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ISO 14971:2019 风险管理的应用

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发表于 2020-7-2 14:15:23 | 显示全部楼层 |阅读模式

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在过去的2019年,医械行业发生了巨大的变化,欧盟对MDR的推行,国家局加大飞检的力度,ISO国际标准化组织发布了新的风险管理,作为医械人的我们应该怎样应对这些变化,小编认为是学习,不断优化调整自身的技术知识。


ISO14971:2019版对风险管理提出了更高更具体的要求,姐妹篇ISO/TR24971也在同步修订,会有更详细的指导方法,预计2020年发布。木之唐将时刻关注,和大家一起学习,不负韶华!


以下是我们在学习过程中对ISO14971:2019的翻译,供大家参考。欢迎交流。感谢各位朋友的支持!


Medical devices — Application of riskmanagement to medical devices

医疗器械—风险管理对医疗器械的应用


Foreword 前言


ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.

ISO(国际标准化组织)是国家标准机构(ISO 成员机构)的全球联合会。制定国际标准的工作通常是通过 ISO 技术委员会来进行的。对建立 了技术委员会的主题感兴趣的每个成员机构均有权代表该委员会。与 ISO 联络的国际组织,政府和非政府国际组织也参加了这项工作。在电子技术标准化的所有问题上,ISO 与国际电子技术委员会(IEC)紧密合作。

The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see w w w.iso.org/directives).

ISO / IEC 指令第 1 部分中描述了本标准的过程以及打算进一 步维护的过程。特别是,应注意不同类型的 ISO 文档所需的不同批准标准。本标准按照 ISO/IEC的编辑规则起草,第 2 部分(请参阅www.iso.org/patents)。

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see w w w.iso.org/patents).

请注意,本标准的某些内容可能涉及到专利权。ISO 不承担识别任何或所有此类专利权的责任。本标准所设计的的任何专利权的详细信息将在导言中和/或ISO收到的专利声明清单中(请参阅www.iso.org/patents)。

Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.
本标准中使用的任何商标名称都是为方便用户理解本标准而提供的信息,并不是对其商品的认可。

For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISO's adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see w w w.iso.org/ iso/foreword.html.

有关标准的自愿性质的解释,与合格评定有关的 ISO 特定术语和表达的含义,以及有关 ISO 遵守《技术性贸易壁垒(TBT)中的世界贸易组织(WTO)原则》的信息,请访问 w w w.iso.org/ iso/foreword.html.

This document was prepared by Technical Committee ISO/TC 210, Quality management and corresponding general aspects for medical devices, and IEC/SC 62A, Common aspects of electrical equipment used in medical practice.
本文档由 ISO / TC 210 技术委员会(医疗设备的质量管理和相应的一般方面)和 IEC / SC 62A(医疗实践中使用的电气设备的常见方面)编写。

This third edition cancels and replaces the second edition (ISO 14971:2007), which has been technically revised. The main changes compared to the previous edition are as follows:
第三版取消并替代了经过技术修订的第二版(ISO 14971:2007)。与 上一版本相比的主要变化如下:

— A clause on normative references has been included, in order to respect the requirements for fixed in Clause 15 of ISO/IEC Directives, Part 2:2018.
— 为了遵守 ISO / IEC 指令第 2 部分 2018 年第 15 条中规定的要求, 已包含有关规范性引用的条款

— The defined terms are updated and many are derived from ISO/IEC Guide 63:2019. Defined terms are printed in italic to assist the reader in identifying them in the body of the document.
— 定义的术语已更新,其中许多术语源自 ISO / IEC 指南 63:2019。定义的术语以斜体显示,以帮助读者在本标准的正文中进行识别。

— Definitions of benefit, reasonably foreseeable misuse and state of the art have been introduced.
— 介绍了受益,合理可预见的误用和现有技术水平的定义。

— More attention is given to the benefits that are expected from the use of the medical device. The term
benefit-risk analysis has been aligned with terminology used in some regulations.
— 更加关注使用医疗设备所带来的受益。术语“ 受益 - 风险分析”已 与某些法规中使用的术语保持一致。

— It is explained that the process described in ISO 14971 can be used for managing risks associated
with medical devices, including those related to data and systems security.
— 介绍了 ISO 14971 中描述的过程可用于管理医疗器械相关的风险, 包括与数据和系统安全性相关的风险。

— The method for the evaluation of the overall residual risk and the criteria for its acceptability are required to be defined in the risk management plan. The method can include gathering and reviewing data and literature for the medical device and for similar medical devices and similar other products on the market. The criteria for the acceptability of the overall residual risk can be different from the criteria for acceptability of individual risks.

— 要求在风险管理计划中定义评估总体剩余风险的方法及其可接受性的标准。该方法可以包括收集和评估市场上同类产品以及同类的其他产品的文献和数据。总体剩余风险的可接受性标准可以不同于单个风险的可接受性标准。

— The requirements to disclose residual risks have been moved and merged into one requirement, after the overall residual risk has been evaluated and judged acceptable.
— 要求关于评估并判定总体剩余风险为可接受之后,剩余风被控制并合并为一项要求。

— The review before commercial distribution of the medical device concerns the execution of the risk management plan. The results of the review are documented as the risk management report.
— 医疗器械销售前应评审所执行风险管理计划,其评审结果应记录与风险管理报告中。

— The requirements for production and post-production activities have been clarified and restructured. More detail is given on the information to be collected and the actions to be taken when the collected information has been reviewed and determined to be relevant to safety
— 对生产和生产后活动的要求进行阐明和调整。当评审和判定医疗器械的安全性需要收集更多的信息及采取更多的控制活动。

— Several informative annexes are moved to the guidance in ISO/TR 24971, which has been revised in parallel. More information and a rationale for the requirements in this third edition of ISO 14971 have been provided in Annex A. The correspondence between the clauses of the second edition and those of this third edition is given in Annex B.

— 将一些资料性附录移至ISO / TR 24971 指南中进行合并。附件 A 中提供了更多有关该 ISO 14971 第三版要求的信息和理由。附件 B 中给出了第二版和第三版的对应关系。

Any feedback or questions on this document should be directed to the user’s national standards body. A complete listing of these bodies can be found at w w w.iso.org/members.html.
对本标准的任何反馈或问题应直接发送给该用户的国家标准机构。这些机构的完整列表,可在以下网址查询w w w.iso.org/members.html

Introduction介绍

The requirements contained in this document provide manufacturers with a framework within which experience, insight and judgment are applied systematically to manage the risks associated with the use of medical devices.
本文档中包含的要求为制造商提供了一个框架,在该框架内可以系统地应用经验,见解和判断来管理与使用医疗设备相关的风险

This document was developed specifically for manufacturers of medical devices on the basis of established principles of risk management that have evolved over many years. This document could be used as guidance in developing and maintaining a risk management process for other products that are not necessarily medical devices in some jurisdictions and for suppliers and other parties involved in the medical device life cycle.

本标准为医疗器械制造商基于风险建立的准则,
本标准专门开发的厂家的医疗器械的既定原则的基础上,风险管理 已经发展了很多年。在某些辖区中不一定是医疗器械的其他产品以及医疗器械生命周期中涉及的供应商和其他各方,本文档可以用作开发和维 护风险管理过程的指南。

This document deals with processes for managing risks associated with medical devices. Risks can be related to injury, not only to the patient, but also to the user and other persons. Risks can also be related to damage to property (for example objects, data, other equipment) or the environment.
本标准是对医疗器械相关的风险管理的过程。风险可能与伤害有关,不仅与患者有关,而且与使用者和其他人员有关,风险也可能与财产(例如物体,数据,其他设备)或环境的损坏有关。

Risk management is a complex subject because each stakeholder can place a different value on the acceptability of risks in relation to the anticipated benefits. The concepts of risk management are particularly important in relation to medical devices because of the variety of stakeholders including medical practitioners, the organizations providing health care, governments, industry, patients and members of the public.

