CE认证中英文介绍

1、1前言Introduction欧洲议会和欧洲理事会于2006年5月17日正式通过了，产品申请CE认证(CE-Marking即CE标志)的最新版机械指导法令(2006/42/EC),此法令是欧盟按照新方法(New approach)制定的有关健康、安全的基本法令之一。与现行机械指令98/37/EC相比，新指令在适用范围、与其他指导法令的界线、市场临督、安全性零组件、合格评定程序以及基本健康和安全要求 等方而都出现了 一些新要求和明显的变化。European Parliament and European Council have adopted the latest version of the

2、 Machinery Directive(2006/42/CE) on 17 May, 2006. This new directive is made according to a new approach; its one of thebasic directives on health and safety concern. Compared with the present Machinery Directive 98/37/ECthere are some new requirements and noticeable changes to the new one on its ap

3、plication, boundarywith other directives, market supervision, safe components, conformity assessment procedure, therequirement for the basic health and safety, etc.面对新的技术壁垒，相关部门和广大企业应提前做好研究，有关欧盟对CE认证(CE-Marking)的新规定，及早从实际应用和技术角度出发加以积极应对。Faced with the new technical barrier, the departments involved

4、and whole enterprises shall conductbetter research in advance to take vigorous action against the new regulations of the CE-marking.新法令由正文和12个附件组成，正文包括：适用机械范围、名词概念定义、市场监督、投 放市场和交付使用、合格推定和协调标准、处理潜在危险机械特定措施、协调标准争议的处 理程序、防护条款、机械合格性评估程序、机械半成品部分完成机械装置规程、指定认证机构、CE标志、指令95/16/EC的修订说明等29个条款。附件主要包括：有关机械设计与制 造

5、的基本健康与安全要求、机械合格声明的要求、CE标志、执行合格性评定的机械类别目录、安全性元件明细清单、机械半成品部分完成机械装置的组装说明要求、技术文档要求、 机械制造过程内部审核的合格性评估、EC型式试验、完善的质量保证规程、各成员指定认证机构时应考虑的最低标准。The new directive is composed by body of the text and 12 appendixes. The body is composed by 29 clausesincluding machines applied to the new directive, some concepts a

6、nd definitions, market supervision,its launch and submission, conformity presumption and adjustment standard, specific measures to dealwith machines with potential hazards, dispute settlement procedure, protective covenant, machineryconformity assessment procedure, designated certification authority

7、, CE marking, revision note fordirective 95/16/EC, etc. Appendixes mainly include: the basic health and safety requirement to designand manufacture the machinery, declaration for the machinery conformity requirement, CE marking,catalogue for the machinery which need conformity assessment, protective

8、component list, requirementfor the technical documents, internal audit assessment on the machine manufacture, EC test, perfectquality assurance, the minimum standard needs to be considered when each member designates thecertification body/authority.整个法令的内容在各方面多加以细化，同时将原98/37/EC指令中阐述相同内容的条款汇总分类组成独立条款

9、，整个法令文件框架更加明确，有助于制造商、认证机构、成员国等相关 各方对法令内容的理解和应用。All aspects of the new directive are more specific in content. Meanwhile, those clauses stated thesame as in the previous directive 98/37/EC are sorted and classified into independent clauses. Theframework for the whole directive is more specific which

10、can also help manufacturer, certificationauthorization/body, member states, etc. understand and apply the directive.2新版机械指导法令的立法依据The Legislation Basis of the New Machinery Directive机械指导法令2006/42/EC是根据新欧盟条约”(EC Treaty)第95条(原条约100条)制定的一系 列措施之一，欧盟条约第95条的主要目的是为实现货物和服务的单一欧洲市场而提出的机械安全、健康方面的要求。新的机械指令的制定同时

11、考虑了来自欧盟委员会的提议以及欧洲 经济与社会委员会的意见。此次修改机械指令的目的是为了提出更好的各种概念的定义，以便澄清相关问题并更好地确保指导法令的统一应用，确保产品在欧盟范围内的自由流通，同时保证在健康、安全和消费者保护方面达到较高的水平。The new machinery directive 2006/42/EC is one of the serial measures made according to Article 95 ofthe new EC Treaty (Article 100 in the previous Treaty). The main purpose for

