关国家标准的标准号;
(b) 符合本条第2款有关国家标准,只要是在此国家标准的覆盖区域不存在协调标准;
2. 各成员国应将他们认为符合第4条所规定的保护要求的第1(b)款所述国家标准文本提交委员会,委员会应将该文本立即转送其他成员国。并应按第8(2)条规定的程序,将据以推断产品符合第4条所述保护要求的这些国家标准通告各成员国;
各成员国应公布这些标准的标准号。委员会也应将它们公布在欧共体官方公报上。
3. 如果制造商没有采用或仅部分采用第1款所述标准。或者不存在上述标准,则须用第10(2)条规定验证(Attestation)方法证明仪器满足了有关保护要求。第8条
1. 如果某一成员国或委员会认为第7(1)(a)条所述的协调标准不完全符合第4条所规定的要求,该成员国或委员会应将此事提交按第83/189/EEC号指令设立的常务委员会(以下简称“常委会”),并阐明提交的理由。常委会应毫不迟延地对此提出意见。
委员会收到常委会的意见后,应尽快通知各成员国是否有必要从第7(1)(a)条提到的公布中全部或部份撤销上述标准。
2. 委员会收到第7(2)条的通知后,应立即与常委会磋商,收到常委会意见后,应就所述国家标准是否可能作为确定合格的依据,立即通知各成员国,如果是,上述国家标准的标准号应予公布。
如果委员会或其一成员国认为,某一国家标准不再满足为了确定符合第4条规定的保护要求所必需的条件,委员会应与常委会磋商,常委会应毫不迟延地提出意见。收到常委会意见后,委员会应就所述标准是否仍可作为确定合格的依据,尽快通知成员国。如果不是,必须从第7(2)条提到的公布中全部或部分撤销上述标准。
第9条
1. 如果某一成员国确认附有第10条规定的证明方式之一的仪器设备,不符合第4条所规定的保护要求时,应采取一切适当措施将该仪器设备撤出市场,禁止其投放市场或限制其自由流通。
有关成员国应将上述任何此类措施立即通知委员会并阐明作出决定的理由,并应特别说明不符合的原因是否因为:
(a) 未满足第4条所规定的保护要求,当该仪器不符合第7(1)条所述标准时;
(b) 对第7(1)条所述标准使用不当;
(c) 第7(1)条所述标准本身存在缺陷。
2. 委员会尽快与有关部门进行磋商。经磋商后若委员会认为所作决定被证明是正确的,应立即就此通知采取措施的成员国和其他成员国。如果按上述第1款所作出的决定是针对标准本身存在的缺陷,则委员会应在两个月内将此事提交常委会: 假若已采取措施的成员国仍坚持其决定,应启动第8条所规定的程序。
3. 如果不符合要求的仪器设备而附有第10条所规定的证明书,主管成员国应对出证书者采取适当行动,并将其通报给委员会和其它成员国。
4. 委员会应保证随时向各成员国通报上述程序的进展情况和结果。
第10条
1. 对于制造商已采用第7(1)条所述标准生产的仪器设备,应由制造商或其设在欧共体内的授权代表签发一份《EC合格声明书》,证明该仪器设备符合本指令要求。该声明书自仪器设备投放市场之时起,至少保存十年,以供主管当局查阅。
制造商或其在欧共体内的授权代表还应将CE合格标志加附到仪器设备上,或包装上,或使用说明书或保证书上。
如果制造商和他的授权代表均未设在欧共体内,则上述保存《EC合格声明书》的义务,应由将该仪器设备投放欧共体市场负有责任的人承担。
指导《EC合格声明书》和CE标志的规定见附录I。
成员国应采取必要措施禁止在仪器设备上,在它的包装.使用说明书和保证书上加附很可能在CE标志的含意和式样上,欺骗第三方的其他标志。但是任何其它标志,在不降低CE标志的醒目性和清晰性的前题下,可以被加附在仪器设备上,它的包装上,使用说明书和保证书上[5]。