风险管理是一个复杂的主题,因为每个利益相关者对于预期收益的风险可接受性赋予不同的评价值。医疗器械的风险管理概念特别重要,因为涉及各种利益相关者,包括执业医生,提供医疗保健的组织,政府,行业,患者和公众。

It is generally accepted that the concept of risk has two key components:
通常风险的概念包含两个关键组成部分

— the probability of occurrence of harm; and
— 发生损害的可能性;

— the consequences of that harm, that is, how severe it might be.
— 这种损害的后果,即损害的严重程度。

All stakeholders need to understand that the use of a medical device involves an inherent degree of risk, even after the risks have been reduced to an acceptable level. It is well known that in the context of a clinical procedure some residual risks remain. The acceptability of a risk to a stakeholder is influenced by the key components listed above and by the stakeholder’s perception of the risk and the benefit. Each stakeholder’s perception can vary depending upon their cultural background, the socio-economic and educational background of the society concerned and the actual and perceived state of health of the patient. The way a risk is perceived also takes into account other factors, for example, whether exposure to the hazard or hazardous situation seems to be involuntary, avoidable, from a man-made source, due to negligence, arising from a poorly understood cause, or directed at a vulnerable group within society.

所有利益相关者都需要了解,即使将风险降低到可接受的水平,使用医疗器械也会带来固有的风险。众所周知,在临床过程中仍然存在一些残留风险。利益相关者对风险的接受标准会受到上面列出的关键组成部分的风险可接受性及利益相关者自身对风险和受益的认知的影响。每个利益相关者的认知可能会 因其文化背景,社会经济和教育背景以及患者的实际情况和感知的健康状况而异。感知风险的方式还考虑了其他因素,例如,由于疏忽,理解不充分导致的对社会中的弱势群体暴露于危害和危害处境中,是非自愿的,可避免的,人为的。

As one of the stakeholders, the manufacturer reduces risks and makes judgments relating to the safety of a medical device, including the acceptability of residual risks. The manufacturer takes into account the generally acknowledged state of the art, in order to determine the suitability of a medical device to be placed on the market for its intended use. This document specifies a process through which the manufacturer of a medical device can identify hazards associated with the medical device, estimate and evaluate the risks associated with these hazards, control these risks, and monitor the effectiveness of the controls throughout the life cycle of the medical device.

作为利益相关者之一,制造商可以降低风险并做出与医疗器械安全性有关的判断,包括可接受的剩余风险。制造商考虑到普遍认可的最新技术水平,以确定要投放市场的医疗器械是否适合其预期用途。本标准是规定医疗设备的制造商可以通过该过程识别与医疗器械的相关危害,估算和评估与这些危害相关的风险,控制这些风险,并在医疗的整个生命周期中监视医疗器械控制有效性的一个过程。

The decision to use a medical device in the context of a particular clinical procedure requires the residual risks to be balanced against the anticipated benefits of the procedure. Such decisions are beyond the scope of this document and take into account the intended use, the circumstances of use, the performance and risks associated with the medical device, as well as the risks and benefits associated with the clinical procedure. Some of these decisions can be made only by a qualified medical practitioner with knowledge of the state of health of an individual patient or the patient’s own opinion.

在特定的临床程序中使用医疗器械的决定要求将剩余风险与该程序的预期收益进行权衡。此类决定超出了本标准的范围,考虑了预期用途,使用环境,与医疗设备相关的性能和风险以及与临床程序相关的风险和收益, 这些决定中的某些决定只能由合格的医生根据个体患者的健康状况或患者的个人意见做出。

For any particular medical device, other standards or regulations could require the application of specific methods for managing risk. In those cases, it is necessary to also follow the requirements  outlined in those documents.
对于任何特定的医疗设备,其他标准或法规可能要求应用特定的方法来管理风险。在这些情况下,必须遵循这些文档中概述的要求。

The  verbal  forms  used  in  this  document  conform  to  the  usage  described  in  Clause  7  of  the   ISO/
IEC Directives, Part 2:2018. For the purposes of this document, the auxiliary verb:
本标准中使用的语言形式符合ISO /IEC指令,第2部分2018第7条。本标准中的辅助动词:
— “shall” means that compliance with a requirement or a test is mandatory for compliance with this
document;
“应”是指必须遵守要求或测试才能遵守本文件;
— “should” means that compliance with a requirement or a test is recommended but is not mandatory for compliance with this document;
“宜”是指建议符合要求或测试,但并非必须遵守本文档;
— “may” is used to describe permission (e.g. a permissible way to achieve compliance with a requirement or test);
“可以”用于描述许可(例如,达到对要求或测试的遵守的允许方式);
— “can” is used to express possibility and capability; and
“能”用来表达可能性和能力;和
—    “must” is used to express an external constraint that is not a requirement of the document.
“必须”用于表示不是文档要求的外部约束。

1 Scope

范围

This document specifies terminology, principlesand a process for risk management of medical devices, including software as amedical device and in vitro diagnostic medical devices. The process describedin this document intends to assist manufacturers of medical devices to identify the hazards associated with the medical device, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.


本标准规定医疗器械风险管理的术语,原则和过程,包括作为医疗器械的软件和体外诊断试剂。本标准中的过程描述指帮助医疗器械制造商识别医疗器械的相关危害,以估计和评估相关的风险,并控制这些风险和监视控制的有效性。


The requirements of this document areapplicable to all phases of the life cycle of a medical device. The process described in this document applies to risks associated with a medical device,such as risks related to biocompatibility, data and systems security,electricity, moving parts, radiation, and usability.


本标准要求适用于医疗器械生命周期的所有阶段。本标准中描述的过程适用于医疗器械相关的风险,如风险相关的生物相容性,数据和系统安全,电力,组件,辐射,和可用性。


The process described in this document canalso be applied to products that are not necessarily medical devices in some jurisdictions and can also be used by others involved in the medical devicelife cycle.

本标准中描述的过程还可以应用于在某些辖区中不一定是医疗设备的产品,并且也可以应用于医疗器械生命周期涉及的其他产品。


This document does not apply to:

本标准不适用于:


—  decisions on the use of a medical device in the context of anyparticular clinical procedure; or

在任何特定的临床手术中使用医疗器械的决定


—   business risk management.

商业风险管理


This document requires manufacturers to establish objective criteria for risk acceptability but does not specify acceptable risklevels.

本标准要求制造商建立风险可接受性的客观标准,但未规定可接受的风险级别。


Risk management can be an integral part ofa quality management system. However, this document does not require the manufacturer to have a quality management system in place.

风险管理是质量管理体系的必不可少的一部分,但是,本标准不要求制造商必须建立质量管理体系。


NOTE Guidance on the application of thisdocument can be found in ISO/TR 24971[9].

注:本标准的应用指南参见 ISO / TR 24971 [ 9 ]。


2  Normativereferences

规范性引用文件

There are no normative references in thisdocument.

本文档中没有规范性引用。


3  Termsand definitions

术语和定义

For the purposes of this document, the following terms and definitions  apply.

本标准中以下术语和定义适用。


ISO and IEC maintain terminological databases for use in standardization at the following  addresses:

ISO 和 IEC 在以下地址维护用于标准化的术语数据库


—   ISO Online browsing platform: available at https:// w w w.iso.org/obp

ISO 在线浏览平台:https://www.iso.org/obp

—   IECElectropedia: available at http:// w w w.electropedia.org/


3.1  accompanying documentation

随附文件

materials accompanying a medical device(3.10) and containing information for the user or those accountable for theinstallation, use, maintenance, decommissioning and disposal of the medicaldevice (3.10), particularly regarding safe use

伴随着材料的医疗装置(3.10),并包含用于所述用户或安装、使用、维护、退役和处置人员信息(3.10),特别是关于安全使用的信息。


Note 1 to entry: The accompanying documentation can consist of the instructions for use, technical description,installation manual, quick reference guide, etc.

