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ISO 14971:2019 医疗器械 — 风险管理对医疗器械的应用 — 中...

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发表于 2020-5-11 14:07:54 | 显示全部楼层 |阅读模式
本文转载自“木之唐咨询”

Annex A
(informative)
Rationale for requirements

A.1General 总则
The ISO/TC 210 — IEC/SC 62A Joint Working Group 1 (JWG 1), Application of risk management to medical devices, developed this rationale to document its reasoning for establishing the various requirements contained in this document. Those who make future revisions can use this annex, along with experience gained in the use of this document, to make this document more useful to manufacturers, regulatory bodies and health care providers.

ISO / TC 210 — IEC / SC 62A,风险管理在医疗器械中的应用,联合工作组1(JWG 1)起草了这一要求的基本说明,以文件说明本标准中建立各种要求的理由。未来标准修订者可以使用本附件,结合使用标准时获得的经验,使本标准对制造商,监管机构和医疗卫生保健提供者更有用。

ISO Technical Committee 210 and IEC Subcommittee 62A decided to combine their efforts on risk management and to form JWG 1 with the task to develop a standard for the application of risk management to medical devices. When discussions on an International Standard for risk management began, crucial features of risk management needed to be addressed, such as the process of risk evaluation as well as the balancing of risks and benefits for medical devices. Manufacturers, regulatory bodies, and health care providers had recognised that “absolute safety” in medical devices was not achievable. In addition, the risks that derive from the increasing diversity of medical devices and their applications cannot be completely addressed through product safety standards. The recognition of these facts and the consequent need to manage risks from medical devices throughout their life cycle led to the decision to develop ISO 14971 as a tool to actively improve the safety of medical devices. The first edition of this standard was published in 2000.

ISO技术委员会210和IEC小组委员会62A决定将他们在风险管理方面的努力结合起来,并成立JWG 1,其任务是制定将风险管理应用于医疗器械的标准。当开始讨论有关风险管理的国际标准时,就需要解决风险管理的关键特征,例如风险评估过程以及医疗器械风险与收益的平衡。制造商,监管机构和医疗保健提供者已经认识到医疗器械的“绝对安全性”是无法实现的。此外,医疗产品及其应用日益多样化所带来的风险无法通过产品安全标准完全解决。对这些事实的认识以及随之而来的在医疗器械整个生命周期中管理风险的需求,导致决定开发ISO 14971作为积极提高医疗器械安全性的工具。该标准的第一版于2000年发布。

The second edition of ISO 14971 was developed and published in 2007 to address the need for additional guidance on its application and on the relationship between hazards and hazardous situations. Minor changes were made to the normative section, such as the addition of the requirement  to plan for post-production monitoring and the removal of the requirement for traceability from the   risk management report.

为阐述有关其应用的附加指南危害和危害处境的关系的需要编制和发布2007第二版的ISO 14971,以解决对其应用以及危害与危险状况之间的关系提供额外指导的需求。对正文部分作了较小的更改,如对计划增加了生产后监视的要求,并从风险管理报告中删除了可追溯性要求。

The systematic review in 2010 revealed the need for further guidance on a few specific topics. It was decided to develop the technical report ISO/TR 24971[9], because even a small update of the guidance would necessitate a revision of the standard. The first edition of this report was published in 2013.

关于未来一些特定主题的需求,在2010年进行了系统的评审, 决定制定ISO / TR 24971[9]技术报告,因为即使对指南进行很小的更改也需要对标准进行修订。该报告的第一版于2013年发布。

This third edition was developed to clarify the normative requirements and to describe them in more detail, in particular the clauses on the evaluation of overall residual risk, on  the  risk management review and report and on production and post-production information. The clarifications were deemed necessary in view of requests for explanation in the systematic review of ISO 14971 in 2016 and in view of stricter requirements from regulatory bodies. More emphasis was put on the benefits that are anticipated from the use of the medical device and the balance between the (overall) residual risks and those benefits. It was explained that the process described in ISO 14971 can be applied to all types of hazards and risks associated with a medical device, for example biocompatibility, data and systems security, electricity, moving parts, radiation or usability. Several informative annexes were moved from this document to the guidance in ISO/TR 24971, which was revised in parallel. This allows for more frequent updates of the guidance independent of revising the standard.

第三版的编制旨在阐明规范要求并对其进行更详细地描述,尤其是有关综合剩余风险评估,风险管理评审和报告以及生产及生产后信息的条款。鉴于2016年对ISO 14971进行系评审的解释要求以及监管机构提出的更严格要求,认为需要进行澄清。更加强调了使用医疗器械预期的收益以及(综合)剩余风险与收益之间的平衡。解释说,ISO 1497中描述的过程可以应用于与医疗器械相关的所有类型的危害和风险,例如生物相容性,数据和系统安全性,电力,运动零件,辐射或可用性。几个信息性附录已从本标准中移至ISO / TR 24971中的指南,该指南同时进行了修订。这样可以更频繁地更新指南,而不需要修改标准。
A.2 Rationale for requirements in particular clauses and subclauses
特定条款和小节中要求的理由
A.2.1 Scope 范围
As explained in the introduction to this document, a risk management standard applying to the life cycle
of medical devices is required. Software as a medical device and in vitro diagnostic medical devices are specifically mentioned in the scope to avoid any misunderstanding that, due to different regulations, these devices might be excluded from this document.

如本标准引言所述,需要一个能应用于医疗器械全生命周期的风险管理标准。在本标准范围内特别提到了作为医疗器械的软件和体外诊断医疗器械,以避免由于法规不同而可能将其排除与本标准之外的任何误解。

Risks can be present throughout the life cycle of the medical device, and risks that become apparent at one point in the life cycle can be managed by action taken at a completely different point in the life cycle. For this reason, the standard needs to be a complete life cycle standard. This means that the standard instructs manufacturers to apply risk management principles to a medical device from its initial conception until its ultimate decommissioning and disposal.

医疗器械的全生命周期均可引入风险,并且,在生命周期某一点上变为明显的风险,可在生命周期内完全不同的点上采取措施加以管理。因此,本标准有必要作为整个生命周期内的标准。这意味着该标准指导制造商从医疗器械的初始概念到最终的停用和处置,将风险管理原则应用于医疗器械。

The process described in ISO 14971 can be applied to hazards and risks associated with the medical device. Risks related to data and systems security are specifically mentioned in the scope, to avoid any misunderstanding that a separate process would be needed to manage security risks related to medical devices. This does not preclude the possibility of developing specific standards, in which specific methods and requirements are provided for the assessment and control of security risks. Such standards can be used in conjunction with ISO 14971, in a similar way as IEC 62366-1[13] for usability, ISO 10993-1[4] for biological evaluation, or IEC 60601-1[12] for electrical and mechanical risks.

