医疗器械指令 93-42-EEC_2007完整版中英文对照

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MDD 93-42-EEC医疗器械指令全部(中文)

欧洲共同体理事会关于医疗器械的93/42/EEC指令1993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。

93_42_EEC 中文版

医疗器械指令（Medical Device Directive）93/42/EEC欧共体医疗器械产品安全共同指令欧洲共同体公报，1993年7月12日，NO. L169/1（此法案对欧共体成员国而言，其公布与否属非强制性）1993年6月14日关于医疗器械的第93/42/EEC号理事会指令欧共体理事会，1考虑到建立欧洲经济共同体的（罗马）条约，特别是其第100a条，2考虑到执委会的提案，以及与欧洲议会的合作，3考虑到经济和社会委员会的意见，4鉴于应就内部市场的完成采取一些措施；鉴于内部市场是一无内部疆界的区域，区域内的货品、人员、服务和资金应可自由流通；5鉴于各成员国间现存有关医疗器械的安全，对健康的保护和功能特性方面的法律、法规和行政命令的内容与范围不尽相同；鉴于各成员国之间对此类器械的认证和检验程序也存在差异；鉴于前述的分歧将在共同体内部构成贸易壁垒；6鉴于为了保护患者、使用者以及必要时其他人员的安全与健康，有关医疗器械使用的国家规定应予以协调，以保证此类器械在内部市场能自由流通；7鉴于协调规定必须与各成员国为管理直接或间接与这类器械有关的公共健康和疾病保险计划的资金筹措所采取的措施相区别；鉴于共同体若与上述措施相符，则这些规定并不影响各成员国实施上述措施的能力；8鉴于医疗器械应向患者，使用者及第三方提供高度的保护并达到制造商赋予其的性能水准；鉴于，因此，维持和改进各成员国已达到的保护水平是本指令的基本目标之一；9鉴于在1965年1月26日的理事会第65/65/EEC号关于使有关根据特许专卖医药产品的法律、法规或管理行为所制定的实施规定趋于一致的指令中某些医疗器械是用于使用药品的；鉴于在这种情况下，医疗器械的市场投放通常受本指令管辖，而药品的市场投放则受第65/65/EEC号指令管辖；鉴于若有某种器械投放市场时器械与其它医疗产品构成一整体的组合单元，并以这种组合形式使用且不能二次使用，则该整体单元产品应受第65/65/EEC号指令管辖；鉴于必须将上述器械与和其它物质组合的医疗器械相区别，特别是若这些物质在单独使用时，按第65/65/EEC号指令可视为药物；鉴于在这种情况下，若这种物质是作为器械的辅助物作用于人体，则这类器械的市场投放受本指令管辖；鉴于，这类物质的安全，质量和效用必须由1975年5月20日理事会第75/318/EEC号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检测协议的法律趋于一致的指令中规定的适当方法加以验证；10 鉴于本指令附录中的基本要求和其它要求包括任何涉及“最低”或“降低”危险的内容的阐述和实施必须考虑设计当时的技术与实际情况，并在符合健康和安全高度保护的原则下考虑技术和经济因素；11 鉴于按照1985年5月7日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制造的规则必须限制在满足基本要求所必需的条款内；鉴于因为这些要求是最基本的，因此它们应取代相应的国家规定；鉴于基本要求的实施应谨慎考虑设计当时的技术水平，并在符合健康和安全高度保护的原则下考虑技术和经济因素；12 鉴于1990年6月20日理事会第90/385/EEC号关于使成员国有关有源植入性医疗器械的法律趋于一致的指令是新方法指令在医疗器械领域中的首次应用；鉴于为了统一共同体的规则使之适用于所有医疗器械，本指令在很大程度上是以第90/385/EEC号指令的条款为依据；鉴于同样的原因第90/385/EEC号指令必须增加本指令制定的一般条款的部分；13 鉴于电磁兼容性问题已成为医疗器械安全不可缺少的组成部分；鉴于本指令应包含与1989年5月3日理事会第89/336/EEC号关于使成员国有关电磁兼容的法律趋于一致的指令中的内容有关的特别条款；14 鉴于本指令应包括对有关释放致电离辐射的器械的设计和制造的要求；鉴于本指令既不影响1980年7月15日理事会第80/836/Euratom指令对有关制定一般公众和工人避免离子辐射危险的健康保护的基本安全标准指令的修改中要求的授权，也不影响1984年9月3日理事会第84/466/Euratom号规定有关接受医疗检查和治疗的人员的辐射保护的基本措施的指令的适用；鉴于1989年6月12日理事会第89/391/EEC号关于鼓励改善工作场所中工人的安全和健康的措施介绍的指令和同样主题的其它特别指令应持续适用；15 鉴于为了证实符合基本要求并使该符合性得以验证，有必要协调欧洲标准以避免与医疗器械的设计、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立法机构制定的，应保持其非强制性的性质；鉴于到目前为止，欧洲标准化委员会（CEN）和欧洲电工标准化委员会（Cenelec），根据1984年11月13日执委会与这两个机构之间签署的合作通则，已被公认为是制定协调标准的职能机构；16 鉴于本指令的协调标准是一种根据执委会的委托，由上述两机构之一，或两个机构共同根据1983年3月18日理事会第83/189/EEC号关于技术标准和法规领域信息传递程序的指令和上述通则的规定而制定的技术规范（欧洲标准或协调文件）；鉴于由于协调标准有可能被修改，执委会应得到根据第83/189/EEC 号指令设立的常设委员会的协助；鉴于所采取的措施必须按理事会第87/373/EEC号决议制定的程序Ⅰ予以阐释；鉴于在特殊领域，如列入欧洲药典专著中的内容，应纳入本指令的框架内；鉴于因此，几部欧洲药典专著应视为等同于前述协调标准；17 鉴于在1990年12月13号决议关于用于技术协调指令不同合格评定程序的各阶段模式中，理事会制定了协调合格评定程序；鉴于将这些模式用于医疗器械可使制造商和公告机构在合格评定中的责任根据有关的器械型式予以确定；鉴于对这些模式的细节所作的补充，根据医疗器械必需验证的性质，证明是合理的；18 鉴于为进行合格评定程序，有必要将器械分为四个产品类别；鉴于分类原则是依据器械技术设计和制造中潜在的危险对人体的易损伤性；鉴于在一般情况下，第Ⅰ类器械具有较低的易损伤性，其合格评定程序可由制造商单独完成；鉴于对第Ⅱa类器械公告机构应在生产阶段强制性介入；鉴于第Ⅱb和第Ⅲ类器械具有较高的潜在危险，公告机构必须对器械的设计与制造阶段进行检验；鉴于第Ⅲ类器械属于最关键的器械，它们在投放市场前需预先就其符合性获得明确授权；19 鉴于在器械的符合性由制造商负责评定的情况下，主管当局必须能够，特别是在紧急情况下，联系到在欧共体内的负责器械市场投放的人员，无论是制造商还是其他在欧共体内经制造商授权的人员；20 鉴于按照一般规则，医疗器械应标示CE标志，表明它们符合本指令的条款，使其能在欧共体内自由流通，并按其预定用途投入使用；21 鉴于为对抗艾滋病和根据1989年5月16日通过的关于在欧共体级别的关于艾滋病预防和控制的进一步行动的理事会决议，用于预防HIV病毒感染的医疗器械必须提供高度的保护；鉴于这类产品的设计和制22 鉴于分类规则通常可对医疗器械进行恰当的分类；鉴于考虑到各种器械的不同性质及该领域内的技术进步，采取的步骤应包括授权执委会决定器械的适当分类或重新分类，必要时调整分类规则；鉴于这些问题与健康保护有密切关系，因此这些决议应按照第87/373/EEC号指令规定的第Ⅲa程序进行；23 鉴于证实符合基本要求可能意味着必须由制造商负责完成临床试验；鉴于为了完成临床试验，必须确定保护公众健康和公共秩序的适当方式；24 鉴于在欧共体级别一体化的医疗器械警戒系统可以更有效地完成健康保护和相关的控制；25 鉴于本指令覆盖了1976年7月27日理事会第76/764/EEC号关于使成员国有关临床用汞柱式温度计最高读数的法律趋于一致的指令中提到的医疗器械；鉴于上述指令应予撤销；鉴于同样原因，1984年9月17日理事会第84/539/EEC号关于使成员国有关用于人或兽医的电子医疗器械的法律趋于一致的指令必须修改。

