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1、 Essential Requirements of the MDD (07/47/EC) 医疗器械指令（07/47/EC）基本要求Applicable(Y/N)适用（是/否）Requirements Standard 所符合的标准要求ManufacturersCompliance/Records 制造商符合性文件/记录Ok / Fail符合/不符合 I.GENERAL REQUIREMENTS基本要求1.The devices must be designed and manufactured in such a way that, when used under the condition
2、s and for the purposes intended, they will not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their use constitute acceptable risks when weighed against the benef
3、its to the patient and are compatible with a high level of protection of health and safety.This shall include: reducing, as far as possible, the risk of use error due to the ergonomic features of the device and the environment in which the device is intended to be used (design for patient safety), a
4、nd consideration of the technical knowledge, experience, education and training and where applicable the medical and physical conditions of intended users (design for lay, professional, disabled or other users).必须确保医疗器械的设计和制造在使用时或将被使用时不危害临床状况或不伤害到患者的健康，或使用者或其他人员的健康和安全，在产品使用过程中产生的与患者利益相关的风险应是可接受的且符合高
5、级别的健康安全防护措施。应包括以下内容：尽可能地降低由于医疗器械的性能特征及其使用时所处的环境（为患者安全所设计）而导致的使用错误风险。考虑技术知识、经验、教育及培训程度、使用者的医疗条件和物理条件（为非专业人士、专业人士、残疾人士及其它使用者所设计）。2.The solutions adopted by the manufacturer for the design and construction of the devices must conform to safety principles, taking account of the generally acknowledged st
6、ate of the art.In selecting the most appropriate solutions, the manufacturer must apply the following principles in the following order:制造商所采用的医疗器械的设计方法和结构方法必须符合安全准则，符合大众公认的技术声明文件。制造商必须依次采用以下准则以选择最适合的方法： eliminate or reduce risks as far as possible (inherently safe design and construction), 尽可能地消除或降
7、低风险（固有安全设计和结构） where appropriate take adequate protection measures including alarms if necessary, in relation to risks that cannot be eliminated, 有关风险不能被消除时，应采取适当的防护措施，必要时包括安装警报装置。 inform users of the residual risks due to any shortcomings of the protection measures adopted. 把采取了安全措施后仍然可能存在的风险告知给使用者
8、。3.The devices must achieve the performances intended by the manufacturer and be designed, manufactured and packaged in such a way that they are suitable for one or more of the functions referred to in Article 1 (2) (a), as specified by the manufacturer.制造商所设计的医疗器械必须达到预期的性能，并且其设计、生产和包装必须符合条款1（2）（a），
9、由制造商规定的至少一项功能。4.The characteristics and performances referred to in sections 1, 2 and 3 must not be adversely affected to such a degree that the clinical condition and safety of the patients and, where applicable, of other persons are compromised during the lifetime of the device as indicated by the
10、 manufacturer, when the device is subjected to the stresses which can occur during normal conditions of use.涉及条款1,2和3的产品的特征和性能在制造商所指明的产品有效期内、在正常使用条件下受到挤压时必须不影响临床状况、患者安全以及其他人员的安全。5.The devices must be designed, manufactured and packed in such a way that their characteristics and performances during t
11、heir intended use will not be adversely affected during transport and storage taking account of the instructions and information provided by the manufacturer医疗器械的设计、制造和包装在其预期使用过程中其特性和性能不应受到损害，在按制造商提供的说明书和资料进行运输和储存时要保证其特性和性能的完整性。6.Any undesirable side effects must constitute an acceptable risk when w
12、eighed against the performances intended.6a. Demonstration of conformity with the essential requirements must include a clinical evaluation in accordance with Annex X.当医疗器械的预期性能受到影响时，任何不良副作用必须是可接受的风险。6a.依据附录X，符合性声明和基本要求中必须含有临床评估。II.REQUIREMENTS REGARDING DESIGN AND CONSTRUCTION 设计和结构要求7. Chemical, p
