93 42 EEC与2007 47 EC的对照表
CE标志、ENIEC标准对应产品(机种一览)
指令 LVD
标志 CE 标志
（交替型）
AON1 AON2 AON2G、AON2F AON3
（按旋转锁定型） （钥匙型） （摇杆型） （推拉开关） （方形双按钮式） （销锁定形）
双按钮交替型
指示灯 （LED 灯泡照明、 白炽灯泡照明）
AJN3 ABN5 ATN4 ATN23 UWQN1 ABN8P
UWQN2 ABBN11 APN1、APNE1 UPQN3B UPQN4、UPQNE4
DC-13：1.1A、125V DC
〈照明元器件额定值〉 （LED 灯泡照明） 全电压型： 6、12、24V AC/DC 变压器型： 100V 〜 480V AC （白炽灯泡照明） 全电压型： 6、12、24V AC/DC 变压器型： 100V 〜 480V AC
（按压检测指示灯） 照明按钮开关 （LED 灯泡照明）
开关／指示灯
照明元器件／ 组合式指示灯
组合式 数字显示器
继电器／插座
定时器
端子台
电源
安全设备
电路保护器
PLC／智能型 应用控制器
人机界面
传感器
通用型 电气控制箱
备注 对应 JIS 和 IEC JIS C8201-1 JIS C8201-5-1 IEC 60947-1 IEC 60947-5-1
防爆设备 各种资料
（白炽灯泡照明）
选择开关
选择按钮开关
ø30HN 系列
照明选择开关 （LED 灯泡照明、 白炽灯泡照明）
按锁旋转复位型 （触点块一体型）
APNI∗P
ALN2、ALNE2 AOLN2、AOLNE2 ALGN2、ALGNE2 AOLGN2 AOLGNE2 AJLN3 ALN3、ALNE3 AOLN3、AOLNE3 ALN、ALNE AOLN、AOLNE3 ALN∗G、ALNE3G ALN∗F、ALNE3F AOLN∗F、 AOLNE3F AJLN ALN3、ALNE3 AOLN3、AOLNE3 ULQN、UOLQN ULQN∗B、 UOLQN∗B ALN∗L ASN、ASN∗L ASN∗K ASTN、ASTN∗L ASTN∗K ABN ABN∗L ASLN
医疗器械指令 93-42-EEC_2007完整版中英文对照
COUNCIL DIRECTIVE 93/42/EECof 14 June 19931993 年 6 月 14 日理事会第 93/42/EEC 号指令concerning medical devices关于医疗器械更改历史记录：z M1 Directive 98/79/EC of the European Parliament and of the Council of L 331 1 7.12.199827 October 1998z M2 Directive 2000/70/EC of the European Parliament and of the Council of L 313 22 13.12.200016 November 2000z M3 Directive 2001/104/EC of the European Parliament and of the Council L 6 50 10.1.2002of 7 December 2001z M4 Regulation (EC) No 1882/2003 of the European Parliament and of the L 284 1 31.10.2003 Council of 29 September 2003z M5 Directive 2007/47/EC of the European Parliament and of the Council of L 247 21 21.9.20075 September 2007THE COUNCIL OF THE EUROPEAN COMMUNITIES,欧洲共同体理事会Having regard to the Treaty establishing the European Economic Community, and in particular Article 100a thereof,依据欧洲经济体所制订的罗马条约, 特别是第 100a 条规定Having regard to the proposal from the Commission依据执委会的建议案In cooperation with the European Parliament配合欧洲议会Having regard to the opinion of the Economic and Social Committee,依据经济暨社会委员会的意见Whereas measures should be adopted in the context of the internal market; whereas the internal market is an area without internal frontiers in which the free movement of goods, persons, services and capital is ensured;鉴于内部市场的完成应采取一些措施; 鉴于内部市场是一无内部疆界的区域, 区域内的货物, 人员, 服务及资金应可自由流通Whereas the content and scope of the laws, regulations and administrative provisions in force in the Member States with regard to the safety, health protection and performance characteristics of medical devices are different; whereas the certification and inspection procedures for such devices differ from one Member State to another; whereas such disparities constitute barriers to trade within the Community;鉴于各会员国间现存有关医疗器械的安全, 对健康的保护及使用特性方面的法律, 法规及行政命令的内容与范围不尽相同; 鉴于各会员国对此器械的验证及检验程序也不相同; 鉴于前述的分歧将阻碍共同体内的贸易活动;Whereas the national provisions for the safety and health protection of patients, users and, where appropriate, other persons, with regard to the use of medical devices should be harmonized in order to guarantee the free movement of such devices within the internal markert;鉴于医疗器械的使用对病患, 使用者, 甚至其他人有关安全及健康保护的相关国家规定应加以调和, 以保证此类器械在内部市场能自由流通;Whereas the harmonized provisions must be distinguished from the measures adopted by the Member States to manage the funding of public health and sickness insurance schemes relating directly or indirectly to such devices; whereas, therefore, the provisions do not affect the ability of the Member States to implement the abovementioned measures provided Community law is complied with;鉴于调和的规定必然与各会员国采取的部分措施有所不同, 这些措施是为筹措公共健康与疾病保险计划的基金, 且直接或间接与医疗器械有关; 鉴于共同体若与上述措施相符, 则这些规定并不影响会员国落实上述措施的能力;Whereas medical devices should provide patients, users and third parties with a high level of protection and attain the performance levels attributed to them by the manufacturer; whereas, therefore, the maintenance or improvementof the level of protection attained in the Member States is one of the essential objectives of this Directive;鉴于医疗器械应提供病患, 使用者及第三者高度的保护, 且应该达到厂商所要求的性能水准; 鉴于维持或改进各会员国对病患等保护的程度乃本指令目的的一;Whereas certain medical devices are intended to administer medicinal products within the meaning of CouncilDirective 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products; whereas, in such cases, the placing on the market of the medical device as a general rule is governed by the present Directive and the placing on the market of the medicinal product is governed by Directive 65/65/EEC; whereas if, however, such a device is placed on the market in such a way that the device and the medicinal product form a single integral unit which is intended exclusively for use in the given combination and which is not reusable, that single-unit product shall be governed by Directive 65/65/EEC; whereas a distinction must be drawn between the abovementioned devices and medical devices incorporating, inter alia, substances which, if used separately, may be considered to be a medicinal substance within the meaning of Directive 65/65/EEC; whereas in such cases, if the substances incorporated in the medical devices are liable to act upon the body with action ancillary to that of the device, the placing of the devices on the market is governed by this Directive; whereas, in this context, the safety, quality and usefulness of the substances must be verified by analogy with the appropriate methods specified in Council Directive75/318/EEC of 20 May 1975 on the approximation of the laws of the Member States relating to analyticalpharmaco-toxicological and clinical standards and protocols in respect of the testing of proprietary medicinal products;鉴于部分医疗器械是符合 1965 年 1 月 26 日理事会第 65/65/EEC 号指令, 与专卖医药产品有关的法律, 法规或管理行为所订的实施规定, 鉴于医疗器械的上市基本上由本指令规范, 但医疗产品的上市则受 65/65/EEC 号指令规范; 鉴于若有某种器械须与其他医疗产品组成一完整的产品而上市销售, 使用, 且无法二次使用时, 则该组合产品应受65/65/EEC号指令规范; 鉴于前述的医疗器械和包含医疗物质且该物质单独使用时符合 65/65/EEC 号指令规定的医疗器械应加以区别; 鉴于前述包含于医疗器械的医疗物质若对人体产生作用以辅助医疗器械的作用时, 则该医疗器械的上市应由本指令规范; 鉴于1975 年 5 月 20 日 75/318/EEC 号理事会指令[制定各会员国在测试专利医疗产品方面有关分析药物毒性和临床的标准及调查书的法律调和], 医疗物质的安全, 品质及效用在前述情况下则须依该指令明定的适当方法加以证实;Whereas the essential requirements and other requirements set out in the Annexes to this Directive, including any reference to ‘minimizing’ or ‘reducing’ risk must be interpreted and applied in such a way as to take account of technology and practice existing at the time of design and of technical and economical considerations compatible with a high level of protection of health and safety;鉴于本指令附录所订的基本要求及其他要求, 包括[最低]或[降低]危险部分的应用, 应考虑设计当时的科技及实施情形,并在符合健康和安全高度保护的原则下考虑技术及经济的因素;Whereas, in accordance with the principles set out in the Council resolution of 7 May 1985 concerning a new approach to technical harmonization and standardization, rules regarding the design and manufacture of medical devices must be confined to the provisions required to meet the essential requirements; whereas, because they are essential, such requirements should replace the corresponding national provisions;鉴于为符合 1985 年 5 月 7 日理事会决议中有关技术调和与标准化新方针所订定的原则, 有关医疗器械的设计及执照应遵守相关条款以符合基本要求; 鉴于这些要求属基本要求, 所以应取代对应的国家规定;whereas the essential requirements should be applied with discretion to take account of the technological level existing at the time of design and of technical and economic considerations compatible with a high level of protection of health and safety;鉴于基本要求的落实应谨慎考虑设计当时的科技水准, 并在符合健康和安全高度保护的原则下考虑技术及经济的因素;Whereas Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices is the first case of application of the new approach to the field of medical devices; whereas in the interest of uniform Community rules applicable to all medical devices, this Directive is based largely on the provisions of Directive 90/385/EEC; whereas for the same reasons Directive 90/385/EEC must be amended to insert the general provisions laid down in this Directive;鉴于 1990 年 6 月 20 日通过的 90/385/EEC 号[各会员国有关主动植入式医疗器械法律调和] 的理事会指令是第一个应用在医疗器械方面的新方法指令; 鉴于为使共同体规定适用于所有的医疗器械, 本指令基本上是以 90/385/EEC 号指令的条款为依据; 鉴于 90/385/EEC 号指令,因此也必须增加本指令所列的一般条款的部分;Whereas the electromagnetic compatibility aspects form an integral part of the safety of medical devices; whereas this Directive should contain specific rules on this subject with regard to Council Directive 89/336/EEC of 3 May 1989 on the approximation of the laws of the Member States relating to electromagnetic compatibility;鉴于医疗器械的电磁相容性是整个产品安全的一部分; 鉴于本指令因此须包括 1989 年 5 月 3 日 89/336/EEC 号[各会员国有关电磁相容性法律调和]的理事会指令中所制订的特定规定;Whereas this Directive should include requirements regarding the design and manufacture of devices emitting ionizing radiation; whereas this Directive does not affect the authorization required by Council Directive 80/836/Euratom of 15 July 1980 amending the Directives laying down the basic safety standards for the health protection of the general public and workers against the dangers of ionizing