注1:随附的文档可以包括使用说明书,技术说明,安装手册,快 速参考指南等。


Note 2 to entry: Accompanying documentationis not necessarily a written or printed document but could involve auditory,visual, or tactile materials and multiple media types.

注2:随附文件不一定是书面或印刷文件,但可以是听觉、视觉或触觉材料和多种媒体类型。


3.2 Benefit

受益

positive impact or desirable outcome of theuse of a medical device (3.10) on the health of an individual, or a positiveimpact on patient management or public health

医疗器械的使用(3.10)对个人健康的积极影响或理想结果,或对患者管理或公共健康的积极影响。


Note 1 to entry: Benefits can includepositive impact on clinical outcome, the patient’s quality of life, outcomesrelated to diagnosis, positive impact from diagnostic devices on clinicaloutcomes, or positive impact on public health.

注释1:收益可包括对临床结果的积极影响,患者的生活质量,与诊断相关的结果,诊断设备对临床结果的积极影响或对公共健康的积极影响。


3.3 Harm

损害

injury or damage to the health of people,or damage to property or the environment

[SOURCE来源: ISO/IEC Guide 63:2019, 3.1]

伤害或损害人类健康,或损害财产或环境


3.4 Hazard

危险(源)

potential source of harm (3.3)

可能导致伤害的潜在的根源

[SOURCE来源: ISO/IEC Guide 63:2019, 3.2]


3.5 hazardous situation

危险情况

circumstance in which people, property or the environment is/are exposed to one or more hazards (3.4)

人员、财产或环境暴露于一个或多个危害中的情形。


Note 1 to entry: See Annex C for anexplanation of the relationship between hazard and hazardous situation.

注1:见附录C中对“危害”和“危害处境”的关系的说明。

[SOURCE来源: ISO/IEC Guide 63:2019, 3.3,modified — Note 1 to entry added.]


3.6 intended use  intended purpose

预期用途  预期目的

use for which a product, process (3.14) orservice is intended according to the specifications, instructions andinformation provided by the manufacturer (3.9)

按照制造商提供的规范、说明书、和信息,对产品、过程或服务的预期使用。


Note 1 to entry: The intended medicalindication, patient population, part of the body or type of tissue interactedwith, user profile, use environment, and operating principle are typical elements of the intended use.

注1:预期的医学适应症,患者人群,身体部位或组织类 型,用户资料,使用环境和操作原理是预期用途的关键要素。

[SOURCE: ISO/IEC Guide 63:2019, 3.4]


3.7 in vitro diagnostic medical device   IVDmedical device

体外诊断医疗器械   IVD医疗器械

device, whether used alone or incombination, intended by the manufacturer (3.9) for the in vitro examination ofspecimens derived from the human body solely or principally to provide information for diagnostic, monitoring or compatibility purposes and including reagents, calibrators, control materials, specimen receptacles, software, andrelated instruments or apparatus or other articles


制造商(3.9)提供的医疗器械,无论是单独使用还是结合使用,主要用于体外检查人体的标本的医疗器械,以提供用于诊断,监测或兼容性目的的信息,包括试剂,校准物,对照材料,标本容器,软件以及相关的仪器或设备或其他物品

[SOURCE: ISO 18113-1:2009, 3.27, modified —NOTE deleted.]


3.8 life cycle

生命周期

series of all phases in the life of amedical device (3.10), from the initial conception to final decommissioning anddisposal

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。

[SOURCE: ISO/IEC Guide 63:2019, 3.5]


3.9 Manufacturer

制造商

natural or legal person with responsibility for the design and/or manufacture of a medical device (3.10) with the intention of making the medical device (3.10) available for use, under his name, whetheror not such a medical device (3.10) is designed and/or manufactured by thatperson himself or on his behalf by another person(s)


负责设计和/或制造医疗器械(3.10)的自然人或法人,目的是使该医疗器械(3.10)以其名义投入使用,无论该医疗器械(3.10)是否为本人或他人代为设计和/或制造的。


Note 1 to entry: The natural or legalperson has ultimate legal responsibility for ensuring compliance with allapplicable regulatory requirements for the medical device in the countries or jurisdictions where it is inten

ded to be made available or sold, unless thisresponsibility is specifically imposed on another person by the Regulatory Authority (RA) within that jurisdiction.


注释1:自然人或法人有最终法律责任,以确保遵守拟提供或出售的医疗器械所在国家或地区对医疗器械的所有适用法规要求,除非该责任由另一个该辖区内监管机构(RA)的人员承担。


Note 2 to entry: The manufacturer’s responsibilities are described in other GHTF guidance documents. These responsibilities include meeting both pre-market requirements and post-market requirements, such as adverse event reporting and notification of correctiveactions.


注2:其他GHTF指导文件中描述了制造商的责任。这些职责包括满足上市前要求和上市后要求,例如不良事件报告和纠正措施通知。


Note 3 to entry:  “Design and/or  manufacture” may  include specification development, production, fabrication, assembly, processing, packaging, repackaging,labelling, relabeling, sterilization, installation, or remanufacturing of amedical device; or putting a collection of devices, and possibly otherproducts, together for a medical purpose.


注3:“设计和/或制造”可以包括医疗器械的规格设计,生产,制造, 组装,加工,包装,重新包装,贴标签,重新贴标签,灭菌,安装或再 制造;或将一组设备以及可能的其他产品放在一起以用于医疗目的。


Note 4 to entry: Any person who assemblesor adapts a medical device that has already been supplied by another person for an individual patient, in accordance with the instructions for use, is not themanufacturer, provided the assembly or adaptation does not change the intendeduse of the medical device.


注释4:按照使用说明的说明,组装或改装已经由他人名义投入使用的产品,并且组装或改装不会改变医疗器械预期用途,这类人都不是制造商。


Note 5 to entry: Any person who changes theintended use of, or modifies, a medical device without acting on behalf of theoriginal manufacturer and who makes it available for use under his own name,should be considered the manufacturer of the modified medical device.

注5 :在未得到原始制造商的授权情况下以自己的名义对医疗器械进行更改,应被视为更改后的医疗器械的制造商。


Note 6 to entry: An authorised representative, distributor or importer who only adds its own address andcontact details to the medical device or the packaging, without covering or changing the existing labelling, is not considered a manufacturer.

进入注释 6:仅将自己的地址和联系方式添加到医疗器械或包装上,未粘贴现有标签或变更后的标签的授权代表,分销商或进口商,不能被视为制造商。


Note 7 to entry: To the extent that anaccessory is subject to the regulatory requirements of a medical device, the person responsible for the design and/or manufacture of that accessory is considered to be a manufacturer.


进入注释 7:在某种程度上,配件符合医疗器械的法规要求配合该医疗器械使用,负责该配件的设计和/或制造的人员应被视为制造商。

[SOURCE: ISO/IEC Guide 63:2019, 3.6]


3.10 medical device

医疗器械

instrument, apparatus, implement, machine,appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer (3.9) to be used,alone or in combination, for human beings, for one or more of the specificmedical purpose(s) of

制造商(3.9)打算单独或组合用于人体的一种仪器,仪器,工具,机器,器具,植入物,体外使用的试剂,软件,材料或其他类似或相关物品 或以上的特定医疗目的


—   diagnosis,prevention, monitoring, treatment or alleviation of disease,

— diagnosis,monitoring, treatment, alleviation of or compensation for an injury,

—   investigation,replacement, modification, or support of the anatomy or of a physiological process,

—   supporting or sustaining life,

—   controlof conception,

—   disinfection of medical devices (3.10),

—   providing information by means of in vitro examination of specimensderived from the human body,


—疾病的诊断,预防,监测,治疗或缓解;

—损伤的诊断、监护、治疗或补偿;

—生理结构或生理过程的研究、替代、调节或支持;

—支持或维持生命;

—妊娠控制;

— 医疗器械消毒(3.10),

-通过对人体标本进行体外检查的方式提供医疗信息,


and which does not achieve its primaryintended action by pharmacological, immunological or metabolic means, in or onthe human body, but which may be assisted in its function by such means

并不能通过药理,免疫或代谢手段在人体内或人体上实现其主要预期作用,但可以通过这种方式辅助其功能。


Note 1 to entry: Products which can beconsidered to be medical devices in some jurisdictions but not in others

include:

注1:在某些司法管辖区可被视为医疗器械的产品,但在其他司法管 辖区则不包括:


—   disinfectionsubstances;

—   aidsfor persons with disabilities;

—   devicesincorporating animal and/or human tissues;

—   devicesfor in vitro fertilization or assisted reproduction technologies.