13、hysical and biological properties 化学性能、物理性能和生物性能7.1The devices must be designed and manufactured in such a way as to guarantee the characteristics and performances referred to in Section 1 on the General requirements. Particular attention must be paid to:医疗器械的设计和制造必须确保其符合“一般要求”中条款1所描述的特征和性能。应特别注意： t
14、he choice of materials used, particularly as regards toxicity and, where appropriate flammability, 所用物料的选择，尤其要注意其毒性，必要时还要考虑其可燃性。 the compatibility between the materials used and biological tissues, cells and body fluids, taking account of the intended purpose of the device. where appropriate, the re
15、sults of biophysical or modelling research whose validity has been demonstrated beforehand. 根据医疗器械的预期用途，确保其所使用的物料与生物组织、细胞和体液之间的兼容性。 必要时，生物或模化研究结果的有效性事先应得到验证。7.2The devices must be designed, manufactured and packed in such a way as to minimise the risk posed by contaminants and residues to the person
16、s involved in the transport, storage and use of the devices and to the patients, taking account of the intended purpose of the product. Particular attention must be paid to the tissues exposed and the duration and frequency of the exposure.考虑到医疗器械的预期用途，医疗器械的设计、制造和包装必须使污染物和残余物质对在运输、存储和使用过程中所涉及到的人员和患者
17、所造成的风险降低到最低。尤其要注意暴露组织、持续时间和暴露频率。7.3The devices must be designed and manufactured in such a way that they can be used safely with the materials, substances and gases with which they enter into contact during their normal use or during routine procedures; if the devices are intended to administer medi
18、cinal products they must be designed and manufactured in such a way as to be compatible with the medicinal products concerned according to the provisions and restrictions governing those products and that their performance is maintained in accordance with the intended use.医疗器械的设计和制造必须确保其所使用的物料、物质和气体
19、在正常使用或惯常使用情况下能安全使用。如果医疗器械用于施用医疗产品，其设计和制造必须符合医疗的相关条款和制度，并按照预期用途保持其性能。7.4Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product as defined in Article 1 of Directive 2001/83/EC and which is liable to act upon the body with ac
20、tion ancillary to that of the device, the quality, safety and usefulness of the substance must be verified by analogy with the methods specified in Annex I to Directive 2001/83/ EC.当医疗器械组合成一个整体部件，其组合所使用的物质在单独使用时按照2001/83EC指令中章节1的规定可视作医疗产品，当作用于人体时，该物质在医疗器械组合部件中起辅助作用，必须根据2001/83/EC指令附录 1中规定的方法类似的方法对物质
21、的质量、安全和效用进行验证。 For the substances referred to in the first paragraph, the notified body shall, having verified the usefulness of the substance as part of the medical device and taking account of the intended purpose of the device, seek a scientific opinion from one of the competent authorities desig
22、nated by the Member States or the European Medicines Agency (EMEA) acting particularly through its committee in accordance with Regulation (EC) No 726/2004 (1) on the quality and safety of the substance including the clinical benefit/risk profile of the incorporation of the substance into the device
23、. 关于第一段中所提到的物质，根据第726/2004号规则（1）中的规定，报告主体应对视作医疗产品组成部分的物质的效用进行验证并考虑到医疗器械的预期用途，关于物质的质量和安全，包括物质组合成医疗器械后产生的临床效益和风险，应通过其委员会寻求来自成员国或欧洲医疗代理机构指定的权威机构的科学观点。When issuing its opinion, the competent authority or the EMEA shall take into account the manufacturing process and the data related to the usefulness of
24、 incorporation of the substance into the device as determined by the notified body. 当提出观点时，权威机构或欧洲医疗代理机构应把报告主体所规定的制造过程和物质组合成医疗器械后的相关效用数据考虑在内。Where a device incorporates, as an integral part, a human blood derivative, the notified body shall, having verified the usefulness of the substance as part of