ISO 14971中描述的过程可以应用于与医疗器械相关的危害和风险。范围中特别提到了与数据和系统安全性有关的风险,为避免任何误解,即需要单独的流程来管理与医疗器械有关的安全性风险。这并不排除制定特定标准的可能性,用特定方法和要求评估和控制安全风险。此类标准可以与ISO 14971结合使用,类似于IEC 62366-1 [13]可用性评估,ISO 10993-1 [4]生物学评估或IEC 60601-1 [12]电气和机械风险的。

The scope of this document does not include clinical decision making, i.e., decisions on the use of a medical device in the context of a particular clinical procedure. Such decisions require the residual risks to be balanced against the anticipated benefits of the procedure or the risks and anticipated benefits of alternative procedures. Such decisions take into account the intended use, performance and risks associated with the medical device as well as the risks and benefits associated with the clinical procedure or the circumstances of use. Some of these decisions can be made only by a qualified health care professional with knowledge of the state of health of an individual patient and the patient’s own opinion.

本标准的范围不包括临床决策,即在特定临床手术中使用医疗器械的决策。此类决策要求将剩余风险与该手术的预期收益或替代手术的风险与预期收益进行平衡。此类决策应考虑到医疗器械的预期用途,性能和风险以及与临床手术或使用环境有关的风险和利益,一些决策只能由有资质的医疗保健专业人员根据个体患者的健康状况和患者的个人意见做出。

The scope of this document also does not include business decision making. Other standards such as ISO 31000[10]  exist for organisational risk management and related topics.

本标准的范围同样不包括商业决策。如其他标准ISO 31000 [10],适用于组织风险管理相关主题。

Although there has been significant debate over what constitutes an acceptable level of risk, this document does not specify acceptability levels. Specifying a universal level for acceptable risk could be inappropriate. This decision is based upon the belief that:

虽然对可接受的风险水平存在很大的争议,但本标准不规定可接受性水平。为可接受的风险规定通用级别可能是不合适的。该决定基于以下信念:

the wide variety of medical devices and situations covered by this document would make a universal level for acceptable risk meaningless;

本标准所涵盖的医疗器械和情况的广泛多样性使通用的水平没有意义;

ocal laws, customs, values and perception of risk are more appropriate for defining risk acceptability for a particular culture or region of the world.

对于世界特定文化或地区,地方法律,习惯,价值观和风险认知定义风险的可接受性更合适。
Because not all countries require a quality management system for medical device manufacturers, a quality management system is not a requirement of this document. However, a quality management system is extremely helpful in managing risks properly. Because of this and because most medical device manufacturers do employ a quality management system, this document is constructed so that it can easily be incorporated into the quality management system that they use.

因为并非所有国家/地区都要求医疗器械制造商建立质量管理体系,所以质量管理体系并不是本标准的要求。然而质量管理体系对于适当地管理风险及其有帮助。因此,并由于大多数医疗器械制造商建立了质量管理体系,本标准的建构使其易于融入制造商所使用的质量管理体系中。

A.2.2 Normative references
规范性引用
No other standards are required in order to establish and maintain a risk management process in accordance with ISO 14971. Clause 15 of ISO/IEC Directives, Part 2:2018, requires standards to include this statement.

根据ISO 14971,无需其他标准即可建立和维护风险管理流程。ISO/ IEC指令第2部分:2018年的第15条要求标准中包括此声明。

A.2.3 Terms and definitions
术语和定义
Most of the definitions used in this document are taken from ISO 9000:2015[3] and ISO/IEC Guide 63:2019[2] which in turn adopted and adapted many of the definitions in ISO/IEC Guide 51:2014[1] and the definitions developed by the Global Harmonization Task Force (GHTF). Some of these definitions have a slightly different meaning in ISO/IEC Guide 63:2019[2] and ISO 14971 than in other standards.

本标准中使用的大多数定义均来自ISO 9000:2015 [3]和ISO / IEC指南63:2019[2]  ,依次采用并改编了ISO / IEC指南51:2014 [1]中的许多定义以及全球协调工作组( GHTF)。其中一些定义在ISO / IEC指南63:2019 [2]和ISO 14971中的含义与其他标准略有不同。

For example, JWG 1 intended the definition of harm (3.3) to have a broad range and to include unreasonable psychological  stress  or  unwanted  pregnancy  as  part  of  “damage  to  the  health of

people”. Such stress can occur after a false positive diagnosis of a disease. “Damage to property and the environment” is undesirable and the associated risks need to be considered as well, for example those related to hazardous waste materials created by the use or disposal of the medical device. The word “physical” is removed from the definition of harm in ISO/IEC Guide 51:2014[1] and thus also in ISO/IEC Guide 63:2019 [2] and this document, because injury by itself already includes physical damage. Breaches of data and systems security can lead to harm, e.g. through loss of data, uncontrolled access to data, corruption or loss of diagnostic information, or corruption of software leading to malfunction of the medical device.

例如,JWG 1打算对伤害(3.3)进行广泛的定义,并将不合理的心理压力或意外怀孕作为“损害人的健康”的一部分。在对疾病进行假阳性诊断后,可能会出现这种压力。应考虑“对财产和环境的损害”相关的风险,例如与因使用或处置医疗器械而产生的危险废物相关的风险。ISO / IEC指南51:2014 [1]中的伤害定义中删除了“物理”一词,因此ISO / IEC指南63:2019 [2]和本标准中也删除了“物理”一词,因为伤害本身已经包括在物理伤害中。违反数据和系统安全性可能导致损害,例如 通过数据丢失,对数据的不受控制的访问,损坏或诊断信息丢失或软件损坏导致医疗器械故障。

The definition of the term intended use (3.6) combines the definition of intended use as used in the United States and intended purpose which is the term in the European Union. These terms have essentially the same definition. It was intended that, when determining the intended use of a medical device, the manufacturer takes into account the intended medical indication, patient population, part of the body or tissue interacted with, user profile, use environment, and operating principle. The definition of life cycle (3.8) was necessary to make it clear that the term as used in this document covers all aspects of the existence of a medical device. The definition for risk management (3.24) emphasises the use of a systematic approach and the need for management oversight. The definition of top management (3.29) uses the definition from ISO 9000:2015[3]. It applies to the person or group at the highest level in the manufacturer’s organization.

“预期用途”(3.6)一词的定义合并了美国使用的 “预期用途”和欧盟中术语中的 “预期目的”。这些术语具有基本相同的定义。在确定医疗器械的预期用途时,制造商应考虑到预期的医疗器械的特征,患者人群,与之互动的身体或组织的一部分,用户资料,使用环境和操作原理。必须明确定义 “生命周期”(3.8),以便本标准中此术语涵盖医疗器械存在的所有方面。风险管理的定义(3.24)强调系统方法的使用和监督管理的的必要性。“最高管理者”(3.29)的定义采用ISO 9000:2015 [3]中的定义。它适用于制造商组织中最高级别的人员或小组。

Three other terms in ISO 14971 are not based on definitions in ISO/IEC Guide 63:2019[2] or in other standards. They are benefit (3.2), post-production (3.12) and risk management file (3.25). The term benefit is defined because of the increased emphasis by regulatory bodies on balancing the (residual) risks against the benefits of the medical device. For the same reason the phrase “benefit-risk analysis” is used. A definition of post-production was added to emphasise that the entire life cycle of the medical device is important for risk management. The concept of a risk management file is now well understood.

