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CE认证常见问题
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哪些产品需要进行CE认证

欧盟委员会针对所有需要进行CE认证的产品制定了相关协调标准(Harmanized Standards)或指令(Directives),主要包括下列产品:


1. 机械设备 Machinery

the "machinery" means:

an assembly of linked parts or components, at least one of which moves, with the appropriate actuators, control and power circuits, etc., joined together for a specific application, in particular for the processing, treatment, moving or packaging of a material; an assembly of machines which, in order to achieve the same end, are arranged and controlled so that they function as an integral whole,;interchangeable equipment modifying the function of a machine, which is placed on the market for the purpose of being assembled with a machine or a series of different machines or with a tractor by the operator himself in so far as this equipment is not a spare part or a tool.

机械是指一个由非人力或其它动物力驱动的、装有或被设计成可以装有驱动系统的,由若干零部件组成的,且至少有一个零部件可以运动的,被设计用来完成特定用途的设备;(工厂用的生产加工设备99%都属于此处定义的机械)

 

2. 建筑产品 Construction Products

The "construction product" means any product which is produced for incorporation in a permanent manner in construction works, including both buildings and civil engineering works。

CPR法规将适用于欧洲市场销售流通的所有建筑产品,如:门窗、壁纸、建筑颜料、钢纤维、土工、玻璃棉等保温材料、地板、屋顶材料、沥青混合料、石膏料、混凝料、水泥、管道、铺地材料、下水道设备、门窗、玻璃、结构金属产品、紧固件、防水材料、结构木料、交通信号指示、防火器材和加热设备等。

 

3. 压力设备 Pressure Equipment Directive PED

The "Pressure Equipment" means vessels, piping, safety accessories and pressure accessories.
Where applicable, pressure equipment includes elements attached to pressurized parts, such as flanges, nozzles, couplings, supports, lifting lugs, etc.
'Vessel` means a housing designed and built to contain fluids under pressure including its direct attachments up to the coupling point connecting it to other equipment. 

凡是设计压力超过0.5bar的设备,主要针对于:锅炉、压力容器、管道、蒸汽锅炉、热交换器、存储罐、压力附件(如阀门、压力计等)、安全附件等,无论其压力、容积为何,从设计、生产、测试方面满足ESR(Essential Safety Requirement)基本安全需求均须符合PED的规定。


 4. 简单压力容器 Simple Pressure Vessels Directive SPVD

The "simple pressure vessel" means any welded vessel subjected to an internal gauge pressure greater than 0,5 bar which is intended to contain air or nitrogen and which is not intended to be fired.

简单压力容器指令适用于所有内压大于0.5 bar,用于存放空气或氮气的焊接容器,但该等容器不得明火加热。一般而言,这些压力容器设计简单,批量生产。

 

5. 电梯 Lift

The "lift" here means an appliance serving specific levels, having a car moving along guides which are rigid and inclined at an angle of more than 15 degrees to the horizontal and intended for the transport of:
   - persons,
   - persons and goods,
   - goods alone if the car is accessible, that is to say, a person may enter it without difficulty, and fitted with controls situated inside the car or within reach of a person inside. 

LIFT指令适用范围:分为整梯和零部件;适用于在永久性建筑物和施工中使用的升降机。并且也适用于列入附录Ⅳ中用于这类升降机的安全性部件,包括:1、门锁装置;2、安全钳;3、限速器;4、缓冲器;5、上行超速保护装置;6、含有电子元件的电梯安全回路

 

6. 计量器具 Measuring Instruments MID

the "measuring instrument" means: any device or system with a measurement function that is covered by Articles 1 and 3;

该指令限定了十类计量器具产品, 包括水表, 气表和容积换算设备, 电能表, 热量表, 计程器, 废气分析仪, 自动衡器等。

 

7. 非自动称量仪器 Non-automatic Weighing Instruments NAWI

A "Weighing Instrument" is defined as a measuring instrument serving to determine the mass of a body by using the action of gravity on that body. A weighing instrument may also serve to determine other mass-related magnitudes, quantities, parameters or characteristics. 
A "non-automatic weighing instrument" is defined as a weighing instrument requiring the intervention of an operator during weighing.


8. 低电压电气设备 Low Voltage Electrical Equipment

The "Electrical Equipment" means any equipment designed for use with a voltage rating of between 50 and 1000 V for alternating current (A.C.) and between 75 and 1500 V for direct current (D.C.). Therefore, it is called often "Low Voltage Electrical Equipment" which includes the vast majority of electrical equipment in everyday use.

LVD(Low Voltage Directive 2014/35/EU)即为低电压指令,其目标是为确保低电压设备在使用时的安全性。指令适用范围是使用电压为交流在50V至1000V和直流75V至1500V之间的电器产品。


 9. 电磁兼容 Electromagnetic Compatibility (EMC)

 电磁兼容性EMC(Electro Magnetic Compatibility),是指设备或系统在其电磁环境中符合要求运行并不对其环境中的任何设备产生无法忍受的电磁干扰的能力。因此,EMC包括两个方面的要求:一方面是指设备在正常运行过程中对所在环境产生的电磁干扰不能超过一定的限值;另一方面是指器具对所在环境中存在的电磁干扰具有一定程度的抗扰度,即电磁敏感性。

 


10. 无线电及电信终端设备 Radio Equipment & Telecommunications Terminal Equipment (R&TTE)

This Directive establishes a regulatory framework for the placing on the market, free movement and putting into service in the Community of radio equipment and telecommunications terminal equipment.

