风险管理控制程序(符合MDR要求的中英文版).docx

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1、PROGRAM FILESNo.： HY/CX-26Rev. ： A/4Risk Management Control ProceduresEffective Date： 2021-09-28Drafted by：Reviewed by：Approved by：Risk Management Control Procedures1. Purpose 目的In order to standardize and effectively manage the risk management activities of medical device products in the company, t

2、his procedure is specially formulated.对公司内医疗器械产品的风险管理活动进行规范和有效的管理，特制定本程序。2. Scope 范围It is suitable for risk analysis and management of medical devices produced by the company.适用于公司内所有的医疗器械产品的风险分析和管理。3. Reference参考文件EN ISO 14971： 2019Medical devices 一 Application of Risk Management to Medical Devices

3、ISO/TR 24971:2020 （Medical devices 一 Guidance on the Application of ISO 149714. Definition 定义4.1 Risk: combination of the probability of occurrence of harm and the severity of that harm.风险：伤害的发生概率与严重程度的结合。4.2 Hazard: Potential source of harm.危险：可能导致伤害的潜在源。4.3 Harm: injury or damage to the health of

4、people, or damage to property or the environment.损害：对人体的伤害或损坏，或是对财产或环境的损坏。4.4 Hazardous Situations: circumstance in which people, property or the environment is/are exposed to one or more hazards.危险情况：人员、财产或环境处于一个或多个危险（源）中。4.5 Life-cycle: series of all phases in the life of a medical device, from in

5、itial concept to final decommission and disposal.生命周期：在医疗器械生命中，从初始概念到最终停用和处置的所有阶段。4.6 Residual risk: risk remaining after risk control measures have been implemented.剩余风险：实施风险控制措施后还存在的风险。documentation shall be maintained in the risk management file.公司应识别并记录可能影响医疗器械平安的定性和定量特征并形成文件。适当时，规定界限。 此信息应保存在风险

6、管理文档中。7.5.4 Identification of hazards and hazardous situations 危险(源)和危险情况的识别7.5.4.1 The manufacturer shall identify and document known and foreseeable hazards associated with the medical device based on the intended use , reasonably foreseeable misuse and the characteristics related to safety in bot

7、h normal and fault conditions.公司应根据正常和故障条件下，基于预期用途、合理可预见性误用以及与平安有关的特征识 别，记录与医疗器械有关的和可预见的危险。7.5.4.2 For each identified hazard, the manufacturer shall consider the reasonably foreseeable sequences or combinations of events that can result in a hazardous situation, which based on the intended use of t

8、he product, the intended audience for the product, and the environment in which the product is used. And shall identify and document the resulting hazardous situation(s). 对于已识别的危害，公司应根据产品的预期用途，产品的适用人群，使用环境，考虑导致危 险情况的合理可预见的一系列事件或事件组合，识别并记录造成的危险情况。Note 1: a sequence of events can be initiated in all p

9、hases of the life cycle, e.g. during transport, storage, installation, maintenance, routine inspection, decommissioning and disposal.这一系列事件可以在生命周期的任何阶段启动，例如运输、储存、安装、维修、例行检查、 退市和处置期间。Note 2: Risk analysis includes the examination of different sequences or combinations of events related to a single ha

10、zard that can lead to different hazardous situations. Each hazardous situation can lead to different types of harm.风险分析包括检查不同系列或组合的事件，单一危险可能导致不同的危险情况，每种危险情 况都可能导致不同类型的伤害。7.5.5 Risk estimation 风险判定7.5.5.1 For each identified hazardous situation, the manufacturer shall estimate the associated risk(s)

11、using available information or data. For hazardous situations for which the probability of the occurrence of harm cannot be estimated, the possible consequences shall be listed for use in risk evaluation and risk control. The results of these activities shall be recorded in the riskmanagement file.针

12、对每种已识别的危险情况，公司应利用现有信息或数据判定相关风险。针对无法估计伤害 发生可能性的危险情况，应列出可能的后果，以用于风险评价和风险控制。这些活动的结果 应记录在风险管理文档中。Information or data for estimating risks can be obtained, for example, from可用的信息或数据可以从以下获得：- Published standards;已发布的标准；- Scientific or technical investigations;学术研究；- Field data from similar medical devices