25、 the medical device and taking into account the intended purpose of the device, seek a scientific opinion from the EMEA, acting particularly through its committee, on the quality and safety of the substance including the clinical benefit/risk profile of the incorporation of the human blood derivativ
26、e into the device. 当医疗器械组合成一个整体部件，一个人体血液衍生物，报告主体应对视作医疗产品组成部分的物质的效用进行验证并考虑到医疗器械的预期用途，关于物质的质量和安全，包括物质组合成医疗器械后产生的临床效益和风险，应通过其委员会寻求来自成员国或欧洲医疗代理机构指定的权威机构的科学观点。When issuing its opinion, the EMEA shall take into account the manufacturing process and the data related to the usefulness of incorporation of th
27、e substance into the device as determined by the notified body.当提出观点时，权威机构或欧洲医疗代理机构应把报告主体所规定的制造过程和物质组合成医疗器械后的相关效用数据考虑在内。Where changes are made to an ancillary substance incorporated in a device, in particular related to its manufacturing process, the notified body shall be informed of the changes an
28、d shall consult the relevant medicines competent authority (i.e. the one involved in the initial consultation) , in order to confirm that the quality and safety of the ancillary substance are maintained.当组合到医疗器械的辅助性物质发生变化时，特别是与之相关的制造过程发生变化时，应把这些变化通知到报告主体且咨询相关医疗权威机构（例如首次咨询的机构），以确保辅助性物质的质量和安全得到保持。The
29、competent authority shall take into account the data related to the usefulness of incorporation of the substance into the device as determined by the notified body, in ()Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for th
30、e authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1) . Regulation as last amended by Regulation (EC) No 1901/2006.根据欧洲议会制定的第726/2004号（EC）规定第（*）条款和和欧洲委员会2004年3月31日制定的关于用于人类和动物的医疗产品的授权和监督程序以及建立欧洲医疗代理
31、机构（OJL 136，30.4.2004，p.1)的决议，权威机构应把报告主体所规定的制造过程和物质组合成医疗器械后的相关效用数据考虑在内。7.5The devices must be designed and manufactured in such a way as to reduce to a minimum the risks posed by substances leaking from the device. Special attention shall be given to substances which are carcinogenic, mutagenic or to
32、xic to reproduction, in accordance with Annex I to Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (*) . If parts of a device (or a device itself) inte
33、nded to administer and/or remove medicines, body liquids or other substances to or from the body, or devices intended for transport and storage of such body fluids or substances, contain phthalates which are classified as carcinogenic, mutagenic or toxic to reproduction, of category 1 or 2, in accor
34、dance with Annex I to Directive 67/548/EEC, these devices must be labelled on the device itself and/or on the packaging for each unit or, where appropriate, on the sales packaging as a device containing phthalates.医疗器械的设计和制造必须确保由于医疗器械的物质泄漏所引起的风险降低到最小值。根据1967年6月27日制定的67/548/EEC指令附录1中的规定以及其它相关的法规、规章和管
35、理规定中关于危险物质的分类、包装和贴标，要特别注意致癌物质、诱导有机体突变的物质或影响生殖的有毒物质。当医疗器械的部件（或医疗器械本身）用于向人体施用和/或移除来自人体的药物、体液或其它物质，或用于运输和存储这些体液或物质，包括根据67/548/EEC指令附录I中目录1或目录2被归类为致癌物质、诱导有机体突变的物质或影响生殖的有毒物质的邻苯二甲酸盐，必须在医疗器械产品上和/或在每一个包装上或必要时在其销售包装上贴上标签，表明其含有邻苯二甲酸盐。If the intended use of such devices includes treatment of children or treatm
36、ent of pregnant or nursing women, the manufacturer must provide a specific justification for the use of these substances with regard to compliance with the essential requirements, in particular of this paragraph, within the technical documentation and, within the instructions for use, information on