—   消毒物质;

—   残疾人辅助用品;

—   包含动物和/或人体组织的设备;

—   体外受精和/或人体组织的设备。

[SOURCE: ISO/IEC Guide 63:2019, 3.7]


3.11 objective evidence

客观证据

data supporting the existence or verity ofsomething

Note 1 to entry: Objective evidence can beobtained through observation, measurement, test or by other means.

[SOURCE: ISO 9000:2015, 3.8.3, modified —Note 2 to entry deleted.]

支持客观事物存在或其真实性的数据

注1:可以通过观察,测量,测试或其他方式获得客观证据。[来源:ISO9000:2015,3.8.3,已修改-删除注 2。]


3.12 post-production

生产后

part ofthe life cycle (3.8) of the medical device (3.10) after the design has beencompleted and the medical device (3.10) has been manufactured

EXAMPLE Transportation,  storage, installation, product use,maintenance, repair, product changes, decommissioning and disposal.

在设计已完成,并且医疗器械(3.10)已经制造后的产品生命周期(3.8)部分。

示例:运输,存储,安装,产品使用,维护,修理,产品更改,退役和处置。


3.13 Procedure

程序

specified way to carry out an activity or aprocess (3.14) Note 1 to entry: Procedures can be documented or not. [SOURCE:ISO 9000:2015, 3.4.5]

为某项活动或过程所规定的途径(3.14)

注1:程序可以文件化也可以不文件化

[来源:ISO9000:2015,3.4.5]


3.14 Process

过程

set of interrelated or interactingactivities that use inputs to deliver an intended  result

将使用输入转化为预期用途的相互关联或相互作用的一组活动、

Note 1 to entry: Whether the “intendedresult” of a process is called output, product or service depends on thecontext of the reference.

注1:一个过程的“预期结果” 称为输出,产品还是服务,取决于引 用的上下文。


Note 2 to entry: Inputs to a process aregenerally the outputs of other processes and outputs of a process are generallythe inputs to other processes.

输入到一个过程通常是其他的输出处理和输出处理通常输入到其它过程。


Note 3 to entry: Two or more interrelatedand interacting processes in series can also be referred to as a  process.

[SOURCE: ISO 9000:2015, 3.4.1, modified —Notes to entry 4, 5 and 6 are deleted.]

注3:两个或多个相互关联且相互作用的过程也可以称为过程。[来源:ISO 9000:2015,3.4.1,已修改-删除条目 4、5 和 6 的注释。]


3.15 reasonably foreseeable misue

合理地可预见的误用

use of a product or system in a way notintended by the manufacturer (3.9), but which can result from readily predictable human behaviour

未按制造商预期使用的方式使用产品或系统(3.9),但这可能源于可预见人为导致。


Note 1 to entry: Readily predictable human behaviour includes the behaviour of all types of users, e.g. lay and professionalusers.

注1:可预测的人为包括所有类型的用户的行为,例如非专业 和专业用户。


Note 2 to entry: Reasonably foreseeable  misuse can be intentional or unintentional.

[SOURCE:ISO/IEC Guide 63:2019, 3.8]

  注2: 合理预见的误用可能是有意的,也可能是无意的。


3.16 Record

记录

document stating results achieved orproviding evidence of activities performed

阐述所取得的结果或提供所完成的活动的证据的文件。


Note 1 to entry: Records can be used, forexample, to formalize traceability and to provide evidence of verification,preventive action and corrective action.

注1:记录可用于例如使可追溯性、提供验证证据、预防措施和纠正措施的证据。


Note 2 to entry: Generally records need notbe under revision  control.

[SOURCE:ISO 9000:2015, 3.8.10]

注2:通常,记录无需版本控制。[来源:ISO 9000:2015,3.8.10]


3.17 residual risk

剩余风险

risk remaining after risk control (3.21)measures have been implemented [SOURCE: ISO/IEC Guide 63:2019, 3.9]

实施风险控制(3.21)后还存在的风险

[来源:ISO / IEC 指南 63:2019,3.9]


3.18 Risk

风险

combination of the probability ofoccurrence of harm (3.3) and the severity (3.27) of that harm (3.3)

[SOURCE: ISO/IEC Guide 63:2019, 3.10,modified — Note 1 to entry deleted.]

伤害发生的概率和伤害发生的严重程度的组合

[来源: ISO/IEC 指南 63:2019, 3.10, 已修改 — 注1 已删除.]


3.19 risk analysis

风险分析

systematic use of available information toidentify hazards (3.4) and to estimate the risk (3.18)

[SOURCE: ISO/IEC Guide 63:2019, 3.11]

系统的运用现有信息确定危害和估计风险的过程。

[来源: ISO/IEC 指南 63:2019, 3.11]


3.20 risk assessment

风险评价

overall process (3.14) comprising a riskanalysis (3.19) and a risk evaluation (3.20)

[SOURCE: ISO/IEC Guide 51:2014, 3.11]

包括风险分析和风险估计的全过程。


3.21 risk control

风险控制

process (3.14) in which decisions are madeand measures implemented by which risks (3.18) are reduced to, or maintained within, specified levels

[SOURCE: ISO/IEC Guide 63:2019, 3.12]

作出决策并实施措施,以便降低风险或把风险维持在规定水平的过程。


3.22 risk estimation

风险估计

process (3.14) used to assign values to theprobability of occurrence of harm (3.3) and the severity (3.27)

of that harm

对损害发生的概率(3.3)和损害的严重程度(3.27)赋值的过程(3.14)

[SOURCE: ISO/IEC Guide 63:2019, 3.13]


3.23 risk evaluation

风险评估

process (3.14) of comparing the estimated risk (3.18) against given risk (3.18) criteria to determine the acceptability of the risk (3.18)

将估计的风险和给定的风险准则进行比较,以决定风险可接受性的过程。

[SOURCE: ISO/IEC Guide 63:2019, 3.14]


3.24 risk management

风险管理

systematic application of management policies, procedures (3.13) and practices to the tasks of analysing,evaluating, controlling and monitoring risk (3.18)

用于风险分析、评价、控制和监视工作的管理方针、程序及其实践的系统运用。

[SOURCE: ISO/IEC Guide 63:2019, 3.15]


3.25 risk management file

风险管理文档

set of records (3.16) and other documents that are produced by risk management (3.24)

由风险管理产生的一组记录和其他文件。


3.26 Safety

安全

freedom from unacceptable risk (3.18)

免除了不可接受的风险状态

[SOURCE: ISO/IEC Guide 63:2019, 3.10]


3.27 Severity

严重度

measure of the possible consequences of ahazard (3.4)

危害可能后果的度量。

[SOURCE: ISO/IEC Guide 63:2019, 3.17]


3.28 state of the art

现有技术水平

developed stage of technical capability ata given time as regards products, processes (3.14) and services, based on therelevant consolidated findings of science, technology and  experience

根据现有科学,技术和经验的综合水平,确定产品,过程(3.14)和服务开发技术能力的发展。

Note 1 to entry: Tently and generally accepted as good practice in technology and medicine. The state of the art doesnot necessarily imply the most technologically advanced solution. The state ofthe art described here is sometimes referred to as the “generally acknowledged state of the art”. The state of the art embodies what is curr.