12、Article 95 in the Treatyis for putting forward some requirements on machine safety and health in order to make a single Europeanmarket for goods and services. The proposal of European Council and suggestion of European Economicand Social Committee are also taken into account when the new machinery d

13、irective is established. Theamendment for machinery directive is to better put forward all concepts and definitions so as to clarifyissues concerned and make sure the better application of the directive, to make sure the free flowof the goods in the European Union countries, and at the same time to

14、ensure that a higher level ofhealth, safety and consumption protection can be reached.最早的机械安全指令是89/392/EEC , 9l/368/EEC增加了原来未包括在内的移动机械和和用于装载货物的升降没备。93/44/EEC增加了电梯指令中未涵盖的载人电梯的要求。日前的98/37/EC增加了对CE标志、合格声明的文件和资料的规定，同时增加了强制性要求。新指 令2006/42/EC目前已进入生效期，将于2009年12月29日正式实施，其中对便携式弹药推动固定器械和其他冲击式机械的要求延期至2011年7月29

15、日开始施行。Mobile machinery and lifting appliance used for cargo loading which are excluded in the earliestdirective 89/392/EEC were added into the directive 91/368/EEC. The requirement for the passengerelevator was added into the directive 93/44/EEC. The regulations for CE marking, documents and datafor

16、 conformity declaration and mandatory requirements were added into the present directive 98/37/EC.The new directive 2006/42/EC now is effective and will officially be implemented on 29 Dec. 2009, amongwhich the requirement for the fixed portable cartridge operated devices and other impact machines w

17、illbe postponed to be put into force on 29 Jul. 2011.3机械安全指令的适用范围及定义The Definition and Application of the Machinery Directive与指令98/37/EC不同，新指令不仅排除了一些机械设备，而且对适用的机械产品也给予了 明确的规定。新指令涵盖范围扩大，建筑现场用卷扬机、弹药推动固定器械和其他冲击式机 械将不再排除在外。同时新指令的涵盖范围明确地将电动机排除，降低了制造商管理中的不确定件。Different from the directive 98/37EC, the new

18、directive not only excludes some mechanical equipmentsbut also gives specific regulations to the mechanical products applicable to the directive. More arecovered by the new directive; winding engines used in the construction spot, fixed portable cartridgeoperated devices and other impact machines ar

19、e no longer excluded in the directive any more. Meanwhile,the electromotor is explicitly excluded in the directive which decreases the amount of uncertain partsin the management of the manufacturers.新指令与低电压(Low V oltage)指令的区分不再根据 生要风险”(MainRisk),其中列出的六类 电子和电气产品由低电压指令涵盖，其他机械则由低电压指令涵盖，但合格评定程序和投放市场要求由机

20、械指令掌控。Main risk is no longer the basis to differentiate the new machinery directive and low voltage directive.The six kinds of electronics and electrical products listed are covered by the low voltage directive;other machines are covered by the low voltage directive while conformity assessment proce

21、dure and launchinto the market shall be controlled by the machinery directive.新指令与电梯指令(Lifts Directive)的界线也给予了澄清，其中升降速度不高于0.15m/s的电梯划归机械安全指令涵盖。指令的适用产品：The boundary between the new machinery directive and lifts directive is also clarified. Elevators whoselifting speed is less than 0.15m/s shall be co

22、vered in the machinery safety directive. Productsapplicable to the new machinery directive:(a)机械没备mechanical equipment(b)可互换设备interchangeable equipment(c)安全性零组件protective components(d)升降机附件elevator accessories(e)链条、绳索、丝网chain, rope, mesh(f)可拆卸的机械传动装置dismountable mechanical gearing(g)机械半成品部分完成的机械装置pa

23、rtly completed mechanical device指令明确提出不属于该指令范畴的产品Products specifically excluded in the new machinery directive(a)原机械设备制造商提供的作为特定元件备用件的安全性零组件Secure components offered by the original mechanical equipment manufacturer to serve as spare partsfor some special parts(b)使用在赛场和/或游乐场的特殊没备Special equipments u

24、sed in the games and/or playgrounds(c)为核用途而特别设计或交付使用的机械设备，其故障会产生核辐射The mechanical equipment specifically designed or submitted for nuclear use whose failure may createnuclear radiation(d)武器，包括枪炮weapons, including guns(e)下歹U运输工具the following transportations指令2003/37/EC所涵盖的农业和林业拖拉机，其上装载的机械除外；Agricultu