radiation, nor application of Council Directive 84/466/Euratom of 3 September 1984 laying down basic measures for the radiation protection of persons undergoing medical examination or treatment; whereas Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work and the specific directives on the same subject should continue to apply;鉴于本指令应包含释放电离辐射医疗器械设计及制造的相关要求;鉴于本指令不影响 1980年7月15日80/836/Euratom理事会指令所需要的授权, 该指令目的在修订为保护大众及工作人员健康, 防止电离辐射危险而制订基本安全标准的其他指令; 本指令亦不影响 1984 年 9 月 3 日 84/466/Euratom 号[制订保护人员在医疗检查或治疗中不受辐射影响的基本方法] 理事会指令的适用; 鉴于 1989 年 6 月 12 日 89/391/EEC 号理事会指令[鼓励改善工作场所中工人的安全与健康]及其他相关主题的指令应持续适用;Whereas, in order to demonstrate conformity with the essential requirements and to enable conformity to be verified, it is desirable to have harmonized European standards to protect against the risks associated with the design, manufacture and packaging of medical devices; whereas such harmonized European standards are drawn up by private-law bodies and should retain their status as non-mandatory texts; whereas, to this end, the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (Cenelec) are recognized as the competent bodies for the adoption of harmonized standards in accordance with the general guidelines on cooperation between the Commission and these two bodies signed on 13 November 1984;鉴于为证明符合基本要求并使该符合性得以落实, 有必要建立调和的欧洲标准, 以避免医疗器械在设计, 制造及包装上所可能带来的危险, 鉴于调和的欧洲标准由私人立法机构制订, 而且应维持自愿性质; 鉴于欧洲标准化委员会(CEN) 及欧洲电工标准化委员会(CENELEC) 被认为是制订调和标准有能力的团体(competent bodies),而此标准符合 1984 年 11 月 13 日执委会与上述两团体所签订的合作纲要为基础的一般指导原则;Whereas, for the purpose of this Directive, a harmonized standard is a technical specification (European standard or harmonization document) adopted, on a mandate from the Commission, by either or both of these bodies in accordance with 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, and pursuant to the abovementioned general guidelines; whereas with regard to possible amendment of the harmonized standards, the Commission should be assisted by the Committee set up pursuant to Directive 83/189/EEC; whereas the measures to be taken must be defined in line with procedure I, as laid down in Council Decision 87/373/EEC; whereas, for specific fields, what already exists in the form of European Pharmacopoeia monographs should be incorporated within the framework of this Directive; whereas, therefore, several European Pharmacopoeia monographs may be considered equal to the abovementioned harmonized standards;鉴于为达本指令目的, 调和标准是前述机构接获理事会命令后, 依理事会 1983 年 3 月 28 日通过的 83/189/EEC 号指令[有关制订技术标准及法规资讯提供的程序]而采纳的技术规范(欧洲标准或调和文件, 符合前述一般纲要的规定 ; 鉴于调和标准的修正有赖于 83/189/EE 号指令建立的委员会的协助; 鉴于应采取的措施须依照理事会 87/378/EEC 号指令程序一的规定; 鉴于特殊领域中现存的欧洲药典专题论文应纳入本指令的架构中; 因此数篇欧洲药典专题论文将视其与前述调和标准有着同等的效力;Whereas, in Decision 90/683/EEC of 13 December 1990 concerning the modules for the various phases of the conformity assessment procedures which are intended to be used in the technical harmonization directives, the Council has laid down harmonized conformity assessment procedures; whereas the application of these modules to medical devices enables the responsibility of manufacturers and notified bodies to be determined during conformity assessment procedures on the basis of the type of devices concerned; whereas the details added to these modules are justified by the nature of the verification required for medical devices;鉴于理事会在1990 年 12 月 13 日通过的90/683/EEC号[有关技术调和指令适用的符合评鉴程序各阶段模式]决定中制定调和的符合评鉴程序; 鉴于这些模式于医疗器械的应用,可以依相关器械的型式决定制造商及公告机构在符合评鉴程序中应负的责任; 鉴于医疗器械的证明有必要在模式里增加细节的规定;Whereas it is necessary, essentially for the purpose of the conformity assessment procedures, to group the devices into four product classes; whereas the classification rules are based on the vulnerability of the human body taking account of the potential risks associated with the technical design and manufacture of the devices; whereas the conformity assessment procedures for Class I devices can be carried out, as a general rule, under the sole responsibility of the manufacturers in view of the low level of vulnerability associated with these products; whereas, for Class IIa devices, the intervention of a notified body should be compulsory at the production stage; whereas, for devices falling within Classes IIb and III which constitute a high risk potential, inspection by a notified body is required with regard to the design and manufacture of the devices; whereas Class III is set aside for the most critical devices for which explicit prior authorization with regard to conformity is required for them to be placed on the market;鉴于为达到符合评鉴的目的有必要将医疗器械分为四类; 鉴于分类是以考虑器械的技术设计及制造对易受伤的人体可能带来的危险程度为原则; 鉴于第 I 类医疗器械对人体可能产生的伤害较轻微,其符合性评鉴程序大致可由制造商完全负责执行; 鉴于对第 II(a)类医疗器械而言, 在生产阶段时公告机构的介入应属强制性质; 鉴于属于第 II(b)类及第 III 类的医疗器械对人体具有较高的潜在危险,因此在器械的设计及制造阶段必须有公告机构的检验;鉴于第III类的器械皆为较特别的器械, 其一致性需在上市的前获得明确授权;Whereas in cases where the conformity of the devices can be assessed under the responsibility of the manufacturer the competent authorities must be able, particularly in emergencies, to contact a person responsible for placing the device on the market and established in the Community, whether the manufacturer or another person established in the Community and designated by the manufacturer for the purpose;鉴于器械的一致性如能由制造商负责评鉴, 相关主管机关, 特别是紧急状况时, 应能联络到一位设于共同体内负责将器械在市场上销售的人员, 该人员可以是制造商本人或其他设于共同体内经制造商授权的人员;Whereas medical devices should, as a general rule, bear the CE mark to indicate their conformity with the provisions of this Directive to enable them to move freely within the Community and to be put into service in accordance with their intended purpose;鉴于医疗器械应附加 CE 标志, 表示其符合本指令的条款, 而得以在共同体市场上自由流通并依其设计的目的使用;Whereas, in the fight against AIDS and in the light of the conclusions of the Council adopted on 16 May 1989 regarding future activities on AIDS prevention and control at Community level, medical devices used for protection against the HIV virus must afford a high level of protection; whereas the design and manufacture of such products should be verified by a notified body;鉴于为抵抗爱滋病, 并顾及理事会于1989 年 5 月 16 日采纳有关共同体层次未来防止暨控制爱滋病相关活动的结论, 用于防止 HIV 病毒感染的医疗器械应提供人体高度的保护; 此类产品的设计及制造应由公告机构的证实;Whereas the classification rules generally enable medical devices to be appropriately classified; whereas, in view of the diverse nature of the devices and technological progress in this field, steps must be taken to include amongst the implementing powers conferred on the Commission the decisions to be taken with regard to the proper classification or reclassification of the devices or, where appropriate, the adjustment of the classification rules themselves;whereas since these issues are closely connected with the protection of health, it is appropriate that these decisions should come under procedure IIIa, as provided for in Directive 87/373/EEC;鉴于前述的分类原则大多可以适当地将医疗器械分类; 鉴于医疗器械性质及相关领域技术进步的性质各异, 因此必须采取一些措施以决定授予执委会的执行权力及有关器械的分类或再分类, 或者于适当时调整分类的原则; 鉴于上述的问题与人员健康的保护有着密切的关联, 因此这些决议应依照 87/373/EEC 号指令程序 IIIa 规定;Whereas the confirmation of complicance with the essential requirements may mean that clinical investigations have to be carried out under the responsibility of the manufacturer; whereas, for the purpose of carrying out the clinical investigations, appropriate means have to be specified for the protection of public health and public order;鉴于制造商有责任执行临床调查以证明其医疗器械符合安全要求; 因此为保证大众健康及秩序应明订执行临床调查的适当方法;Whereas the protection of health and the associated controls may be made more effective by means of medical device vigilance systems which are integrated at Community level;鉴于健康的保护及相关的管制方法以在共同体层次上建立一个医疗装置警戒系统为最有效;Whereas this Directive covers the medical devices referred to in Council Directive 76/764/EEC of 27 July 1976 on the approximation of the laws of the Member States on clinical mercury-in-glass, maximum reading thermometers; whereas the abovementioned Directive must therefore be repealed; whereas for the same reasons Council Directive 84/539/EEC on 17 September 1984 on the approximation of the laws of the Member States relating to electro- medical equipment used in human or veterinary medicine must be amended,鉴于理事会于 1976 年 7 月 27 日通过 76/764/EEC 号[有关各会员国水银玻璃最高温度计法律调和] 的指令中所提及的医疗器械亦受本指令规范; 前述指令因此必须撤销;基于同样原因, 理事会 1984 年 9 月 17 日通过的 84/539/EEC 号指令[有关各会员国人类或动物医疗使用的电动医疗器械法律调和],HAS ADOPTED THIS DlRECTIVE:爰制订本指令:Article 1第 1 条Definitions, scope定义, 范围1. This Directive shall apply to medical devices and their accessories. For the purposes of this Directive, accessories shall be treated as medical devices in their own right. Both medical devices and accessories shall hereinafter be termed devices.本指令适用于医疗器械及其附属物. 附属物在本指令的适用范围内亦视其为医疗器械. 