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Essential Requirements Checklist of the MDD(07 47 EC)基本要求检查表(中英文)

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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 Manufacturers Ok / Fail Compliance/Records 制造商符合性文件/记录符合/不符合

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I. 1. GENERAL REQUIREMENTS基本要求 The devices must be designed and manufactured 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 constitute 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 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）。页眉内容

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 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。页眉内容

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），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 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。 The devices must be designed, manufactured and packed in such a way 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 5. 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 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 REGARDING DESIGN AND CONSTRUCTION 设计和结构要求页眉内容

7. 7.1 Chemical, physical and biological properties 化学性能、物理性能和生物性能 The 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： • 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 intended 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。页眉内容

7.2 The 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, 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。 The 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 medicinal 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。 7.3 页眉内容

7.4 Where 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 action 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 designated 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. 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 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。页眉内容

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 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. 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 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。页眉内容

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 and 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 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 the 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。页眉内容

7.5 The 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 toxic 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) intended 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 accordance 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。页眉内容

If the intended use of such devices includes treatment of children or treatment 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 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。 The devices must be designed and manufactured in such a way as to reduce as much as possible, risks 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。 Infection and microbial contamination病毒传染和微生物污染 The devices and their 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。 7.6 8. 8.1 8.2 Tissues 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 shall 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。页眉内容

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 transferable 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。 Devices delivered in a sterile state must be designed, manufactured and 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。 Devices 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。 Devices intended to be sterilised must be manufactured in appropriately controlled (e.g. environmental) conditions.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。 8.3 8.4 8.5 8.6 Packaging 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 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。 The packaging and/or label of the device must distinguish between identical or similar products sold in both sterile and non-sterile condition.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。 Construction and environmental properties结构和环境特性 8.7 9. 页眉内容

9.1 If 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。 Devices must be designed and manufactured in such a way as to remove or minimise as far as possible: 医疗器械的设计和制造必须尽可能消除或减少： • the risk of injury, in connection with their physical features, including the volume/pressure ratio, dimensional, and where appropriate the ergonomic features, • 由其物理特性，包括体积/压力，尺寸，必要时还包括人体工程特性所引起的受伤风险。 • risks connected with reasonably foreseeable environmental conditions, such as magnetic fields, external electrical influences, electrostatic discharge, pressure, temperature or variations in pressure, and acceleration, • 与一定的可预见性环境条件，例如磁场、外部电力影响，静电放电，气压，温度或压力变化和加速度有关的风险。 • the risks of reciprocal interference with other devices normally used in the investigations or for the treatment given, • 与通常用于研究或治疗的其它医疗器械发生相互干扰的风险。 • risks arising where maintenance or calibration are not possible (as with implants) from ageing of the materials used or loss of accuracy of any measuring or control mechanism. • 在不可能进行维修保养或校准（当移植时）时，由于所使用的物料老化或任何测量失准或操作不当所产生的风险。 9.2 页眉内容

9.3 Devices must be designed and manufactured in such a way as to minimise the risks of fire or explosion during normal use and in single fault condition. Particular attention must be paid to devices whose intended use includes exposure to flammable substances which could cause combustion. 医疗器械的设计和制造必须能够降低在其正常使用过程中和出现单一故障时所产生的火灾风险或爆炸风险。应特别注意含有在使用时由于曝光而可能引起燃烧的易燃物质的医疗器械。 10. 10.1 Devices with a measuring function具有测量功能的医疗器械 Devices with a measuring function must be designed and manufactured in such a way as to provide sufficient accuracy and stability within appropriate limits of accuracy and taking account of the intended purpose of the device. The limits of accuracy must be indicated by the manufacturer. 具有测量功能的医疗器械的设计和制造应考虑其预期用途，并确保其在适当的精确限制值范围内具有高精确度和稳定性。制造商必须指明精确度范围。 The measurement, monitoring and display scale must be designed in line with ergonomic principles, taking account of the intended purpose of the device. 考虑到医疗器械的预期用途，测量、监测和显示刻度的设计必须符合人类工程学原理。 The measurements made by devices with a measuring function must be expressed in legal units conforming to the provisions of Council Directive 80/181/EEC (OJ No L 39, 15. 2. 1980, p. 40. Directive as last amended by Directive 89/617/EEC (OJ No L 357, 7. 12. 1989, p. 28)). 具有测量功能的医疗器械的测量必须用 80/181/EEC 指令(OJ No L 39, 15. 2. 1980, p. 40. 由 89/617/EEC 指令(OJ No L 357, 7. 12. 1989, p. 28))修订而来）所规定的法定单位表示。 Protection against radiation辐射防护 10.2 10.3 11. 页眉内容