25、ral and forestry tractor covered in the directive 2003/37/EC, exclusive of the devices loadedin it指令70/156/EEC所涵盖的机动车辆和其拖车，其上装载的机械除外；Motor vehicle and its trailer truck covered in the directive 70/156/EEC, exclusive of the devices loadedin it指令2002/24/EC所涵盖的车辆上装载的机械除外；Equipments loaded in the vehicl

26、es covered in the directive 2002/24/EC are excluded专门用于竞赛的机动车辆；Motor vehicles specifically used in the race航空、水路和铁路用运输工具，这些运输工具上装载的机械除外。Transportations used in aviation, waterway and railway, exclusive of the equipments loaded in thesetransportations(f)航海船只、移动的海上设备和安装在其板上的机械设备Vessels, mobile offshor

27、e set-up and mechanical devices installed on its boards(g)为军用和警用专门没计的机械装置Mechanical equipments specifically designed for the military use and police use(h)为实验室暂时研究使用而专门设计和制造的机械没备The mechanical equipment specifically designed and manufactured for the temporary research in thelaboratory(i)矿井卷扬机mine wi

28、ndlass艺术表演中用于移动演员的机械装置The mechanical equipment used to move the actor or actress in the art performance(k)指令73/23/EEC(关于使各成员国有关特定电压范围内工作的电气设备的法律趋于一致的 理事会指令，于1973年2月19日颁布)所包含的以下电气和电子产品：The following electronics and electrical products included in the directive 73/23/EEC-家用电器household appliances-音频和视频

29、设备audio and video equipments-信息技术设备information technological equipments-普通办公用机械设备ordinary office mechanical equipments-彳氐压开关设备和控制装置low voltage switchgear and control device-电动机electromotor(z)下歹U型式的高压电气设备the following high voltage electrical equipments-开关装置和控制装置switch device and control device-变压器vol

30、tage changer与其他指令的关系Relationship with other directives:该指令所述附件I中的相关危险，如全部或部分地为特定欧盟指令所涵盖，则该指令不应适用或从其他指令执行日期起终止适用。该指导法令采用的定义：Concerned risks in the appendix I of this directive , if partly or completely covered by the specificEU directive, this directive shall not be applied or cease to be applied fro

31、m the date when otherdirectives are complemented. Definitions adopted by this directive:(a)机械设备Mechanical equipments:与驱动系统装配在一起或准备与驱动系统装配在一起的机械装置，不直接通过人力或物力来运转，包括连接用零组件， 零组件中至少有一个移动件，这些零组件组装在一起可用于某 种特定的用途；Mechanical devices assembled or are to be assembled together with driving system which are not

32、directlyrun through manpower or material resources, include components used for connection. There must be atleast one moveable part in the components; these components can be used for a special purpose afterassembled together;(II)以上第条中提到的机械装置，只是缺少能够在现场将它们连接起来或与动力源相连接 的零组件；Mechanical devices mentione

33、d in the above article (I), only without components which can be used toconnect devices or power source on the spot;(III)以上第(1)、(II)条中提到的机械装置，己经为安装做好了准备，只有被安装到运输工具、 建筑物或某结构上时才能够发挥其原功能；The mechanical devices mentioned in the above article (1) and (II) which have been ready for installation.They can o

34、nly perform their original function when installed in the transportation, building or certainstructure.(Iv)以上第、(II)、(III)条中提到的机械装置或机械半成品部分完成机械的组合装置，为达 到相同的目的，对其进行排列和控制以便作为一个整体发挥功能；Mechanical devices or partly completed mechanical units; put them in order or control them in orderto make them perform

35、in whole units;(v)连接用零件或组件的组合装置，这些零组件中至少有一个移动件，它们组装在一起，预 定用于提升重物，惟一的动力源是直接利用人力。Combined equipment (parts or components) used for connection. There must be at least one moveable partin these components. They are assembled together to be used to hoist heavy objects. Direct manpoweris the only power so

36、urce.(b)可互换设备exchangeable equipments:机械装置或牵引机交付使用后，由操作员自己将这种设备与该装置或牵引机组装存一起，以便改变其功能或获得一种新功能，但可互换设备不是工具。After the mechanical device or hauling engine is submitted, operator shall connect this exchangeableequipment with this device or hauling engine so as to change its function or gain a new function.

