基本要求检查表 空白.docx

1、基本要求检查表 空白Product name:产品名：Type(s)/Model(s):类型/型号Product group:产品族Issue date of Technical File:技术文档发布日：Revision of Technical File:技术文档修订版本：Legal Manufacturer:法定制造商Name 名字：Street 街道 ：Postal code邮编Place地点Country 国家Accessories: 附件：Date 日期Name Reviewer 1/审核人1的名字Signature Reviewer 1/审核人1签字Date日期Name Revi

2、ewer 2/审核人2的名字Signature Reviewer 2/审核人2签字Checklist according to annex I of the Medical Device Directive (MDD)按 医 疗 器 械 指 令 （MDD） 附 录 一 的 基 本 要 求 检 查 表A/NA适用/不适用Standards, other directives and other rules applied by manufacturer制造商引用的标准，其它指令或规则Documentation (test reports, protocols, literature or rea

3、son for no applicability)支持性文件(测试报告，方案，文献或不适用的理由)Requirements fulfilled( to be filled in byNotified Body)要求满足(由公告机构填写)Ok / Fail符合 / 不符合I.General Requirements通 用 要 求1.The devices must be designed and manufactured in such a way that, when used under the conditions and for the purposes intended, they w

4、ill 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 intended use constitute acceptable risks when weighed against the benefits to the patient and are com

5、patible with a high level of protection of health and safety.器械的生产和设计必须保证：按照其预定用途和条件使用，器械不会损害临床条件、或患者安全、或操作者或其他人员的安全和健康；假设与器械预期用途相关的任何风险，与之给患者带来的益处相比，并与健康安全的保护程度相一致，则是可接受的。 This shall include: reducing, as far as possible, the risk of use error due to the ergonomic features of the device and the env

6、ironment in which the device is intended to be used (design for patient safety), and 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).应包括： 尽可

7、能地降低由于器械的人体工学特征和器械预期使用的环境（为患者安全设计的）的错误使用而产生的风险， 和 考虑技术知识、经验、教育和培训，预期用户（为非专业人员、专业人员、伤残人员或其他人）的医疗和身体条件。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 state of the art.In selectin

8、g the most appropriate solutions, the manufacturer must apply the following principles in the following order: eliminate or reduce risks as far as possible (inherently safe design and construction), where appropriate take adequate protection measures including alarms if necessary, in relation to ris

9、ks that cannot be eliminated,(l) Inform users of the residual risks due to any shortcomings of the protection measures adopted.制造商采用的器械结构和设计方案，必须考虑在当前工艺技术条件下遵守安全原则。在选择最合适方案时，制造商应按照以下顺序遵守原则： 尽可能地降低或避免风险（固有的安全设计和结构） 对无法避免的风险，如适用，采取适当的防护措施，包括必要的报警。 告知用户由于所提供防护措施的缺陷而带来的残留风险。3.The devices must achieve th

10、e 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.器械最后必须取得制造商期望获得的功能。器械设计、制造和包装应与第1条(2)(a)制造商所规定的一项或多项功能相适应。4.The characterist

11、ics 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 manufacturer, when the device i

12、s subjected to the stresses which can occur during normal conditions of use.在制造商确定的器械使用寿命期内，在正常使用可能出现的压力下，第1，2，3款指的各项特征和性能应不能影响临床条件、危害患者或其它人员的安全。 5.The devices must be designed, manufactured and packed in such a way that their characteristics and performances during their intended use will not be ad

13、versely affected during transport and storage taking account of the instructions and information provided by the manufacturer.器械设计、生产和包装应当保证器械的特征和性能在运输和储存过程中，只要遵守制造商提供的有关说明和信息，就不会受到重大影响。6.Any undesirable side effects must constitute an acceptable risk when weighed against the performances intended.副

14、作用的大小同器械的预期性能相比，是可接受的风险。6a.Demonstration of conformity with the essential requirements must include a clinical evaluation in accordance with Annex X.证明符合基本要求必须包括按照附录X的临床评估II.REQUIREMENTS REGARDING DESIGN AND CONSTRUCTION设计和结构的要求7. Chemical, physical and biological properties化学、物理和生物特征7.1The devices

15、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: the choice of materials used, particularly as regards toxicity and, where appropriate flammability, the com