11.1 11.1.1 General总则 Devices shall be designed and manufactured such that exposure of patients, users and other persons to radiation shall be reduced as far as possible compatible with the intended purpose, whilst not restricting the application of appropriate specified levels for therapeutic and diagnostic purposes. 在未对辐射用于治疗和诊断时的标准进行规定时，医疗器械的设计和制造应尽可能的避免患者、使用者和其他人员受到过多的辐射。 11.2 11.2.1 Intended radiation预期辐射 Where devices are designed to emit hazardous levels of radiation necessary for a specific medical purpose the benefit of which is considered to outweigh the risks inherent in the emission it must be possible for the user to control the emissions. Such devices shall be designed and manufactured to ensure reproducibilty and tolerance of relevant variable parameters. 当为特定医疗目的所设计的医疗器械，其释放的有害辐射物质的医疗成效大于其固有的风险时，使用者应尽可能的控制该辐射物质。这类医疗器械的设计和制造必须确保相关变化因素的再现性和所允许的偏差。 Where devices are intended to emit potentially hazardous, visible and/or invisible radiation, they must be fitted, where practicable, with visual displays and/or audible warnings of such emissions. 当医疗器械可能释放可见的和/或不可见的有害辐射时，可行时，医疗器械必须安装辐射视频显示器和/或音响报警器。 11.2.2 11.3 11.3.1 Unintended radiation非预期辐射 Devices shall be designed and manufactured in such a way that exposure of patients, users and other persons to the emission of unintended, stray or scattered radiation is be reduced as far as possible. 医疗器械的设计和制造应尽可能的避免患者、使用者和其他人员受非预期辐射、杂散辐射或散射辐射的辐射。页眉内容

11.4 11.4.1 Instructions说明书 The operating instructions for devices emitting radiation must give detailed information as to the nature of the emitted radiation, means of protecting the patient and the user and on ways of avoiding misuse and of eliminating the risks inherent in installation. 释放辐射的医疗器械的操作说明书必须提供有关所释放的辐射的性质、保护患者和使用者的方法以及避免滥用的方法和消除安装风险的方法方面的详细内容。 11.5 11.5.1 Ionising radiation电离辐射 Devices intended to emit ionising radiation must be designed and manufactured in such a way as to ensure that, where practicable, the quantity, geometry and quality of radiation emitted can be varied and controlled taking into account the intended uses. 用于释放电离辐射的医疗器械的设计和制造，可行时，必须确保能够根据其预期用途对所释放的电离辐射的数量、几何结构和质量进行改变和控制。 Devices emitting ionising radiation intended for diagnostic radiology shall be designed and manufactured in such a way, as to achieve appropriate image and/or output quality for the intended medical purpose whilst minimising radiation exposure of the patient and user. 释放电离辐射的医疗器械用于放射诊断时，其设计和制造应达到适当的图像和/或特定医疗目的所需的输出质量，同时应减少患者和使用者所受到的辐射。 Devices emitting ionising radiation intended for therapeutic radiology shall be designed and manufactured in such a way as to enable reliable monitoring and control of the delivered dose, the beam type and energy and where appropriate the quality of the radiation. 释放电离辐射的医疗器械用于放射治疗时，应能够对辐射的输出剂量、光速类型和能量以及一定的质量进行有效的监测和控制。 Requirements for medical devices connected to or equipped with an energy source连接或装配有能源的医疗器械的要求 11.5.2 11.5.3 12. 页眉内容