ISO 14971中的其他三个术语不是基于ISO / IEC指南63:2019 [2]或其他标准的定义。它们是 “受益”(3.2), “生产后”(3.12)和 “风险管理文档”(3.25)。定义受益是因为监管机构越来越重视平衡(剩余)风险与医疗器械的受益。出于同样的原因,使用了“收益风险分析”一词。增加“生产后”的定义,以强调风险管理对医疗器械全生命周期的重要性。风险管理文件的概念现已广为人知。

A.2.4 General requirements for risk management system
风险管理体系的一般要求
A.2.4.1 Risk management process
管理过程

The risk management system consists of the elements in 4.1 through 4.5.
风险管理系统由4.1至4.5中的元素组成。
The manufacturer needs to establish a risk management process as part of the design and development of a medical device. This is required so that the manufacturer can systematically ensure that the required elements are in the process. Risk analysis, risk evaluation and risk control are commonly recognised as essential parts of risk management. In addition to these elements, this document emphasises that the risk management process does not end with the design and production (including, as relevant, sterilization, packaging, and labelling) of a medical device, but continues on into the post-production phase. Therefore, the collection and review of production and post-production information was identified as a required part of the risk management process. Furthermore, it was felt that when a manufacturer employs a quality management system, the risk management process should be fully integrated into that quality management system.

制造商需要建立风险管理流程,作为医疗器械设计开发的一部分。这样要求可使制造商能够确保所有必要的要素都包含在过程之中。风险分析,风险评估和风险控制通常作为是风险管理的基本组成部分。除了这些要素之外,本标准还强调,风险管理过程不会以医疗器械的设计和生产(包括相关的灭菌,包装和标签)为结束,而是继续到后期生产阶段。因此,生产及生产后信息的收集和评审被定为风险管理过程的必要部分。此外,当制造商建立质量管理体系时,风险管理过程宜完整合到该质量管理体系中。

Although risk management activities are highly individual to the medical device being considered, there are basic elements that need to be included in the risk management process. This need is addressed in 4.1. This subclause also recognises that there can be some differences in regulatory approaches to applying risk management to medical devices.

尽管风险管理活动对于所考虑的医疗器械来说是高度个性化的,但风险管理过程中仍需要包含一些基本要素。4.1条款阐述了这一需求。本标准也认识到在将风险管理应用于医疗器械时,法规方面可能存在一些差异。

Subclauses 4.2 and 4.3 closely follow the risk-related requirements of quality management system standards. In some countries a quality management system is always required to market a medical device (unless the medical device is specifically exempted). In other countries manufacturers can choose whether to apply a quality management system. However, the requirements of 4.2 and 4.3 are always needed for an effective risk management process, whether or not the manufacturer operates all the other elements of a quality management system.

4.2和4.3很紧密遵循质量管理体系标准中与风险相关的要求。在某些国家总是要求医疗器械上市要建立质量管理体系(除非该医疗器械经过特别豁免的)。在其他国家,制造商可以选择是否应用质量管理体系。然而,4.2和4.3要求的要对于一个有效的风险管理过程总是必需的,不管制造商是否操作质量管理体系的所有其他要素。

A.2.4.2 Management responsibilities
管理职责
The commitment of top management is critical for an effective risk management process. These individuals are responsible for overall guidance of the risk management process and this subclause is intended to emphasise their role. In particular:

最高管理者的承诺对于有效的风险管理流程至关重要。最高管理者负责险管理过程的全面指导,本小节旨在强调他们的作用。特别是:

in the absence of adequate resources, risk management activities would be less effective, even if complying, to the letter, with the other requirements of this document;

—在缺乏足够资源的情况下,即使遵守本标准的其他要求,风险管理活动的有效性也会降低;

— risk management is a specialized discipline and requires the involvement of competent individuals trained in risk management techniques (see A.2.4.3);

—风险管理是专业化的学科,要求参与人员受过风险管理技术培训(见A.2.4.3);
— because this document does not define acceptable risk levels, top management is required to establish a policy on how acceptable risks will be determined;
由于本标准没有规定可接受的风险水平,最高管理者必须建立一个如何决策可接受风险的方针;

risk management is an evolving process and periodic review of the risk management activities is needed to ascertain whether they are being carried out correctly, to rectify any weaknesses, to implement improvements, and to adapt to changes.
风险管理是一个不断发展的过程,需要定期评审风险管理活动,以确定其是否正确实施,调整薄弱环节,实施改进并适应变化。

A.2.4.3 Competence of personnel
人员能力
It is most important to get competent people with the knowledge and experience necessary to perform risk management tasks. The risk management process requires people with knowledge and experience in areas such as:
最重要的是具备完成风险管理工作所需的专业知识和经验的人。风险管理过程要求人员具有下列领域的专业知识:

how the medical device is constructed;
how the medical device works;
how the medical device is produced;
how the medical device is actually used;
how to apply the risk management process.

医疗器械是如何构造的;
医疗器械是如何工作的;
医疗器械是如何生产的;
医疗器械的实际是如何使用的;
如何应用风险管理流程。

In general, this usually requires several representatives from various functions or disciplines, each contributing their specialist knowledge. The balance and relation between those representatives should be considered.

通常,这通常需要来自不同职能或学科的几个代表,每个人都贡献自己的专业知识。宜考虑代表之间的协作和关系。

Records are required to provide objective evidence of competence. In order to avoid duplication and because of confidentiality and data protection considerations, this document does not require these records to be kept in the risk management file.

需要记录以提供胜任力的客观证据。为了避免重复,并且出于机密性和数据保护的考虑,本标准不要求将这些记录保留在风险管理文件中。

A.2.4.4 Risk management plan
风险管理计划
A risk management plan is required because:
an organized approach is essential for good risk management;
the plan provides the roadmap for risk management;
the plan encourages objectivity and helps prevent essential elements being forgotten. The elements a) to g) of 4.4 are required for the following reasons.

需要风险管理计划,因为:
—有组织的方法对良好的风险管理至关重要;
—该计划提供了风险管理的路线图;
—该计划加强了客观性,并有助于防止遗漏基本要素。由于下列理由,4.4的元素a)至g 要素是需要的。

a)There are two distinct elements in the scope of the plan. The first identifies the medical device, the other identifies the phase of the life cycle for which each element of the plan is applicable. By defining the scope, the manufacturer establishes the baseline on which all the risk management activities are built.

在计划范围内有两个不同的要素。第一个是识别医疗器械,另一个识别计划的每个要素所覆盖的生命周期阶段。通过规定范围,制造商可以建立全部风险管理活动构建的基线。

b)Allocation of responsibilities and authorities is needed to ensure that no responsibility is omitted.
需要对责任和权限进行分配,以确保职责不被遗漏。

c)Review of activities such as risk management is included as a generally recognised responsibility of management.
诸如风险管理活动的评审,包括在通常认可的管理职责之中。

d)The criteria for risk acceptability are fundamental to risk management and should be decided upon
before risk analysis begins. This helps to make the risk evaluation in Clause 6 objective.
风险可接受性的标准是风险管理的基础,应确定在风险分析开始之前。这有助于使第6章中的风险评估更客观。

e)After implementing all risk control measures, the manufacturer is required to evaluate the overall impact of all residual risks together. The evaluation method and the criteria for acceptability of the overall residual risk should be decided upon before this evaluation is performed. This helps to make the evaluation of overall residual risk in Clause 8 objective.