两者以下皆称器械.2. For the purposes of this Directive, the following definitions shall apply:为本指令的目地, 下列定义适用于:(a) ►M5‘medical device’ means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:[医疗器械] 是指制造商预定用于人体以下目的的任何仪器、装置、器具、材料或其他物品，无论它们是单独使用还是组合使用，包括製造商預定的用於人體診斷和/或治療目的的軟體及為其正常使用所需的軟體：- diagnosis, prevention, monitoring, treatment or alleviation of disease,诊断, 预防, 追踪, 治疗或减轻疾病,- diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,诊断, 追踪, 治疗或修整伤处或残障部位,- investigation, replacement or modification of the anatomy or of a physiological process,解剖或生理过程中的检查, 换置或修正,- control of conception,生育控制,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 in its function by such means;这些器械不可借药性, 免疫力或新陈代谢的方法在人体内达到其主要设计的目的, 但可用这些器械辅助其功能者;(b) ‘accessory’ means an article which whilst not being a device is intended specifically by its manufacturer to beused together with a device to enable it to be used in accordance with the use of the device intended by the manufacturer of the device;[附属物]是指本身不可独立使用的物品, 制造商设计附属件的目地是配合其他器械合并使用, 使该器械得以依其设计目地发生功用;(c) ‘device used for in vitro diagnosis’ means any device which is a reagent, reagent product, kit, instrument, equipment or system, whether used alone or in combination, intended by the manufacturer to be used in vitro forthe examination of samples derived from the human body with a view to providing information on thephysiological state, state of health or disease, or congenital abnormality thereof;[体外诊断用器械] 是指任何自成单位或与其他物件组合的任何试剂, 试剂品, 套装用具, 仪器, 设备或系统形态的器械. 这种器械是制造商设计作为检查人体组织标本用的器械, 以期能够提供有关其生理状况, 健康或生病或任何先天不正常等讯息;▼M1‘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:[体外诊断用器械] 是指任何试剂、校正物质、对照物质、检测仪器、装置、设备或系统的医疗器械，无论是单独或合并使用，由制造商指定其用途为用于体外检验采自人体的样本，例如受捐得到的血液，组织等，单独或主要用以提供以下相关信息者：—concerning a physiological or pathological state, or人体的生理或病理状态—concerning a congenital abnormality, or先天性畸形—to determine the safety and compatibility with potential recipients, or确定是否与潜在的受体相融合。
EEC_ECE_EC与CE区别
EEC就是欧洲经济共同体的简写，European Economic Community；是实现欧洲一体，成员国必须执行；ECE就是欧洲经济委员会的简写，Economic Commission for Europe；是联合国下属机构，成员国对法规可作参考，有权决定是否接受；日本就是其中一成员国。
CE是从法语“Communate Europpene”缩写而成，是欧洲共同体的意思。
欧洲是第二次世界大战的主战场，战争使欧洲受到了巨大的破坏。
大战结束后，欧洲面临着全面复兴的局面。
为此，1947年联合国成立了欧洲经济委员会（ECE）来促进欧洲的复兴。
欧洲国家有一个特点，就是除横跨欧亚的苏联外，每一个国家的面积都不太大，因此跨界的陆运特别频繁。
这就势必带来涉及交通运输的一些汽车性能需要统一的问题，例如灯光的颜色应根据不同的用途需要统一。
于是1953年在欧洲经济委员会（ECE）内陆运输委员会（TRANS）的公路运输分委员会（SC1）中成立了车辆结构工作组（WP29）来研究和管理这方面的事务。
到1958年在日内瓦签署了欧洲范围内的一个联合国协议书《关于采用统一条件批准车辆、装备和部件并互相承认此批准的协议书》，简称58年“日内瓦协议书”，这样就在ECE范围内建立了一套技术法规—ECE法规和型式认证制度以及各国型式认证的互相认可。
后来欧洲国家为了实现统一组建了共同体。
共同体作为一个“形式上国家”也要建立一套对机动车产品的管理，于是欧洲共同体在欧洲经济委员会ECE法规的基础上也演变出了一套管理体制。
欧洲共同体成立后，做为一个统一体，在机动车技术法规方面也需要统一，当时还没有在全球范围内统一机动车技术法规的趋势，因此欧洲共同体在ECE法规之外又建立了一套适用于共同体国家的技术法规：EEC 指令。
在ECE法规以外建立EEC指令的原因有几个，一是ECE法规是非强制的，共同体各国采用的数量各不相同，需要在共同体内统一所采用的技术法规；二是共同体做为未来的“统一国家”也有建立机动车法规的必要性；三是ECE法规所涉及的认证主要是零部件和整车的一部分要求，没有专门针对某种车型的认证，而共同体要开展对M1类汽车和摩托车整车的型式认证和互相承认。
欧盟指令(EC-EEC)目录
N2，N3，O3，O4
45
M1类机动车辆质量及尺寸
92/21/EEC
（关于M1类机动车的质量和尺寸）
95/48/EC
M1
46
机动车辆及其挂车安全玻璃及玻璃材料
92/22/EEC
（关于机动车及其挂车的安全玻璃以及玻璃材料）
2001/92/EC
47
机动车辆及其挂车轮胎及其安装
92/23/EEC
88/77/EEC
（缺失）
2005/55/EC
（各成员国关于防治车用压燃式发动机气体和颗粒污染物排放以及燃用天然气和液化石油气的车用点燃式发动机气体污染物排放的法律）
91/542/EEC
96/1/EEC
1999/96/EC
2001/27/EC
2005/55/EC
2005/78/EC
2006/51/EC
2006/81/EC（未更新）
2008/74/EC（未更新）
2005/55/EC替代88/77/EEC
43
机动车辆及其挂车侧面保护
89/297/EEC
（各成员国关于机动车及其挂车侧面防护（侧面保护装置）的法律）
N2，N3，O3，O4
44
机动车辆及其挂车防飞溅系统
91/226/EEC
（各成员国关于某类机动车及其挂车溅射抑制系统的法律）
70/157/EEC
（各成员国关于机动车允许噪声限值和排气系统的法律）
73/350/EEC
77/2123/EEC
81/334/EEC
84/372/EEC
84/424/EEC
89/491/EEC
92/97/EEC
96/20/EC
1999/101/EC
93-42-EEC中文版
欧洲共同体理事会关于医疗器械的93/42/EEC指令来源：日期：2005-4-28 10:44:371993年6月14日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；考虑到欧洲共同体委员会提交的议案；考虑到与欧洲议会合作；考虑到经济与社会委员会的意见；鉴于应在欧洲共同体内部市场范围内正式通过必要的措施；鉴于欧洲共同体内部市场是一个确保商品、人员、服务和资本自由流通的无内部边界的区域；鉴于各成员国有关医疗器械的安全、健康保护和工作特性的法律、法规和行政条款的内容和范围是不同的；鉴于各成员国之间对这类器械的认证和检验程序存在差异；鉴于这种差异在欧洲共同体内形成贸易壁垒；鉴于各国针对医疗器械的使用所制定的有关患者、使用者及其他人员的安全和健康保护的条款应予以协调，以保证此类器械在欧洲共同体内部市场自由流通；鉴于协调条款必须与成员国为管理直接或间接与这类器械有关的公共健康和医疗保险计划的资金筹措而采取的措施相区别；鉴于因而只要遵守欧洲共同体法律，这些条款并不影响各成员国实施上述措施的能力；鉴于医疗器械应向患者、使用者及第三方提供高水平的保护并达到制造商赋予其的性能水平；鉴于因此保持和提高各成员国已达到的保护水平是本指令的基本目的之一；鉴于在1965年1月26日欧洲共同体理事会关于使有关特许专卖药品的法律、法规或行政措施趋于一致的65/65/EEC指令中，某些医疗器械是用于施药的；鉴于在这种情况下，医疗器械投放市场通常由本指令管理，而药品投放市场由65/65/EEC指令管理；鉴于如果这种器械投放市场的方式使器械与药品构成一种规定只供组合使用且不能再次使用的整体，则这个单一整体产品应由65/65/EEC指令管理；鉴于必须将上述器械与包含某种物质，特别是当其单独使用时，按65/65/EEC指令可视为药物的医疗器械相区别；鉴于在这种情况下，若这种物质能配合医疗器械对人体产生辅助作用，则这类器械投放市场由本指令管理；鉴于这类物质的安全性、质量和有效性必须比照欧洲共同体理事会1975年5月20日关于使成员国有关分析标准、药物毒理学标准和临床标准及特许专卖药品试验协议的法律趋于一致的75/318/EEC指令规定的适当方法加以验证；鉴于本指令附录中的基本要求和其他要求，包括对“减小”或“降低”危险的任何引用，在解释和实施时必须考虑设计时的技术现状和实际做法及高水平的健康和安全相适应的技术与经济条件；鉴于按照1985年5月7日欧洲共同体理事会关于技术协调与标准化新方法的决议所规定的原则，有关医疗器械设计和生产的规定必须限于满足基本要求所必须的条款；鉴于因为这些要求是基本的，因此它们应取代各国相应的条款；鉴于实施基本要求应审慎考虑设计时的技术水平和与高水平的健康及安全保护相适应的技术、经济条件；鉴于1990年6月20日欧洲共同体理事会关于使成员国有关有源植入式医疗器械的法律趋于一致的90/385/EEC指令是新方法指令在医疗器械领域中的首次应用案例；鉴于为了使欧洲共同体的统一规定适用于所有医疗器械，本指令基本上是以90/385/EEC指令的条款为依据的；鉴于为此必须修订90/385/EEC指令，以便放入本指令规定的一般性条款；鉴于电磁兼容性问题是医疗器械安全的一个组成部分；鉴于就1989年5月3日欧洲共同体理事会关于使成员国有关电磁兼容的法律趋于一致的89/336/EEC指令而言，应包含这方面的专门规定；鉴于本指令应包括有关发射电离辐射的器械在设计和制造方面的要求；鉴于本指令既不影响1980年7月15日欧洲共同体理事会80/836/Euratom指令对有关保护公众和工人免受电离辐射危险的基本安全标准的指令进行修订所要求的授权，也不影响欧洲共同体理事会1984年9月3日对接受医疗检查和治疗的人员的辐射防护规定了基本措施的84/466/Euratom指令的实施；鉴于欧洲共同体理事会1989年6月12日关于采取措施鼓励改善工人工作中的安全和健康的89/391/EEC指令以及有关这一问题的专门指令应继续予以实施；鉴于为了证实符合基本要求并使这种符合得到验证，需要制定欧洲协调标准来防止与医疗器械的设计、制造和包装有关的危险；鉴于这类欧洲协调标准是由非官方机构制定的，应保持其非强制性的地位；鉴于为此欧洲标准化委员会（CEN）和欧洲电工标准化委员会（CENELEC）按照1984年11月13日欧洲共同体委员会与这两个机构之间签署的合作总指导原则，被认可为批准协调标准的主管机构；鉴于在本指令中，协调标准是受欧洲共同体委员会委托，由上述两机构之一，或两个机构共同根据欧洲共同体理事会1983年3月18日关于在技术标准和法规领域提供信息程序的83/189/EEC指令，依照上述总指导原则而批准的技术规范（欧洲标准或协调文件）；鉴于对协调标准进行修订，欧洲共同体委员会应得到根据83/189/EEC 指令建立的常设委员会的帮助；鉴于应采取的措施必须按欧洲共同体理事会87/373/EEC决定中规定的程序Ⅰ而规定；鉴于在特定领域，欧洲药典专著这类现有的形式应包括在本指令的范围内；鉴于因此有几部欧洲药典专著可视为等同于上述协调标准。
发动机变速箱对照表
AZ2201000041/7 AZ2201000041/8 AZ2201000290 AZ2201000290/7 AZ2201000290/8 AZ2201000454 AZ2201000454/7 AZ2201000454/8 AZ2201000459 AZ2201000459/7 AZ2201000459/8 AZ2201000463 AZ2201000484 AZ2201000495 AZ2201000499 AZ2201000499/7 AZ2201000499/8 AZ2201000500 AZ2201000500/7 AZ2201000500/8 AZ2201000601 AZ2201000601/7 AZ2201000601/8 AZ2201000610 AZ2201000610/7 AZ2201000610/8 AZ2201000650 AZ2201000650/7 AZ2201000650/8 AZ6100003153 AZ6100003153/1 AZ6100005227 AZ6100005227/1 AZ6100005227/3 AZ6100005577 AZ6100005577/1 AZ6100005577/3 AZ6100005578 AZ6100005578/1 AZ6100005578/3 AZ6100005579 AZ6100005579/1 AZ6100005579/3 AZ6100005580 WO/两气门共轨/EVB/MT/ST越野车/出口/221KW/国Ⅲ HW9709643LHOWO/两气门共轨/EVB/MT/ST越野车/电加热/221KW/国Ⅲ HW9709643L济/HOWO/两气门共轨/EVB/MT/ST越野车/电加热/221KW/国Ⅲ HW9709643L杭/HOWO/两气门共轨/EVB/MT/ST越野车/电加热/221KW/国Ⅲ HW9709653L/HOWO/两气门共轨/EVB/MT/ST越野车/出口/电加热/221KW/国Ⅲ HW9709653L济/HOWO/两气门共轨/EVB/MT/ST越野车/出口/电加热/221KW/国 HW9709653L杭/HOWO/两气门共轨/EVB/MT/ST越野车/出口/电加热/221KW/国 HW9709663L/HOWO/两气门共轨/EVB/MT/ST越野车/硅油风扇/电加热/221KW/ HW9709663LJI济/HOWO/两气门共轨/EVB/MT/ST越野车/硅油风扇/电加热/221 HW9709663L杭/HOWO/两气门共轨/EVB/MT/ST越野车/硅油风扇/电加热/221KW HW9709673LHOWO/两气门共轨/EVB/MT/ST越野车/出口/硅油风扇/电加热/221K HW9709673L济/HOWO/两气门共轨/EVB/MT/ST越野车/出口/硅油风扇/电加热/22 HW9709673L杭/HOWO/两气门共轨/EVB/MT/ST越野车/出口/硅油风扇/电加热/22 ST/2气门EGR/221KW/300车架/国Ⅲ/ST9709023M ST/2气门EGR/221KW/300车架/国Ⅲ/ST9709023M济 ST/2气门EGR/221KW/300车架/国Ⅲ/ST9709023M
医疗器械200747EC指令(9342EEC指令的修订案)
DIRECTIVE 2007/47/EC OF THE EUROPEAN PARLIAMENT AND OF THECOUNCILof 5 September 2007amending Council Directive 90/385/EEC on the approximation of the laws ofthe Member Statesrelating to active implantable medical devices, Council Directive 93/42/EECconcerning medicaldevices and Directive 98/8/EC concerning the placing of biocidal products onthe market医疗器械指令更改的分析(针对2007/47/EC)September 5, 2007, the European Union issued a new Directive (2007/47/EC) that will affect all manufacturers selling medical devices in Europe.2007年9月5日，欧盟发布了一个将影响所有在欧洲出售医疗器械的制造商的新指令(2007/47的/EC)。
Essentially, this new Directive is the first significant modification to the Medical Device Directive since 1993 and there are several changes you may need to prepare for WELL BEFORE it becomes mandatory in March 2010. Here is a brief overview of major changes本质上讲，这份新指令是自1993年起,对医疗器械指令的第一个重大的修改，在2010年3月强制执行之前，你们需要好好准备它相应的改变。
MDD指令测验(范卷)
欧盟医疗器械指令MDD试卷姓名：岗位：得分：一、是非题：（对“√”错“×”）每题3分共30分1．2007/47/EC 是对93/42/EEC 的第5 次修订。
（√）2．含有致癌、导致基因突变及毒性的可能性物质，必须遵循67/548/EC。
（√）3．说明书应有版本及发行日期。
（√）4．对孕妇、哺乳期女性、婴幼儿等产品应明确使用产品的风险。
（√）5．2007/47/EC软件被明确定义为有源医疗器械，必须证明其有效性。
（√）6．注册责任人的信息，需要保密。
（×）7．医疗产品分类,将根据主要作用方式来确定,而不是预期用途。
（√）8．所有器械都将需要临床数据,包括Ⅰ类产品。
（√）9．临床评价可以做对比的方法，不一定做临床。
（√）10．一个设备停用或移走，被另一个相同的设备所替代，将影响分类。
（√）二、选择题：每题5分，共20分。
1．.在英国，违反CE标记的惩罚为：（G ）A．扣留，罚没 B．5000英镑的罚款C．3个月的监禁 D．通报欧盟-产品消失E．撤出市场或回收所有在用产品 F．追究刑事责任 G．以上的一种和数种并罚2．2007年9月欧盟正式发布对93/42/EEC更新指令2007/47/EC （D ）A．这份新指令是自1993年起,对医疗器械指令的一个重大的修改B．2010年3月21日为最终执行期C．所有已经申请CE或即将申请认证的客户所提供的技术文件必须完全符合新指令要求。
D．以上全部3．2007/47/ec医疗器械指令（ D ）A．2007/47/ec 是新的医疗器械指令。
B．2007/47/ec中仅仅包含3个指令中被修订部分的局部内容，而不是3个指令的完整内容。
C．2007/47/ec 并非新的医疗器械指令。
D． B＋C4．2007/47/EC中明确规定记录保存时间不得小于产品使用周期（ D ）A．自生产之日起五年以备检查B．对植入设备产品生产之日起15年C．拿到证书后，必须到销售国注册，包括Ⅰ类产品D．以上全部三、填充：每空格3分，共30分1．MDD 93/42/EEC共包括23个条款和12附件。
最全ASCII码对照表