注1:在技术和医学上暂时并被普遍认为是良好实践。现有技术不一定意味着技术最先进的解决方案。此处描述的最新技术水平有时被称为“公认的现有技术水平”。现有技术水平体现了所发生的一切。

[SOURCE: ISO/IEC Guide 63:2019, 3.18]


3.29 top management

最高管理者

person or group of people who directs and controls a manufacturer (3.9) at the highest level

在最高层指挥和控制制造商的一个人或一组人。

[SOURCE: ISO 9000:2015, 3.1.1, modified —“An organization” replaced by “a manufacturer”,组织替换为制造商 Notes to entry deleted.注释已删除]


3.30 use error

使用错误

user action or lack of user action while using the medical device (3.10) that leads to a different result than that intended by the manufacturer (3.9) or expected by the user

由于一个动作或动作的疏忽,而造成不同于制造商预期或用户期望的医疗器械的响应。


Note 1 to entry: Use error includes theinability of the user to complete a task.

注1:用户使用错误包括能力不足的用户进行使用


Note 2 to entry: Use errors can result froma mismatch between the characteristics of the user, user interface, task, oruse environment.

注2:用户,用户界面,任务或使用环境的特性不匹配可能导致使用错误。


Note 3 to entry: Users might be aware or unaware that a use error has occurred.

注2:用户可能意识到或未意识到用户错误已产生。


Note 4 to entry: An unexpected physiological response of the patient is not by itself considered use  error.

患者非预期的生理反应通常不被认为是使用错误。


Note 5 to entry: A malfunction of a medicals not considered a use error.device that causes an unexpected result i

注5:医疗器械故障导致的非预期结果不认为是使用错误

[SOURCE: IEC 62366-1:2015, 3.21, modified —Note 6 to entry deleted.]


3.31 Verification

验证

confirmation, through the provision ofobjective evidence (3.11), that specified requirements have been fulfilled

提供客观证据对规定的要求已得到满足的认定。


Note 1 to entry: The objective evidence needed for a verification can be the result of an inspection or of other formsof determination such as performing alternative calculations or reviewing  documents.

注1:验证所需的客观证据可以是检查的结果,也可以是其他确定形式的结果,例如执行替代计算或查看文档。


Note 2 to entry: The activities carried outfor verification are sometimes called a qualification process.

进行验证的活动有时称为资格过程。


Note 3 to entry: The word “verified” isused to designate the corresponding  status.

“已验证”一词用于指定相应的状态

[SOURCE: ISO/IEC Guide 63:2019, 3.19]


4 General requirements for risk management system

风险管理的通用要求


4.1 Riskmanagement process

风险管理的过程

The manufacturer shall establish,implement, document and maintain an ongoing process for:

制造商应建立,实施,记录和维护正在进行的过程,以用于:

a)    identifying hazards and hazardous situations associated with a medical device;

识别与医疗设备有关的危害和危害处境;

b)    estimating and evaluating the associated risks;

估计和评估相关风险;

c)    controlling these risks, and

并控制这些风险;

d)    monitoring the effectiveness of the risk control measures.

监视风险控制措施的有效性;

This process shall apply throughout the life cycle of the medical device.

此过程应适用于医疗设备的整个生命周期。


This process shall include the following elements:

该过程应包括以下要素:

—   riskanalysis;

风险分析

—   riskevaluation;

—   风险评估

—   riskcontrol; and

风险控制

—   productionand post-production activities.

生产和生产后的信息

Where a documented product realizationprocess exists, it shall incorporate the appropriate parts of the risk management process.

如果存在文件化的产品实现过程,则应将其纳入风险管理过程的相应部分。

NOTE 1 Product realization processes are described in, for example, Clause 7 ofISO  13485:2016[5].

注1:产品实现过程在ISO 13485:2016 [5]的第7条中有所描述。


NOTE 2 A documented process within aquality management system can be used to address safety in a systematic manner,in particular to enable the early identification of hazards and hazardous situations in complex medical devices.

注2:质量管理体系文件化的过程可用于系统地解决安全问题,特别是能够及早识别复杂医疗器械中的危害和危害处境。


NOTE 3 A schematic representation of therisk management process is shown in Figure 1. Depending on the specific lifecycle phase, individual elements of risk management can have varying emphasis.Also, risk management activities can be performed iteratively or in multiple steps as appropriate to the medical device. Annex B contains  a more detailed overview of the steps in therisk management process.

注3:风险管理过程的示意图如图1所示。按照特定的生命周期阶段,风险管理的各个要素可能有不同的侧重点。次外,对某个医疗器械风险管理活动可以适当的重复执行或在多个步骤中执行。附件B包含风险管理过程中各个步骤的更详细概述。

Compliance is checked by inspection of the appropriate documents.

用查看适当文件的方法检查符合性。            

Figure 1 — A schematic representation ofthe risk management process

风险管理过程示意图


4.2 Managementresponsibilities

管理职责

Top management shall provide evidence ofits commitment to the risk management process by ensuring:

最高管理者应在下列方面对风险管理过程的承诺提供证据:

—   the provision of adequate resources; and

提供充分的资源;

— the assignment of competent personnel (see 4.3) for risk management.

为风险管理分配有资质的人员。

Top management shall define and documenta  policy for  establishing  criteria for  risk acceptability. The policy shall provide a framework that ensures that criteria are based upon applicable national or regional regulations and relevant International Standards, and take into account available information such as the generally acknowledged state of the art and known stakeholder concerns.

最高管理者确定风险管理可接受的准则的方针并形成文件。此方针应提供一个风险管理的框架,应确保准则是基于适用的国家或地区法规和相关的标准,并考虑到可用的信息,例如普遍的现有技术水平和利益相关方的关注点。


NOTE 1  The manufacturer’s policy for establishing criteria for risk acceptability can define the approaches to risk control: reducing risk as low as reasonably practicable, reducing risk as low asreasonably achievable, or reducing risk as far as possible without adversely affecting the benefit-risk ratio. See ISO/TR 24971[9] for guidance on definingsuch policy.

制造商用于建立风险可接受性标准的方针可以定义风险控制的方法:将风险降低到合理可行的最低水平,将风险降低到合理可实现的最低水平,或在不损害利益比率的前提下尽可能降低风险。有关定义此类方针的指南,请参见ISO / TR 24971 [9]。


Top management shall review the suitability of the risk management process at planned intervals to ensure continuing effectiveness of the risk management process and shall document any decisionsand actions taken. If the manufacturer has a quality management system inplace, this review may be part of the quality management system review.

最高管理者应按计划的时间间隔评审风险管理过程的适宜性,以确保风险管理过程的持续有效性,并将任何决策和采取的行动形成文件。如果制造商建立了质量管理体系,这些评审可作为质量管理体系评审的一部分。

NOTE 2 The results of reviewing production and post-production information canbe an input to the review of  the suitability of the risk management process.


注2:评审生产和后期生产信息的结果可以作为对风险管理过程适用性的评审的输入。


NOTE 3 The documents described in this subclause can be incorporated within thedocuments produced by the

manufacturer’s quality management systemand these documents can be referenced in the risk management file.

注3:本小节中描述的文件可以整合到制造商的质量管理体系生产的文件中,且这些文件可以在风险管理文档中引用。

Compliance is checked by inspection of the appropriate documents.

用查看适当的文件的方法检查符合性。


4.3 Competenceof personnel

人员资质

Persons performing risk management tasks shall be competent on the basis of education, training, skills and experience appropriate to the tasks assigned to them. Where appropriate, these personsshall have knowledge of and experience with the particular medical device (orsimilar medical devices) and its use, the technologies involved or the risk management techniques employed. Appropriate records shall be maintained.

执行风险管理任务的人员,应具有与赋予给他们的任务相适应的教育,培训,技能和经验。适当时,应包括特定医疗器械(或类似医疗器械)及其使用的知识和经验、有关技术或风险管理技术。应保留资格鉴定记录。

NOTE Riskmanagement tasks can be performed by representatives of several functions, eachcontributing their specialist knowledge.