实施所有风险控制措施之后,要求制造商共同评估所有剩余风险的总体影响。在执行此评估之前,应确定评估方法和总体剩余风险的可接受性标准。这有助于客观地评估第8章中的总体剩余风险。

f)Verification is an essential activity and is required by 7.2. Planning this activity helps to ensure that essential resources are available when required. If verification is not planned, important parts of the verification could be neglected.

验证是7.2要求的一项基本活动。计划此活动有助于确保获得必要的资源。如果验证没有策划,验证的重要部分可能被忽略。

g)Methods for the collection and review of production and post-production information need to be established so that there is a formal and appropriate way to feed back production and post- production information into the risk management process.

需建立收集和评审生产及生产后信息的方法,以便有正式和适当的途径将生产和后期生产信息反馈到风险管理流程中。

The requirement to keep a record of changes is to facilitate audit and review of the risk management process for a particular medical device.
对特定医疗器械,记录更改的要求有助于风险管理过程的审核和评审。

A.2.4.5 Risk management file
风险管理文档
This document uses this term to signify where the manufacturer can locate or find the locations of all the records and other documents applicable to risk management. This facilitates the risk management process and enables more efficient auditing to this document. Traceability is necessary to demonstrate that the risk management process has been applied to each identified hazard.

本标准使用这一术语旨在表明制造商可以查到或找到所有记录和适用于风险管理其他文件的出处。这有助于风险管理流程,并且能更有效的按本标准进行审核。为证明风险管理过程已应用于每个已识别的危害,可追溯性是必要的。

Completeness is very important in risk management. An incomplete task can mean that an identified hazard is not controlled and harm can be the consequence. The problem can result from incompleteness at any step in risk management, e.g. unidentified hazards, risks not assessed, unspecified risk control measures, risk control measures not implemented, or risk control measures that prove ineffective. Traceability is needed to ensure completeness of the risk management process.

在风险管理中,完整性非常重要。一个不完整的工作可能意味着一项已识别的危害未被控制,并且可能会造成伤害。问题可产生于风险管理中任何阶段的不完整,例如 未识别的危害,未评估的风险,未规定的风险控制措施,未实施的风险控制措施或证明无效的风险控制措施。追溯性可以确保风险管理过程的完整性。

A.2.5 Risk analysis
风险分析

A.2.5.1Risk analysis process
风险分析过程
Note 1 of 5.1 describes how to deal with the availability of a risk analysis for a similar medical device. When adequate information already exists, this information can be applied to save time, effort and resources. Users of this document need to be careful, however, to assess systematically the previous work for applicability to the current risk analysis.

5.1的注释1描述了如何处理相似医疗器械的风险分析的可用性。当有充分的信息时,可以应用此信息以节省时间,精力和资源。但是,本标准的使用者需要谨慎地系统地评估先前的工作对于当前风险分析工作的适宜性。

The details required by a), b), and c) form the basic minimum data set for ensuring traceability and are important for management reviews and for subsequent audits. The requirement in c) also helps clarify what is in the scope of the analysis and verifies completeness.

a),b)和c)的具体要求构成了明确可追溯性的一套基本的最少的资料,对于管理评审和后续审核非常重要。c)中的要求还有助于阐明分析范围内的内容并验证完整性。

A.2.5.2Intended use and reasonably foreseeable misuse
预期用途和合理可预见的误用

The intended use of the medical device is an important aspect and is the starting point of the risk analysis. This should include the elements listed in the note to 3.6, where appropriate. The manufacturer should also consider the intended user(s) of the medical device, e.g., whether a lay user or a trained medical professional will use the medical device. This analysis should consider that medical devices can also be used in situations other than those intended by the manufacturer and in situations other than those foreseen when the idea for a medical device was first conceived. It is important that the manufacturer tries to look into the future to see the hazards due to potential uses of their medical device and also the reasonably foreseeable misuse.

医疗器械的预期用途是一个重要方面,并且是风险分析的起点。在适当的情况下,这应包括3.6注释中列出的元素。制造商还应考虑医疗器械的预期用户,例如,非专业使用者或训练有素的医疗专业人员使用该医疗器械。该分析还应考虑医疗器械可能在不用于制造商所预期的情况下使用以及在最初构思时可预见的情况下使用。重要的是,制造商应着眼于未来,以了解由于其医疗器械潜在风险以及合理可预见的误用而造成的危害。

A.2.5.3 Identification of characteristics related to safety
识别与安全有关的特性

This step forces the manufacturer to think about all the characteristics that could affect the safety of the medical device. These characteristics can be qualitative or quantitative and can be related to the operating principle of the medical device, its intended use and/or the reasonably foreseeable misuse. Such characteristics can relate to the performance or operating principle of the medical device, the measuring function or the sterility of the medical device, the materials used for parts coming into contact with the patient, the use of radiation for diagnostic or therapeutic purposes, or other. Where applicable, the limits of those characteristics need to be considered as well, because the operation and/or safety of the medical device could be affected when those limits are exceeded.

此步骤迫使制造商考虑可能影响医疗器械安全性的所有特征。这些特征可以是定性的或定量的,并且可以与医疗器械的工作原理、其预期用途和/或合理可预见误用有关。此类特性可能与医疗器械的性能或工作原理,医疗器械的测量功能或无菌性,与患者接触的部位所使用的材料,用于诊断或治疗目的的辐射使用或其他相关 。在适用的情况下,还应考虑这些特性的限制,因为超过这些限制可能会影响医疗器械的操作和/或安全性。

A.2.5.4 Identification of hazards and hazardous situations
识别危害和危害处境
This step requires the manufacturer to be systematic in the identification of anticipated hazards in both normal and fault conditions. The identification should be based upon the intended use and reasonably foreseeable misuse identified in 5.2 and the characteristics related to safety identified in  5.3.

此步骤要求制造商系统地识别正常和故障条件下的预期危害。识别应基于5.2中确定的预期用途和合理可预见的误用以及5.3中确定的与安全有关的特性。

A risk can only be assessed and managed once a hazardous situation has been identified. Documenting the reasonably foreseeable sequences of events that can transform a hazard into a hazardous situation allows this to be done systematically. Annex C aims to assist manufacturers in identifying hazards and hazardous situations. Typical hazards are listed and the relationships between hazards, foreseeable sequences of events, hazardous situations and associated possible harm are demonstrated.

当危害处境被识别出才可能评估和管理风险。将能把危害转化为危害处境的合理可预见的事件序列形成文件,才能系统地进行评定和管理。列出典型的危害并论证危害、可预见的事件顺序、危险处境以及相关的可能危害之间的关系。

A.2.5.5 Risk estimation
风险估计
This is the final step of risk analysis. The difficulty of this step is that risk estimation is different for every hazardous situation that is under investigation as well as for every medical device. Therefore, this subclause was written generically. Because hazards can occur both when the medical device functions normally and when it malfunctions, one should look closely at both situations. In practice, both components of risk, probability of occurrence and severity of harm, should be analysed separately. When a manufacturer uses a systematic way of categorizing the severity levels or the probability of occurrence of harm, the categorization scheme should be defined and recorded in the risk management file. This enables the manufacturer to treat equivalent risks consistently and serves as evidence that the manufacturer has done so.