（完整word版）MDD医疗器械指令

（完整word版）MDD医疗器械指令医疗器械指令（MDD）93/42/EEC 简介什么是医疗器械？“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；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的评估等级：所有进入欧盟市场的产品，企业必须具有表示自我符合声明的CE 标志，以说明产品符合欧盟制定的相关指令。

医疗器械指令（MDD），MDD指令适用于大多数进入欧盟销售的医疗设备。

它根据不同的要求共分为6个等级，供认证机构评估。

设计阶段生产阶段I级自我符合声明自我符合声明I级（测量功能）自我符合声明申报机构I级（灭菌）自我符合声明申报机构IIａ级自我符合声明申报机构IIｂ级申报机构申报机构III级申报机构申报机构认证机构的统一评估包括根据指令规定的基本要求评审技术文件、根据标准EN 46001 或EN/ISO 13485评审质量体系。

由于美国、加拿大和欧洲普遍以ISO 9001, EN 46001或ISO 13485作为质量保证体系的要求，故建议质量保证体系的建立均以这些标准为基础。

医疗器械的风险分析：EN1441失效模式及后果分析（FMEA）；失效树分析（FTA）；上市后的监控（客户投诉情况等）；临床经验根据EN1441风险分析的一些例子；器械的预期用途；预期与病人和第三者的接触；有关在器械中所使用的材料/元件的风险；供给患者或来自患者的能量；在无菌条件下生产的器械；用于改变病人环境的器械；说明用器械；用于控制其它器械或药品或与其配合使用的器械；不需要的能量或物质的输出；易受环境影响的器械；带有重要消耗品或附件的器械；必要的日常维护和校正；含有软件的器械；货架寿命有限制的器械；延迟或长期使用可能造成的影响；普通风险；所有的适用项目必须论述包括可能的危险和降低风险的方法。

MDD_93-42-EEC医疗器械指令_全部(中文)

93-42-EEC_2007完整版中英文对照

12.200016 November 2000●M3 Directive 2001/104/EC of the European Parliament and of the Council L 6 50 10。

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2002of 7 December 2001●M4 Regulation （EC) No 1882/2003 of the European Parliament and of the L 284 1 31。

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2003 Council of 29 September 2003●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 analytical pharmaco—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 deviceon 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 Directive84/539/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。