最全ASCII码对照表2009-04-15 00:00Bin Dec Hex 缩写/字符解释0000 0000 0 00 NUL (null) 空字符0000 0001 1 01 SOH (start of handing) 标题开始0000 0010 2 02 STX (start of text) 正文开始0000 0011 3 03 ETX (end of text) 正文结束0000 0100 4 04 EOT (end of transmission) 传输结束0000 0101 5 05 ENQ (enquiry) 请求0000 0110 6 06 ACK (acknowledge) 收到通知0000 0111 7 07 BEL (bell) 响铃0000 1000 8 08 BS (backspace) 退格0000 1001 9 09 HT (horizontal tab) 水平制表符0000 1010 10 0A LF (NL line feed, new line) 换行键0000 1011 11 0B VT (vertical tab) 垂直制表符0000 1100 12 0C FF (NP form feed, new page) 换页键0000 1101 13 0D CR (carriage return) 回车键0000 1110 14 0E SO (shift out) 不用切换0000 1111 15 0F SI (shift in) 启用切换0001 0000 16 10 DLE (data link escape) 数据链路转义0001 0001 17 11 DC1 (device control 1) 设备控制1 0001 0010 18 12 DC2 (device control 2) 设备控制2 0001 0011 19 13 DC3 (device control 3) 设备控制3 0001 0100 20 14 DC4 (device control 4) 设备控制4 0001 0101 21 15 NAK (negative acknowledge) 拒绝接收0001 0110 22 16 SYN (synchronous idle) 同步空闲0001 0111 23 17 ETB (end of trans. block) 传输块结束0001 1000 24 18 CAN (cancel) 取消0001 1001 25 19 EM (end of medium) 介质中断0001 1010 26 1A SUB (substitute) 替补0001 1011 27 1B ESC (escape) 溢出0001 1100 28 1C FS (file separator) 文件分割符0001 1101 29 1D GS (group separator) 分组符0001 1110 30 1E RS (record separator) 记录分离符0001 1111 31 1F US (unit separator) 单元分隔符0010 0000 32 20 空格0010 0001 33 21 !0010 0010 34 22 "0010 0011 35 23 #0010 0100 36 24 $0010 0101 37 25 %0010 0110 38 26 &0010 0111 39 27 '0010 1000 40 28 (0010 1001 41 29 )0010 1101 45 2D - 0010 1110 46 2E . 0010 1111 47 2F / 0011 0000 48 30 0 0011 0001 49 31 1 0011 0010 50 32 2 0011 0011 51 33 3 0011 0100 52 34 4 0011 0101 53 35 5 0011 0110 54 36 6 0011 0111 55 37 7 0011 1000 56 38 8 0011 1001 57 39 9 0011 1010 58 3A : 0011 1011 59 3B ; 0011 1100 60 3C < 0011 1101 61 3D = 0011 1110 62 3E > 0011 1111 63 3F ? 0100 0000 64 40 @ 0100 0001 65 41 A 0100 0010 66 42 B 0100 0011 67 43 C 0100 0100 68 44 D 0100 0101 69 45 E 0100 0110 70 46 F 0100 0111 71 47 G 0100 1000 72 48 H 0100 1001 73 49 I 0100 1010 74 4A J 0100 1011 75 4B K 0100 1100 76 4C L 0100 1101 77 4D M 0100 1110 78 4E N 0100 1111 79 4F O 0101 0000 80 50 P 0101 0001 81 51 Q 0101 0010 82 52 R 0101 0011 83 53 S 0101 0100 84 54 T 0101 0101 85 55 U 0101 0110 86 56 V 0101 0111 87 57 W 0101 1000 88 58 X0101 1100 92 5C \0101 1101 93 5D ]0101 1110 94 5E ^0101 1111 95 5F _0110 0000 96 60 `0110 0001 97 61 a0110 0010 98 62 b0110 0011 99 63 c0110 0100 100 64 d0110 0101 101 65 e0110 0110 102 66 f0110 0111 103 67 g0110 1000 104 68 h0110 1001 105 69 i0110 1010 106 6A j0110 1011 107 6B k0110 1100 108 6C l0110 1101 109 6D m0110 1110 110 6E n0110 1111 111 6F o0111 0000 112 70 p0111 0001 113 71 q0111 0010 114 72 r0111 0011 115 73 s0111 0100 116 74 t0111 0101 117 75 u0111 0110 118 76 v0111 0111 119 77 w0111 1000 120 78 x0111 1001 121 79 y0111 1010 122 7A z0111 1011 123 7B {0111 1100 124 7C |0111 1101 125 7D }0111 1110 126 7E ~0111 1111 127 7F DEL (delete) 删除ESC键VK_ESCAPE (27)回车键：VK_RETURN (13)TAB键：VK_TAB (9)Caps Lock键：VK_CAPITAL (20)Shift键：VK_SHIFT ()Ctrl键：VK_CONTROL (17)Alt键：VK_MENU (18)空格键：VK_SPACE (/32)退格键：VK_BACK (8)左徽标键：VK_LWIN (91)右徽标键：VK_LWIN (92)鼠标右键快捷键：VK_APPS (93) Insert键：VK_INSERT (45) Home键：VK_HOME (36) Page Up：VK_PRIOR (33) PageDown：VK_NEXT (34)End键：VK_END (35)Delete键：VK_DELETE (46)方向键(←)：VK_LEFT (37)方向键(↑)：VK_UP (38)方向键(→)：VK_RIGHT (39)方向键(↓)：VK_DOWN (40)F1键：VK_F1 (112)F2键：VK_F2 (113)F3键：VK_F3 (114)F4键：VK_F4 (115)F5键：VK_F5 (116)F6键：VK_F6 (117)F7键：VK_F7 (118)F8键：VK_F8 (119)F9键：VK_F9 (120)F10键：VK_F10 (121)F11键：VK_F11 (122)F12键：VK_F12 (123)Num Lock键：VK_NUMLOCK (144) 小键盘0：VK_NUMPAD0 (96) 小键盘1：VK_NUMPAD0 (97) 小键盘2：VK_NUMPAD0 (98) 小键盘3：VK_NUMPAD0 (99) 小键盘4：VK_NUMPAD0 (100) 小键盘5：VK_NUMPAD0 (101) 小键盘6：VK_NUMPAD0 (102) 小键盘7：VK_NUMPAD0 (103) 小键盘8：VK_NUMPAD0 (104) 小键盘9：VK_NUMPAD0 (105) 小键盘.：VK_DECIMAL (110) 小键盘*：VK_MULTIPLY (106) 小键盘+：VK_MULTIPLY (107) 小键盘-：VK_SUBTRACT (109) 小键盘/：VK_DIVIDE (111) Pause Break键：VK_PAUSE (19) Scroll Lock键：VK_SCROLL (145)。
MDD 93-42-EEC简介
M用
MDD
简介
有源植入医疗器械指令 90/385/EEC（AIMDD） COUNCIL DIRECTIVE of 20 June 1990, on the approximation of the laws of the Member States relating to Active Implantable Medical Devices (90/385/EEC) 医疗器械指令93/42/EEC（MDD） COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993, concerning Medical Devices (Directive) 体外诊断医疗器械指令98/79/EC（IVMDD） DIRECTIVE 98/79/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 27 October 1998，on In Vitro Diagnostic medical devices
MDD 93/42/EEC
质量法规部 2014-07
目录
• CE Marking • MDD
CE Marking
简述
目的
适用范围
适用对象
获取方法
CE Marking
简述
① 1993年7月22日发表《欧盟产品指令Product Directive》，93/68/EEC，’CE’ 标识诞 生； ② ‘CE’，法语“Communate Europpene”的缩写，意思即“欧洲共同体”； ③ 具有’CE’标识的商品，意味着该商品满足欧盟相关法规及协调标准的要求，制造 商负有相应责任。
23项条款
条款号 Article 1 Article 2 Article 3 Article 4 Article 5 Article 6 Article 7 Article 8 Article 9 Article 10 Article 11 Article 12 Article 13 Article 14 Article 15 Article 16 Article 17 Article 18 Article 19 Article 20 Article 21 Article 22 Article 23 Definition，Scope Placing on the market and putting into service Essential Requirements Free movement, devices intended for special purposes Reference to standards Committee on standards and Technical regulations Committee on Medical device Safeguard clause Classfication Information on incidents occuring following placing of devices on the market Conformity assessment procedures Particular procedure for systems and procedure packs Decisions with regards to classfication， derogation clause Registration of persons responsible for placing devices on the market Clinical investigation Notified bodies CE marking Wrongly affixed CE Marking Decision in respect of refusal or restriction Confidentiality Repeal and amendment of Directives Implementation，transitional provisions This directive is addressed to the member states 内容 定义，范围 上市及使用 基本要求 自由流通及特殊目的的器械 标准的参考 标准及技术法规委员会 医疗器械委员会 保护条款 分类 器械上市后偶发事件的资讯 符合评鉴程序 成套医疗系统及程序的特殊程序 分类决定的排除条款 负责器械上市行销人员的登录 临床调查 公告机构 CE标示 误加的CE标示 有关拒绝或限制的决定 机密性 指令的撤销及修订 实施及过渡条款 本指令通告所有会员国
MDD 93-42-EEC简介
2014/07/01，欧盟网站共计公布25类需进行CE
Marking的商品大类
1. 有源植入医疗器械； 2. 燃气炉具；
3. 载人的索道装置；
4. 建筑产品；
5. 能源相关产品生态设计；
6. 电磁兼容；
7. 使用于具有爆炸性环境中的设备和保护系统；
8. 民用爆破器材；
9. 热水锅炉；
10. 体外诊断试剂；
② ‘CE’，法语“Communate Europpene”的缩写，意思即“欧洲 共同体”；
③ 具有’CE’标识的商品，意味着该商品满足欧盟相关法规及协 调标准的要求，制造商负有相应责任。
CE Marking
目的 消除商品流通壁垒，保护公众利益.
CE Marking
适用范围
Member states of EU 欧盟成员国（28个，24种官方语言）
基本要求 一般要求 有关设计及架构的要求
EC符合性声明（完全品质保证系统）
内容 Definition，Scope Placing on the market and putting into service Essential Requirements Free movement, devices intended for special purposes Reference to standards Committee on standards and Technical regulations Committee on Medical device Safeguard clause Classfication Information on incidents occuring following placing of devices on the market Conformity assessment procedures Particular procedure for systems and procedure packs Decisions with regards to classfication， derogation clause Registration of persons responsible for placing devices on the market Clinical investigation Notified bodies CE marking Wrongly affixed CE Marking Decision in respect of refusal or restriction Confidentiality Repeal and amendment of Directives Implementation，transitional provisions This directive is addressed to the member states
2007／47／EC欧盟新版医疗器械指令
DIRECTIVE2007/47/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCILof5September2007amending Council Directive90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices,Council Directive93/42/EEC concerning medical devices and Directive98/8/EC concerning the placing of biocidal products on the market(Text with EEA relevance)THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Commu-nity,and in particular Article95thereof,Having regard to the proposal from the Commission,Having regard to the opinion of the European Economic and Social Committee(1),Acting in accordance with the procedure laid down in Article251 of the Treaty(2),Whereas:(1)Council Directive93/42/EEC(3)requires the Commissionto submit a report to the Council,no later than five years from the date of implementation of that Directive, concerning:(i)information on incidents occurring follow-ing the placing of devices on the market,(ii)clinical investigation carried out in accordance with the procedure set out in Annex VIII to Directive93/42/EEC,and(iii) design examination and EC type examination of medical devices that incorporate,as an integral part,a substance which,if used separately,may be considered to be a medicinal product as defined in Directive2001/83/EC of the European Parliament and of the Council of6November 2001on the Community code relating to medicinal products for human use(4)and which is liable to act upon the body with action ancillary to that of the device.