13、 already in use, including publicly available reports of incidents;已在使用的类似医疗器械的现场数据，包括可公开获得的事故报告；- Usability tests employing typical users;使用典型用户的可用性测试；- Clinical evidence;临床证据；- Result or relevant investigations or simulations;相关研究或模拟的结果；- Expert opinion;专家意见；- External quality assessment schemes f

14、or in vitro diagnostic medical devices.体外诊断医疗器械的外部质量评价方法。7.5.5.2 The system used for qualitative or quantitative categorization of probability of occurrence of harm and severity of harm shall be recorded in the risk management file. 用于对伤害发生概 率和伤害严重性进行定性或定量分类的体系，应记录在风险管理文档中。7.5.5.3 Risk analysis shou

15、ld be completed at the proposal stage of design and development.风险分析须在医疗器械产品开发产品输入阶段完成。7.6 Risk evaluation 风险评价The manufacturer shall establish criteria for risk acceptability (7.2). Risk acceptance criteria are a measure of risk, which is mainly evaluated by two indicators: severity and occurrence.

16、公司应建立风险可接受准那么(7.2)。风险接受标准是对风险的一种测量，其主要以伤害发生的 严重度和发生度两项指标作为评估。7.6.1 Severity(S) is an evaluation of the possible consequences of the harm. Severity applies only to consequences. When we evaluate the severity, we consider not only injury or damage to the health of people, but also damage to property o

17、r the environment. The reduction of severity can only be changed through design changes. The severity is assessed in terms of the S1-S5 range as the following table, Considering the low risk of our medical devices, it is only applicable to HS1-S3:严重度是指伤害的可能后果的度量。严重度仅适用于后果，除了人体伤害以外，还应考 虑对人心理、财产、环境等方面

18、的伤害。严重度的降低，只能通过设计变更去改变。严重度 以”165这个范围来评估（如下表）：等级Grade代号Code定义Definitions灾难的CatastrophicS5导致患者死亡Resulting in the death of the patient.危重的CriticalS4导致永久性损伤或危及生命的伤害Result in permanent impairment or life- threatening injury严重的SeriousS3导致专业医疗介入的伤害或损伤Cause injury or damage requiring professional medical in

19、tervention轻度MinorS2导致不要求专业医疗介入的暂时伤害或损伤Cause temporary injury or damage that does not require professional medical intervention可忽略 NegligibleS1不便或暂时不适Inconvenience or temporary discomfort7.6.3 Occurrence(O) is the probability of occurrence of harm. The probability of occurrence gradeindex has implica

20、tions, but not necessarily a numerical value. Eliminating or controlling the cause/mechanism of one or more failure modes through design changes will be the only way to effectively reduce the occurrence level. The probability of occurrence of potential failure causes/mechanisms is assessed in five l

21、evels of Pl、 P2 P3、 P4 and P5. The company can assign a value to the occurrence rating based on previous shipments (e.g., number of product failures/number of products shipped per year). Each risk management report must assign an occurrence rating.发生度（Occurrence: 0）：发生度是指发生伤害的可能性。发生度等级指数是指失效发生原 因的可能

22、性，以Pl、P2、P3、P4、P5五个等级范围来评估。发生度等级指数有其含意，但 不一定是一个数值。公司可以根据以往出货量，为发生度等级赋值（如产品故障发生次数/ 产品每年出货台数）。每份风险管理报告必须为发生度等级赋值。GradeCodeFrequency (medical equipment events in every year)FrequentP5210-3ProbableP410-4OccasionalP3105RemoteP210-6ImprobablePl10-6Risk acceptance criteria are defined in the following tabl

23、e:本公司的风险接受标准定义如下表：损害发生概率 Occurrence probability of damage严重程度 SeverityS5S4S3S2SI灾难性的Catastrophic危重的Critical严重的Serious轻度Minor可忽略Negligible经常FrequentP5UUUUU有时SometimesP4UUUUA偶然OccasionalP3UuUAA很少RemoteP2UuAAA非常少ImprobablePluAAAA注 Note:U:不可接受风险 Unacceptable risksA：可接受的风险Acceptable risksFor the U part,

24、the designer must reduce the calculated risk index through various corrective measures.针对不可接受的风险，公司应采取适当的风险控制措施，将风险水平降低到可接受水平(7.7)。7.6.4 For each identified hazard situation, the manufacture shall evaluate the estimated risks and determine if the risk is acceptable or not, using the criteria for ris