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19 鉴于在器械的符合性由制造商负责评定的情况下，主管当局必须能够，特别是在紧急情况下，联系到在欧共体内的负责器械市场投放的人员，无论是制造商还是其他在欧共体内经制造商授权的人员；
20 鉴于按照一般规则，医疗器械应标示 CE 标志，表明它们符合本指令的条款，使其能在欧共体内自由流通，并按其预定用途投入使用；
23 鉴于证实符合基本要求可能意味着必须由制造商负责完成临床试验；鉴于为了完成临床试验，必须确定保护公众健康和公共秩序的适当方式；
24 鉴于在欧共体级别一体化的医疗器械警戒系统可以更有效地完成健康保护和相关的控制； 25 鉴于本指令覆盖了 1976 年 7 月 27 日理事会第 76/764/EEC 号关于使成员国有关临床用汞柱式温度计最高
15 鉴于为了证实符合基本要求并使该符合性得以验证，有必要协调欧洲标准以避免与医疗器械的设计、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立法机构制定的，应保持其非强制性的性质；鉴于到目前为止，欧洲标准化委员会（CEN）和欧洲电工标准化委员会（Cenelec），根据 1984 年 11 月 13 日执委会与这两个机构之间签署的合作通则，已被公认为是制定协调标准的职能机构；
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11 鉴于按照 1985 年 5 月 7 日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制造的规则必须限制在满足基本要求所必需的条款内；鉴于因为这些要求是最基本的，因此它们应取代相应的国家规定；鉴于基本要求的实施应谨慎考虑设计当时的技术水平，并在符合健康和安全高度保护的原则下考虑技术和经济因素；
17 鉴于在 1990 年 12 月 13 号决议关于用于技术协调指令不同合格评定程序的各阶段模式中，理事会制定了协调合格评定程序；鉴于将这些模式用于医疗器械可使制造商和公告机构在合格评定中的责任根据有关的器械型式予以确定；鉴于对这些模式的细节所作的补充，根据医疗器械必需验证的性质，证明是合理的；

医疗器械的9342EEC指令

医疗器械的93/42/EEC指令第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；——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。

(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。

医疗设备常用英文汉字对照

医疗设备常用英文汉字对照Adjustment-调整，调节Analysis Limit-分析范围Aperture Clog -堵孔Blank Error-空白出blank-空白Calibrator Mode-校准模式calibrator-校准、定标cancel-取消,废除,抵消Change-改变Clog Adjustment-堵孔调整Clog-阻塞,堵塞Cont. Error-控制器出错Continuous Mode-连续模式Control Mode-质控模式Cycle Counter-计数器Deprime Seq.-排空程序Discard Waste-倒掉废液Gain Adjustment-增益调整Hardware limit-硬件极限HC Output Test-测试通过串行端口至主机的数据传输Init.Pos-初始位置Initialize-初始化IP Output Test-测试打印至内置机的数据LAN Output Test- 测试通过以太网端口至主机的数据传输Menu-设置菜单Mix-Chamb-混匀室Noise Error-噪音出错Parameters-参数Piercer Adjust-穿刺针调整Piercer Pos.-穿刺针位置Print settings-打印设置Printer Buffer Full- 打印机缓冲满载Product Settings-产品设置RAM Error-RAM出错Raw Data-原始数据RBC Noise Error-RBC 噪音出错RBC Sam’g Error-RBC 采样错Replace Diluent-更换稀释Replace Lyse-更换溶血素Return-传回、返回Rinse-清洗ROM Error-ROM出错Sam’g Error-采样错误Sample-样品，标本Service Data-维修数据Setting Seq.Error-设置程序出错Setting Seq.-灌注程序Settings Error-设置出错Status Display-状态显示Stored Data-存储数据Stroed Error-存储出错Syringe MC Error-注射器马达控制器出错(稀释液) Target-目标，靶，屏极TEMP H-温度监测上限TEMP L-温度监测下限Temp. Error (H)-温度出错(高)Temp. Error(L)-温度出错(低)Test Operation-测试操作Tube holder Err.试管出错固定器·User Calib. -用户校准User Settings-用户设置V acuum Error 负压出错V ACUUM1 L-负压下限(用于负压出错监测)V ACUUM2 L-负压下限(用于混匀室排空出错监测) Waste C. Error-废液室错误。