2. 在制造商未采用或仅部分采用第7(1)条所述标准,或尚无此种标准的情况下,仪器设备一旦投放市场,制造商或其设在欧共体内的代表,应立即向仪器设备所投放的市场的有关主管当局,提交一份技术结构档案。该档案应对该仪器设备,为保证仪器设备符合第4条所规定的保护要求所使用的程序加以描述,并包括一份由这个或那个权能认证机构签发的技术报告或证书。
上述档案自该仪器投放市场之日起,至少保存十年,以供主管当局查阅。
如果制造商和他的授权代表均未设在欧共体内,则上述保存《EC合格声明书》的义务,应由将该仪器设备投放欧共体市场负有责任的人承担。
仪器设备符合技术档案所描述的要求,应按第1款规定的程序予以说明。
符合本款规定的仪器设备,各成员国应推定为符合第4条所规定的保护要求。
3. (经92/31/EEC指令删除)
4. 一旦制造商或其授权代表取得本条第6款所述的一个注册认证机构签发的有关该仪器设备的《EC型式试验证书》,则应按上述第1款规定的程序证明86/361/EEC指令第2(2)条所述仪器设备符合本指令规定。
5. 一旦制造商或其设在共同体内的代表取得下述第6款所述的一个注册认证机构签发的有关该仪器的(EC型式试验证书),则应按上述第1款规定的程序,证明属于国际电讯联盟公约定义范围的无线电通讯发射仪器设备符合本指令规定。
此规定不适用于为第2(3)条所指无线电业余爱好者专门设计和使用的上述仪器设备。
6. 各成员国应将本条所述的主管当局和第4款和第5款所述负责签发《EC型式试验证书》的注册认证机构,连同他们被当局指定执行的特定评定项目和由委员会事先授予的识别编号一并通知委员会和其他成员国[6]。
委员会应在官方公报上公布一份这些主管当局和注册认证机构的名单连同注册认证机构的识别编号和被指定执行的任务。委员会应保证该名单的及时更新。
通知中应声明这些机构是否胜任本指令涵盖的所有设备,或者其职责是否仅限于某些特定范围。
各成员国应适用附录II中的标准对注册认证机构进行评估。
符合由相关协调标准确定的评估标准的机构,应推定符合上述标准。
已注册了认证机构的成员国如果发现该机构不再满足附录II列出的标,应撤回其许可,并立刻通知委员会及其它成员国。
7. 不损害第9条规定:
(a) 一旦某成员国或某一主管局证实CE标志使用不当,制造商或其在共同体内的授权代表必须按照成员国强制提出的条件,负责使其产品符合加附CE标志的有关规定,并终止其违反行为;
(b) 如果不符合的问题继续发生,该成员国必须按第9条规定程序采取一切适当措施,限制或者禁止所述产品投放市场,或者确保将其产品从市场撤出[7]。
第11条
第76/889/EEC号指令和76/890/EEC号指令自1992年1月1日起作废。
第12条
1. 各成员国应在1994年7月1日之前通过并颁布遵守本指令所必须的法律、法规和监管条例,并应立刻通知委员会。
以上法令应于1995年1月1日起生效。
但是,各成员国在1995年12月31日以前,对符合有关国家1992年6月30日前在其领土上实施的法规的有关本指令的仪器设备,应准许投放市场和/或投入使用。
各成员国在通过这些法令之时,应包含对本指令的引用或在官方公报时随附本指令。对指令的引用方法由成员国规定[8]。
2. 在1997年1月1日之前,各成员国应允许将符合1995年1月1日之前有效的标志设计的产品投放市场和投入使用。
3. 各成员国应将其在本指令涵盖的范围内通过的国家法律的文本送交委员会。委员会应将其通知其它成员国[9]。
第13条
本指令发送各成员国。
1989年5月3日通过于布鲁塞尔
理事会主席 P. SOLEBES

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