注:风险管理的任务可以由多个职能部门的代表来执行,每个职能部门都贡献自己的专业知识。

Compliance is checked by inspection of the appropriate records.

用查看适当的文件的方法检查符合性。


4.4  Riskmanagement plan

风险管理计划

Risk management activities shall  be planned.  For  the particular  medical  device being  considered, themanufacturer shall establish and document a risk management plan in accordancewith the risk management process. The risk management plan shall be part of therisk management file.

应计划风险管理活动。对于所考虑的特定医疗器械,制造商应根据风险管理过程,建立一项风险管理计划并形成文件。风险管理计划应作为风险管理文档的一部分。


This plan shall include at least thefollowing:

此计划应至少包含以下内容:

a)  thescope of the planned risk management activities, identifying and describing the medical device

and the life cycle phases for which each element of the plan is applicable;

策划的风险管理活动的范围,识别和描述医疗器械和使用与计划每个要素的生命周期阶段;

b) assignment of responsibilities and authorities;

职责和权限的分配

c) requirements for review of risk management activities;

风险管理活动评审的要求

d) criteriafor risk acceptability,  based  on the  manufacturer’s  policy for  determining  acceptable risk, including criteria foraccepting risks when the probability of occurrence of harm cannot be estimated;

基于制造商确定的可接受风险方针的风险可接受准则,包括在伤害发生概率不能估计时的可接受风险的准则。


NOTE 1 The criteria for risk acceptability are essential for the ultimate effectiveness of the risk management process. For each risk management plan the manufacturer needs to establish risk acceptability criteriathat are appropriate for the particular medical device.

注1:风险可接受性的标准对于风险管理过程的最终有效性至关重要。对于每个风险管理计划,制造商需要建立适合特定医疗医疗的风险可接受性标准。


e)    amethod to evaluate the overall residual risk, and criteria for acceptability ofthe overall residual risk based on the manufacturer’s policy for determining acceptable risk;

基于制造商确定可接受风险的方针的评估总体剩余风险的方法以及总体剩余风险的可接受性标准;

NOTE 2 The method to evaluate the overall residual risk can include gathering and reviewing data and literature for themedical device being considered and similar medical devices on the market and can involve judgment by a cross-functional team of experts with application knowledge and clinical expertise.

注2:评估总体剩余风险的方法可以包括收集和评审所考虑的医疗器械以及市场上类似医疗器械的数据和文献,并且可以由具有应用知识和临床专业知识的跨职能专家小组进行判断。

f) activitiesfor verification of the implementation and effectiveness of risk control measures; and

验证风险控制措施的实施和有效性的活动;

g) activities related to collection and review of relevant production and post-production information.

收集和评审有关生产及生产后信息有关的活动。

NOTE 3 See ISO/TR 24971[9] for guidance ondeveloping a risk management plan and on establishing criteria for risk acceptability.

注3:关于制定风险管理计划和建立风险可接受性标准的指南,请参见ISO / TR 24971 [9]。


NOTE 4  Not  all parts of  the plan  need  to be  created at  the same  time. The  plan or  parts of  it  canbe

developed over time.

注4:并非计划的所有部分都需要同时制定。可以随着时间的推移制定计划或计划的一部分。

If the plan changes during the life cycleof the medical device, a record of the changes shall be maintained in the risk management file.

如果计划在医疗器械的生命周期内发生更改,则更改的记录应保留在风险管理文件中。

Compliance is checked by inspection of the risk management file.

用查看风险管理文档的方法检查符合性。


4.5  Riskmanagement file

风险管理文档

For the particular medical device being considered, the manufacturer shall establish and maintain a risk management file. In addition to the requirements of other clauses of this document, the risk management file shall provide traceability for each identified hazard to:

对于所考虑的特定医疗设备,制造商应建立并维护风险管理文件。除了本标准其他条款的要求之外,风险管理文档应提供对每种已识别危害下列各项的可追溯性:

—   the risk analysis;

风险分析;

—   the risk evaluation;

—   分析评价;

—   the implementation and verification of the risk control measures; and

—   风险控制的实施和验证;

—   the results of the evaluation of the residual risks.

—   剩余风险评价的结果

NOTE 1 The records and other documents that make up the risk management file can form part of other documents and files required, for example, by a manufacturer’squality management system. The risk management file need not physically contain all the records and other documents.However, it needs to contain at least references or pointers to all required documentation, so that the manufacturer can assemble the information referenced in the risk management file in a timely manner.

注1:构成风险管理文件的记录和其他文件,可以形成其他文件和文档的一部分,例如,制造商的质量管理系统要求相关记录。风险管理文件不需要包含所有记录和其他文件。但是,它至少包含所有要求文件的引用或提示,以便制造商可以及时搜集风险管理文件中引用的信息。


NOTE 2 The risk management file can be in any form or type of medium.

注2:风险管理文件可以是任何形式或类型的媒介。


NOTE 3 See ISO/TR 24971[9]  for guidanceon establishing a risk management file for components and  devices that were designed without using ISO14971.

注3:关于未使用ISO 14971设计的组件和器械建立风险管理文件的,请参见ISO / TR 24971[9]。


5 Riskanalysis

风险分析


5.1 Riskanalysis process

风险分析的过程

The manufacturer shall perform risk analysis for the particular medical device as described in 5.2 to 5.5. The implementation of the planned risk analysis activities and the results of the risk analysis shall be recorded in the risk management file.

制造商应按照5.2至5.5中所述对特定医疗器械进行风险分析。风险分析活动的计划的实施和风险分析的结果应记录在风险管理文件中。


NOTE 1  If a risk analysis or other relevant information is available for asimilar medical device, that analysis or information can be used as a starting point for the new risk analysis. The degree of relevance depends the differences between the medical devices and whether these introduce new hazards or significant differences inoutputs, characteristics, performance or results. The extent of use of anexisting risk analysis is based on a systematic evaluation of the effects that the differences can have on the occurrence of hazardous  situations.

注1:如果类似医疗器械有风险分析或其他相关信息可获时,则该分析或信息用作新风险分析的起点。这种相关程度取决于医疗器械之间的差异,以及这些差异是否会带来新的危害或输出,特性,性能或结果是否存在重大差异。对于已有分析的利用程度,也基于变化部分对危险情况形成的影响系统性的评价。


NOTE 2 See ISO/TR 24971[9]  for guidance on selected risk analysis techniques and on risk analysis techniques

for in vitro diagnostic medical devices.

注2:关于选择的风险分析技术和体外诊断医疗设备的风险分析技术的指南,请参见ISO / TR 24971 [9]。


In addition to the records required in 5.2to 5.5, the documentation of the conduct and results of the risk analysis shall include at least the following:

除5.2至5.5要求的记录外,风险分析的实施和结果的文件还应至少包括以下内容:

a)    identification and description of the medical device that was analysed;

描述和识别所分析的医疗器械;

b)    identification of the person(s) and organization who carried out the risk analysis; and

识别完成风险分析的一个或多个人和组织

c)    scopeand date of the risk analysis.

风险分析的范围和日期。

NOTE 3 The scope of the risk analysis can be very broad (as for the development of a new medical device with which amanufacturer has little or no experience) or the scope can be limited (as foranalysing the impact of a change to an existing medical device for which muchinformation already exists in the manufacturer’s  files).

注3:风险分析的范围可能非常宽泛(如制造商对新医疗器械的开发经验不足或没有经验)或风险分析的范围进行限制(如分析变更对现有器械的影响,有关该器械更多信息的已经存在于制造商的档案中)。

Compliance is checked by inspection of the risk management file.

用查看风险管理文档的方法检查符合性。


5.2 Intendeduse and reasonably foreseeable misuse

预期用途和合理可预见的误用

The manufacturer shall document the intended use of the particular medical device being considered.