欧洲医疗器械93-42-EEC

歐洲共同體理事會關於醫療器械的93/42/EEC指令1993年6月14日歐洲共同體理事會考慮到建立歐洲經濟共同體的條約，特別是其第100a條；考慮到歐洲共同體委員會提交的議案；考慮到與歐洲議會合作；考慮到經濟與社會委員會的意見；鑒於應在歐洲共同體內部市場範圍內正式通過必要的措施；鑒於歐洲共同體內部市場是一個確保商品、人員、服務和資本自由流通的無內部邊界的區域；鑒於各成員國有關醫療器械的安全、健康保護和工作特性的法律、法規和行政條款的內容和範圍是不同的；鑒於各成員國之間對這類器械的認證和檢驗程序存在差異；鑒於這種差異在歐洲共同體內形成貿易壁壘；鑒於各國針對醫療器械的使用所制定的有關患者、使用者及其他人員的安全和健康保護的條款應予以協調，以保證此類器械在歐洲共同體內部市場自由流通；鑒於協調條款必須與成員國為管理直接或間接與這類器械有關的公共健康和醫療保險計劃的資金籌措而採取的措施相區別；鑒於因而只要遵守歐洲共同體法律，這些條款並不影響各成員國實施上述措施的能力；鑒於醫療器械應向患者、使用者及第三方提供高水準的保護並達到製造商賦予其的性能水平；鑒於因此保持和提高各成員國已達到的保護水平是本指令的基本目的之一；鑒於在1965年1月26日歐洲共同體理事會關於使有關特許專賣藥品的法律、法規或行政措施趨於一致的65/65/EEC指令中，某些醫療器械是用於施藥的；鑒於在這種情況下，醫療器械投放市場通常由本指令管理，而藥品投放市場由65/65/EEC指令管理；鑒於如果這種器械投放市場的方式使器械與藥品構成一種規定只供組合使用且不能再次使用的整體，則這個單一整體產品應由65/65/EEC指令管理；鑒於必須將上述器械與包含某種物質，特別是當其單獨使用時，按65/65/EEC指令可視為藥物的醫療器械相區別；鑒於在這種情況下，若這種物質能配合醫療器械對人體產生輔助作用，則這類器械投放市場由本指令管理；鑒於這類物質的安全性、質量和有效性必須比照歐洲共同體理事會1975年5月20日關於使成員國有關分析標準、藥物毒理學標準和臨床標準及特許專賣藥品詴驗協定的法律趨於一致的75/318/EEC指令規定的適當方法加以驗證；鑒於本指令附錄中的基本要求和其他要求，包括對“減小”或“降低”危險的任何引用，在解釋和實施時必須考慮設計時的技術現狀和實際做法及高水準的健康和安全相適應的技術與經濟條件；鑒於按照1985年5月7日歐洲共同體理事會關於技術協調與標準化新方法的決議所規定的原則，有關醫療器械設計和生產的規定必須限於滿足基本要求所必須的條款；鑒於因為這些要求是基本的，因此它們應取代各國相應的條款；鑒於實施基本要求應審慎考慮設計時的技術水平和與高水準的健康及安全保護相適應的技術、經濟條件；鑒於1990年6月20日歐洲共同體理事會關於使成員國有關有源植入式醫療器械的法律趨於一致的90/385/EEC 指令是新方法指令在醫療器械領域中的首次應用案例；鑒於為了使歐洲共同體的統一規定適用於所有醫療器械，本指令基本上是以90/385/EEC指令的條款為依據的；鑒於為此必須修訂90/385/EEC指令，以便放入本指令規定的一般性條款；鑒於電磁相容性問題是醫療器械安全的一個組成部分；鑒於就1989年5月3日歐洲共同體理事會關於使成員國有關電磁相容的法律趨於一致的89/336/EEC指令而言，應包含這方面的專門規定；鑒於本指令應包括有關發射電離輻射的器械在設計和製造方面的要求；鑒於本指令既不影響1980年7月15日歐洲共同體理事會80/836/Euratom指令對有關保護公眾和工人免受電離輻射危險的基本安全標準的指令進行修訂所要求的授權，也不影響歐洲共同體理事會1984年9月3日對接受醫療檢查和治療的人員的輻射防護規定了基本措施的84/466/Euratom指令的實施；鑒於歐洲共同體理事會1989年6月12日關於採取措施鼓勵改善工人工作中的安全和健康的89/391/EEC指令以及有關這一問題的專門指令應繼續予以實施；鑒於為了證實符合基本要求並使這種符合得到驗證，需要制定歐洲協調標準來防止與醫療器械的設計、製造和包裝有關的危險；鑒於這類歐洲協調標準是由非官方機構制定的，應保持其非強制性的地位；鑒於為此歐洲標準化委員會（CEN）和歐洲電工標準化委員會（CENELEC）按照1984年11月13日歐洲共同體委員會與這兩個機構之間簽署的合作總指導原則，被認可為批准協調標準的主管機構；鑒於在本指令中，協調標準是受歐洲共同體委員會委託，由上述兩機構之一，或兩個機構共同根據歐洲共同體理事會1983年3月18日關於在技術標準和法規領域提供資訊程序的83/189/EEC指令，依照上述總指導原則而批准的技術規範（歐洲標準或協調文件）；鑒於對協調標準進行修訂，歐洲共同體委員會應得到根據83/189/EEC指令建立的常設委員會的幫助；鑒於應採取的措施必須按歐洲共同體理事會87/373/EEC決定中規定的程序Ⅰ而規定；鑒於在特定領域，歐洲藥典專著這類現有的形式應包括在本指令的範圍內；鑒於因此有幾部歐洲藥典專著可視為等同於上述協調標準。

医疗器械200747EC指令(9342EEC指令的修订案)

