安全和性能要求检查表GSPR Check List.docx

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1、MDR Annex I 附录一General safety and performance requirements Checklist通用安全和性能要求检查表General safety and performance requirements通用安全和性能要求Applica blity 适用性Standards Used 应用标准Evidence compliance or reason for no applicability 符合性证据或不适用逆由Location-section 位置一章节CHAPTER 1 GENERAL REQUIREMENTS 第 1章一般要求1. Device

2、s shall achieve the performance intended by their manufacturer and shall be designed and manufactured in such a way that, during normal conditions of use, they are suitable for their intended purpose. They shall be safe and effective and shall not compromise the clinical condition or the safety of p

3、atients, 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.1.器械应具备制造商预期的性能，并确保其设计和结构在正常使用条件下适用于其 预期用途。器械应安全有

4、效，且不得对患者的临床症状或安全或者使用者或其他人 员（如适用）的安全和健康造成损害，在最大限度保护健康和安全的同时，器械 使用的可接受风险与其对患者的受益相比，应在可接受范围内，并应考虑到 符合现有认知水平。2. The requirement in this Annex to reduce risks as far as possible means the reduction of risks as far as possible without adversely affecting the benefit-risk ratio.2.本附录中尽可能降低风险的要求，指尽可能降低风险的同时

5、不会对受益-风险 比产生不利影响。3. Manufacturers shal 1 establ ish, implement, document and maintain a risk management system.1. .4.3.Guidelines on phthalates10. 4.3邻苯二甲酸酯使用指南For the purposes of Section 10.4., the Commission shall, as soon as possible and by 26 May 2018, provide the relevant scientific committee w

6、ith a mandate to prepare guidelines that shall be ready before 26 May 2020. The mandate for the committee shall encompass at least a benefit-risk assessment of the presence of phthalates which belong to either of the groups of substances referred to in points (a) and (b) of Section 10.4.1. The benef

7、it-risk assessment shall take into account the intended purpose and context of the use of the device, as well as any available alternative substances and alternative materials, designs or medical treatments. When deemed appropriate为达到本附录第10.4条的目的，委员会应尽快并于2018年5月26日向相 关科学委员会提供任务以制定指南，且本指南应在2020年5月26日

8、前编制好。 委员会的任务至少应包含对邻苯二甲酸酯存在的利益风险评价，其中邻苯二甲酸酯 属于第10. 4.1节要点（a）和（b）中所所述物质组中的任何一组。利益风险评 价应考虑器械、可用替代物质和替代材料、设计和/或药物治疗使用的预期目的和 环境。虽然根据最新科学证据认为是适当的，但应至少每五年更新一次本指 南。(1) Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of

9、 substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 ( OJ L 353, 31.12.2008, p.l).(2) Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration,Evaluation, Aut

10、horisation and Restriction of Chemicals (REACH) (OJ L 396, 30.12.2006, p. 1).(3) Regulation (EU) No 528/2012 of the European Parliament and the(1)欧洲议会和理事会于2008年12月16日签发的关于物质和混合物分类、标签和包装的第1272/2008号法规，修订和废除第67/548/EEC号指令和第1999/45/EC号指 令，并修订了第修07/2006 号法规(0J L 353, 31. 12.2008, p. 1)0(2)欧洲议会和理事会于2006年

11、12月18日签发的关于化学品注册、评价、授权和限制(REACH)的第1907/2006号法规(0J L 396, 30. 12. 2006, p. 1)。(3)欧洲议会和理事会于2012年5月22日签发的关于在市场上提供和使用杀生物产品的第528/2012号法规(0J L 167, 27. 06. 2012, p. l)o10.4.4Guidelines on other CMR and endocrine-disrupting substances 其他CMR和内分泌干扰物质的指南Subsequently, the Commission shall mandate the relevant

12、scientific committee to prepare guidelines as referred to in Section 10.4.3. also for other substances referred to in points (a) and (b) of Section 10.4.1., where appropriate.随后，委员会应授权相关科学委员会按照第中所述的要求，也为第 10. 4. 1节要点(a)和(b)中所所述的其他物质制定指南。10.4.5 Labelling贝占标Where devices, parts thereof or materials us