(2)The Commission brought forward the conclusions of thatreport in its Communication to the Council and the European Parliament on medical devices which,at the request of the Member States,was expanded to cover all aspects of the Community regulatory framework for medical devices.(3)This Communication was welcomed by the Council in itsConclusions on medical devices of2December2003(5).Itwas also discussed by the European Parliament which on 3June2003adopted a resolution on the health implications of Directive93/42/EEC(6).(4)Following from the conclusions drawn in that Commu-nication it is necessary and appropriate to amend Council Directive90/385/EEC(7),Directive93/42/EEC and Direc-tive98/8/EC of the European Parliament and of the Council(8).(5)To ensure consistency of interpretation and implementationbetween Directives93/42/EEC and90/385/EEC the legal framework related to issues such as authorised representa-tive,the European databank,health protection measures, and the application of Directive93/42/EEC as regards medical devices incorporating stable derivates of human blood or human plasma,as introduced by Directive2000/ 70/EC(9),should be extended to Directive90/385/EEC.The application of the provisions on medical devices incorpor-ating stable derivates of human blood or human plasma includes application of Directive2002/98/EC of the European Parliament and of the Council of27January 2003setting standards of quality and safety for the collection,testing,processing,storage and distribution of human blood and blood components and amending Directive2001/83/EC(10).(6)It is necessary to clarify that software in its own right,whenspecifically intended by the manufacturer to be used for one or more of the medical purposes set out in the definition ofa medical device,is a medical device.Software for generalpurposes when used in a healthcare setting is not a medical device.(7)Particular care should be taken to ensure that thereprocessing of medical devices does not endanger patients’safety or health.It is therefore necessary to provide clarification on the definition of the term‘single use’,as well as to make provision for uniform labelling and(1)OJ C195,18.8.2006,p.14.(2)Opinion of the European Parliament of29March2007(not yetpublished in the Official Journal)and Council Decision of23July 2007.(3)OJ L169,12.7.1993,p.1.Directive as last amended by Regulation(EC)No1882/2003of the European Parliament and of the Council (OJ L284,31.10.2003,p.1).(4)OJ L311,28.11.2001,p.67.Directive as last amended byRegulation(EC)No1901/2006of the European Parliament and of the Council(OJ L378,27.12.2006,p.1).(5)OJ C20,24.1.2004,p.1.(6)OJ C68E,18.3.2004,p.85.(7)OJ L189,20.7.1990,p.17.Directive as last amended by Regulation(EC)No1882/2003.(8)OJ L123,24.4.1998,p.1.Directive as last amended by CommissionDirective2007/20/EC(OJ L94,4.4.2007,p.23).(9)Directive2000/70/EC of the European Parliament and of theCouncil of16November2000amending Council Directive93/42/ EEC as regards medical devices incorporating stable derivates of human blood or human plasma(OJ L313,13.12.2000,p.22). (10)OJ L33,8.2.2003,p.30.instructions for use.Moreover,the Commission should engage in further analysis in order to see if additional measures are appropriate to ensure a high level of protection for patients.(8)In the light of technical innovation and the development ofinitiatives at the international level it is necessary to enhance the provisions on clinical evaluation,including clarification that clinical data is generally required for all devices regardless of classification and the possibility to centralise data on clinical investigations in the European databank.(9)In order to provide clearer evidence of the compliance ofcustom-made device manufacturers,an explicit requirement for a post market production review system involving incident reporting to authorities should be introduced,as is already in place for other devices,and to enhance patient information,a requirement should be introduced that the ‘Statement’under Annex VIII to Directive93/42/EEC should be available to the patient and that it should contain the name of the manufacturer.(10)In the light of technical progress in information technologyand medical devices,a process should be provided to allow information supplied by the manufacturer to be available by other means.(11)Manufacturers of Class I sterile and/or measuring medicaldevices should be given the option of using the full quality assurance conformity assessment module in order to provide them with more flexibility in the choice of compliance modules.(12)In order to support market surveillance activities byMember States it is necessary and appropriate,in the case of implantable devices,to increase the time period for the retention of documents for administrative purposes to at least15years.(13)For the appropriate and efficient functioning of Directive93/42/EEC as regards regulatory advice on classification issues arising at national level,in particular on whether or not a product falls under the definition of a medical device, it is in the interest of national market surveillance and the health and safety of humans to establish a procedure for decisions on whether or not a product falls under the medical device definition.(14)To ensure that,where a manufacturer does not have aregistered place of business in the Community,authorities have a single individual person authorised by the manufacturer whom they can address in matters relating to the compliance of the devices with the Directives it is necessary to introduce an obligation for such manufacturers to designate an authorised representative for a device.This designation should be effective at least for all devices of the same model.(15)To further ensure public health and safety it is necessary toprovide for a more consistent application of the provisions on health protection measures.Particular care should be taken to ensure that,when in use,the products do not endanger patients’health or safety.(16)In support of transparency in Community legislation,certain information related to medical devices and their conformity with Directive93/42/EEC,in particular infor-mation on registration,on vigilance reports and on certificates,should be available to any interested party and the general public.(17)To better coordinate the application and efficiency ofnational resources when applied to issues related to Directive93/42/EEC,the Member States should cooperate with each other and at international level.(18)As design for patient safety initiatives play an increasingrole in public health policy,it is necessary to expressly set out the need to consider ergonomic design in the essential requirements.In addition the level of training and knowl-edge of the user,such as in the case of a lay user,should be further emphasised within the essential requirements.The manufacturer should place particular emphasis on the consequences of misuse of the product and its adverse effects on the human body.(19)In the light of experience gained regarding activities of boththe notified bodies and the authorities in the assessment of devices which require intervention of the appropriate authorities for medicines and human blood derivatives their duties and tasks should be clarified.(20)Taking account of the growing importance of software inthe field of medical devices,be it as stand alone or as software incorporated in a device,validation of software in accordance with the state of the art should be an essential requirement.(21)In the light of the increased use of third Parties to carry outthe design and manufacture of devices on behalf of the manufacturer,it is important that the manufacturer demonstrates that he applies adequate controls to the third party to continue to ensure the efficient operating of the quality system.(22)The classification rules are based on the vulnerability of thehuman body taking account of the potential risks associated with the technical design and manufacture of the devices.Explicit prior authorisation with regard to conformity,including an assessment of the design documentation,is required for Class III devices to be placed on the market.In performing its duties under the quality assurance and verification conformity assessment modules for all other classes of devices,it is essential and necessary for a notified body,in order to be assured of thecompliance of the manufacturer with Directive93/42/EEC, to review the design documentation for the medical device.The depth and extent of this review should be commensu-rate with the classification of the device,the novelty of the intended treatment,the degree of intervention,the novelty of the technology or construction materials,and the complexity of the design and/or technology.This review can be achieved by taking a representative example of design documentation of one or more type(s)of devices from those being manufactured.Further review(s),and in particular the assessment of changes to the design that could affect conformity with the essential requirements, should be part of the surveillance activities of the notified body.