CE认证中英文介绍

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 Machinery Directive (2006/42/CE) on 17 May, 2006. This new directive is made according to a new approach; its one of the basic directives on health and safety concern. Compared with the present Machinery Directive 98/37/EC there are some new requirements and noticeable changes to the new one on its application, boundary with other directives, market supervision, safe components, conformity assessment procedure, the requirement 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 and whole enterprises shall conduct better 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 clauses including machines applied to the new directive, some concepts and definitions, market supervision, its launch and submission, conformity presumption and adjustment standard, specific measures to deal with machines with potential hazards, dispute settlement procedure, protective covenant, machinery conformity assessment procedure, designated certification authority, CE marking, revision note for directive 95/16/EC, etc. Appendixes mainly include: the basic health and safety requirement to design and manufacture the machinery, declaration for the machinery conformity requirement, CE marking, catalogue for the machinery which need conformity assessment, protectivecomponent list, requirement for the technical documents, internal audit assessment on the machine manufacture, EC test, perfect quality assurance, the minimum standard needs to be considered when each member designates the certification 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，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 the
same as in the previous directive 98/37/EC are sorted and classified into independent clauses. The framework for the whole directive is more specific which can also help manufacturer, certification authorization/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 of the new EC Treaty (Article 100 in the previous Treaty). The main purpose for Article 95 in the Treaty is for putting forward some requirements on machine safety and health in order to make a single European market for goods and services. The proposal of European Council and suggestion of European Economic and Social Committee are also taken into account when the new machinery directive is established. The amendment for machinery directive is to better put forward all concepts and definitions so as to clarify issues concerned and make sure the better application of the directive, to make sure the free flow of the goods in the European Union countries, and at the same time to ensure that a higher level of health, 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日开始施行。

Mobile machinery and lifting appliance used for cargo loading which are excluded in the earliest directive 89/392/EEC were added into the directive 91/368/EEC. The requirement for the passenger elevator was added into the directive 93/44/EEC. The regulations for CE marking, documents and data for 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, among which the requirement for the fixed portable cartridge operated devices and other impact machines will be 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 directive not only excludes some mechanical equipments but also gives specific regulations to the mechanical products applicable to the directive. More are covered by the new directive; winding engines used in the construction spot, fixed portable cartridge operated devices and other impact machines are no longer excluded in the directive any more. Meanwhile, the electromotor is explicitly excluded in the directive which decreases the amount of uncertain parts in the management of the manufacturers.
新指令与低电压(Low V oltage)指令的区分不再根据“主要风险”(Main Risk)，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 procedure and launch into 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 whose lifting speed is less than 0.15m/s shall be covered in the machinery safety directive. Products applicable 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partly 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 parts for some special parts
(b)使用在赛场和/或游乐场的特殊没备
Special equipments used 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 create nuclear radiation
(d)武器，包括枪炮weapons, including guns
(e)下列运输工具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；
Agricultural and forestry tractor covered in the directive 2003/37/EC, exclusive of the devices loaded in 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 loaded in it
——指令2002/24/EC所涵盖的车辆上装载的机械除外；
Equipments loaded in the vehicles 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 these transportations
(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 offshore 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 the laboratory
(i)矿井卷扬机mine windlass
(j)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
——低压开关设备和控制装置low voltage switchgear and control device
——电动机electromotor
(z)下列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voltage 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 appendixⅠof this directive，if partly or completely covered by the specific EU directive, this directive shall not be applied or cease to be applied from the date when other directives are complemented. Definitions adopted by this directive:
(a)机械设备Mechanical equipments:
(I)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 directly run through manpower or material resources, include components used for connection.
There must be at least one moveable part in the components; these components can be used for a special purpose after assembled together;
(II)以上第(I)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 mentioned in the above article (I), only without components which can be used to connect 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 only perform their original function when installed in the transportation, building or certain structure.
(Iv)以上第(I)、(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 order to make them perform 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 part in these components. They are assembled together to be used to hoist heavy objects. Direct manpower is the only power source.
(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 exchangeable equipment with this device or hauling engine so as to change its function or gain a new function. 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 necessary for the running of mechanical device, or can be used to replace the normal parts.
(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 attached to the lifting machinery. They can be used for dead load (usually placed between lifting machinery and load or on load) or be destined for an integral part of the load which can be released into the market 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 and manufactured 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 the detachable power transmission component between automatic propelling machine (or hauling engine) and other machines. Automatic propelling machine is connected with other machines firstly through fixed bearing. When this device, together with a protective device is put on the market, it is considered 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 assembled with a certain gearing. These devices basically are complete appliances, but they don’t have particular purpose on their own. Generally, partly completed machinery is usually used after connected with one or more mechanical machines and at last form into a single mechanical device which is covered in this directive.
(h)投放市场是指将机械装置首次在市场上推出，不管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 purpose is 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 mechanical devices 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 or trade name. If the manufacturer is not existed, anyone who put them on the market or submit them shall be regarded as the manufacturer.
(j)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 area who can perform or go through part or complete obligations or procedures related to this directive in 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 machines covered by the directive 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 is
approved by CEN, CENELEC 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 the text. Take “protective component”for example, there was only a general definition in the previous directive 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. With the development of technology, machinery industry commission is entitled to revise the list to cover more 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 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 the performance of the certification authority. EU members are entitled to cancel or suspend the certification authority if they find the confirmation authority does not completely perform its obligations. Meanwhile, EU members’ responsibility for conducting market supervision is more specifically regulated in the directive. Mutual cooperation is included in their obligations; also confidentiality 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 assessment and prefect quality assurance are added to the machinery conformity assessment.
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 are required: (1) machinery assembly directions shall be given; (2) assembly instruction shall be attached to the package of the machine.
由上可知，新指令已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 internal production measures in the new directive, at the same time assessment on the enterprise
quality assurance system is also involved in the new directive. These should be paid attention to by all manufacturers.
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: (1)增加了运输车(carriage)的概念定义，同时在第1章里用“carriage''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''’取代"car”，使法令内容更加符合实际应用。