37、 However,exchangeable equipments are not tools.(C)安全性零组件是指一种组件protective components are kind of components-用于实现安全功能used to secure safety;-独立地投放市场independently released on the market;-其出现故障和/或欠灵会威胁人的安全whose failure will cause safety threat to human beings;不一定是机械装置运转所必需的，或者也可用于代替正常的组件are not always ne

38、cessary for the running of mechanical device, or can be used to replace the normalparts.(d)升降机械附件是指一种组件或设备，其不附属于升降机械，可用于固定负载，此时通常置于升降机械和负载之间或者放在负载上；也可预定用于构成负载的整体部分，独立地投放市场；吊索和其组件也被称为升降机械的附件。Lifting mechanical accessories are defined as a kind of components or devices which are not attachedto the lif

39、ting machinery. They can be used for dead load (usually placed between lifting machineryand load or on load) or be destined for an integral part of the load which can be released into themarket independently; sling and its components are also the accessories of the lifting machinery.(e)链条、绳索和丝网是指用于升

40、举目的而设计和制造的链条、绳索和丝网，其作为升降机 械的组件或升降机械的附件。Chains, ropes and meshes, as the components or accessories of the lifting machinery, are designed andmanufactured for lifting.(f)可移动机械传动装置是指自动推进机械(或牵引机)和其他机器之间的可拆卸动力传输组件，自动推进机械(或牵引机)和其他机器之间首先通过固定轴承来连接。当此装置带有防护 装置投放市场时，将被作为一个产品考虑。Moveable mechanical gearing is t

41、he detachable power transmission component between automaticpropelling machine (or hauling engine) and other machines. Automatic propelling machine is connectedwith other machines firstly through fixed bearing. When this device, together with a protective deviceis put on the market, it is considered

42、 as a product.(g)机械半成品部分完成机械是指与某传动装置装配在一起或将要装配在一起的连接组件或机械组件，这种装置基本上是一个整机，但它们自己不能有特定的用途。部分完成的机械装置通常都和一个或多个机械装置 (或其他部分完成的机械装置 )连接在一起使用，最后形成一 个属于本指导法令范围内的单一机械装置。Partly completed machinery is connecting component or mechanical component which is or will be assembledwith a certain gearing. These devices

43、basically are complete appliances, but they don have particularpurpose on their own. Generally, partly completed machinery is usually used after connected with oneor more mechanical machines and at last form into a single mechanical device which is covered in thisdirective.(h)投放市场是指将机械装置首次在市场上推出， 不管

44、推出的目的是为了作为奖品来提供还 是免费提供，都叫投放市场。Launch is defined as the first time to put the mechanical device on the market no matter its purposeis supplying for prizes or supply for free.(i)制造商是指任何设计或制造本指导法令所包含的机械装置或机械半成品的自然人或法人，并为其机械装置或机械半成品符合本指令的要求负责，这些机械是按他自己的名字或商标投放到市场中或自己使用。当缺少上面提到的制造商时，任何将本指导法令所包含的机械装置或机械半成

45、品投放市场或交付使用的都将被当作制造商。The manufacturer is defined as any natural person or legal person who designs or manufactures mechanicaldevices or partly completed machinery covered under this directive and take responsibility for them.These machines are put on market or used by himself with the name of himself

46、 or trade name. If themanufacturer is not existed, anyone who put them on the market or submit them shall be regarded asthe manufacturer.授权代表是指在欧盟区域内确定的、由制造商书面命令履行或办理其全部或部分与本指令有关的义务或手续的任何自然人或法人。The authorized reprehensive is defined as the natural person or legal person appointed in the EU areawho c

47、an perform or go through part or complete obligations or procedures related to this directivein the written form ordered by the manufacturer.(k)交付使用是指奉指令所涵盖的机械设备在欧盟范围内按其预定使用目的的首次使用。Submission is defined as the first time, according to its original usage purpose, of using the machinescovered by the d

48、irective in the EU area.(Z)协调标准是指受欧盟委员会的委托，由欧洲标准化委员会(CEN)、欧洲电工标准化委员会(CENELEC)和欧洲电信标准学院(ETSI)按照1998年6月22日欧洲议会与欧盟理事会关于在 技术标准规范和信息社会服务法规领域提供信息程序的98/34/EC指令要求，依据其中指导原则而批准的不具强制约束力的技术规范。The Harmonized Standard is a kind of technical specifications without binding restriction. It isapproved by CEN, CENELEC