16、patibility between the materials used and biological tissues, cells and body fluids, taking account of the intended purpose of the device.(p) Where appropriate, the results of biophysical or modelling research whose validity has been demonstrated beforehand.器械的设计和生产必须保证达到本附录第I部分的通用要求，另外应特别注意： 合理选择原料

17、，特别是易燃物质和有毒物质的选择； 从器械预定功能出发考虑所选材料同人体生物组织、细胞和体液的相容性。 如适用，事先已确认有效的生物物理学或模型研究的结果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 persons involved in the transport, storage and use of the devices and to the patients,

18、 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.器械的设计、制造和包装应当保证器械在运输、储存和使用过程中的污染和残留物对人体危害最低，应特别注意观察暴露于器械下的人体组织及其时间和频率。7.3The devices must be designed and manufactured in such a way that th

19、ey 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 medicinal products they must be designed and manufactured in such a way as to be compatible with the medic

20、inal products concerned according to the provisions and restrictions governing those products and that their performance is maintained in accordance with the intended use.器械设计和生产必须保证在正常使用和常规过程中接触其它材料、物质和气体不会影响其安全使用；如果器械需要加载其它药品，器械的设计和生产必须保证同该药品相兼容，必须考虑法规对该药品的规定和限制，保证器械达到预定功能。7.4Where a device incorp

21、orates, 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 action ancillary to that of the device, the quality, safety and usefulness of the substance mu

22、st be verified by analogy with the methods specified in Annex I to Directive 2001/83/EC.如果某种器械含有某种物质作为其组成部分，而且该物质单独使用时可被认为是2001/83EC第1条含义内的药品，并且它能够帮助该器械对人体产生辅助作用，这种物质的安全性、质量和有效性必须通过2001/83/EC指令附录I涉及的适用方法进行类推来确认。For the substances referred to in the first paragraph, the notified body shall, having ve

23、rified 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 designated by the Member States or the European Medicines Agency (EMEA) acting particularly through its commi

24、ttee in accordance with Regulation (EC) No 726/2004 on the quality and safety of the substance including the clinical benefit/risk profile of the incorporation of the substance into the device. When issuing its opinion, the competent authority or the EMEA shall take into account the manufacturing pr

25、ocess and the data related to the usefulness of incorporation of the substance into the device as determined by the notified body.对于第一段提到的物质，在考虑到该器械的预期用途时确认了该物质作为医疗器械一部分的有效性之后，公告机构应按Regulation (EC) No 726/20041法规，就该物质的质量和安全性包括该物质与器械整合的临床受益/风险特性，向成员国指定的一个主管当局或欧洲药品评价署（EMEA）特别是其委员会寻求科学意见。当发表其意见时，主管当局或E

26、MEA应考虑公告机构认定的关于该物质与器械整合有效性的生产过程和数据。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 the medical device and taking into account the intended purpose of the device, seek a scientific opinion

27、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 derivative into the device. When issuing this opinion, the EMEA shall take into account the manufacturing process a

28、nd the data related to the usefulness of incorporation of the substance into the device as determined by the notified body.如果某种器械含有人血制品作为其组成部分，在确认了该血制品作为医疗器械一部分的有效性，并考虑到该器械的预期用途的基础上，公告机构应就该制品的质量和安全性包括该制品与器械整合的临床受益/风险特性，向欧洲药品评价署（EMEA）特别是其委员会寻求科学意见。当发表其意见时，主管当局或EMEA应考虑公告机构认定的关于该物质与器械整合有效性的生产过程和数据。Wher

29、e 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 and shall consult the relevant medicines competent authority (i.e. the one involved in the initial consultation), in order to

30、confirm that the quality and safety of the ancillary substance are maintained. The 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 order to ensure that the changes have no negative

31、 impact on the established benefit/risk profile of the addition of the substance in the medical device. 如果器械整合的辅助物质发生了变更，特别是关系到其生产过程，公告机构应被通知并向相关的药品主管当局（也就是最初的咨询机构）咨询，以确认辅助物质的质量和安全性得以维持。主管当局应考虑公告机构认定的关于该物质与器械整合有效性的数据，以确保这种变更对已经建立的医疗器械中的增加物质的临床受益/风险特性没有负面影响。When the relevant medicines competent authority (i.e. the one involved in the initial consultation) has obtained information on the ancillary substance, which could have an impact on the established benefit/risk profile of the addition of the substance in the medical device, it shall provide the notified