The definition of carriage is added; meanwhile “car” is replaced by “carriage”in the article 1 which made 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 is less than 0.15m/s
——自动扶梯和机械式走道
Escalator and mechanical type walkway
(3)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 carriage
6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 health 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 lifting machine in the directive has extended to apply to all machines, especially:
——搬运期间的突然运动the jerky motion during carrying;
——多控制台的相关特定条款particular provisions concerned of the multiple consoles
——闪电产生的危险risks caused by lightning
(2)说明书的相关要求更加详细，更容易理解
The relevant requirement of the specification is more specific and easier to understand
(3)在每个章节均加入关于特殊危险的警告信息，以提醒相关用户注意此种机械必须符合所有的基本健康和安全要求。

Warnings on extraordinary danger are added to each article so as to remind the user that the application of the machine must meet the basic health and safety requirements
(4)对新增涵盖的机械装置给出了具体要求。

Put forward specific requirement to the newly added mechanical machinery
新指令同时附加对下列特殊类别机械的补充要求:
Meanwhile, the following additional requirements to the special machinery have been added to the
new directive:
(1)化妆用品或药品生产机械没备; Cosmetic or drug production mechanical equipments;
(2)便携式手提和/或手控机械设备；Portable laptop or/and manual mechanical equipments;
(3)用于加工木材或相似物理参数材料的机械设备；
Equipment used to process wood or materials with the similar physical parameter;
(4)因其工作移动而引起危险的机械设备；
Equipment which may cause risks due to its movement during work;
(5)由于升降操作引起危险的机械设备；
Equipment which may cause risks due to its rise or drop;
(6)拟用于地下工作的机械设备；
Equipment tends to be used in the underground work;
(7)升降运送人员存在特殊危险的机械设备。

Mechanical equipment used to carry workers by rising or dropping which has special risks.
7强制合格性评估的机械种类
Machines Which Need Mandatory Conformity Assessment
(1)加工木材及类似物理参数材料，或加工肉类及类似物理参数材料的圆锯(单刀片或多刀片) Circular law (single blade or multi blades) used to process wood and the material with the similar physical parameter, or process meat and the material with the similar physical material
(2)手动进料木工平刨床hand-fed woodworking jointer planer
(3)木工用单面厚板刨床，内设机械式工件进给装置，手动装卸工件
Single-sided thick plank planer with mechanical workpiece feeding device in; manual load or unload of the workpiece
(4)加工木材及类似物理参数材料，或加工肉类及类似物理参数材料的带锯。

Band saw used to process wood and materiasl with similar physical parameter, or process meat and materials with similar physical parameter
(5)用于加工木材及类似物理参数材料的组合式机械，本节第(1)、(2)、(3)、(4)条以及第(7)条所述的机械均可作为其组合机械装置。

Combined machinery used to process wood and the materials with similar physical parameter. Machines mentioned in the article (1), (2), (3), (4) and (7) are regarded as combined mechanical devices.
(6)手动进料多刀夹木工开榫机
Hand-fed woodworking tenon making machine
(7)用于加工木材及类似物理参数材料的手动进料立轴铣床。

Vertical shaft milling machine used to process wood and materials with similar physical parameter
(8)木工用手提链条锯Woodworking portable chain saw
(9)手动装卸的金属冷加工用压床(包括弯板机)，其可动工作部件行程可达6mm以上，移动速度超过30mm/s。

Manual handling press (including plate bender) used for cold-working of metal. The stoke of movable part can reach over 6mm; its moving speed is over 30mm/s
(10)手动上下料的塑料注塑或压塑成型机。

Manual charging/discharging plastic injection/compression molding machine
(1I)手动上下料的橡胶注塑或压塑成型机。