(23)It is necessary to remove the incoherence in theclassification rules as a result of which invasive devices with respect to body orifices intended for connection to an active Class I medical device were not classified.(24)The measures necessary for the implementation ofDirective90/385/EEC and Directive93/42/EEC should be adopted in accordance with Council Decision1999/468/EC of28June1999laying down the procedures for the exercise of implementing powers conferred on the Commission(1).(25)In particular,power should be conferred on the Commis-sion to adapt classification rules for medical devices,to adapt the means by which the information needed to use medical devices safely and properly may be set out,to determine conditions for making certain information publicly available,to adapt the provisions on clinical investigations set out in certain Annexes,to adopt particular requirements for placing certain medical devices on the market or putting them into service,and to take decisions to withdraw such devices from the market for reasons of protection of health or safety.Since those measures are of general scope and are designed to amend or supplement Directive90/385/EEC and Directive93/42/EEC by the modification or addition of non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article5a of Decision1999/468/EC.(26)When,on imperative grounds of urgency,the normal timelimits for the regulatory procedure with scrutiny cannot be complied with,the Commission should be able to use the urgency procedure provided for in Article5a(6)of Decision 1999/468/EC for taking decisions on withdrawal of certain medical devices from the market and for the adoption of particular requirements for placing such devices on the market or putting them into service for reasons of protection of health or safety.(27)The Commission should give a mandate to CEN and/orCenelec to specify technical requirements and a suitable specific label for phthalate-containing devices within12 months after entry into force of this Directive.(28)Many Member States have established recommendationswith the aim of reducing or limiting the use of medical devices containing critical phthalates on children,pregnant and nursing women and other patients at risk.To enable medical professionals to avoid such risks,devices which possibly release phthalates to the body of the patient should be labelled accordingly.(29)In accordance with the essential requirements on the designand manufacture of medical devices,manufacturers should avoid the use of substances that may possibly compromise the health of patients,in particular of substances which are carcinogenic,mutagenic or toxic to reproduction,and should,as appropriate,strive to develop alternative substances or products with a lower risk potential.(30)It should be clarified that alongside Directives90/385/EECand93/42/EEC,in vitro diagnostic medical devices,which are the subject of Directive98/79/EC of the European Parliament and of the Council of27October1998on in vitro diagnostic medical devices(2),should also be excluded from the scope of Directive98/8/EC.(31)In accordance with point34of the Interinstitutionalagreement on better law-making(3),Member States are encouraged to draw up,for themselves and in the interests of the Community,their own tables illustrating,as far as possible,the correlation between this Directive and the transposition measures,and to make them public.(32)Directives90/385/EEC,93/42/EEC and98/8/EC shouldtherefore be amended accordingly,HAVE ADOPTED THIS DIRECTIVE:Article1Directive90/385/EEC is hereby amended as follows:1.Article1shall be amended as follows:(a)paragraph2shall be amended as follows:(i)point(a)shall be replaced by the following:‘(a)“medical device”means any instrument,apparatus,appliance,software,material orother article,whether used alone or incombination,together with any accessories,including the software intended by its(1)OJ L184,17.7.1999,p.23.Decision as amended by Decision2006/512/EC(OJ L200,22.7.2006,p.11).(2)OJ L331,7.12.1998,p.1.Directive as last amended by Regulation(EC)No1882/2003.(3)OJ C321,31.12.2003,p.1.manufacturer to be used specifically fordiagnostic and/or therapeutic purposes andnecessary for its proper application,intended by the manufacturer to be usedfor human beings for the purpose of:—diagnosis,prevention,monitoring,treatment or alleviation of disease,—diagnosis,monitoring,treatment,alle-viation of or compensation for aninjury or handicap,—investigation,replacement or modifi-cation of the anatomy or of aphysiological process,—control of conception,and which does not achieve its principalintended action in or on the human bodyby pharmacological,immunological ormetabolic means,but which may beassisted in its function by such means;’(ii)points(d),(e)and(f)shall be replaced by the following:‘(d)“custom-made device”means any device specifically made in accordance with a dulyqualified medical practitioner's written pre-scription which gives,under his responsi-bility,specific design characteristics and isintended for the sole use of a particularpatient.Mass-produced devices which needto be adapted to meet the specific require-ments of the medical practitioner or anyother professional user shall not be con-sidered to be custom-made devices;(e)“device intended for clinical investigation”means any device intended for use by aduly qualified medical practitioner whenconducting clinical investigations asreferred to in Section2.1of Annex7inan adequate human clinical environment.For the purpose of conducting clinicalinvestigation,any other person who,byvirtue of his professional qualifications,isauthorised to carry out such investigationshall be accepted as equivalent to a dulyqualified medical practitioner;(f)“intended purpose”means the use forwhich the device is intended according tothe data supplied by the manufacturer onthe labelling,in the instructions and/or inpromotional material;’(iii)the following points shall be added:‘(j)“authorised representative”means any nat-ural or legal person established in theCommunity who,explicitly designated bythe manufacturer,acts and may beaddressed by authorities and bodies in theCommunity instead of the manufacturerwith regard to the latter's obligations underthis Directive;(k)“clinical data”means the safety and/orperformance information that is generatedfrom the use of a device.Clinical data aresourced from:—clinical investigation(s)of the deviceconcerned,or—clinical investigation(s)or other stu-dies reported in the scientific litera-ture,of a similar device for whichequivalence to the device in questioncan be demonstrated,or—published and/or unpublished reportson other clinical experience of eitherthe device in question or a similardevice for which equivalence to thedevice in question can be demon-strated.’;(b)paragraph3shall be replaced by the following:‘3.Where an active implantable medical device is intended to administer a substance defined as a medicinal product within the meaning of Article1of Directive2001/83/EC(*),that device shall be gov-erned by this Directive,without prejudice to the provisions of Directive2001/83/EC with regard to the medicinal product.(*)OJ L311,28.11.2001,p.67.Directive as last amended by Regulation(EC)No1901/2006(OJL378,27.12.2006,p.1)’(c)paragraph4shall be replaced by the following:‘4.Where an active implantable medical device incorporates,as an integral part,a substance which, if used separately,may be considered to be a medicinal product within the meaning of Article1of Directive 2001/83/EC and which is liable to act upon thehuman body with action that is ancillary to that of the device,that device shall be evaluated and authorised in accordance with this Directive.’;(d)the following paragraph shall be inserted:‘4a.Where a device incorporates,as an integral part,a substance which,if used separately,may beconsidered to be a medicinal product constituent ora medicinal product derived from human blood orhuman plasma within the meaning of Article1of Directive2001/83/EC and which is liable to act upon the human body with action that is ancillary to that of the device,hereinafter referred to as a“human blood derivative”,that device shall be assessed and authorised in accordance with this Directive.’;(e)paragraph5shall be replaced by the following:‘5.This Directive constitutes a specific Directive within the meaning of Article1(4)of Directive2004/ 108/EC(*).