这是风险分析的最后一步。此步骤的难点在于对所研究的的每个危险情况以及每种医疗器械,风险估计是各不相同的,因此,本条款是通用的。由于在医疗器械正常运行和发生故障时都可能发生危害,因此应密切注意两种情况。在实践中,风险的两个组成部分风险、发生概率和伤害的严重程度应该分别进行分析。当制造商对严重程度或发生概率使用系统的方法进行分类时,应对分类方案加以规定,并其记录在风险管理文档中。这使制造商能够一致地处理等同的风险,并作为制造商已经如此处理的证据。

Some hazardous situations occur because of systematic faults or sequences of events. There is no consensus on how to calculate the probability of a systematic fault. Where the probability of occurrence of harm cannot be calculated, hazards still have to be addressed and listing resulting hazardous situations separately allows the manufacturer to focus on reducing the risks due to these hazardous situations.

一些危险情况的发生是因为系统性故障或事件序列。对应如何计算系统性故障概率没有一致的意见。当伤害的发生概率不能计算时,仍然必须对危害进行处理,并且单独列出导致的危害处境,使制造商关注由于这些危害处境造成的风险的降低。

Frequently, good quantitative data are not readily available, especially in development of an entirely new medical device or for security risks. The suggestion that risk estimation should be done only in a quantitative way has therefore been avoided.

通常,不易获得可靠的定量数据,特别是在开发全新的医疗器械或出于安全风险的情况下。因此,不再建议仅以定量的方式进行评估风险。

A.2.6 Risk evaluation
风险评估

Decisions have to be made about the acceptability of risk. Manufacturers can use the estimated risks and evaluate them using the criteria for risk acceptability defined in the risk management plan. They can investigate the risks to determine which ones need to be controlled. Clause 6 was carefully worded to allow the user of this document to avoid unnecessary work.

对风险的可接受性必须做出决定。制造商可以使用估计的风险,并使用风险管理计划中定义的风险可接受性标准对其进行评估。他们可以对风险进行调查以确定哪些风险需要控制。第6章已经认真的措辞,以使本标准的使用者避免不必要的工作。

A.2.7 Risk control
风险控制

A.2.7.1Risk control option analysis
风险控制方案分析

Often there will be more than one way to reduce a risk. There are three mechanisms listed, which are all standard risk reduction measures and are derived from ISO/IEC Guide 63:2019[2]. The priority order listed is important. This principle is found in several places, including IEC TR 60513[11] and local or regional regulations. Inherently safe design and manufacture is the first and most important option in the risk control option analysis, becausedesign solutions inherent to the characteristics of the medical device are likely to remain effective, whereas experience has shown that even well-designed guards and protective measures can fail or be violated and information for safety might not be followed. If practicable, the medical device should be designed and manufactured to be inherently safe. If this is not practicable, then protective measures such as barriers or alarms are appropriate. The third option is to provide information for safety such as a written warning or contra-indication. Training to users can be an important aspect of delivering information for safety. The manufacturer can consider to provide mandatory training for the intended users.

通常,减少降低风险的方法不止一种。有三种途径,都是降低风险措施标准,并且源自于ISO / IEC指南63:2019 [2]。列出的优先顺序很重要。可以在多个地方找到该原理,包括IEC TR 60513 [11]和地方或地区法规。固有安全的设计和制造是风险控制分析方案中的最初和最重要的选项,因为医疗器械特性固有的设计解决方案可能会保持有效,而经验表明,即使设计良好的防护装置和防护措施也可能失败或被违反,及不会遵循安全信息。如果可行,医疗器械的设计和制造应具有固有的安全性。如果这不可行,则应采用防护措施,例如屏障或警报。第三种选择是提供安全信息,例如书面警告或禁忌证。对用户的培训可能是传递安全信息的重要方面。制造商可以考虑为目标用户提供强制性培训。

The manufacturing process can contribute to risks, for example originating from contamination of components, residues of hazardous substances used in the process, or mix-up of parts. Such risks can be controlled by designing the manufacturing process to be inherently safe (e.g. eliminating hazardous substances or using separate production lines) or by applying protective measures (e.g. visual inspection steps in the process).

制造过程可能会带来风险,例如源自组件的污染,过程中使用的有害物质的残留或零件的混合。可以通过将生产过程设计为固有安全的方法(例如消除有害物质或使用单独的生产线)或采取保护措施(例如过程中的目视检查步骤)来控制此类风险。

It is recognised that one possible result of the risk control option analysis could be that there is no practicable way of reducing the risk to acceptable levels according to the pre-established criteria for risk acceptability. For example, it could be impractical to design a life-supporting medical device with such an acceptable residual risk. In this case, a benefit-risk analysis can be carried out as described in 7.4 to determine whether the benefit of the medical device, to the patient, outweighs the residual risk. This option is included at this point in the document to make sure that every effort was first made to reduce risks to the pre-established acceptable levels.

认识到风险控制方案分析的一种可能的结果是,根据事先建立的风险可接受性准则,没有可行的方法把风险降低到可接受水平,例如,设计一个具有可接受的剩余风险的生命支持用医疗器械可能是不实际的。在这种情况下,可以执行7.4中描述的风险/受益分析,以便决定医疗器械给予患者的受益是否超过剩余风险。为确保首先要尽一切可能的努力把风险降低至事先确定的可接受水平,在这一点上本标准包括了这一方案。

A.2.7.2 Implementation of risk control measures
风险控制措施的执行
Two distinct verifications are included. The first verification is required to make sure that the risk control measure has been implemented in the final design of the medical device or in the manufacturing process. The second verification is required to ensure that the risk control measure (including information for safety) as implemented actually reduces the risk. In some instances, a validation study can be used for verifying the effectiveness of the risk control measure.

包括两个不同的验证。要求第一种验证为了确认风险控制措施已在最终设计和制造过程中设施。要求第二种为确保所实施的风险控制措施(包括有关安全的信息)确实降低了风险。在某些情况下,确认研究可用于验证风险控制措施的有效性。

Obtaining sufficient data and information for risk estimation can be difficult, resulting in uncertainty of the residual risk evaluation. It can therefore be practical for the manufacturer to focus effort on verification of effectiveness of risk control measures to establish a convincing residual risk evaluation. Level of effort should be commensurate with the level of risk. Testing with users might be needed to verify the effectiveness of the risk controls, for example usability testing (see IEC 62366-1[13]), clinical investigation of medical devices (see ISO 141551)[6]) or clinical performance studies for in vitro diagnostic medical devices (see ISO 20916[8]). A usability test can verify effectiveness of information for safety and a test according to a test standard can verify effectiveness of designed risk control measures related to, for example, mechanical strength.