12.1 Devices incorporating electronic programmable systems must be designed to ensure the repeatability, reliability and performance of these systems according to their intended use. In the event of a single fault condition (in the system) appropriate means should be adopted to eliminate or reduce as far as possible consequent risks.带有电子可编程系统的医疗器械的设计和制造必须根据其预期用途确保这些系统的再现性、可靠性和性能。倘若（系统中）出现单一故障，应尽可能采取措施消除或降低随之发生的风险。 12.1a For devices which incorporate software or which are medical software in themselves, the software must be validated according to the state of the art taking into account the principles of development lifecycle, risk management, validation and verification. 对于装有软件或内置有医疗软件的医疗器械，软件必须在现有的研发生命周期、风险管理、确认和验证规范下按照目前的工艺水平进行确认。 Devices where the safety of the patients depends on an internal power supply must be equipped with a means of determining the state of the power supply.当患者的安全取决于医疗器械的内部电源时，医疗器械的安装必须确保能够测定电源的使用状态。 Devices where the safety of the patient depends on an external power supply must include an alarm system to signal any power failure. 当患者的安全取决于医疗器械的外部电源时，医疗器械必须安装报警系统以便对任何电力故障发出报警信号。 Devices intended to monitor one or more clinical parameters of a patient must be equipped with appropriate alarm systems to alert the user of situations which could lead to death or severe deterioration of the patient's state of health. 用于监测患者的一个或多个临床参数的医疗器械必须安装适当的报警系统以提醒使用者患者的健康状况严重恶化或可能会导致其死亡。 12.2 12.3 12.4 12.5 Devices must be designed and manufactured in such a way as to minimise the risks of creating electromagnetic fields which could impair the operation of other devices or equipment in the usual environment. 医疗器械的设计和制造应能够降低在寻常环境中使用时所产生的电磁场对其它医疗器械或设备的操作造成损害的风险。页眉内容

12.6 Protection against electrical risks电气风险防护 Devices must be designed and manufactured in such a way as to avoid, as far as possible, the risk of accidental electric shocks during normal use and in single fault condition, provided that the devices are installed correctly. 医疗器械的设计和制造应尽可能避免在其安装正确的情况下，正常使用时或发生单一故障情况时产生的意外电击风险。 12.7 12.7.1 Protection against mechanical and thermal risks机械风险和热量风险防护 Devices must be designed and manufactured in such a way as to protect the patient and user against mechanical risks connected with, for example, resistance, stability and moving parts.医疗器械的设计和制造应保护患者和使用者免受例如阻力、稳定性和动件方面的机械风险。 Devices must be designed and manufactured in such a way as to reduce to the lowest possible level the risks arising from vibration generated by the devices, taking account of technical progress and of the means available for limiting vibrations, particularly at source, unless the vibrations are part of the specified performance.根据技术进步和可用于限制震动（特别是震源处的震动）的方法，医疗器械的设计和制造应能够把医疗器械所产生的震动风险降低到最低水平，除非震动是医疗器械本身所特有的性能。 Devices must be designed and manufactured in such a way as to reduce to the lowest possible level the risks arising from the noise emitted, taking account of technical progress and of the means available to reduce noise, particularly at source, unless the noise emitted is part of the specified performance.根据技术进步和可用于降低噪音（特别是噪音源处的噪音）的方法，医疗器械的设计和制造应把其产生的噪音风险降低到最低水平，除非噪音是医疗器械本身所特有的性能。 12.7.2 12.7.3 12.7.4 The terminals and connectors to the electricity, gas or hydraulic and pneumatic energy supplies which the user has to handle must be designed and constructed in such a way as to minimise all possible risks.供应给使用者操作的与电流、天然气或液压能和气能相连的终端设备或连接器的设计和制造应能够降低所有可能产生的风险。页眉内容

12.7.5 Accessible parts of devices (excluding any parts or areas intended to supply heat or reach given temperatures) and their surroundings must not attain potentially dangerous temperatures under normal use.在正常使用情况下，医疗器械中易触及的部件（用于供应热量或达到指定温度的任何部件或区域除外）及其周边的温度不能达到潜在的危险温度。 Protection against the risks posed to the patient by energy supplies or substances所供应的能量或物质对患者造成危害的风险的防护 Devices for supplying the patient with energy or substances must be designed and constructed in such a way that the flow rate can be set and maintained accurately enough to guarantee the safety of the patient and of the user. 为患者提供能量或物质的医疗器械的设计和制造应确保其流速可被设定并保持准确性，以充分保证患者和使用者的安全。 Devices must be fitted with the means of preventing and/or indicating any inadequacies in the flow-rate which could pose a danger. Devices must incorporate suitable means to prevent, as far as possible, the accidental意外 release of dangerous levels of energy from an energy and/or substance source. 医疗器械必须安装能预防和/或指出由于流速的不充分可能产生危险的设备。医疗器械必须组装适当的设备以尽可能的预防来自于能源和/或物质源的能源意外外泄的危险。 12.8 12.8.1 12.8.2 12.9 The function of the controls and indicators must be clearly specified on the devices. Where a device bears instructions required for its operation or indicates operating or adjustment parameters by means of a visual system, such information must be understandable to the user and, as appropriate, to the patient. 控制键和指示灯的功能必须清晰地标注在医疗器械上。当医疗器械有操作说明书或有通过目视系统指示其运行参数或平均参数的说明书，这些说明书必须利于使用者理解，必要时还要利于患者理解。 13. Information supplied by the manufacturer制造商提供的资料页眉内容