制造商应记录所考虑的特定医疗器械的预期用途。


The intended use should take into account information such as the intended medical indication, patient population, partof the body or type of tissue interacted with, user profile, use environment, and operating principle.

预期用途应考虑以下信息,例如预期的医学适应症,患者人群,身体部位或组织类型,用户资料,使用环境和操作原理。

The manufacturer shall also document reasonably foreseeable misuse.

制造商还应记录合理可预见的误用。

This documentation shall be maintained inthe risk management file.

该文件应保存在风险管理文件中。

NOTE 1 The use specification (see 3.23 ofIEC 62366-1:2015[13]) can be an input to determining the intended use.

注1:使用规范(参见IEC 62366-1:2015 [13]的3.23)可以作为确定预期用途的输入。

NOTE 2 See ISO/TR 24971[9]  for factorsto consider in determining the intended use and for an explanation   of

reasonably foreseeable misuse.

注2:参见ISO / TR 24971 [9],在确定预期用途时应考虑的因素以及对合理可预见的滥用。

Compliance is checked by inspection of the risk management file.

用查看风险管理文档的方法检查符合性。


5.3 Identificationof characteristics related to safety

安全相关特性的识别

For the particular medical device being considered, the manufacturer shall identify and document those qualitative and quantitative characteristics that could affect the safety of the medical device. Where appropriate, the manufacturer shall define limits of those characteristics. This documentation shall be maintained in the risk management file.

对于所考虑的特定医疗器械,制造商应识别并记录可能影响医疗器械安全性的定性和定量特性。制造商应在适当情况下定义这些特性的极限。该文件应保存在风险管理文件中。


NOTE 1 See  ISO/TR  24971[9] for  a  list of questions  that can serve  as a  guide  in identifying medical device characteristics that could have an impact on safety.

注1:参见ISO / TR 24971 [9]中的问题列表,这些问题可以用作识别可能对安全性产生影响的医疗器械特性的指南。


NOTE 2 Characteristics related to loss or degradation of the clinical performance of a medical device that can result in unacceptable risk, are sometimes referred to as essential performance (see forexample IEC  60601-1[12]).

注2:可能导致医疗器械临床性能丧失或退化有关的风险不可接受,有时被称为基本性能(参见IEC 60601-1 [12])。

Compliance is checked by inspection of the risk management file.

用查看风险管理文档的方法检查符合性。


5.4 Identificationof hazards and hazardous situations

识别危害和危害处境

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 both normal and fault conditions.

制造商应根据正常用途和故障情况下的预期用途,合理可预见的误用以及与安全有关的特性,识别并记录与医疗设备有关的已知和可预见的危害。

For each identified hazard, the manufacturer shall consider the reasonably foreseeable sequences or combinations of events that can result in a hazardous situation, and shall identify and document the resulting hazardous situation(s).

对于每种已识别的危害,制造商应考虑可能导致危害处境的合理可预见的事件顺序或组合,并应识别并记录所导致的危害处境。


NOTE 1 A sequence of events can be initiated in all phases of the life cycle, e.g. during transport, storage,installation, maintenance, routine inspection, decommissioning and disposal.


注1:一系列事件可以在生命周期的所有阶段发起,例如在运输,存储,安装,维护,常规检查,退役和处置。

NOTE 2 An explanation of the relationship between hazard, hazardous situationand harm including examples

is given in Annex C.

注2:附件C中给出了危害,危害处境和伤害之间关系的解释,包括示例。


NOTE 3 Risk analysis includes the examination of different sequences or combinations of events related to asingle hazard that can lead to different hazardous situations. Each hazardous situation can lead to different types of harm.

注3:风险分析包括检查与可能导致不同危害的单一危险有关的不同顺序或事件组合。每种危险情况都可能导致不同类型的伤害。


NOTE 4 When identifying hazardous situations not previously recognised, systematic techniques for  risk  analysis that cover the specific situationcan be used. Guidance on some available techniques is provided in ISO/TR24971[9].

注4:在识别以前未认识到的危害处境时,可以使用涵盖特定情况的系统的风险分析技术。ISO / TR 24971 [9]提供了一些可用技术的指南。

The documentation shall be maintained inthe risk management file.

文件应保存在风险管理文档中。

Compliance is checked by inspection of the risk management file.

用查看风险管理文档的方法检查符合性。


5.5 Riskestimation

风险估计

For each identified hazardous situation,the manufacturer shall estimate the associated risk(s) 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 risk management file.

对于每种已识别的危害处境,制造商应使用可用的信息或数据来估计相关的风险。对于无法估计伤害发生概率的危害处境,应列出一个可能的后果的清单,以用于风险评估和风险控制。这些活动的结果应记录在风险管理文件中。


The system used for qualitative orquantitative categorization of probability of occurrence of harm  and

severity of harm shall be recorded in the risk management file.

用于对对伤害发生概率和伤害的严重程度进行定性或定量分类的系统,应记录在风险管理文件中。


NOTE 1 Risk estimation incorporates an analysis of the probability of occurrence of harm and the severity of the harm. Depending on the area of application, only certain elements ofthe risk estimation process might need to be considered in detail. For example,when the harm is minimal, an initial hazard and consequence analysis could  be sufficient, or when insufficient information or data are available, a conservative estimate of the probability of occurrence can give some indication of the risk. See also ISO/TR 24971[9].

注1:风险估计包括对伤害发生概率和伤害严重性的分析。根据应用部位的不同,可能仅需要详细考虑风险评估过程中的某些要素。例如,当危害最小时,要求充分的初步的危害和分析的结果,或者,当没有足够的信息或数据可用时,对发生概率的保守估计可以为风险提供一些指示。另请参见ISO / TR 24971 [9]。


NOTE 2 Risk estimation can be qualitativeor quantitative. Methods of risk estimation, including those resulting from systematic faults, are described in ISO/TR 24971[9], which also gives information useful for estimating risks forin vitro diagnostic medical devices.

注2:风险估计可以是定性或定量的。ISO / TR 24971 [9]中描述了风险估算方法,包括由系统故障引起的风险,该方法还提供了有用的信息,可用于估算体外诊断医疗器械的风险。


NOTE 3 Information or data for estimating risks can be obtained, for example,from:

注3:可以从例如以下途径获得估计风险的信息或数据:

—   published standards;

—   发布的标准

—   scientific or technical investigations;

—   科学或技术调查;

—   field data from similar medical devices already in use, including publicly available reports of incidents;

—   来自以投入的使用的类似医疗器械的现场数据,包括可公布的事故报告;

—   usability tests employing typical users;

—   使用典型用户的可用性测试;

—   clinical evidence;

—   临床证据;

—   results of relevant investigations or simulations;

—   有关调查或模拟的结果;

—   expert opinion; or

—   专家意见;

—   external quality assessment schemes for in vitro diagnostic medical devices.

—   体外诊断医疗器械的外部质量评估计划。

Compliance is checked by inspection of the risk management file.

用查看风险管理文档的方法检查符合性。


6 Riskevaluation

风险评估

For each identified hazardous situation,the manufacturer shall evaluate the estimated risks and determine if the riskis acceptable or not, using the criteria for risk acceptability defined in therisk management plan.

对于每种已识别的危害处境,制造商应使用风险管理计划中定义的风险可接受性准则,评估和估计的风险并确定该风险是否可接受。


If the risk is acceptable, it is not required to apply the requirements given in 7.1 to 7.5 to this hazardous situation (i.e., proceed to 7.6) and the estimated risk shall be treated asresidual risk.

如果风险是可以接受的,则不需要将7.1至7.5中给出的要求应用于这种危害处境(即前进至7.6),并且将估计风险视为剩余风险。


If the risk is not acceptable, then the manufacturer shall perform risk control activities as described in 7.1 to7.6.

如果风险不可接受,则制造商应按照以下内容进行风险控制活动:7.1至7.6。


The results of this risk evaluation shall be recorded in the risk management file.