获取足够的数据和信息以进行风险估计可能有困难,从而导致剩余风险评估的不确定性。因此,制造商将通过验证风险控制措施的有效性,以证明剩余风险评估是可行。投入程度应与风险程度相适应。可能需要与用户进行测试以验证风险控制的有效性,例如可用性测试(请参见IEC 62366-1 [13]),医疗器械的临床研究(请参见ISO 141551)[6])或针对以下方面的临床性能研究:体外诊断医疗器械(请参阅ISO 20916 [8])。可用性测试可以验证安全性信息的有效性,而根据测试标准进行的测试可以验证如机械强度有关的设计风险控制措施的有效性。

A.2.7.3 Residual risk evaluation
剩余风险评估
A check was introduced here to determine whether the implemented risk control measures have made the risk acceptable. If the risk exceeds the acceptability criteria established in the risk management plan, the manufacturer is instructed to investigate additional risk control measures. This iterative procedure should be continued until further risk control is not practicable and the residual risk does not exceed the acceptability criteria established in the risk management plan.
在此引入一项检查,以确定已实施的风险控制措施是否使风险可以接受。如果风险超过了风险管理计划中确定的可接受标准,要求制造商调查其他风险控制措施。重复这一程序直至风险降低到风险管理计划中建立的接受准则。

A.2.7.4 Benefit-risk analysis
受益/风险分析
There can be particular hazardous situations for which the risk exceeds the manufacturer’s criteria for risk acceptability. This subclause enables the manufacturer to provide a high-risk medical device for which they have done a careful evaluation and can show that the benefit of the medical device   outweighs the risk. However, this subclause cannot be used to weigh residual risks against economic advantages or business advantages (i.e. for business decision making).

在某些特定的危险情况下,医疗器械的风险大于制造商的风险可接受性标准。此条款使制造商能够提供经过仔细评估的高风险医疗器械,并且可以证明医疗器械的受益高于风险。但是,本条款不能用来权衡剩余风险与经济利益或商业利益(即用于商业决策)的风险。

1) Under preparation. Stage at the time of publication ISO/FDIS 14155:2019.
ISO / FDIS 14155:2019发布时的阶段在准备之中。

A.2.7.5 Risks arising from risk control measures
风险控制措施产生的风险
This subclause recognises that risk control measures alone or in combination might introduce a new and sometimes quite different hazard, and that risk control measures introduced to reduce one risk might increase another risk.

此条认为单独或组合使用风险控制措施可能会带来新的,有时甚至完全不同的危害,而为降低一种风险而采取的风险控制措施可能会增加另一种风险。

A.2.7.6 Completeness of risk control
风险控制的完整性
At this point, the risks of all the hazardous situations should have been evaluated. This check was introduced to ensure that no hazardous situations were left out in the intricacies of a complex risk analysis.

在此阶段,宜完成对所有危害处境的风险的评估。进行此项检查是为了确错综复杂的风险分析中,没有遗漏认任何危害处境。

A.2.8 Evaluation of overall residual risk
综合剩余风险评估
During the process defined by Clauses 5 to 7, manufacturers identify hazards and hazardous situations, evaluate the risks, and implement risk control measures in their medical device design one at a time. This is the point where the manufacturer has to step back, consider the combined impact of all individual residual risks, and make a decision as to whether to proceed with the medical device. It is possible that the overall residual risk exceeds the manufacturer’s criteria for risk acceptability, even though individual residual risks do not. This is particularly true for complex systems and medical devices with a large number of risks. The method to evaluate the overall residual risk as defined in the risk management plan includes balancing the overall residual risk against the benefits of the medical device. This is particularly relevant in determining whether a high-risk, but highly beneficial, medical device should be marketed.

在第5章-第7章规定的过程中,制造商识别危害,并评估其危险处境,并在医疗器械设计中逐一实施风险控制措施。此时制造商必须返回,考虑所有单个剩余风险的综合影响,并决定是否继续进行该医疗器械。即使单个剩余风险没有,综合剩余风险有可能超过制造商的风险可接受性标准。这对于具有大量风险的复杂系统和医疗器械而言尤其如此。风险管理计划中定义的评估综合剩余风险的方法包括在综合剩余风险与医疗器械受益之间取得平衡。这对于制造商决定一个高风险且高收益的医疗器械是否宜上市尤为重要。

The manufacturer is responsible for providing users with relevant information on significant residual risks, so that they can make informed decisions on the use of the medical device. Thus, manufacturers are instructed to include pertinent information on residual risks in the accompanying documentation. However, it is the manufacturer’s decision as to what and how much information should be provided. This requirement is consistent with the approach taken in many countries and regions.

制造商负责向用户提供有关重大剩余风险的相关信息,以便他们可以就医疗器械的使用做出明智的决定。因此,制造商应在随附文档中包含有关剩余风险的相关信息。但是,由制造商决定应提供哪些信息以及应提供多少信息。该要求与许多国家和地区所采用的方法一致。

A.2.9 Risk management review
风险管理评审
The risk management review is an important step before the commercial release of the medical device. The final results of the risk management process, as obtained by executing the risk management plan, are reviewed. The risk management report contains the results of this review and is a crucial part of the risk management file. The report serves as the high-level document that provides evidence that the manufacturer has ensured that the risk management plan has been satisfactorily fulfilled and the results confirm that the required objective has been achieved. Subsequent reviews of the execution of the risk management plan and updates of the risk management report can be needed during the life cycle of the medical device, as a result of the execution of production and post-production activities.

风险管理评审是医疗器械上市之前的重要步骤。评审通过执行风险管理计划获得的风险管理过程的最终结果。风险管理报告包含此评审的结果,并且是风险管理文件的关键部分。报告作为高层次的文件提供了制造商已确保风险管理计划已经圆满的完成,并且风险管理过程的结果证实所要求的目标已经达到。作为生产和后期生产活动的结果,在医疗器械的生命周期中可能需要对风险管理计划的执行情况进行后续评审,并对风险管理报告进行更新。

A.2.10 Production and post-production activities
生产和后期生产活动

It cannot be emphasized too often that risk management does not stop when a medical device goes into production. Risk management often begins with an idea, before there is any physical manifestation of the medical device. Manufacturers collect information from many sources, including experience with similar medical devices and technologies. Risk estimation is refined throughout the design process and can be made more accurate when a functioning prototype is built. However, no amount of modelling can substitute for an actual medical device in the hands of actual users.

在医疗器械投入生产时,要特别经常地强调风险管理并未停止,通常风险管理是在医疗器械尚未实际显现的情况下从概念开始的。制造商从许多来源收集信息,包括类似的医疗器械和技术的经验。风险评估在整个设计过程中都会进行完善,并且在构建功能正常的原型时可以使其更加准确。但是,没有任何模型可以代替实际用户手中的实际医疗器械。

Therefore, the manufacturer needs to collect and review production and post-production information and evaluate its relevance to safety. The information can relate to new hazards or hazardous situations, and/or can affect their risk estimates or the balance between benefit and overall residual risk. Either can impact the manufacturer’s risk management decisions. The manufacturer should also take into account considerations of the generally acknowledged state of the art, including new or revised standards. When the information is determined to be relevant to safety, the risk management process requires that it be considered as an input for modification of the medical device, and also as an input to improve the process itself. With effective production and post-production activities, the risk management process truly becomes an iterative closed-loop process to ensure the continued safety of the medical device.