13.1 Each device must be accompanied by the information needed to use it safely and properly, taking account of the training and knowledge of the potential users, and to identify the manufacturer考虑到每个潜在用户的培训程度和知识水平，每台医疗器械必须附有如何安全和正确使用该器械的资料，以及鉴定制造商的资料。 Where appropriate, this information should take the form of symbols. Any symbol or identification colour used must conform to the harmonised standards. In areas for which no standards exist, the symbols and colours must be described in the documentation supplied with the device.当适用时，这些资料应采用符号形式。所使用的任何符号或颜色鉴定法须符合协调标准。在没有协调标准的地方，须在医疗器械所附带的文件中对符号和颜色进行描述。 The label must bear the following particulars:标签必须含有以下详细内容： a) the name or trade name and address of the manufacturer. For 13.2 13.3 devices imported into the Community, in view of their distribution in the Community, the label, or the outer packaging, or instructions for use, shall contain in addition the name and address of the authorised representative where the manufacturer does not have a registered place of business in the Community;制造商的名称或贸易名称和地址。当制造商在欧洲市场没有已注册的营业场所时，对于进口到欧洲市场的医疗器械，考虑到其在欧洲市场销售，其标签或外部包装或使用说明书还应包括授权代理人的姓名和地址； b) the details strictly necessary to identify the device and the contents of the packaging especially for the users; 使用者识别医疗器械及包装物品所须的详细资料； c) where appropriate, the word \"STERILE\"; 当适用时，在标签上标注“STERRILE”字体； d) where appropriate, the batch code, preceded by the word \"LOT\serial number;当适用时，在“LOT”前标注上批号或者编号； e) where appropriate, an indication of the date by which the device should be used, in safety, expressed as the year and month；当适用时，在标签上标注医疗器械的有效使用期，安全起见以年和月表示；页眉内容

f) where appropriate, an indication that the device is for single use. A manufacturer's indication of single use must be consistent across the Community;当适用时，注明医疗器械做一次性使用。制造商的一次性使用标识在欧洲市场内必须一致； 13.3 g) if the device is custom made, the words \"custom made device\"; 如果医疗器械是定制的，应标注“定制的医疗器械”； h) if the device is intended for clinical investigations, the words \"exclusively for clinical investigations\"; 如果医疗器械用于临床研究，应标注“专供临床研究之用”； i) any special storage and/or handling conditions; 任何特殊的存储和/或处理条件； j) any special operating instructions;任何特殊的操作说明书； k) any warnings and/or precautions to take; 任何警告和/或采取的预防措施； l) year of manufacture of active devices other than除了 those covered by e). This indication may be included in the batch or serial number; 有源医疗器械除了满足e）中所列的信息，还应标注上制造年份。制造年份可能包含在批号或编号中； m) where applicable, method of sterilisation.当适用时，标注上灭菌方法。 If the intended purpose of the device is not obvious to the user, the manufacturer must clearly state it on the label and in the instructions for use. 如果医疗器械的用途不太明显，制造商应在使用说明书和标签上陈述清楚。 13.4 13.5 Wherever reasonable and practicable, the devices and detachable components must be identified, where appropriate in terms of batches, to allow all appropriate action to detect any potential risk posed by the devices and detachable components.当合理和可行时，当适用时必须根据批号对医疗器械及其部件进行识别，以便采取所有适当措施查明由医疗器械及其部件引起的任何潜在风险。 Where appropriate, the instructions for use must contain the following particulars:当适用时，使用说明书必须含有以下详细资料： 13.6 页眉内容

