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1、Essential Requirements Checklist of the MDD (07/47/EC) 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 manufact
2、ured in such a way that, when used under the conditions 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 cons
3、titute acceptable risks when weighed against the benefits 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
4、 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).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
5、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 princ
6、iples, taking account of the generally acknowledged state 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 possib
7、le (inherently safe design and construction), 尽可能地消除或降低风险（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
8、 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。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 manuf
9、acturer.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），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
10、 during the lifetime of the device as indicated by the 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 wa
11、y that their characteristics and performances during their 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
12、side effects must constitute an acceptable risk when weighed 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 R
13、EGARDING DESIGN AND CONSTRUCTION 设计和结构要求7. Chemical, physical 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
14、 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： the 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 int
15、ended purpose of the device. where appropriate, the results 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 persons involved in the transport, storage and use of the devices and to