因此,制造商需要收集和评审生产及生产后信息,并评估其与安全性。该信息可能与新的危害和危害处境相关,和/或可能影响其风险估计或受益与综合剩余风险之间的平衡。两者都会影响制造商的风险管理决策。制造商还应考虑公认的最新技术水平,包括新的或修订的标准。当确定该信息与安全相关时,风险管理过程要求将其视为修改医疗器械的输入,并且还应将其视为改善其过程的输入。通过有效的生产及生产后活动,风险管理过程真正成为一个重复的循环的过程,以确保医疗器械的持续安全性。

In reply to feedback and requests for additional guidance and in response to changing regulatory requirements, the requirements for production and post-production activities are elaborated in more detail in this third edition. The clause is divided into subclauses. More sources of information are listed, including information on the generally acknowledged state of the art and feedback from the supply chain. The latter includes suppliers of components or subsystems, and also third-party software. The possible need for actions regarding medical devices already on the market is made more explicit. The conditions under which follow-up actions need to be considered, are extended with changes in the state of the art that can be relevant to safety, such as alternative medical devices and/or therapies becoming available on the market, as well as changes in risk perception or risk acceptability.

为了回应反馈和其他附加指导要求,及响应不断变化的法规要求,在第三版中对生产和生产后活动的要求进行了详细说明。该条款分为两节。列出了更多的信息来源,包括有关公认的最新技术信息和来自供应链的反馈。后者包括组件或子系统的供应商,以及第三方软件。明确了市场上已经存在的有关医疗器械的可能措施。随着最新技术水平的变化,可能需要考虑采取后续行动的条件,这些变化可能与安全相关,例如市场上的替代性医疗器械和/或疗法,以及风险感知或可接受风险

Annex B
(informative)

Risk management process for medical devices
医疗器械风险管理流程

B.1Correspondence between second and third editions
第二版和第三版之间的对应
The numbering of clauses and subclauses has changed with this third edition of ISO 14971. Table B.1 provides the correspondence between clauses and subclauses in the second edition ISO 14971:2007 and those in the third edition ISO 14971:2019. This table is provided to assist users of this document in transitioning from the second to the third edition and to facilitate updating of references to ISO 14971 in other documents.

在ISO 14971的此第三版中,条款和子条款的编号发生了变化。表B.1提供了第二版ISO 14971:2007和第三版ISO 14971:2019中条款和子条款之间的对应关系。提供此表是为了帮助本标准的用户从第二版过渡到第三版,并有助于更新其他文档中对ISO 14971的引用。

Table B.1 — Correspondence between elements of ISO 14971:2007 and ISO 14971:2019 ISO 14971:2007和ISO 14971:2019的要素之间的对应关系




B.2 Risk management process overview
风险管理过程概述

Figure B.1 is provided to give the user of this document an overview of the risk management process. It is for illustrative purposes only. As indicated in Figure B.1, the process needs to be iterative, covering each risk in turn, and returning to earlier steps if risk control measures introduce new hazards or hazardous situations, or if new information becomes available.
提供图B.1是为了给本标准的用户提供风险管理过程的概述。它仅用于说明目的。如图B.1所示,该过程必须是迭代的,依次覆盖每个风险,如果风险控制措施引入了新的危险或危险情况,或者有新的信息可用,则返回到先前的步骤。



Figure B.1 — Overview of risk management activities as applied to medical devices
适用于医疗器械的风险管理活动概述

Annex C
(informative)

Fundamental risk concepts
基本风险概念

C.1 General 总则
This document requires the manufacturer to compile a list of known and foreseeable hazards associated with the medical device in both normal and fault conditions and to consider the foreseeable sequences of events that can produce hazardous situations and harm. According to the definitions, a hazard cannot result in harm until such time as a sequence of events or other circumstances (including normal use) lead to a hazardous situation. At this point, the risk can be assessed by estimating both severity and probability of occurrence of harm that could result (see Figure C.1). The probability of occurrence of harm can be expressed as a combination of separate probabilities (P1, P2) or as a single probability (P). A decomposition into P1 and P2 is not mandatory.

该文件要求制造商编制一份在正常和故障情况下与医疗器械相关的已知和可预见危险的清单,并考虑可导致危险情况和伤害的可预见事件顺序。根据定义,在一系列事件或其他情况(包括正常使用)导致危险情况发生之前,危险不会导致伤害。在这一点上,可以通过估计严重性和可能造成伤害的可能性来评估风险(见图C.1)。伤害发生的概率可以表示为单独概率(P1,P2)的组合,也可以表示为单个概率(P)。分解为P1和P2不是强制性的。

Probabilities (P1, P2) or as a single probability (P).
A decomposition into P1 and P2 is not mandatory.


NOTE 1Depending on the complexity of the medical device, a hazard can lead to multiple hazardous situations, and each hazardous situation can lead to multiple harms.

注1 根据医疗器械的复杂程度,危害可能导致多种危害处境,每种危害处境都可能导致多种伤害。

NOTE 2The probability of occurrence of harm (P) can be composed of separate P1 and P2   values.

注2 伤害发生的概率(P)可以由单独的P1和P2值组成。

NOTE 3The thin arrows represent elements of risk analysis and the thick arrows depict how a hazard
can lead to harm

注3 细箭头表示风险分析的元素,粗箭头表示危险的程度可能导致伤害

Figure C.1 — Pictorial example of the relationship between hazard, sequence of events,
hazardous situation and harm (from ISO/IEC Guide 63:2019[2])

图C.1 —危害,事件顺序,危险情况和危害(摘自ISO / IEC指南63:2019 [2])

A good starting point for this compilation is  a  review  of  experience  with  the  same  and  similar types of medical devices. The review should take into account a manufacturer’s own experience and, where appropriate, the experience of other manufacturers as reported in adverse event databases, publications, scientific literature and other available sources. This type of review is particularly useful for the identification and listing of typical hazards and hazardous situations for a medical device and the associated harm that can occur. Next, this listing and aids such as the list of examples in Table C.1 can be used to compile an initial list of hazards.

此汇编的一个很好的起点是回顾相同和相似类型的医疗器械的经验。评审应考虑制造商自身的经验,适当时,应考虑不良事件数据库,出版物,科学文献和其他可用资源中报告的其他制造商的经验。这种类型的检查对于识别和列出医疗器械的典型危害和危险情况以及可能发生的相关危害特别有用。接下来,该清单和辅助工具(如表C.1中的示例清单)可用于编制危险的初始清单。

It is then possible to begin identification of some of the sequences of events that together with hazards could result in hazardous situations and harm. Since many hazards might never result in harm and can be eliminated from further consideration, it could be useful to perform this analysis by starting with the harm that the medical device might cause and work backwards to the hazardous situations, hazards and initiating causes. However, although this approach is useful for the reason described, it should be recognised that it is not a thorough analysis. Many sequences of events will only be identified by the systematic use of risk analysis techniques (such as those described in ISO/TR 24971[9]). Analysis and identification are further complicated by the many events and circumstances that have to be taken into consideration such as those listed in Table C.2. Thus, more than one risk analysis technique, and especially complementary techniques, are often used to complete a comprehensive analysis. Table C.3 provides examples of the relationship between hazards, sequences of events, hazardous situations, and harm.