25、k acceptability defined in the risk management plan.针对每一种已识别的危害情况，公司应利用风险管理计划中定义的风 险可接受性准那么(741),对估计的风险进行评估，并确定该风险是否可接受。7.6.5 If the risk is acceptable, it is not required to apply the requirements given in 7.7 to this hazardous situation and the estimated risk shall be treated as residual risk.如果风险

26、可接受，那么不需要进行7.7要求的风险控制活动，直接将该估计的风险视为剩余风险。7.6.6 If the risk in not acceptable, then the manufacturer shall perform risk control activities as described in 7.7如果风险不可接受，那么需要执行7.7风险控制活动。7.6.7 The results of this risk evaluation shall be recorded in the risk management file.风险评估的结果应记录于风险管理文档中。7.7 Risk Con

27、trol 风险控制Risk control option analysis 风险控制策略分析The manufacturer shall determine risk control measures that are appropriate for reducing the risks to an acceptable level. The manufacturer shall use one or more of the following risk control options in the priority order listed:公司应确定适当的风险控制措施，将风险水平降低到可接

28、受的水平。公司应按照所列的优先 顺序依次选择一种或多种风险控制策略：- Inherently safe design and manufacture;用设计和生产方法取得固有平安- Eliminate the hazards消除特定的危险（源）- Reduce the probability of harm降低伤害的概率- Reduce the severity of harm降低伤害的严重程度a. Protective measures in the medical device itself or in the manufacture process;医疗器械本身或生产过程中的防护措施b.

29、 Information for safety and, where appropriate, training to users.提供平安信息，适用时，对使用者进行培训。- Warn in the label of the medical device （such as labels, user manual etc.） 在医疗器械标记中给出警告；（如标记、说明书平安警告）Restriction of the use of the medical device or the environmental it used.限制医疗器械的使用或限制使用环境；-Recommend using per

30、sonal protective equipment when dealing with toxic or hazardous substances, such as gloves and glasses.促进个人处理毒性或者有害物质时使用个人防护设备，如手套和眼镜；Measures and information of reducing harm.包括降低伤害的措施和信息；- Provide training to operators to improve their performance or improve their ability to detect errors对操作者提供培训以

31、改进他们的表现或提高其检出错误的能力；- Specify the necessary maintenance and maintenance intervals, the maximum expected service life of the product, or how to properly dispose of medical devices规定必需的维护和维护时间间隔，最大的产品预期服务寿命，或如何适当地处置医疗器械。The risk control measures selected shall be recorded in the management file. If, du

32、ring risk control option analysis, the manufacturer determines that risk reduction is not practicable, the manufacturer shall conduct a benefit-risk analysis of the residual risk.风险控制措施的选择需要记录在风险管理文档中。如果在风险控制措施策略分析中，认为降 低风险不可行，那么应对剩余风险进行风险/受益分析。（执行7.7.4）Implementation of risk control measures 风险控制措施

33、的实施1.1.2.1 相关负责人须实施在中选择的一个或多个风险控制措施。1.1.2.2 The implementation of each risk control measure should be validated, and the validation should be recorded in The risk management files.公司应验证每项风险控制措施的实施，验证实施的记录应记录于风险管理文档中。Verification of implementation can be performed as part of design and development ve

34、rification or process qualification within a quality management system.实施的验证可以作为设计和开发验证或过程确认的一局部进行。1.1.2.3 The effectiveness of the risk control measures should be verified and the results should be recorded in risk management documents.公司应验证风险控制措施的有效性，有效性的验证结果应记录于风险管理文档中。Verification of effectivene

35、ss can be performed as part of design and development verification or process qualification within a quality management system.有效性的验证可以作为设计和开发验证或过程确认的一局部进行。1.1.2.4 PM is responsible for checking whether all risk reduction measures listed in the risk control documents have been implemented and checki

36、ng and confirming that all damage and risk reduction measures have been validated.PM检查是否风险控制文件中所列的所有风险降低措施已经得到执行，并检查和确认对于所 有损害与风险降低措施的验证已经完成。1.1.3 Residual Risk Evaluation 剩余风险评价1.1.3.1 After the risk control measures are implemented, the manufacturer shall evaluate the residual risk using the crite