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。

医疗设备中英文对照表

医疗设备中英文对照表AABSS 自动（磁带）空白部分扫描ABL（automatic bright limiting）自动亮度限制ABL ON OFF 自动黑电平开／关ABL SW ON 自动黑电平开关接通ABO 自动电子束最佳化ABO ADJ 自动电子束最佳化调整ABO VIDEO 自动电子束最佳化视频ABO VIDEO ADJ 自动电子束最佳化视频调整ABO VIDEO IN 自动电子束最佳化视频输入AC （alternating current）交流电AC IN 交流输入AC MOTOR 交流电机AC MOTOR SWAC 交流电机开关AC 自动色（饱和度）控制AC mains input 交流电输入ACC AMP ＡＣＣ放大ACC AMP (REC) ＡＣＣ放大录制ACC/APC BURST FLAG 自动色度控制／自动相位控制旗脉冲ACC (automatic chrominance control) 自动色度控制ACC AMP (automatic chrominance control amplifier) 自动色度控制ACC BF PHASE 自动控制旗脉冲相位ACC LEVEL 自动色度控制电平ACC LEVEL SW 自动色度控制电平开关ACC BURST GATE ＡＣＣ色同步选通门ACC DC AMP ＡＣＣ直流放大ACC DET 自动消色放大ACTION 作用ADAPTOR 适配器ADC(automatic degaussing circuit)自动消磁电路ADD CIRUIT 相加电路ADD RESSING 寻址ADJ (ADJUSTMENT) 调整ADV (一桢一桢）步进AERIAL 天线AFC (automatic frequency control) 自动频率控制AFC BALANCN 自动频率控制平衡调节AFC CENTER AＦＣ中心AFC DC 自动频率控制（ＡＦＣ）直流AFC DC BIAS AFC 直流偏置AFC (DC) OUT 自动频率控制（ＤＣ）输出AFC DRIVE 自动频率控制推动AFC ERROR 自动频率控制误差信号AFC ERROR BUFFER ＡＦＣ误差缓冲AFC FH TUNING ＡＦＣ行频调谐AFC FH TUNING AMP ＡＦＣ行频调谐放大AFC GAIN ＡＦＣ增益AFC GATE 自动频率控制门AFC IN 自动频率控制输入AFC OUT ＡＦＣ输出AFC PULSE AMP 自动频率控制脉冲放大AFC SET 自动频率控制设定AFC VCO ＡＦＣ压控振荡器AFC VCO FREQ ＡＦＣ压控振荡器频率AFPC (automatic frequency phase control) 自动频率相位控制AFS(automatic frequency stabilization)自动频率稳定AFTER CLOCK 时钟后AFTER CLOCK PULSE 时钟脉冲之后AGC 自动增益控制AGC AMP ＡＧＣ放大AGC DETECTOR 自动增益控制检测AGC ERROR BUFFER 自动增益控制误差缓冲器AGC PROT ＡＧＣ保护AH(AUDIO/CTLHEAD) AH（音频控制磁头）ALARM TONE BURST 告警音频缓冲ALT 行交替ALT PULSE 行交替脉冲ALTERNATEDSC 交替的副载波ALU 运算器AMP(amplifier)放大器AMPLIFIER DETECTOR 放大器／检波器AMPLITUED LIMIER 限幅器ANALOG SWITCH 模拟开关ANODE 阳极ANC 自动消噪电路ANTENNA 天线APC(automatic phase control)自动相位控制APC BF INV APC 旗脉冲倒相APC 自动相位控制（检波）ARC(automatic resolution control)自动清晰度控制AT(Ampere turns)安（培）匝数ATT (ATTENUATOR) 衰减器AUTOMATIC 地自动BB(blue)蓝色B(brightness)亮度BA(buffer amplifier)缓冲放大器BALANCE 平衡BALUN 平衡-不平衡转换器BRIGHT 亮度BRIGHTNESS 亮度调节BLLE OUT OFF 蓝枪截止调节BLUE OUT 蓝色输出BURST 色同步信号BURST GATE 色同步选通电路BURST PHASE 色同步信号相位CCURRENT LIMITTER 电流限制器CEN 中心CHROMA 色度CHROMA AMP 色度放大器CHROMA BURST AMP 色度、色同步信号放大器CHROMA BOARD 色通道板CHROMA FILTER 色度滤波器CHROMINANCE 色度通道CLAMPER 钳位器CMOS （complementary metal -oxide-semiconductor) 互补型金属-氧化物半导体COLOUR CONT（color controller) 彩色控制器COLOUR DIFFERENCE 色差COLOUR SYNC 彩色同步调节COLORKILLER 消色器COLORTONE 色调CONT 对比度、控制CONTRAST 对比度CONTROL 控制CONSOLE-控制柜CPT （color picture tube) 彩色显像管CPT BOARD 彩色显像管座板CRT （cathode - ray tube) 阴极射线管（显像管）CRT DRIVE BOARD 显像管激励电路板DDC （direct current)直流电DAMPER 阻尼器DGC （degaussing coil) 消磁线圈DL (delay line ) 延时线DRIVE 激励、推动DRIVE TRANSF 推动变压器DY （deflection yoke）偏转线圈EEHT （extra -high tension) 极高压EMERGENCY-急停装置ERROR AMP (error amplifier) 误差电压放大器E-W CORRECTION(east - west correction) 东西向校正FFBT (fly back transformer) 逆程变压器FILTER 滤波器FLIP FLOP 双稳态触发器FIYEACK BLANKING 回扫消隐FOCUS 焦点FOCUS VR (focus variable rheostat) 聚焦电位器f.(fuse) (fuse) 保险丝GGANTRY-机架G (green) 绿色的GND (ground) 接地GREEN CUT OFF 绿枪截止调节GREEN OUT 绿色输出GREY 灰度G - Y MATRIX （G - Y ）矩阵HH. BLK （horizontal blanking) 行消隐H.DY （horizontal deflection yoke) 行偏转线圈HFC （high frequency choke) 高频扼流圈H.HOLD （horizontal hold) 行同步调节H （L）.DRIVE (horizontal driver) 行推动放大器HLIN （horizontal linearity) 行线性H（L）OUT BOARD 行输出板H .M（module）厚膜电路HOR AFC （horizontal automatic frequency control) 行自动频率控制HOR DRIVE TRANS 行激励变压器HORIZONTAL 行（水平）扫描部分HORIZ O/P （horizontal out put ) 行脉冲输出H.OSC(horizontal oscillator) 行振荡器H.PHASE (horizontal phase) 行（同步）相位调节H.SIZE 水平幅度调节器HV （high voltage）高压IIC （integrated circuit)集成电路INPUT 输入KKC (kilohertz) 千周KHz（kilohertz) 千赫KILLER AMP （killer amplifier）消色放大器LLEVER 电平LINE-FILTER-滤波器LOW 低的LPF（low-pass filter）低通滤波器MMAIN BOARD 主电路板MC （megacycles per second)兆赫MF （ceramic filter) 陶瓷滤波器MFD；mfd(microfarad) 微法ms (millisecond) 毫秒mV (mill volt) 毫伏OON/OFF 开/关operating point 工作点OSC （oscillator) 振荡器OUT 输出端OVERLOAD -FUSE 过载保险丝OVERLOAD -PROTECTION 过载保护OVER-VOLTGE PROTECTION 过压保护PPOSITIVE THERMISTOR 正温度系数热敏电阻POWER BOARD 电源板POWER CORD 电源线POWER DRIVE 功率激励POWER RECT（power rectifier) 电源整流器POWER REG（power regulation) 功率调整POWER REG RM (power regulation reluctance) 功率调整管散热片POWER SUPPLY 电源POWER TRANS （power transformer) 电源变压器PROTECTOR-保护装置PEDESTAL CLAMP 消隐脉冲钳位PEDESTAL CLAMPER 消隐脉冲钳位电路PF （Pico farad) 微微法PHASE CONT （phase controller）相位控制器RR (red) 红色的R.GBL( red background) 红色背景（暗平衡）调节RECT (rectifier) 整流器R.DRIVE (red drive) 红色驱动（白平衡）调节RED CUT OFF 红色截止调节RED OUT 红色输出REFERENCE VOLTAGE 基准电压REGULATOR 稳压器SSHIELD-防护SIDE-PINAMP 左校正放大器STACK-硅堆SUB BRIGHT 副亮度调节SYNC （synchonization) 同步（信号）SAW （surface acoustic wave) 声表面滤波器SCREEN 帘栅极（加速器）电压调节SYNC （synchronous separator）同步信号分离器TTF （temperature fuse) 温度保险丝THERMO-SENSOR 温度探头TO CPT BOARD 接到显像管印刷板VOUT SWITCH 垂直泵浦开关V.BLK (vertical blanking) 场消隐V.DY (vertical deflection yoke) 场消隐线圈VERT CENT (vertical center) 场中心调节VERT DRIVE AMP 场推动放大器VERT OSC (vertical oscillator) 场振荡器VERT SIZE （vertical size) 垂直幅度调节VERT TRIGG （vertical trigger) 场触发V HOLD 场同步调节VIDEO 视频放大VIDEO& CHROMA BOARD 视频与色度印制板VOLTAGE DIVIDER 分压器XX (crystal) 石英晶体谐振器YY AMP 亮度放大器yoke 偏转线圈。