13、ed therein as referred to in Section 10.4.1. contain substances referred to in points (a) or (b) of Section 10.4.1. in a concentration above 0,1 % weight by weight (w/w), the presence of those substances shall be labelled on the device itself and/or on the packaging for each unit or,where appropriat

14、e, on the sales packaging, with the list of such substances. If the intended use of such devices includes treatment of children or treatment of pregnant or breastfeeding women or treatment of other patient groups considered particularly vulnerable to such substances and/or materials, information on

15、residual risks for those patient groups 按照第10. 4.1节所述的要求，若此中所使用的器械、其部件或材料，包含第 10. 4.1节中所述的浓度高于0.现重量比的物质，则应在器械本身和/或各单元的 包装上或，(适当时)在销售包装上把此类物质清单标识清楚。若此类器械的预 期用途，包括儿童治疗，或孕妇或哺乳妇女治疗，或对视为特别易受到此类物质和 /或材料影响的其他患者群体的治疗.，则关于这些患者群体的剩余风险、(如适 用)预防措施信息，均应在使用说明中给出。10.5.Devices shall be designed and manufactured in

16、such a way as to reduce as far as possible the 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.必须合理设计及生产器械，以尽量降低因物质意外进入器械而造成的风险，并且 应考虑到器械及其预期使用环境的性质。10.6.Devices shall be design

17、ed and manufactured in such a way as to reduce as far as possible the risks linked to the size and the properties of particles which are or can be released into the patients or users body, unless they come into contact with intact skin only. Special attention shall be given to nanomaterials.器械的设计和生产

18、应尽可能减少与微粒尺寸和性能相关的风险，除非这些微粒接 触到的是完好的皮肤，否则这些微粒会位于或可释放到患者或使用者体内。应特 别注意纳米材料。11. Infection and microbial contamination感染及微生物污染11.1. Devices and their manufacturing processes shall be designed in such a way as to eliminate or to reduce as far as possible the risk of infection to patients, users and, where

19、 applicable, other persons. The design shall:(a) reduce as far as possible and appropriate the risks from unintended cutsand pricks, such as needle stick injuries,(b) allow easy and safe handling,(c) reduce as far as possible any microbial leakage from the device and/or microbial exposure during use

20、, and(d) prevent microbial contamination of the device or its content such as specimens or fluids.器械和生产过程的设计应尽可能消除或减少感染患者、使用者和(适用时)其他 人的风险。设计应：(a)尽可能减少并消除意外由于切割和刺破造成的风险，例如针刺损伤；(b)使用便捷安全；(c)尽可能降低器械的微生物泄漏和/或使用过程中的微生物暴露；(d)防止器械或其所包含之物(例如样本或液体)受到微生物的污染。11.2. Where necessary devices shall be designed to

21、facilitate their safe cleaning, disinfection, and/or re-sterilisation.必要时，应将器械设计成便于进行安全清洁、消毒和/或再灭菌。11.3.Devices labelled as having a specific microbial state shall be designed, manufactured and packaged to ensure that they remain in that state when placed on the market and remain so under the transp

22、ort and storage conditions specified by the manufacturer.应对标记为具有特殊微生物种群的器械进行设计、生产和包装，以确保在投放到 市场时，及在制造商规定的运输和储存条件下，器械依旧保持原样。11.4. Devices delivered in a sterile state shall be designed, manufactured and packaged in accordance with appropriate procedures, to ensure that they are sterile when placed on

23、 the market and that, unless the packaging which is intended to maintain their sterile condition is damaged, they remain sterile, under the transport and storage conditions specified by the manufacturer, until that packaging is opened at the point of use. It shall be ensured that the integrity of th

24、at packaging is clearly evident to the final user.应根据适当流程，对在无菌状态下运输的器械进行设计、生产和包装，以确保在投 放到市场时，及在制造商指定的运输和储存条件下，器械能保持无菌状态，除非旨 在保持其无菌状态的包装遭到损坏，仍保持无菌，直至保护包装破损或出于 使用目的而打开时。这些措施应确保最终使用者可清晰可见无菌包装的完整性。11.5. Devices labelled as sterile shall be processed, manufactured, packaged and, sterilised by means of ap