Manual charging/discharging rubber injection/compression molding machine
(12)以下用于地下工作的机械设备the following equipments used for underground work ——机车头和司闸车locomotive and brake-van
——液压传动的顶架fluid-drive cabane
(13)装有压实机构的人工装载收集家庭垃圾的卡车。

Hand loading truck used to collect household refuse
(14)带有防护装置的可拆卸式机械传动设备
Detachable mechanical transmission equipment with protective structure
(15)可拆卸式机械传动设备所用的防护装置。

Protective structure the detachable mechanical transmission equipment used
(16)起重用的车辆lifting appliances
(17)具有从3米以上垂直高度跌落危险的载人或载人载物升降设备。

Lifting appliance used to carry human beings or materials which has a risk of falling down from a vertical height of more than 3 meters
(18)便携式弹药推动固定器械或其他冲击式机械设备。

Portable cartridge operated fixed machine or other impulsive type mechanical equipment
(19)为检测人员存在而设计的保护装置。

Protective structures designed for inspectors if existed
(20)第(9)、(10)、(11)条中所述的用以机械防护的动力驱动联锁式可移动防护装置Removable power-drive interlocking type protective structure mentioned in the above (9), (10) and (11) used for mechanical protection
(21)确保安全功能的逻辑装置logical system used for ensuring safety
(22)倾覆防护装置(ROPS) roll over protective structure
(23)物体跌落防护装置(FOPS) falling object protective structure
8安全元件明细清单Protective Element List
新机械指令给出的下列安全性零组件的清单，可根据工业发展和科技进步的水平，更新清单来涵盖新产品
The following protective element list given in the new machinery directive can be updated according to the development of industry and progress of technology to cover new items.
(1)可拆卸式机械传动设备所用的防护装置。

Safeguard device used in the detachable mechanical power transmission equipment
(2)为检测人员存在而设计的保护装置。

Protective structure designed for inspectors if existed
(3)强制合格性评估机械种类中第(9)、(10)、(11)条所述的用以机械防护的动力驱动联锁式可移动防护装置。

Movable power-drive interlocking type protective device mentioned in the article (9), (10), (11) in the enforced conformity assessment machines used for machinery protection.
(4)确保安全功能的逻辑装置logical structure used for ensuring safety
(5)带有故障检测附加措施的阀门，拟用于机械危险运动的控制
Valve with failure detection add-on measure which intends to control the dangerous activities of the machine
(6)机械排放物的收集系统collecting system for collecting machinery emission
(7)没计用于保护人员不受机械工作过程中运动部件伤害的防护和保护装置。

Protective structure designed to protect the operators from being hurt by the moveable part during the working process of the machine
(8)用于升降机械装载和运动控制的监控设备
Monitoring equipment used for lifting machine loading and motion control
(9)维持人员呆在操作座位上的约束系统
Restraint system used to keep the operator stay on the operating seat
(10)紧急停止装置Emergency stop structure
(11)防止潜在危险静电电荷聚集的放电系统
Discharge system used to keep the electrostatic charge from gathering to eliminate the potential hazards
(12)新指令附件l中第1.5.7、3.4.7和4.1.2.6条提到的能量限制器币¨释放装置。

(13)降低噪音和振动排放的系统装置。

Structure used for noise reduction and vibration discharge
(14)倾覆防护装置(ROPS) Roll over protective structure
(15)物体跌落防护装置(FOPS) Falling object protective structure
(16)双手控制设备two-hand control device
(17)设计用于在不同平台间升降运送人员的机械所用的零组件
Components designed for machines that used to lift and deliver persons between different platforms
9完善的质量保证规程Perfect Quality Assurance
新指令引入的对制造商质量保证体系的要求非常详细，制造商采取此程序进行机械合格性评估时，必须在机械设计、制造、最终检验和测试过程运行符合相关要求的质量管理体系并接受指定机构的监督。

It is specifically introduced in the new directive the requirement for the quality assurance system of the manufacturer. That machine design, manufacture, final inspection and testing processes must be in accordance to those regulated in the quality assurance system when making assessment by adopting this procedure and the manufacturer shall accept the supervision of the designated organization.
制造商或其授权代表必须向指定认证机构提出对其质量体系进行评定的中请。

The manufacturer or its authorized representative must make an application for the assessment of the quality system to the designated organization.
质量体系的实施必须确保机械设备符合本指令的相关要求。

制造商对其质量体系通过的所有要素、要求和条款必须以措施、程序、书面说明的形式形成系统化和有序化的质量文件。

The implementation of quality system must make sure that mechanical equipment meet the requirement concerned in this directive. All key elements, requirements and clauses passed by quality system shall be formed into quality documentations by the manufacturer in the form of measures, procedures or written instructions
质量体系文件对其程序和质量措施作统一阐述，诸如：质量方案、质量计划、质量手册和质量记录等。

质量体系文件特别应该描述质量目标，组织结构，技术设计规范，对机械设计的。