欧盟医疗器械9342EEC

欧盟医疗器械9342EEC
凡是要出⼝到欧盟的医疗器械都需要通过医疗器械的认证。

欧盟的医疗器械指令为93/42/EEC。

93/42/EEC有23个Article和12个Annex。

Article主要介绍定义，范围和介绍。

Annex主要介绍认证模式，基本要求和分类。

基本要求：
Annex I是基本要求，所有的医疗器械必须符合基本要求，基本要求中可能有部分不适⽤，但适⽤部分必须符合基本要求。

分类：
Annex IX是分类的要求。

CE-MDD中分类可分为：
Class I;
Class IIa;
Class IIb;
Class III;
危险等级由低到⾼。

认证模式：
Annex II~VII都是认证模式，不同的分类选择不同的模式，⼀个分类可能有多个认证模式，具体认证模式选择由制造商决定，如果制造商不清楚，可以授权公告机构来决定。

公告机构：
公告机构是由欧盟授权，机构所在国的相关部门批准，批准后有⼀个公告号，可在欧盟⽹站上查询公告范围，起始⽇期和有效期。

93-42-EEC_2007完整版中英文对照汇编

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：●M1 Directive 98/79/EC of the European Parliament and of the Council of L 331 1 7.12.199827 October 1998●M2 Directive 2000/70/EC of the European Parliament and of the Council of L 313 22 13.12.200016 November 2000●M3 Directive 2001/104/EC of the European Parliament and of the Council L 6 50 10.1.2002of 7 December 2001●M4 Regulation (EC) No 1882/2003 of the European Parliament and of the L 284 1 31.10.2003 Council of 29 September 2003●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：- 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。

欧盟医疗器械指令9342EEC指令

10
第1章定义和范围附件: ‘accessory’ means an article which whilst not being a device is intended specifically by its manufacturer to be used 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;
生效日期：2010-03-21
2
第1章定义和范围
93/42/EEC指令不适用于： - A. 98/79/EC 指令涉及的体外诊断器械 - 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,包括涉及的89/381/EEC指令的来源于血液的药品 - 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
15
第1章定义和范围预期用途: 指产品说明或标签或宣传资料载明的, 使用器械应取得的功效.
‘intended purpose’ means the use for which the device is intended according to the data supplied by the manufacturer on the labelling, in the instructions and/or in promotional materials;

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。

MDD9342EEC欧盟医疗器械分类总则介绍说明

醫療器械分類原則醫療器械之分類原則主要依據其特性，如非侵入式器材、侵入式器材、主動式器材，以及其它特殊原則。

而分類別的界定，則可根據MDD的guidelines、93/42/EEC Annex IX 中之敘述、或使用英國衛生署的disk來判斷，並由廠商自行決定。

依據MDD93/42/EEC附錄九中詳定18條規則，考慮醫療器械之設計及製造對人體可能帶來的危險程度，可將醫療器械分為以下4類: •Class I 低風險 (Low risk)•Class IIa 低到中風險 (Low to medium risk)•Class IIb 中風險 (Medium risk)•Class III 高風險 (High risk)產品分類規則：1、規則應用由器械的預期使用目的決定；2、如果器械是和其它器械配合使用，分類規則分別適用於每種器械；3、附件可以和其它一起使用的器械分開單獨分類；4、啟動或影響某種器械的軟件與器械屬於同一類型。

分類準則：時間：暫時（<60分鐘）、短期（<30天）、長期（>30天）創傷性：非創傷、通過孔徑創傷，外科創傷、植入。

適用位置：中央循環、中樞神經系統，其它地方。

能量供應：無源，有源。

MDD 93/42/EEC附錄IX 18條規則規則1?4、所有非創傷性器械均屬於I類，除非他們：用於儲存體液(血袋例外) II a類於Ila類或更高類型的有源醫療器械類 II a類改變體液成分II a∕II b類一些傷口敷料II a∕II b類規則5、侵入人體孔徑的醫療器械暫時使用(牙科壓縮材料、檢查手套) I類短期使用(導管、隱形眼鏡) II a類長期使用(正常牙線) II b類規則6-8、外科創傷性器械再使用的外科器械(鉗子，斧子) I類暫時或短期使用(縫合針。

