9342EEC完整版中英文对照.docx

1、9342EEC完整版中英文对照COUNCIL DIRECTIVE 93/42/EECof 14 June 19931993 年 6 月 14 日理事会第 93/42/EEC 号指令concerning medical devices关于医疗器械更改历史记录：M1 Directive 98/79/EC of the European Parliament and of the Council of L 331 1 7.12.1998 27 October 1998M2 Directive 2000/70/EC of the European Parliament and of the Counc

2、il of L 313 22 13.12.200016 November 2000M3 Directive 2001/104/EC of the European Parliament and of the Council L 6 50 10.1.2002of 7 December 2001M4 Regulation (EC) No 1882/2003 of the European Parliament and of the L 284 1 31.10.2003Council of 29 September 2003M5 Directive 2007/47/EC of the Europea

3、n 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 C

4、ommission 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

5、 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

6、 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

7、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 intern

8、al 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; wh

9、ereas, 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 provi

10、de 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 Directi

11、ve;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 administrat

12、ive 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

13、 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

14、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 l

15、iable 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

16、 Directive 75/318/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

17、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

18、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

19、 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

20、 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

21、 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 technica

22、l 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

23、 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 mu

24、st 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 for

25、m 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

26、; 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

27、 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

28、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

29、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 conf

30、ormity 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 priv

31、ate-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 ac

32、cordance 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 ei