(*)Directive2004/108/EC of the European Parlia-ment and of the Council of15December2004on the approximation of the laws of the MemberStates relating to electromagnetic compatibility(OJ L390,31.12.2004,p.24).’;(f)the following paragraph shall be added:‘6.This Directive shall not apply to:(a)medicinal products covered by Directive2001/83/EC.In deciding whether a product falls underthat Directive or this Directive,particularaccount shall be taken of the principal modeof action of the product;(b)human blood,blood products,plasma or bloodcells of human origin or to devices whichincorporate at the time of placing on the marketsuch blood products,plasma or cells with theexception of devices referred to in paragraph4a;(c)transplants or tissues or cells of human origin orto products incorporating or derived fromtissues or cells of human origin,with theexception of devices referred to in paragraph4a;(d)transplants or tissues or cells of animal origin,unless a device is manufactured utilising animaltissue which is rendered non-viable or non-viable products derived from animal tissue.’;2.Article2shall be replaced by the following:‘A rticle2Member States shall take all necessary steps to ensure that the devices may be placed on the market and/or put into service only if they comply with the requirements laid down in this Directive when duly supplied,properly implanted and/or properly installed,maintained and used in accordance with their intended purposes.’;3.Article3shall be replaced by the following:‘A rticle3The active implantable medical devices referred to in Article1(2)(c),(d)and(e),hereinafter referred to as “devices”,shall satisfy the essential requirements set out inAnnex1which apply to them,account being taken of the intended purpose of the devices concerned.Where a relevant hazard exists,devices which are also machinery within the meaning of Article2(a)of Directive 2006/42/EC of the European Parliament and of the Council of17May2006on machinery(*)shall also meet the essential health and safety requirements set out in Annex I to that Directive to the extent to which those essential health and safety requirements are more specific than the essential requirements set out in Annex1to this Directive.(*)OJ L157,9.6.2006,p.24.’;4.in Article4,paragraphs1,2and3shall be replaced by thefollowing:‘1.Member States shall not create any obstacle to the placing on the market or the putting into service within their territory of devices complying with the provisions of this Directive and bearing the CE marking provided for in Article12,which indicates that they have been the subject of an assessment of their conformity in accordance with Article9.2.Member States shall not create any obstacles to:—devices intended for clinical investigations being made available to duly qualified medical practitioners orauthorised persons for that purpose if they satisfy theconditions laid down in Article10and in Annex6,—custom-made devices being placed on the market and put into service if they satisfy the conditions laiddown in Annex6and are accompanied by thestatement,which shall be available to the particularidentified patient,referred to in that Annex.These devices shall not bear the CE marking.3.At trade fairs,exhibitions,demonstrations,etc.,Member States shall not create any obstacle to the showing of devices which do not conform to this Directive,provided that a visible sign clearly indicates that such devices do not conform and cannot be marketed or put into service until they have been made to comply by the manufacturer or his authorised representative.’;5.Article5shall be replaced by the following:‘A rticle51.Member States shall presume compliance with theessential requirements referred to in Article3in respect of devices which are in conformity with the relevant national standards adopted pursuant to the harmonised standards the references of which have been published in the Official Journal of the European Union;Member States shall publish the references of such national standards.2.For the purposes of this Directive,reference toharmonised standards also includes the monographs of the European Pharmacopoeia notably on interaction between medicinal products and materials used in devices containing such medicinal products,the references of which have been published in the Official Journal of the European Union.’;6.Article6shall be amended as follows:(a)in paragraph1the reference‘83/189/EEC’shall bereplaced by the reference‘98/34/EC(*)(*)Directive98/34/EC of the European Parliament and of the Council of22June1998laying downa procedure for the provision of information inthe field of technical standards and regulationsand of rules on Information Society services(OJL204,21.7.1998,p.37).Directive as lastamended by the2003Act of Accession.’;(b)paragraph2shall be replaced by the following:‘2.The Commission shall be assisted by a standingcommittee(hereinafter referred to as the Committee).3.Where reference is made to this paragraph,Articles5and7of Decision1999/468/EC shallapply,having regard to the provisions of Article8thereof.The period laid down in Article5(6)of Decision1999/468/EC shall be set at three months.4.Where reference is made to this paragraph,Article5a(1)to(4)and Article7of Decision1999/468/EC shall apply,having regard to the provisions ofArticle8thereof.5.Where reference is made to this paragraph,Article5a(1),(2),(4)and(6),and Article7ofDecision1999/468/EC shall apply,having regard tothe provisions of Article8thereof.’;7.Article8shall be replaced by the following:‘A rticle81.Member States shall take the necessary steps to ensurethat information brought to their knowledge regarding the incidents mentioned below involving a device is recorded and evaluated in a centralised manner:(a)any malfunction of or deterioration in the character-istics and performances of a device,as well as anyinadequacy in the labelling or in the instructions foruse which might lead to or might have led to the deathof a patient or user or to a serious deterioration in hisstate of health;(b)any technical or medical reason in relation to thecharacteristics or performances of a device for thereasons referred to in point(a),leading to systematicrecall of devices of the same type by the manufacturer.2.Where a Member State requires medical practitionersor the medical institutions to inform the competent authorities of any incidents referred to in paragraph1,it shall take the necessary steps to ensure that the manufacturer of the device concerned,or his authorised representative,is also informed of the incident.3.After carrying out an assessment,if possible togetherwith the manufacturer or his authorised representative, Member States shall,without prejudice to Article7, immediately inform the Commission and the other Member States of measures that have been taken or are contemplated to minimise the recurrence of the incidents referred to in paragraph1,including information on the underlying incidents.4.The measures necessary for the implementation of thisArticle shall be adopted in accordance with the regulatory procedure referred to in Article6(3).’;8.Article9shall be amended as follows:(a)paragraph8shall be replaced by the following:‘8.Decisions taken by the notified bodies inaccordance with Annexes2,3and5shall be validfor a maximum of five years and may be extended onapplication,made at a time agreed in the contractsigned by both Parties,for further periods of amaximum length of five years.’;(b)the following paragraph shall be added:‘10.The measures designed to amend non-essentialelements of this Directive,inter alia by supplementingit,relating to the means by which,in the light of。
MDD_93_42_EEC(amended_by_2007_47_EC)中英对照版
1.1.1. Either a critical evaluation of the relevant scientific literature currently available relating to the safety,
performance, design characteristics and intended purpose of the device, where:
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最全ASCII码对照表2009-04-15 00:00Bin Dec Hex 缩写/字符解释0000 0000 0 00 NUL (null) 空字符0000 0001 1 01 SOH (start of handing) 标题开始0000 0010 2 02 STX (start of text) 正文开始0000 0011 3 03 ETX (end of text) 正文结束0000 0100 4 04 EOT (end of transmission) 传输结束0000 0101 5 05 ENQ (enquiry) 请求0000 0110 6 06 ACK (acknowledge) 收到通知0000 0111 7 07 BEL (bell) 响铃0000 1000 8 08 BS (backspace) 退格0000 1001 9 09 HT (horizontal tab) 水平制表符0000 1010 10 0A LF (NL line feed, new line) 换行键0000 1011 11 0B VT (vertical tab) 垂直制表符0000 1100 12 0C FF (NP form feed, new page) 换页键0000 1101 13 0D CR (carriage return) 回车键0000 1110 14 0E SO (shift out) 不用切换0000 1111 15 0F SI (shift in) 启用切换0001 0000 16 10 DLE (data link escape) 数据链路转义0001 0001 17 11 DC1 (device control 1) 设备控制1 0001 0010 18 12 DC2 (device control 2) 设备控制2 0001 0011 19 13 DC3 (device control 3) 设备控制3 0001 0100 20 14 DC4 (device control 4) 设备控制4 0001 0101 21 15 NAK (negative acknowledge) 拒绝接收0001 0110 22 16 SYN (synchronous idle) 同步空闲0001 0111 23 17 ETB (end of trans. block) 传输块结束0001 1000 24 18 CAN (cancel) 取消0001 1001 25 19 EM (end of medium) 介质中断0001 1010 26 1A SUB (substitute) 替补0001 1011 27 1B ESC (escape) 溢出0001 1100 28 1C FS (file separator) 文件分割符0001 1101 29 1D GS (group separator) 分组符0001 1110 30 1E RS (record separator) 记录分离符0001 1111 31 1F US (unit separator) 单元分隔符0010 0000 32 20 空格0010 0001 33 21 !0010 0010 34 22 "0010 0011 35 23 #0010 0100 36 24 $0010 0101 37 25 %0010 0110 38 26 &0010 0111 39 27 '0010 1000 40 28 (0010 1001 41 29 )0010 1101 45 2D - 0010 1110 46 2E . 0010 1111 47 2F / 0011 0000 48 30 0 0011 0001 49 31 1 0011 0010 50 32 2 0011 0011 51 33 3 0011 0100 52 34 4 0011 0101 53 35 5 0011 0110 54 36 6 0011 0111 55 37 7 0011 1000 56 38 8 0011 1001 57 39 9 0011 1010 58 3A : 0011 1011 59 3B ; 0011 1100 60 3C < 0011 1101 61 3D = 0011 1110 62 3E > 0011 1111 63 3F ? 0100 0000 64 40 @ 0100 0001 65 41 A 0100 0010 66 42 B 0100 0011 67 43 C 0100 0100 68 44 D 0100 0101 69 45 E 0100 0110 70 46 F 0100 0111 71 47 G 0100 1000 72 48 H 0100 1001 73 49 I 0100 1010 74 4A J 0100 1011 75 4B K 0100 1100 76 4C L 0100 1101 77 4D M 0100 1110 78 4E N 0100 1111 79 4F O 0101 0000 80 50 P 0101 0001 81 51 Q 0101 0010 82 52 R 0101 0011 83 53 S 0101 0100 84 54 T 0101 0101 85 55 U 0101 0110 86 56 V 0101 0111 87 57 W 0101 1000 88 58 X0101 1100 92 5C \0101 1101 93 5D ]0101 1110 94 5E ^0101 1111 95 5F _0110 0000 96 60 `0110 0001 97 61 a0110 0010 98 62 b0110 0011 99 63 c0110 0100 100 64 d0110 0101 101 65 e0110 0110 102 66 f0110 0111 103 67 g0110 1000 104 68 h0110 1001 105 69 i0110 1010 106 6A j0110 1011 107 6B k0110 1100 108 6C l0110 1101 109 6D m0110 1110 110 6E n0110 1111 111 6F o0111 0000 112 70 p0111 0001 113 71 q0111 0010 114 72 r0111 0011 115 73 s0111 0100 116 74 t0111 0101 117 75 u0111 0110 118 76 v0111 0111 119 77 w0111 1000 120 78 x0111 1001 121 79 y0111 1010 122 7A z0111 1011 123 7B {0111 1100 124 7C |0111 1101 125 7D }0111 1110 126 7E ~0111 1111 127 7F DEL (delete) 删除ESC键VK_ESCAPE (27)回车键：VK_RETURN (13)TAB键：VK_TAB (9)Caps Lock键：VK_CAPITAL (20)Shift键：VK_SHIFT ()Ctrl键：VK_CONTROL (17)Alt键：VK_MENU (18)空格键：VK_SPACE (/32)退格键：VK_BACK (8)左徽标键：VK_LWIN (91)右徽标键：VK_LWIN (92)鼠标右键快捷键：VK_APPS (93) Insert键：VK_INSERT (45) Home键：VK_HOME (36) Page Up：VK_PRIOR (33) PageDown：VK_NEXT (34)End键：VK_END (35)Delete键：VK_DELETE (46)方向键(←)：VK_LEFT (37)方向键(↑)：VK_UP (38)方向键(→)：VK_RIGHT (39)方向键(↓)：VK_DOWN (40)F1键：VK_F1 (112)F2键：VK_F2 (113)F3键：VK_F3 (114)F4键：VK_F4 (115)F5键：VK_F5 (116)F6键：VK_F6 (117)F7键：VK_F7 (118)F8键：VK_F8 (119)F9键：VK_F9 (120)F10键：VK_F10 (121)F11键：VK_F11 (122)F12键：VK_F12 (123)Num Lock键：VK_NUMLOCK (144) 小键盘0：VK_NUMPAD0 (96) 小键盘1：VK_NUMPAD0 (97) 小键盘2：VK_NUMPAD0 (98) 小键盘3：VK_NUMPAD0 (99) 小键盘4：VK_NUMPAD0 (100) 小键盘5：VK_NUMPAD0 (101) 小键盘6：VK_NUMPAD0 (102) 小键盘7：VK_NUMPAD0 (103) 小键盘8：VK_NUMPAD0 (104) 小键盘9：VK_NUMPAD0 (105) 小键盘.：VK_DECIMAL (110) 小键盘*：VK_MULTIPLY (106) 小键盘+：VK_MULTIPLY (107) 小键盘-：VK_SUBTRACT (109) 小键盘/：VK_DIVIDE (111) Pause Break键：VK_PAUSE (19) Scroll Lock键：VK_SCROLL (145)。
MEDDEV 2.7.1_REV 3_医疗器械指南_中文版
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10 在评估临床评价资料过程中公告机构的角色…………
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10.1 设计档案的检查
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10.2 作为质量体系程序一部分的评价
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10.3 公告机构特定程序和专门知识 Nhomakorabea24
附件....................................................................................................................……
关于上市后行动，制造商被期望执行和保持监督程序，日常监测器械的临床性能 和安全，作为质量管理体系的一部分。上市后监督的范围和性质应适用于该器械 以及它的预期用途。使用由此程序(比如安全报告, 包括不良事件报告; 出版文献 的结果, 任何进一步的临床调查和正式的上市后监督研究等)生成的资料, 制造商 应通过临床评价定期评审器械的性能，安全和利害评估，并相应地更新临床证 据。这个持续的临床评价过程应允许制造商根据当地的报告要求，以及任何对器 械的利害评估有重要影响或需要对关于禁忌症，注意事项或说明书要做出更改的 任何信息，与符合性评估机构和监管当局进行交流。
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2.0 范围................................................................................................................................ 6
3.0 参考文献........................................................................................................................ 7
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医疗器械指令条款颜色表示:红色表示已删除, 黄色表示已被代替, 绿色表示增加的内容, Gr灰色表示是依据 L331/199 8修订, Turkis表示依据L331/1998修订出处关于医疗器械的欧盟指令93/42/EEC 关于医疗器械的欧盟指令2007/47/EC第1条定义, 适用范围1. 本指令适用于医疗器械及其附件。
在本指令中，附件本身应被视为医疗器械。
医疗器械和附件以下均称为器械。
2. 在本指令中，适用以下定义：(a) "医疗器械"是指制造商预定用于人体以下目的的任何仪器、装置、器具、材料或其他物品，无论它们是单独使用还是组合使用，包括为其正常使用所需的软件：-疾病的诊断、预防、监视、治疗或减轻；-损伤或残障的诊断、监视、治疗、减轻或修补；定义, 适用范围1. 本指令适用于医疗器械及其附件。
在本指令中，附件本身应被视为医疗器械。
医疗器械和附件以下均称为器械。
2. 在本指令中，适用以下定义：(a) "医疗器械"是指制造商预定用于人体以下目的的任何仪器、装置、器具、材料或其他物品，无论它们是单独使用还是组合使用，包括制造商预定的用于人体诊断和/或治疗目的的软件及为其正常使用所需的软件：-疾病的诊断、预防、监视、治疗或减轻；-损伤或残障的诊断、监视、治疗、减轻或修补；-解剖学或生理过程的-解剖学或生理过程的探查，替换或变更；-妊娠的控制。
医疗器械不是通过药理学、免疫学或代谢作用等方式在人体内或人体上达到其预定的主要作用，但这些方式有助于其功能的实现。
(b) "附件"是指本身虽然不是器械，但由其制造商专门指定与器械一起使用，使其能按照器械制造商预定的器械用途来使用的物品。
‘(c) "体外诊断用器械"是指任何试剂、校正物质、对照物质、仪器、装置、设备或系统的医疗器械，无论是单独或合并使用，由制造商指定其用途为用于体外检验采自人体的样本包括血液与组织，单独或主要用以提供以下相关信息者：—关于生理或病理状态，或—关于先天异常, 或探查，替换或变更；-妊娠的控制。
医疗器械不是通过药理学、免疫学或代谢作用等方式在人体内或人体上达到其预定的主要作用，但这些方式有助于其功能的实现。
(b) "附件"是指本身虽然不是器械，但由其制造商专门指定与器械一起使用，使其能按照器械制造商预定的器械用途来使用的物品。
‘(c) "体外诊断用器械"是指任何试剂、校正物质、对照物质、仪器、装置、设备或系统的医疗器械，无论是单独或合并使用，由制造商指定其用途为用于体外检验采自人体的样本包括血液与组织，单独或主要用以提供以下相关信息者：—关于生理或病理状态，或—关于先天异常, 或—决定与潜在接受移植人员之安全性与兼容性,或—监控治疗效果。
样本容器也被认为是体外诊断医疗器材，无论—决定与潜在接受移植人员之安全性与兼容性, 或—监控治疗效果。
样本容器也被认为是体外诊断医疗器材，无论是否为真空形式，由制造商指定用以储存采取自人体的样本，供体外诊断检验之用者皆属之。
比如一次性真空采血管。
一般实验室器材并不属于体外诊断医疗器材之列，除非根据其产品特征，制造商特别声明该器材是体外诊断医疗器材。
(d) "定制器械"是指按照执业医师开具的处方而专门制作的器械，由医师负责提供专门的设计特性，指定只适用于特定患者。
上述处方也可由具有执业资格的其他人开具。
为满足执业医生或其他任何专业人员特殊需要而成批生产的器械，不认为是定制器械。
(e) "临床检查用器械"是指预定供执业医生在适当的人类是否为真空形式，由制造商指定用以储存采取自人体的样本，供体外诊断检验之用者皆属之。
比如一次性真空采血管。
一般实验室器材并不属于体外诊断医疗器材之列，除非根据其产品特征，制造商特别声明该器材是体外诊断医疗器材。
(d) "定制器械"是指按照执业医师开具的处方而专门制作的器械，由医师负责提供专门的设计特性，指定只适用于特定患者。
上述处方也可由具有执业资格的其他人开具。
为满足执业医生或其他任何专业人员特殊需要而成批生产的器械，不得被认为是定制器械。
(e) "临床检查用器械"是指预定供执业医生在适当的人类临床环境下进行附录Ⅹ中第2.1点所述的检查所使用的器械。
在临床检查中，任何具备专业资格、被准予从事此项检查的人员均可等同地被认可为具有正式资格的执业医生。
临床环境下进行附录Ⅹ中第2.1点所述的检查所使用的器械。
在临床检查中，任何具备专业资格、被准予从事此项检查的人员均可等同地被认可为具有正式资格的执业医生。
(f) "制造商"是指在以其名义将器械投放市场前负责器械的设计、制造、包装和标签的自然人或法人，无论这些工作是他自己完成的，还是由第三方代表他完成的。
本指令规定制造商必须履行的义务也适用于负责对一件或几件制成品进行装配，包装、加工、全面整修和/或加贴标志和/或对其作为一件器械规定其预定用途，以便其以自己的名义投放市场的自然人或法人。
本小段所述不适用虽不属第一小段含意内的制造商，但对已上市的(f) "制造商"是指在以其名义将器械投放市场前负责器械的设计、制造、包装和标签的自然人或法人，无论这些工作是他自己完成的，还是由第三方代表他完成的。
本指令规定制造商必须履行的义务也适用于负责对一件或几件制成品进行装配，包装、加工、全面整修和/或加贴标志和/或对其作为一件器械规定其预定用途，以便其以自己的名义投放市场的自然人或法人。
本小段所述不适用虽不属第一小段含意内的制造商，但对已上市的器械进行装配或改装，从而达到预定供个别患者使用目的的人。
(g) "预定用途"是指根据制造商在标签、说明书和/或宣传材料中提供的资料对器械预定的用途。
(h) "投放市场"是指一种非用于临床检查的器械为在向欧洲共同体市场销售或使用，而第一次以收费或免器械进行装配或改装，从而达到预定供个别患者使用目的的人。
(g) "预定用途"是指根据制造商在标签、说明书和/或宣传材料中提供的资料对器械预定的用途。
(h) "投放市场"是指一种非用于临床检查的器械为在向欧洲共同体市场销售或使用，而第一次以收费或免费方式提供，无论其是新的还是经过全面整修的。
(i) “投入市场”是指器械在欧共体市场上第一次按照预定的用途投入使用的阶段；(J) “授权代表”是指欧共体内的自然人或法人，由制造商明确指定或经欧共体内机构组织指示，就制造商本指令项下规定的义务，代替制造商履行；费方式提供，无论其是新的还是经过全面整修的。
(i) “投入市场”是指器械在欧共体市场上第一次按照预定的用途投入使用的阶段；(J) “授权代表”是指欧共体内的自然人或法人，由制造商明确指定或经欧共体内机构组织指示，就制造商本指令项下规定的义务，代替制造商履行；(k) “临床数据”是指由于本器械的使用而产生的关于安全和/或性能方面的信息。
临床数据源于：— 相关器械的临床试验；或—科学文献中与本器械相类似的器械的可证实的临床试验或其研究报告；或— 器械和/或类似器械的临床试验可证实的公开或未公开的报告；(l) “同类器械”是指具有相同的预定用途或相同技术特征的一套器械。
(m) “普通器械”是指具有相同或类似的预定用途和技术特征的一套器械，依据普通方式进行分类，并不反映特定特3. 如果器械是用于65/65/EEC指令第1条含义内的施药，则该器械受本指令管辖，但不得违反65/65/EEC 指令中有关药品的条款。
然而，假如这种器械在投放市场时是与药品构成了一个整体，只可组合使用且不能重复使用，则只是药品应受65/65/EEC指令管辖。
但就器械有关安全和性能的特性而言，本指令附录Ⅰ的基本要求仍适用。
征；(n) “单独使用器械”是指仅为一个病人使用的器械；3. 如果器械是用于2001/83/EEC (*)指令第1条含义内的施药，则该器械受本指令管辖，但不得违反2001/83/EEC指令中有关药品的条款。
然而，假如这种器械在投放市场时是与药品构成了一个整体，只可组合使用且不能重复使用，则只是药品应受2001/83/EC指令管辖。
但就器械有关安全和性能的特性而言，本指令附录Ⅰ的基本要求仍适用。
(*) 欧洲议会和理事会2001年11月6日2001/83/EC指令，关于供人类使用的医疗产品的欧共体法令 (2001年11月8日 OJ L 第67页)。
该指令最终由1901/2006欧共体指令修订。
(2006年12月27日 OJ L 378，第1页).’;4. 如果某种器械与一种作为其组成部分的物质组合，而这种物质如果单独使用，按65/65/EEC 指令可视为药品，并且它对人体起到辅助作用，则该器械必须按照本指令进行评定和批准。
5. 本指令不适用于：(a) 体外诊断器械；(b) 90/385/EEC指令涉及的有源植入式器械；(c) 65/65/EEC指令涉及的药品；(d) 76/768/EEC指令涉及的化妆品；(e) 人血、人血制品、人血浆或人血细胞，或在投放市场时含有这种血制品、血浆或细胞的器械；(f) 人体移植物、人体组织或细胞，或含有人体组织或细胞或由其衍生的制4. 如果某种器械与一种作为其组成部分的物质组合，而这种物质如果单独使用，按2001/83/EC指令可视为药品，并且它对人体起到辅助作用，则该器械应当按照本指令进行评定和批准。
5. 本指令不应适用于：(a) 体外诊断器械；(b) 90/385/EEC指令涉及的有源植入式器械；(c) 2001/83/EC指令涉及的药品；在决定某类产品是否为指令所涉及的产品时，应当考虑产品的主要运行模式。
(d) 76/768/EEC指令涉及的化妆品；(e) 人血、人血制品、人血浆或人血细胞，或在投放市场时含有这种血制品、血浆或细胞的器械；(f) 人体移植物、人体组织或细胞，或含有人体组织或细胞或由其衍生的制品，除第 4a段所指的器械外；(g) 动物移植物或动物组织或细胞，除非品；(g) 动物移植物或动物组织或细胞，除非器械是利用不能存活的动物组织或从动物组织中衍生的不能存活的产品制造的；6. 本指令不适用于89/686/EEC指令所涉及的人身保护器械。
确定一种产品是由上述指令还是由本指令管辖，应特别考虑该产品预定的主要用途。
7. 本指令是89/336/EEC指令第2条第2款含义内的一个专项指令。
8. 本指令不影响80/836/Euratom指令和84/466/Euratom指令的实施。
器械是利用不能存活的动物组织或从动物组织中衍生的不能存活的产品制造的；6. 当制造商所生产的器械，依据欧盟2007年9月21日官方文件L247/30 EN89/686/EEC (*)的议会指令和本指令关于人身保护器械的规定， 89/686/ EEC 指令相关的基本健康和安全要求应当执行。