外科手套) 11a類長期使用(假關節，眼內晶體) II b類與中央循環系統(CCS)或中樞神經系統接觸的器械 III類規則9、給予或交換能量的治療器械 II a類（肌肉刺激器、電鑽、皮膚光療機、助聽器）一種潛在危險方式工作的 II b類（嬰兒培養箱、高頻電刀、超聲碎石機、X光機）規則10、診斷器械提供能量(核磁共振，超聲診斷儀) II a類診斷∕監視體內放射藥物分佈 II a類(r照相機、正電子發射成像儀)診斷∕監視生理功能(心電圖、腦電圖) II a類危險情況下監視生理功能 II b類(手術中的血氣分析儀)發出電離輻射(X射線診斷議) II b類規則11控制藥物或其它物質進出人體的有源器械 II a類(吸引設備、供給泵)如以一種潛在危險方式工作 II b類(麻醉機、呼吸機、透析機、高壓氧艙)規則12．所有其它有源醫療器械屬於I類(觀察燈、牙科椅、輪椅、牙科用治療燈、記錄處理觀察診斷圖像用的有源器械)規則13、與醫用物質結合的器械（含殺精子的避孕套、含抗生素的牙髓材料） III類規則14、避孕用具（避孕套、子宮帽 II b類） II b/III類 (子宮內避孕器 III類)規則15、清洗或消毒的器械醫療器械(內窺鏡消毒) II a類接觸鏡(消毒液、護理液) II a類規則16、用於記錄X射線圖像的器械(X光片) II a類規則17、利用動物組織的器械（生物）心臟瓣膜、腸線、膠原）III類規則18、血袋 II b類。

医疗器材指令 93 42 eec 20141016

分級的原則一般是依照醫療器材的風險程度，有少部分特殊規則（血袋或含藥醫材）的醫療器材採用例外的分及方法。 MDD指令附錄IX有18條分類規則作為分類指導。類別越高，意味著風險級別越高，符合性評估的要求也就越高。
符合性評鑑 Conformity Assessment
歐盟的符合性評鑑程序乃依照歸類後的醫療器材分級而決定，業者可以在醫療器材指令的規定程序內選擇對自己最便利的符合性評鑑程序(Conformity Assessment Procedure)。在歐盟的符合性評鑑證書其有效期限為3年，而其不同等級的醫療器材會有不同的符合性評鑑程序路徑。新版2007/47/EC指令與舊版93/42/EEC指令對所採用的符合性評鑑方式是一致的，在新版2007/47/EC指令中，部分醫療器材分級和舊版93/42/EEC 指令的分級不同，將會產生同樣醫療器材而變更成不同的符合性評鑑程序。
需要注意的是以往歐盟的醫療器材指令（MDD）都是遵循93/42/EEC指令，然而在2009年開始進行「歐盟醫療器材指令93/42/EEC新方案」（New Approach EU Medical Device Directive 93/42/EEC）的修訂，並於今年（2010年）3月21日起生效實施，新要求載錄於修改的2007/47/EC指令中，並明確指出歐盟醫療器材符合新指令的規定將無過渡期，故現今送審歐盟的醫療器材則需遵循新指令，也就是2007/47/EC指令
選擇代施查核機構
符合性評鑑都需要代施查核機構（Notified Body）的介入（除Annex Ⅶ程序例外），並且新版 2007/47/EC指令更強制規定申請CE mark時就必須要有歐體代表。代施查核機構的產生是由各國最高衛生主管機關（Competent Authority）審查通過後，提供給歐盟指委會，相關名單可以在歐盟指委會網頁上查詢。

93-42-EEC(中文)