包括:短距离无线遥控产品(SRD) 例如:遥控玩具汽车、遥控报警系统、遥控门铃、遥控开关、遥控鼠标、键盘等;专业无线电遥控产品(PMR) 例如:专业无线对讲机、无线麦克风等。 有绳电话、传真、MODEM、电话答录机、小总机(PABX)、无绳电话CTO、CT1、CT1+…、 ISDN(数字电话产品) 、DECT(增强型数字无绳电话) 、 GSM、CDMA…;蓝牙产品 例如:蓝牙耳机。

 

11. 游艇 Recreational Craft RCD

The "Recreational craft" means any boat of any type, regardless of the means of propulsion, from 2,5 to 24 m hull length, measured according to the appropriate harmonized standards intended for sports and leisure purposes.

游艇Recreational Craft 指的是 不限船只采用的推进方式,按照使用的协调标准测量,船身长度2.5至24米之间,用于运动和休闲的任何类型的船只。

 

12. 个人防护设备 Personal Protective Equipment (PPE)

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

用于个人防护用途的面罩、安全玻璃、安全鞋、呼吸防护设备、防护服、包括安全帽、护目镜、听觉保护器(耳塞)、安全手套、安全鞋、呼吸器和安全带。

 

13. 玩具 Toys

A "toy" shall mean any product or material designed or clearly intended for use in play by children of less than 14 years of age.

适用于年龄14岁以下儿童使用的任何类型玩具。


14. 一般产品安全  General Product Safety

一般产品安全指令,也称为“通用产品安全指令标准”。2006年7月22日,涉及户外家具、健身器材、儿童护理产品:婴儿车、奶嘴、婴儿床、溜冰鞋、服装等;打火机、自行车等产品。


15. (普通)医疗器械 Medical Devices

A "Medical Device" is defined in Directive (93/42/EEC) as: any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for the proper application, intended by the manufacturer to be used for human beings for the purpose of :

diagnosis, prevention, monitoring, treatment or alleviation of a disease, an injury or a handicap.

investigation, replacement or modification of the anatomy or of a physiological process.

control of conception and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted by such means.

 

16. 主动可植入医疗器械 Active Implantable Medical Devices

The "active medical device" means any medical device relying for its functioning on a source of electrical energy or any source of power other than that directly generated by the human body or gravity
The "active implantable medical device" means any active medical device which is intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice, and which is intended to remain after the procedure.

 

17. 体外诊断医疗器械 In Vitro Diagnostic Medical Devices

The "in vitro diagnostic medical device" means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information:
  - concerning a physiological or pathological state, or
  - concerning a congenital abnormality, or
  - to determine the safety and compatibility with potential recipients, or
  - to monitor therapeutic measures..


18. 燃气炉具 Gas appliances (GAD)

This Directive shall apply to appliances and fittings.

‘appliances’ means appliances burning gaseous fuels used for cooking, heating, hot water production, refrigeration, lighting or washing and having, where applicable, a normal water temperature not exceeding 105 °C. Forced draught burners and heating bodies to be equipped with such burners shall also be considered as appliances;

‘fittings’ means safety devices, controlling devices or regulating devices and sub-assemblies, other than forced draught burners and heating bodies to be equipped with such burners, separately marketed for trade use and designed to be incorporated into an appliance burning gaseous fuel or assembled to constitute such an appliance;

‘gaseous fuel’ means any fuel which is in a gaseous state at a temperature of 15 °C under a pressure of 1 bar.

 

19. 载人索道装置 Cableway Installations to Carry Persons 

The "cableway installations designed to carry persons" shall mean installations made up of several components, designed, manufactured, assembled and put into service with the object of carrying persons.
These on-site installations are used for the carriage of persons in vehicles or by towing devices, whereby the suspension and/or traction is provided by cables positioned along the line of travel.

 

20. 使用于具有爆炸性环境中的设备和防护系统 Equipment and Protective Systems for Used in Potentially Explosive Atmospheres (ATEX)

Equipment means machines, apparatus, fixed or mobile devices, control components and instrumentation thereof and detection or prevention systems which, separately or jointly, are intended for the generation, transfer, storage, measurement, control and conversion of energy for the processing of material and which are capable of causing an explosion through their own potential sources of ignition.

Protective systems means design units which are intended to halt incipient explosions immediately and/or to limit the effective range of explosion flames and explosion pressures. Protective systems may be integrated into equipment or separately placed on the market for use as autonomous systems.

 

21. 燃烧液体或气体燃料的热水锅炉 Hot Water Boilers

The "hot-water boilers" here means a boiler fired by liquid or gaseous fuels with a rated output of between 4 kW and 400 kW (including 4 kW and 400 kW)


22. 包装及包装废弃物指令 Packaging and packaging waste

 

23. Chemical Substances(REACH)

REACH是欧盟法规《化学品注册、评估、许可和限制》(Regulation concerning the Registration, Evaluation, Authorization and Restriction of Chemicals)的简称,是欧盟建立的,并于200761日起实施的化学品监管体系。SVHCSubstances of Very High Concern)即高关注度物质。


24.ROHS Restriction of the use of certain hazardous substances


25.Explosives for Civil Uses 

The "Explosives" here shall mean the materials and articles considered to be such in the United Nations recommendationson the transport of dangerous goods and falling within Class 1 of those recommendations.

适用于《联合国关于危险货物运输建议》的1类爆破材料,但不包括军火及烟花。


26. 烟火装置Pyrotechnic articles 

This Directive shall apply to pyrotechnic articles.

包括烟花及车用点火装置


27. Cosmetic products  化装品


来源:欧盟官方网站 http://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/