a) the details referred to in 13.3, with the exception of d) and e)；第13.3中所述的除 (d)和(e)之外的内容； b) the performances referred to in section 3 and any undesirable side effects;条款3中提到的性能和任何不良副作用； c) if the device must be installed with or connected to other medical devices or equipment in order to operate as required for its intended purpose, sufficient details of its characteristics to identify the correct devices or equipment to use in order to obtain a safe combination;如果器械必须同其他医疗器械或设备安装或连接在一起，以便按其预定用途要求进行工作，爲了实现安全的组合，要标明识别使用器械和设备的特性的详细细节。 d) all the information needed to verify whether the device is properly installed and can operate correctly and safely, plus details of the nature and frequency of the maintenance and calibration needed to ensure that the devices operate properly and safely at all times;验证医疗器械是否正确安装和能否正常运行和安全运行所需的所有资料，以及确保医疗器械一直正确运行和安全运行所需的维护和校准的性质和频率方面的详细资料； e) where appropriate, information to avoid certain risks in connection with implantation of the device;当适用时，预防与医疗器械的植入有关的必然风险方面的资料。 f) information regarding the risks of reciprocal interference posed by the presence of the device during specific investigations or treatment;在进行特殊研究或治疗时由于医疗器械的存在而产生的相互干扰风险方面的资料。 g) the necessary instructions in the event of damage to the sterile packaging and, where appropriate, details of appropriate methods of re-sterilisation; 无菌包装遭到损坏时的必要说明，当适用时，还应包括适当的再灭菌方法方面的详细内容；页眉内容

13.6 h) if the device is reusable, information on the appropriate processes to allow reuse, including cleaning, disinfection, packaging and, where appropriate, the method of sterilisation of the device to be re-sterilised, and any restriction on the number of reuses. Where devices are supplied with the intention that they may be sterilised before use, the instructions for cleaning and sterilisation must be that, if correctly followed, the device will still comply with the requirements in Section I; If the device bears an indication that the device is for single use, information on known characteristics and technical factors known to the manufacturer that could pose a risk if the device were to be re-used. If in accordance with Section 13.1 no instructions for use are needed, the information must be made available to the user upon request 如果医疗器械可重复使用，应有适当加工以允许重复使用方面的资料，包括清洁、消毒、包装和，当适用时，医疗器械被重新灭菌的灭菌方法及其可重复使用的次数。当医疗器械在使用前要进行消毒，如果其按照医疗器械的清洁和灭菌说明书进行正确的清洁和灭菌，医疗器械仍符合本要求中的条款1；如果医疗器械是一次性使用品，应有制造商所掌握的如果重复使用可能会发生风险的已知的特征和技术因素方面的资料。如果根据条款13.1不需要使用说明书，在使用者提出要求时必须向其提供相关资料。 i) details of any further treatment or handling needed before the device can be used (for example, sterilisation, final assembly, etc.); 在医疗器械被使用之前，需进行进一步处理或处置的详细资料（例如消毒、最后组装等）； j) in the case of devices emitting radiation for medical purpose, details of the nature, type intensity and distribution of this radiation. 当医疗器械用于放射治疗时，提供该辐射的性质、强度和分配方面的资料。页眉内容

The instruction for use must also include details, allowing the medical staff to brief the patient on any contra-indications and any precautions to be taken. These details should cover in particular: 使用说明书中必须有这些资料，以便医务人员对患者讲解禁忌症和注意事项。这些资料必须包括： k) precautions to be taken in the event of changes in the performance of the device;医疗器械的性能发生变化时所采取的预防措施； l) precautions to be taken as regards exposure, in reasonably foreseeable environmental conditions, to magnetic fields, external electrical influences, electrostatic discharge, pressure or variations in pressure, acceleration, thermal ignition sources etc.;在一定的可预见性环境条件中，对于暴露于磁场、外部电力影响、静电放电、气压或气压变化、加速度、热引燃来源的医疗器械所采取的措施。 m) adequate information regarding the medicinal product or products which the device in question is designed to administer, including any limitations in the choice of substances to be delivered;提交相关医疗产品或正在设计用于施用药物的医疗器械的全部资料，包括所选物质的任何限制性条款。 n) precautions to be taken against any special, unusual risks related to the disposal of the device;对涉及医疗器械的处理方面的任何特殊的、不同寻常的风险所采取的预防措施。 o) medicinal substances, or human blood derivatives incorporated into the device as an integral part in accordance with Section 7.4; 按照7.4条款中所规定的要求组合到医疗器械中作为其组成部分的医学物质或人体血液衍生物； 14. p) degree of accuracy claimed for devices with a measuring function. 具有测量功能的医疗器械的准确度申明文件。 q) date of issue or the latest revision of the instructions for use 使用说明书的发行日期或最新版本 Where conformity with the essential requirements must be based on clinical data, as in section 1 (6), such data must be established in accordance with Annex X.如必须有条款1第（6）点中所规定的临床资料来证明与本基本要求相符合，则必须根据附录X建立这些资料。页眉内容

Prepared by: Julie Date:2012-07-27

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