医疗器械指令（Medical Device Directive）93/42/EEC欧共体医疗器械产品安全共同指令欧洲共同体公报，1993年7月12日，NO. L169/1（此法案对欧共体成员国而言，其公布与否属非强制性）1993年6月14日关于医疗器械的第93/42/EEC号理事会指令欧共体理事会，1考虑到建立欧洲经济共同体的（罗马）条约，特别是其第100a条，2考虑到执委会的提案，以及与欧洲议会的合作，3考虑到经济和社会委员会的意见，4鉴于应就内部市场的完成采取一些措施；鉴于内部市场是一无内部疆界的区域，区域内的货品、人员、服务和资金应可自由流通；5鉴于各成员国间现存有关医疗器械的安全，对健康的保护和功能特性方面的法律、法规和行政命令的内容与范围不尽相同；鉴于各成员国之间对此类器械的认证和检验程序也存在差异；鉴于前述的分歧将在共同体内部构成贸易壁垒；6鉴于为了保护患者、使用者以及必要时其他人员的安全与健康，有关医疗器械使用的国家规定应予以协调，以保证此类器械在内部市场能自由流通；7鉴于协调规定必须与各成员国为管理直接或间接与这类器械有关的公共健康和疾病保险计划的资金筹措所采取的措施相区别；鉴于共同体若与上述措施相符，则这些规定并不影响各成员国实施上述措施的能力；8鉴于医疗器械应向患者，使用者及第三方提供高度的保护并达到制造商赋予其的性能水准；鉴于，因此，维持和改进各成员国已达到的保护水平是本指令的基本目标之一；9鉴于在1965年1月26日的理事会第65/65/EEC号关于使有关根据特许专卖医药产品的法律、法规或管理行为所制定的实施规定趋于一致的指令中某些医疗器械是用于使用药品的；鉴于在这种情况下，医疗器械的市场投放通常受本指令管辖，而药品的市场投放则受第65/65/EEC号指令管辖；鉴于若有某种器械投放市场时器械与其它医疗产品构成一整体的组合单元，并以这种组合形式使用且不能二次使用，则该整体单元产品应受第65/65/EEC号指令管辖；鉴于必须将上述器械与和其它物质组合的医疗器械相区别，特别是若这些物质在单独使用时，按第65/65/EEC号指令可视为药物；鉴于在这种情况下，若这种物质是作为器械的辅助物作用于人体，则这类器械的市场投放受本指令管辖；鉴于，这类物质的安全，质量和效用必须由1975年5月20日理事会第75/318/EEC号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检测协议的法律趋于一致的指令中规定的适当方法加以验证；10 鉴于本指令附录中的基本要求和其它要求包括任何涉及“最低”或“降低”危险的内容的阐述和实施必须考虑设计当时的技术与实际情况，并在符合健康和安全高度保护的原则下考虑技术和经济因素；11 鉴于按照1985年5月7日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制造的规则必须限制在满足基本要求所必需的条款内；鉴于因为这些要求是最基本的，因此它们应取代相应的国家规定；鉴于基本要求的实施应谨慎考虑设计当时的技术水平，并在符合健康和安全高度保护的原则下考虑技术和经济因素；12 鉴于1990年6月20日理事会第90/385/EEC号关于使成员国有关有源植入性医疗器械的法律趋于一致的指令是新方法指令在医疗器械领域中的首次应用；鉴于为了统一共同体的规则使之适用于所有医疗器械，本指令在很大程度上是以第90/385/EEC号指令的条款为依据；鉴于同样的原因第90/385/EEC号指令必须增加本指令制定的一般条款的部分；13 鉴于电磁兼容性问题已成为医疗器械安全不可缺少的组成部分；鉴于本指令应包含与1989年5月3日理事会第89/336/EEC号关于使成员国有关电磁兼容的法律趋于一致的指令中的内容有关的特别条款；14 鉴于本指令应包括对有关释放致电离辐射的器械的设计和制造的要求；鉴于本指令既不影响1980年7月15日理事会第80/836/Euratom指令对有关制定一般公众和工人避免离子辐射危险的健康保护的基本安全标准指令的修改中要求的授权，也不影响1984年9月3日理事会第84/466/Euratom号规定有关接受医疗检查和治疗的人员的辐射保护的基本措施的指令的适用；鉴于1989年6月12日理事会第89/391/EEC号关于鼓励改善工作场所中工人的安全和健康的措施介绍的指令和同样主题的其它特别指令应持续适用；15 鉴于为了证实符合基本要求并使该符合性得以验证，有必要协调欧洲标准以避免与医疗器械的设计、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立法机构制定的，应保持其非强制性的性质；鉴于到目前为止，欧洲标准化委员会（CEN）和欧洲电工标准化委员会（Cenelec），根据1984年11月13日执委会与这两个机构之间签署的合作通则，已被公认为是制定协调标准的职能机构；16 鉴于本指令的协调标准是一种根据执委会的委托，由上述两机构之一，或两个机构共同根据1983年3月18日理事会第83/189/EEC号关于技术标准和法规领域信息传递程序的指令和上述通则的规定而制定的技术规范（欧洲标准或协调文件）；鉴于由于协调标准有可能被修改，执委会应得到根据第83/189/EEC号指令设立的常设委员会的协助；鉴于所采取的措施必须按理事会第87/373/EEC号决议制定的程序Ⅰ予以阐释；鉴于在特殊领域，如列入欧洲药典专著中的内容，应纳入本指令的框架内；鉴于因此，几部欧洲药典专著应视为等同于前述协调标准；17 鉴于在1990年12月13号决议关于用于技术协调指令不同合格评定程序的各阶段模式中，理事会制定了协调合格评定程序；鉴于将这些模式用于医疗器械可使制造商和公告机构在合格评定中的责任根据有关的器械型式予以确定；鉴于对这些模式的细节所作的补充，根据医疗器械必需验证的性质，证明是合理的；18 鉴于为进行合格评定程序，有必要将器械分为四个产品类别；鉴于分类原则是依据器械技术设计和制造中潜在的危险对人体的易损伤性；鉴于在一般情况下，第Ⅰ类器械具有较低的易损伤性，其合格评定程序可由制造商单独完成；鉴于对第Ⅱa类器械公告机构应在生产阶段强制性介入；鉴于第Ⅱb和第Ⅲ类器械具有较高的潜在危险，公告机构必须对器械的设计与制造阶段进行检验；鉴于第Ⅲ类器械属于最关键的器械，它们在投放市场前需预先就其符合性获得明确授权；19 鉴于在器械的符合性由制造商负责评定的情况下，主管当局必须能够，特别是在紧急情况下，联系到在欧共体内的负责器械市场投放的人员，无论是制造商还是其他在欧共体内经制造商授权的人员；20 鉴于按照一般规则，医疗器械应标示CE标志，表明它们符合本指令的条款，使其能在欧共体内自由流通，并按其预定用途投入使用；21 鉴于为对抗艾滋病和根据1989年5月16日通过的关于在欧共体级别的关于艾滋病预防和控制的进一步行动的理事会决议，用于预防HIV病毒感染的医疗器械必须提供高度的保护；鉴于这类产品的设计和制造应通过公告机构验证；22 鉴于分类规则通常可对医疗器械进行恰当的分类；鉴于考虑到各种器械的不同性质及该领域内的技术进步，采取的步骤应包括授权执委会决定器械的适当分类或重新分类，必要时调整分类规则；鉴于这些问题与健康保护有密切关系，因此这些决议应按照第87/373/EEC号指令规定的第Ⅲa程序进行；23 鉴于证实符合基本要求可能意味着必须由制造商负责完成临床试验；鉴于为了完成临床试验，必须确定保护公众健康和公共秩序的适当方式；24 鉴于在欧共体级别一体化的医疗器械警戒系统可以更有效地完成健康保护和相关的控制；25 鉴于本指令覆盖了1976年7月27日理事会第76/764/EEC号关于使成员国有关临床用汞柱式温度计最高读数的法律趋于一致的指令中提到的医疗器械；鉴于上述指令应予撤销；鉴于同样原因，1984年9月17日理事会第84/539/EEC号关于使成员国有关用于人或兽医的电子医疗器械的法律趋于一致的指令必须修改。

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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。