Electromagnetic Compatibility Directive 2014/30/EU
(1) ‘equipment’ means any apparatus or fixed installation;设备指为任何仪器或固定装置
(2) ‘apparatus’ means any finished appliance or combination thereof made available on the market as a single functional unit, intended for the end-user and liable to generate electromagnetic disturbance, or the performance of which is liable to be affected by such disturbance; “设备”是指市场上作为单一功能部件提供给最终用户的、可能产生电磁干扰或其性能可能受到电磁干扰影响的任何成品器具或其组合;
(3) ‘fixed installation’ means a particular combination of several types of apparatus and, where applicable, other devices, which are assembled, installed and intended to be used permanently at a predefined location; “固定安装”系指在预定地点组装、安装并打算永久使用的几种类型的设备以及(如适用)其他设备的特定组合;
(4) ‘electromagnetic compatibility’ means the ability of equipment to function satisfactorily in its electromagnetic environment without introducing intolerable electromagnetic disturbances to other equipment in that environment; “电磁兼容性”指设备在其电磁环境中令人满意地工作，而不会对该环境中的其他设备造成不可容忍的电磁干扰的能力;
(5) ‘electromagnetic disturbance’ means any electromagnetic phenomenon which may degrade the performance of equipment; an electromagnetic disturbance may be electromagnetic noise, an unwanted signal or a change in the propagation medium itself; “电磁干扰”是指任何可能使设备性能下降的电磁现象;电磁干扰可以是电磁噪声、一个不想要的信号或传播介质本身的变化;
(6) ‘immunity’ means the ability of equipment to perform as intended without degradation in the presence of an electromagnetic disturbance; “抗扰性”指设备在存在电磁干扰的情况下按预期运行而不退化的能力;
Compliance of apparatus with the essential requirements set out in Annex I shall be demonstrated by means of either of the following conformity assessment procedures:
(a) internal production control set out in Annex II; 附件二所列的内部生产控制;
(b) EU type examination that is followed by Conformity to type based on internal production control set out in Annex III.
EU declaration of conformity DOC自我声明要求
1. The EU declaration of conformity shall state that the fulfilment of the essential requirements set out in Annex I has been demonstrated. 欧盟符合性声明应说明已满足附件I所列的基本要求。
2. The EU declaration of conformity shall have the model structure set out in Annex IV, shall contain the elements specified in the relevant modules set out in Annexes II and III and shall be continuously updated. It shall be translated into the language or languages required by the Member State in which the apparatus is placed or made available on the market.
3. Where apparatus is subject to more than one Union act requiring an EU declaration of conformity, a single EU declaration of conformity shall be drawn up in respect of all such Union acts. That declaration shall contain the identification of the Union acts concerned including their publication references. 如果仪器受到多于一项要求欧盟合格声明的欧盟法案的约束，则应针对所有此类欧盟法案起草一份单一的欧盟合格声明。该声明应载有对有关联盟行为的说明，包括其发表的参考文献。
4. By drawing up the EU declaration of conformity, the manufacturer shall assume responsibility for the compliance of the apparatus with the requirements laid down in this Directive. 在制订欧盟符合性声明后，制造商须负责使该仪器符合本指示所载的规定。
1.The CE marking shall be affixed visibly, legibly and indelibly to the apparatus or to its data plate. Where that is not possible or not warranted on account of the nature of the apparatus, it shall be affixed to the packaging and to the accompanying documents.CE标志应清晰、易读且不可擦掉地贴在设备或其数据板上。如果由于仪器的性质不能做到或不能保证，则应将其贴在包装和随附的文件上。
2.The CE marking shall be affixed before the apparatus is placed on the market. 在器械投放市场前，必须贴上CE标志。
3.Member States shall build upon existing mechanisms to ensure correct application of the regime governing the CE marking and shall take appropriate action in the event of improper use of that marking. 成员国应在现有机制的基础上确保管理CE标志的制度的正确应用，并应在该标志使用不当的情况下采取适当行动。
1. Apparatus shall be accompanied by information on any specific precautions that must be taken when the apparatus is assembled, installed, maintained or used, in order to ensure that, when put into service, the apparatus is in conformity with the essential requirements set out in point 1 of Annex I. 仪器应附有在组装、安装、维护或使用时必须采取的任何具体预防措施的信息，以确保在投入使用时，仪器符合附件I第1点所规定的基本要求。
2. Apparatus for which compliance with the essential requirements set out in point 1 of Annex I is not ensured in residential areas shall be accompanied by a clear indication of such restriction of use, where appropriate also on the packaging. 未能确保在住宅区内符合附件I第1点所列基本要求的仪器，须在其包装上(如适用)注明限制使用的明确指示。
3. The information required to enable apparatus to be used in accordance with the intended purpose of the apparatus shall be included in the instructions accompanying the apparatus.
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