25、propriate,validated methods.应通过适当的经过验证的处理、生产、包装和灭菌方法标识为无菌器械。11.6.Devices intended to be sterilised shall be manufactured and packaged in appropriate and controlled conditions and facilities.用于灭菌的器械应采用适当且可控条件和设备进行生产和包装11.7. Packaging systems for non-sterile devices shall maintain the integrity andcle

26、anliness of the product and, where the devices are to be sterilised prior to use, minimise the risk of microbial contamination; the packaging11.7若器械在使用前灭菌，则非无菌器械的包装系统应保持产品的完整性和清 洁度，以尽量减少微生物污染风险；此外，包装系统应适当考虑制造商指定的灭 菌方法。11.8.The labelling of the device shall distinguish between identical or similar de

27、vices placed on the market in both a sterile and a non-sterile condition additional to the symbol used to indicate that devices are sterile.11.8器械标识除带有灭菌产品的指示符号外，还应可区别市场上相同或相似器 械的灭菌和非灭菌状态。12. Devices incorporating a substance considered to be a medicinal product and devices that are composed of subs

28、tances or of combinations of substances that are absorbed by or locally dispersed in the human body.12包含被认为是药品物质的器械，及由人体吸收或局部喷洒在人体上的物质或 物质组合构成的器械。12.1. In the case of devices referred to in the first subparagraph of Article 1(8), the quality, safety and usefulness of the substance which, if used sep

29、arately, would be considered to be a medicinal product within the meaning of point (2) of Article 1 of Directive 2001/83/EC, shall be verified by analogy with the methods specified in Annex 1 to Directive 2001/83/EC, as required by the applicable conformity assessment procedure under this Regulation

30、.12.1对于第1(8)条第一子段所指的器械，若单独使用，则该物质的质量、安全 性和可用性将被视为是符合第2001/83/EC号指令第1条(2)点的医药产品，则应 按照本法规中适用的符合性评价流程的规定，使用与第2001/83/EC号指令附录 I所规定方法相似的方法进行验证。12.2.Devices that are composed of substances or of combinations of substances that are intended to be introduced into the human body, and that are absorbedby or l

31、ocally dispersed in the human body shall comply, where applicable and in a manner limited to the aspects not covered by this Regulation, with the relevant requirements laid down in Annex 1 to Directive 2001/83/EC for the evaluation of absorption, distribution,metabolism, excretion, local tolerance,

32、toxicity, interaction with other devices, medicinal products or other substances and potential12.2预期植入到人体，以及由人体吸收或局部喷泗在人体上的物质或物质组合 构成的器械，应遵从，（适用时）并受限于本法规与第2001/83/EC号指令附录I 中规定的相关要求未涵盖方面，而这些相关要求用于按照本法规适用的符合性评价 流程，对吸收、分配、新陈代谢、排泄、局部耐受性、毒性，与其他器械、医 药产品呼呼其他物质和相互影响，及副作用的潜在影响进行评价。13.Devices incorporating ma

33、terials of biological origin13 含有生物来源材料的器械13.1. For devices manufactured utilising derivatives of tissues or cells of human origin which are non-viable or are rendered non-viable covered by this Regulation in accordance with point (g) of Article 1(6), the following shall apply: 13.1对于使用由本法规涵盖的非活性或处理

34、为非活性人源生物组织或细胞生产 成的器械，根据第1(6)条(的点，适用以下规定：(a) donation, procurement and testing of the tissues and cells shall be done in accordance with Directive 2004/23/EC;对用于器械生产的人源组织和细胞的捐赠、购买和测试应根据第2004/23/EC号 指令完成。(b) processing, preservation and any other handling of those tissues and cells or their derivative

35、s shall be carried out so as to provide safety for patients, users and, where applicable, other persons. In particular,safety with regard to viruses and other transmissible agents shall be addressed by appropriate methods of sourcing and by implementation of validated methods of elimination or inact

36、ivation in the course of the manufacturing process;应对那些组织和细胞或其 衍生物进行处理、保存和任何其他操作，从而为患者、使用者、(适用时)其他 人员提供安全保障。特别是，应通过适当的来源方法，以及通过在生产过程中实施 经验证的消除或灭活方法处理与病毒和传染因子安全性相关的问题。(c) the traceability system for those devices shall be complementary and compatible with the traceability and data protection requirem