识别某些事件序列,以及这些事件序列与危害可能导致危害情况和伤害。由于许多危害可能永远不会造成伤害,而且可以不再考虑,因此从医疗器械可能造成的危害开始进行分析,并将其推向危害处境,危害和始发原因,尽管上述方法有用,但应该认识到,这不是一个全面的分析。只有通过系统地使用风险分析技术(例如,ISO / TR 24971 [9]中所述的那些技术),才能识别出许多事件序列。由于必须考虑许多事件和情况,例如表C.2中列出的事件和情况,使得分析和识别更加复杂。因此,经常使用一种以上的风险分析技术,尤其是补充技术来完成全面的分析。表C.3提供了危害,事件顺序,危害情况和危害之间处境关系的示例。

Although compilation of the lists  of  hazards,  hazardous  situations  and  sequences of events should be completed as early as possible in the design and development process to facilitate risk control, in practice identification and compilation is an ongoing activity that continues throughout the life cycle of the medical device through post-production to disposal.

尽管在设计和开发过程中尽早完成危害,危险情况和事件顺序清单的编制,以促进风险控制,但在实践中,识别和编制清单是一项持续不断的活动,贯穿整个医疗器械的生命周期从生产后到处置。

This annex provides a non-exhaustive list of possible hazards that can be associated with different medical devices (Table C.1) and a list of events and circumstances (Table C.2) that can result in hazardous situations, which can result in harm. Table C.3 provides examples in a logical progression of how a hazard can be transformed into a hazardous situation and produce harm by a sequence of events or circumstances.

本附件提供了一份可能与不同医疗设备有关的危险的非详尽清单(表C.1)和一份可能导致危险情况的事件和情况的清单(表C.2),这种情况可能导致伤害。表C.3按逻辑顺序提供了一些例子,说明危害如何转变成危险处境,并由一系列事件或情况产生危害。

Recognising how hazards  progress  to  hazardous  situations  is  critical for  estimating the  probability of occurrence and severity of harm that could result. An objective of the process is to compile a comprehensive set of hazardous situations. The identification of hazards and sequences of events are stepping stones to achieve this. The lists in the tables in this annex can be used to aid in the identification of hazardous situations. What is called a hazard needs to be determined by the manufacturer to suit the particular analysis.

认识到危险如何发展到危险情况对于估计发生的可能性和可能造成的危害的严重性至关重要。该过程的目标是收集一系列危险情况。识别危害和事件顺序是实现这一目标的垫脚石。本附件表格中的列表可用于帮助识别危险情况。制造商需要确定所谓的危害以适合特定的分析。

C.2Examples of hazards
危害示例
The list in Table C.1 can be used to assist in the identification of hazards associated with a particular
medical device, which could ultimately result in harm.
表C.1中的列表可用于帮助识别与特定危险相关的危害医疗器械,最终可能导致伤害。

Table C.1 — Examples of hazards
危害示例


C.3 Examples of events and circumstances
事件和环境示例
In order to identify foreseeable sequences of events, it is often useful to consider events and circumstances that can cause them. Table C.2 provides examples of events and circumstances, organized into general categories. Although the list is certainly not exhaustive, it is intended to demonstrate the many different types of events and circumstances that need to be taken into account to identify the foreseeable sequences of events for a medical device.

为了识别可预见的事件序列,通常考虑可能导致其发生的事件和环境。表C.2提供了事件和情况的示例,分为一般类别。尽管该列表并不详尽,但它旨在演示识别医疗器械的可预见事件序列时需要考虑的许多不同类型的事件和情况。

Table C.2 — Examples of events and circumstances
事件和环境示例




Table C.2 (continued)


C.4 Examples of relationships between hazards, foreseeable sequences of events, hazardous situations and the harm that can occur.
危害,可预见的事件顺序,危害状况和可能发生的伤害之间的关系示例

Table C.3 illustrates the relationship between hazards, foreseeable sequences of events, hazardous situations and harm for some simplified examples. Remember that one hazard can result in more than one harm and that more than one sequence of events can give rise to a hazardous situation.

表C.3说明了一些简化示例中的危害,可预见的事件顺序,危害处境和伤害之间的关系。值得注意的是,一个危害可能导致一个以上的伤害,而一个以上的事件序列可能导致危害处境的情况。

The decision on what constitutes a hazardous situation needs to be made to suit the particular analysis being carried out. In some circumstances it can be useful to describe a cover being left off a high voltage terminal as a hazardous situation, in other circumstances the hazardous situation can be more usefully described as when a person is in contact with the high voltage terminal.

为适合正在进行的特定的分析,需要做出什么构成危害处境的决策。在某些情况下,在其他情况下,可以将一个人接触高电压端子描述为危害处境。

Table C.3 — Relationship between hazards, foreseeable sequences of events, hazardous situations and the harm that can occur
危害之间的关系,可预见的事件顺序,危险情况以及可能发生的危害



Bibliography 参考文献

[1]ISO/IEC Guide 51:2014, Safety aspects — Guidelines for their inclusion in standards
ISO / IEC指南51:2014,安全方面-纳入标准的指南
[2]ISO/IEC Guide 63:2019, Guide to the development and inclusion of aspects of safety in international standards for medical devices
ISO / IEC指南63:2019,安全性方面的开发和纳入医疗器械国际标准的指南
[3]ISO 9000:2015, Quality management systems — Fundamentals and vocabulary
ISO 9000:2015,质量管理体系-基本原理和词汇
[4]ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
ISO 10993-1,医疗器械的生物评估-第1部分:风险管理过程中的评估和测试
[5]ISO 13485:2016, Medical devices — Quality management systems — Requirements for   regulatory purposes
ISO 13485:2016,医疗器械-质量管理体系-法规要求
[6]ISO 14155, Clinical investigation of medical devices for human subjects — Good clinical practice
ISO 14155,人体医疗器械的临床研究-良好的临床实践
[7]ISO 18113-1:2009, In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements
ISO 18113-1:2009,体外诊断医疗器械-制造商提供的信息(标签)-第1部分:术语,定义和一般要求
[8]ISO 20916, In vitro diagnostic medical devices — Clinical performance studies using specimens from human subjects — Good study practice
ISO 20916,体外诊断医疗器械-使用人类受试者的标本进行临床性能研究-良好的研究实践
[9]ISO/TR 24971, Medical devices — Guidance on the application of ISO 14971
ISO / TR 24971,医疗器械-ISO 14971应用指南
[10]ISO 31000, Risk management — Guidelines
ISO 31000,风险管理-准则
[11]IEC/TR 60513, Fundamental aspects of safety standards for medical electrical equipment
IEC / TR 60513,医用电气设备安全标准的基本方面
[12]IEC 60601-1, Medical electrical equipment — Part 1: General requirements for basic safety and essential performance IEC 60601-1,医疗电气设备-第1部分:基本安全性和基本性能的一般要求
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