37、 residual risks for these patient groups and, if applicable, on appropriate precautionary measures当医疗器械的使用对象包括儿童或孕妇或哺乳妇女，制造商必须提供使用这些物质的详细理由及其所符合的基本要求，特别是本节要求，所要提供的资料包括技术性文件、使用说明书、残余风险相关信息，若可以，应提供相关预防措施。7.6The devices must be designed and manufactured in such a way as to reduce as much as possible, r
38、isks posed by the unintentional ingress of substances into the device taking into account the device and the nature of the environment in which it is intended to be used.考虑到医疗器械及其预期使用的环境特性，医疗器械的设计和制造必须尽可能的降低由于外来物质进入医疗器械所造成的风险。8.Infection and microbial contamination病毒传染和微生物污染8.1 The devices and their
39、 manufacturing processes must be designed in such a way as to eliminate or reduce as far as possible the risk of infection to the patient, user and third parties. The design must allow easy handling and, where necessary, minimise contamination of the device by the patient or vice versa during use.医疗
40、器械及其生产过程的设计必须尽可能的消除或降低患者、使用者和第三方被传染的风险。医疗器械的设计必须易于操作，必要时，降低医疗器械在使用过程中被患者污染的程度或医疗器械对患者的污染程度。8.2Tissues of animal origin must originate from animals that have been subjected to veterinary controls and surveillance adapted to the intended use of the tissues.动物组织必须来源于组织的预期用途由兽医控制和监督的动物。Notified Bodies s
41、hall retain information on the geographical origin of the animals.认证主体应保留动物原产地相关信息。Processing, preservation, testing and handling of tissues, cells and substances of animal origin must be carried out so as to provide optimal security. In particular safety with regard to viruses and other transferabl
42、e agents must be addressed by implementation of validated methods of elimination or viral inactivation in the course of the manufacturing process.对动物组织、细胞和物质进行加工、存储、测试和处理时必须能够确保其最佳安全性。特别是在生产加工过程中，必须通过执行有效的根除或灭菌方法对病毒和其它可传播媒介进行处理。8.3Devices delivered in a sterile state must be designed, manufactured a
43、nd packed in a non-reusable pack and/or according to appropriate procedures to ensure they are sterile when placed on the market and remain sterile, under the storage and transport conditions laid down, until the protective packaging is damaged or opened.以无菌形式提供的医疗器械的设计、制造和包装必须采用一次性包装，并且/或根据适当的程序确保其
44、在规定的存储和运输条件下在上市时是无菌的并继续有效，直到其包装受损或被拆开。8.4Devices delivered in a sterile state must have been manufactured and sterilised by an appropriate, validated method.以无菌形式提供的医疗器械必须采用适当的、经认可的方法进行生产和灭菌。8.5Devices intended to be sterilised must be manufactured in appropriately controlled (e.g. environmental) co
45、nditions.无菌医疗器械的制造必须在有适当控制的（例如：环境控制）条件中进行。8.6Packaging systems for non-sterile devices must keep the product without deterioration at the level of cleanliness stipulated and, if the devices are to be sterilised prior to use, minimise the risk of microbial contamination. The packaging system must be
46、suitable taking account of the method of sterilisation indicated by the manufacturer.非无菌医疗器械的包装系统必须确保产品在所规定的洁净水平下没有变质，医疗器械在使用前要消毒以降低微生物污染风险。包装系统必须适当考虑制造商所指定的消毒方法。8.7The packaging and/or label of the device must distinguish between identical or similar products sold in both sterile and non-sterile co
47、ndition.包装和/或标签必须能够区分以无菌状态或非无菌状态销售的同类产品或相似产品。9.Construction and environmental properties结构和环境特性9.1If the device is intended for use in combination with other devices or equipment, the whole combination, including the connection system must be safe and must not impair the specified performance of the devices. Any restrictions on use must be indicated on the label or in the instruction for use.如果医疗器械与其它医疗器械或仪器结合使用，那么整个组合体、包括连接系统必须安全且不损害该医疗器械的特有性能。任何使用限制必须在标签或使用说明书中标明。9.2Devices must be designed and manufactured in such a way as to remove or minim