37、ents laid down in Directive 2004/23/EC and in Directive 2002/98/EC.这些器械的可追溯体系应与第2004/23/EC号指令和第2002/98/EC号指令所规定 可溯源性和数据保护要求是互补和相兼容13.2. For devices manufactured utilising tissues or cells of animal origin, or their derivatives, which are non-viable or rendered non-viable the following shall apply：(a

38、) where feasible taking into account the animal species, tissues and cells of animal origin, or their derivatives,shall originate from animals that have been subjected to veterinary controls that are adapted to the intended use of the tissues. Information on the geographical origin of the animals sh

39、all be retained by manufacturers;(b) sourcing, processing, preservation, testing and handling of tissues, cellsand substances of animal origin, or their derivatives, shall be carried out so as to provide safety for patients, users and, where applicable, other persons. In particular safety with regar

40、d to viruses and other transmissible agents shall be addressed by implementation of validated methods of elimination or viralinactivation in the course of the manufacturing process, except when the use of such methods would lead to unacceptable degradation compromising the clinical benefit of the de

41、vice;(c) in the case of devices manufactured utilising tissues or cells of animal origin, or their derivatives, as referred to in Regulation (EU) No 722/2012 the particular requirements laid down in that Regulation shall apply.13. 2对于使用非活性或处理非活性动物源组织或细胞，或其衍生物生产的器械， 应适用以下规定：在可行的情况下，考虑到动物种类，动物源组织和细胞或其

42、衍生物应来自己经 受兽医控制，即适合于组织预期使用的动物。由制造商保留动物地理来源信 息。(b)应获取动物源组织、细胞和物质或其衍生物，并对其进行处理、保存、测试和 操作，从而为患者、使用者和其他人员(如适用)提供安全保障。特别是关于 病毒和其他传播因子的安全性，应通过在生产过程中，实施经验证的消除或 病毒灭活方法来解决，除非此类方法的使用会导致不可接受的降解，损害器 械的临床益处。在使用动物来源的组织或细胞或其衍生物生产的器械，如第722/2012号法 规所述，应适用该法规规定的特别要求。13.3. For devices manufactured utilising non-viable

43、biological substances other than those referred to in Sections 13.1 and 13.2, the processing, preservation, testing and handling of those substances shall be carried out so as to provide safety for patients, users and, where applicable, other persons, including in the waste disposal chain. In partic

44、ular, safety with regard to viruses and other transmissible agents shall be addressed by appropriate methods of sourcing and by implementation of validated methods of elimination or inactivation in the course of the manufacturing process.对于使用其他非活性生物物质生产的器械，在第13. 1和13. 2节所述的情况下，应对这些物质的进行加工、保存、测定和处理，以

45、便为患者、使用者和其他人（如适 用）提供安全性，包括整条废物处理链。特别是，应通过适当的来源方法，及通过 在生产过程中实施经验证的消除或失活方法处理与病毒和传染因子安全性相关的 问题。14. Construction of devices and interaction with their environment14.器械构造及其与环境之间的相互作用14.1. If the device is intended for use in combination with other devices or equipment the whole combination.including the

46、connection system shall be safe and shall not impair the specified performance of the devices.Any restrictions on use applying to such combinations shall be indicated on the label and/or in the instructions for use. Connections which the user has to handle, such as fluid, gas transfer, electrical or

47、 mechanical coupling, shall be designed and constructed in such a way as to minimise all possible risks, such as misconnection.若器械预定与其他器械或设备一起配合使用，必须保证整个系统(包括连接系统) 具有安全性，同时不得改变本器械的指定性能。此类组合结构的任何使用限制应在 标签和/或使用说明书上标明。应以尽量减少所有可能的风险(如误连接)的方式设 计和构造使用者必须处理的连接件，例如流体、气体输送、电气或机械联 轴节。14.2. Devices shall be de

48、signed and manufactured in such a way as to remove or reduce as far as possible:(a) the risk of injury, in connection with their physical features, including the volume/pressure ratio, dimensional and where appropriate ergonomicfeatures;(b) risks connected with reasonably foreseeable external influences or environmental conditions, such as magnetic fields, external electrical and electromagnetic effects, electrostatic discharge, radiation associated with diagno