37、ria for risk acceptability defined in the risk management plan. The results of this evaluation shall be recorded in the risk management file.在采取风险控制措施后，公司应使用风险管理计划中规定的准那么进行评价。剩余风险评价的 结果应记录于风险管理文档中。1.1.3.2 If a residual risk is not judged acceptable using these criteria, further risk control measures

38、 shall be considered.如果剩余风险判定为不可接受，应采取进一步的风险控制措施。（执行7.7.1）7.73.3 After risk control measures have been taken, any residual risks should be evaluated using the criteria in the risk management plan. The evaluation result should be documented in the risk management file. For residual risks that are jud

39、ged to be acceptable, the risk management team should decide which residual risks should be disclosed, and the information needs to be included in the accompanying document in order to disclose those residual risks. （eg. add warning information and so on in the manual.在采取风险控制措施后，对于任何剩余风险，都应使用风险管理计划中

40、规定的标准进行评价。 此项评价结果应记入风险管理文档。如果剩余风险使用这些标准判断为不可接受的，应采取 进一步的风险控制措施。对于判断为可接受的剩余风险，风险管理团队应决定哪些剩余风险 应予以公开，并且需要将信息包括在随附文件中，以便公开那些剩余风险。（比方在说明书 增加警告信息等）Benefit-risk Analysis 风险/受益分析1.1.3.3 If a residual risk is not judged acceptable using the criteria established in the risk management plan and further risk c

41、ontrol is not practicable, the manufacturer may gather and review data and literature to determine if the benefits of the intended use outweigh this residual risk.如果使用风险管理计划中建立的标准，判定剩余风险是不可接受的，而进一步的风险控制又 不可行，风险管理团队可以收集、评审资料和文献，以确定预期使用的医疗受益是否超过剩 余风险。1.1.3.4 If this evidence does not support the concl

42、usion that the benefits outweigh this residual risk, then the manufacturer may consider modifying the medical device or its intended use. Otherwise, this risk remains unacceptable.如果该证据不支持受益大于剩余风险的结论，那么公司可能会考虑修改医疗设备或其预期用 途。1.1.3.5 If the benefits outweigh the residual risk, then proceed to 7.7.5. Th

43、e results of the benefit-risk analysis shall be recorded in the risk management file.如果医疗受益超过剩余风险，那么进行775。分析的风险/受益结果应记录于风险管理文档中。1.1.3.6 The regulatory group collects post-production information, clinical literature, and data from regulatory authorities, and analyze the type, size, probability and du

44、ration of device benefit. At the same time, the risk of device related serious injury/non-serious injury, complications, incidence probability of adverse events, duration and so on are evaluated. The size of risk and benefit can be obtained by combining the risk points, benefit points and the people

45、 expected to use them. Combined with the situation of risk points, benefit points and expected users, we can get the size of risks and benefits, and include them in the risk Management report.法规组收集上市后信息、临床文献、监管当局的数据，对器械受益的类型、大小、概率及持 续时间等方面对受益进行分析。同时对器械的风险所带来的相关严重伤害/非严重伤害、并 发症、不良事件发生概率、持续时间等以评估器械的风险。

46、结合风险点、受益点及预期使用 的人群的情况综合得出风险与受益的大小情况，并纳入至风险管理报告中。1.1.4 Risks arising from risk control measures 由风险控制措施产生的风险1.1.4.1 The manufacture shall review the effects of the risk control measures with regard to whether:公司应检查风险控制措施是否有以下影响： hazards or hazardous situations are introduced;是否引入新的危险（源）或危险情况； the est

47、imated risks for previously identified hazardous situations are affected by the introduction of the risk control measures.是否由于风险控制措施的实施，影响了先前确定的危险情况所估计的风险；Any new or increased risks shall be managed in accordance with 7.6 to 7.7.4. The results of this review shall be recorded in the risk management

48、file.在风险管理报告中，应在每一项风险控制措施后加入是否产生新的风险的评估。对于任何新 的或者增加的风险，应按照7.6至管理。评审的结果应记录于风险管理文档中。1.1.5 Completeness of risk control 风险控制的完整性The manufacturer shall review the risk control activities to ensure that the risks from all identified hazardous situations have been considered and all risk control activities are complete.公司应评审风险控制活动，确保已考虑到所有已识别危险情况的风险，并完成了所有风险控 制活动。审核结果应记录在风险管理文档中。7.8 Evaluation