49、 and ETSI according to the instructions of directive 98/34/EC.指令中新增的概念定义有益于清楚地解释文中条款。例如 安全性零组件”，原指令98/37/EC文本中只有其笼统的定义，由于缺乏明确定义带来了很多应用中条款解释方面的问题。新指令不仅给予清晰的定义，而且采用列举方式给出明细清单，随着科技进步，机械委员会有权修订此列表进而涵盖新产品。The newly added concepts and definitions in the directive can more clearly explain the clauses in th

50、etext. Take protective component for example, there was only a general definition in the previousdirective 98/37/EC which caused many problems on the interpretation of clauses during application.There are not only clear definitions in the new directive, but also gives a list of examples. Withthe dev

51、elopment of technology, machinery industry commission is entitled to revise the list to covermore new products.4市场监督和合格性评定Market Supervision and Conformity Assessment新指导法令完善了与市场监督有关的条款，以及和合格性认证机构通告有关的条款。The clauses related to the market supervision and clauses related to the conformity certification

52、authority have been perfected in the new directive.新指令规定欧盟成员同有义务监督认证机构的表现。 如发现它们没有充分地履行职责，则成员国有权撤销和暂停该机构的资格。 同时更为明确地规定了成员国开展市场监督的责任， 其 义务包含互相合作，并要尊承保密性和透明度。It is regulated in the new directive that all EU members shall have the obligations to supervise theperformance of the certification authority.

53、EU members are entitled to cancel or suspend thecertification authority if they find the confirmation authority does not completely perform itsobligations. Meanwhile, EU members responsibility for conducting market supervision is morespecifically regulated in the directive. Mutual cooperation is inc

54、luded in their obligations; alsoconfidentiality and transparency shall be followed and kept.机械的合格性评定程序在原EC型式试验基础上新增机械制造过程内部审核合格性评估和完善的质量保证规程。Based on the original EC test, manufacture procedure internal audit conformity assessmentand prefectquality assurance are added to the machinery conformity ass

55、essment.针对机械半成品部分完成机械的合格性评定要求有两点：(1)做出机械设备的组装说明；(2)随机附装配说明书。Refer to the conformity assessment of the partly completed machinery; the following two aspects arerequired: (1) machinery assembly directions shall be given; (2) assembly instruction shall be attachedto the package of the machine.由上可知，新指令已

56、经明确对制造商的内部制造措施做出评估要求，同时新指令开始介入企业质量保证体系的评估，这些是广大生产厂家必须注意的问题。We get to know through all the above that there put forward assessment requirements to the internalproduction measures in the new directive, at the same time assessment on the enterprise qualityassurance system is also involved in the new di

57、rective. These should be paid attention to by allmanufacturers.5对指令95/16/EC的修订Amendment for the directive 95/16/EC新的机械指令对电梯指令95/16/EC作了部分修订，主要有Amendment to the lifts directive 95/16/EC is made in the new machinery directive, mainly:增加了运输车(carriage)的概念定义，同时在第1章里用acarriage取代car ；使法令内容更加符合实际应用。The defi

58、nition of carriage is added; meanwhileacar is replaced byacarriage in the article 1 whichmade the content more accordant to the practical application.(2)新增不属于其涵盖范围的机械设备Mechanical equipment exclusive of its previous coverage is newly added- 升降速度不大于0.15m/s的机械设备Mechanical equipment whose lifting speed

59、is less than 0.15m/s- 自动扶梯和机械式走道Escalator and mechanical type walkway基本健康与安全要求中第1.2条变为对运输车(carriage-)的要求The article 1.2 of the basic health and safety requirement was changed to the demand of carriage6基本的健康和安全要求Basic Health and Safety Requirement新指令中基本健康和安全要求出现的变化主要有The main changes to the basic hea

60、lth and safety requirement in the new directive are:(1)指令98/37/EC中针对由于机械运动部件或升降机械移动所造成的危险的特殊要求已经扩展到适用于所有机械。特别是：The special requirement with risks caused by the moving elements or the movement of the liftingmachine in the directive has extended to apply to all machines, especially:- 搬运期间的突然运动the jerk