风险评估的结果应记录在风险管理文件中。

Compliance is checked by inspection of the risk management file.

用查看风险管理文档的方法检查符合性。


7  Risk control

风险控制


7.1 Riskcontrol option analysis

风险控制方法分析

The manufacturer shall determine risk control measures that are appropriate for reducing the risks to

an acceptable level.

制造商应确定将风险降低到可接受水平的风险控制措施。

The manufacturer shall use one or more of the following risk control options in the priority order listed:

制造商应按照列出的优先顺序使用以下风险控制选项中的一项或多项:

a)    inherently safe design and manufacture;

固有安全的设计和制造;

b) protective measures in the medical device itself or in the manufacturing process;

医疗器械本身或制造过程中的保护措施;

c)  information for safety and, where appropriate, training to users.

有关安全的信息,并在适当情况下对用户进行培训。

NOTE 1 The rationale for the priority order in selecting the risk control options is given in A .2.7.1.

注1:选择风险控制选项时优先顺序的依据在A .2.7.1中给出。


NOTE 2 Risk control measures can reduce the severity of the harm or reduce the probability of occurrence of

the harm, or both.

注2:风险控制措施可以减轻损害的严重性或减少发生损害的可能性危害,或两者都减少。


NOTE 3 See ISO/TR 24971[9] for guidance on providing information for safety.

注3:关于提供安全信息的指南,请参见ISO / TR 24971 [9]。

Relevant standards should be applied aspart of the risk control option analysis.

相关标准应作为风险控制方案分析的一部分。


NOTE 4 Many standards address inherentsafety, protective measures, and information for safety for medical devices. Inaddition, some medical device standards have integrated elements of the risk management process (e.g. electromagnetic compatibility, usability, biological evaluation). See ISO/TR 24971[9] for information on the role of International Standards in risk management.

注4:许多标准都针对医疗设备的固有安全性,防护措施和安全信息。此外,某些医疗设备标准还整合了风险管理流程的要素(例如电磁兼容性,可用性,生物学评估)。有关国际标准在风险管理中的作用的信息,请参见ISO / TR 24971 [9]。


The risk control measures selected shall be recorded in the risk management file.

选择的风险控制措施应记录在风险管理文件中。

If, during 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 (proceed to 7.4).

如果在风险控制选项分析过程中,制造商确定降低风险不可行,则制造商应对剩余风险进行受益风险分析(进行至7.4)。

Compliance is checked by inspection of the risk management file.

用查看风险管理文档的方法检查符合性。


7.2 Implementationof risk control measures

风险控制措施的实施

The manufacturer shall implement the risk control measures selected in 7.1.

制造商应执行7.1中选择的风险控制措施。

Implementation of each risk control measure shall be verified. This verification shall be recorded in the

risk management file.

每项风险控制措施的实施应予以验证。该验证应记录在风险管理文件中。

NOTE 1 Verification of implementation can be performed as part of design and development verification or

process qualification within a quality management system.

注1:可以在质量管理体系内,验证可作为设计和开发验证或过程确认的一部分来执行。


The effectiveness of the risk controlmeasures shall be verified. The results of this verification shall be

recorded in the risk management file.

应验证风险控制措施的有效性。验证结果应记录在风险管理文件中。


NOTE 2  Verificationof effectiveness can be performed as part of design and development validation within a quality management system and can include testing with users. See A .2.7.2.

注2:有效性验证可以作为质量管理体系中设计和开发验证的一部分来执行,并且可以包括与用户的测试。见A 2.2.7.2。


NOTE 3 Verification of effectiveness can also be performed as part of design and development verification or process qualification, if the relationship between the effectiveness in risk reduction and the result of design and development verification or process qualification is known.

注3:如果已知降低风险的有效性与设计和开发验证或过程验证的结果之间的关系,则也可以将有效性验证作为设计和开发验证或过程确认的一部分。


EXAMPLE 1 Design  verification of  a  certain performance  characteristic,  such as  dose  accuracy of  a  drug injector, can serve as verification ofeffectiveness of risk control measures ensuring safe drug  dosing.

实施例1对某些性能特征的设计验证,例如药物注射器的剂量准确性,将确保安全药物剂量的风险控制措施作为有效性的验证。


EXAMPLE 2  Process qualification can serve asverification of effectiveness of risk control measures related to

risk caused by variations in production output.

例2:过程鉴定可以用作验证与风险有关的控制措施的有效性,这些控制措施是由生产产量的变化引起的。


NOTE 4  See ISO 13485[5] for more information on design and development verification and validation. See also
ISO/TR 24971[9] for more guidance.
注4:有关设计和开发验证与确认的更多信息,请参见ISO 13485 [5]。另请参见ISO/ TR 24971 [9]。
Compliance is checked by inspection of the risk management file.
用查看风险管理文档的方法检查符合性。

7.3 Residualrisk evaluation
剩余风险评估
After the risk control measures areimplemented, the manufacturer shall evaluate the residual risk using the criteriafor risk acceptability defined in the risk management plan. The results of this evaluation shall be recorded in the risk management file.
实施风险控制措施后,制造商应使用风险管理计划中定义的风险可接受性标准评估剩余风险。评估结果应记录在风险管理文件中。

If a residual risk is not judged acceptable using these criteria, further risk control measures shall be considered (goback to 7.1).
如果使用这些标准判定残留风险不可接受,则应考虑采取进一步的风险控制措施(回到7.1)。
Compliance is checked by inspection of therisk management file.
用查看风险管理文档的方法检查符合性。

7.4 Benefit-riskanalysis
风险-受益分析
If a residual risk is not judged acceptable using the criteria established in the risk management plan and further risk control is not practicable, the manufacturer may gather and review data andliterature to determine if the benefits of the intended use outweigh thisresidual risk.
如果使用风险管理计划中确定的准则无法判定剩余风险为可接受的风险,并且进一步的风险控制不可行,则制造商可以收集并查看数据和文献,以确定预期用途的收益是否大于该剩余风险。

If this evidence does not support the conclusion that the benefits outweigh this residual risk, then the manufacturer may consider modifying the medical device or its intended use (go back to 5.2).Otherwise, this risk remains unacceptable.
如果该证据不能证明受益大于剩余风险,则制造商可以考虑修改医疗器械或其预期用途(返回5.2)。否则,这种风险仍然无法接受。

If the benefits outweigh the residual risk,then proceed to 7.5.
如果收益大于剩余风险,则继续执行7.5。
The results of the benefit-risk analysis shall be recorded in the risk management file.
受益风险分析的结果应记录在风险管理文件中。
NOTE See ISO/TR 24971[9] for guidance onperforming a benefit-risk analysis.
注:参见ISO / TR 24971 [9],以获取进行利益风险分析的指南。
Compliance is checked by inspection of therisk management file.
用查看风险管理文档的方法检查符合性。

7.5 Risksarising from risk control measures
由风险管理控制产生的风险
The manufacturer shall review the effectsof the risk control measures with regard to whether:
制造商应对控制措施的有关以下方面的影响进行评审:
—   new hazards or hazardous situations are introduced; or
新的危害和危害处境的引入;
—  the estimated risks for previously identified hazardous situations areaffected by the introduction of
the risk control measures.
是否由于风险控制程序的引入,影响了对以前识别的危险处境所估计的风险。
Any new or increased risks shall be managedin accordance with 5.5 to  7.4.
任何新的或增加的风险均应按照5.5至7.4进行管理。
The results of this review shall berecorded in the risk management file.
评审结果应记录在风险管理文件中。
Compliance is checked by inspection of the risk management file.
用查看风险管理文档的方法检查符合性。

7.6 Completenessof 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 completed.
制造商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风险控制活动。
The results of this review shall be recorded in the risk management file.
评审结果应记录在风险管理文件中。
Compliance is checked by inspection of the risk management file.
用查看风险管理文档的方法检查符合性。

8 Evaluationof overall residual risk
综合剩余风险的评估
After all risk control measures have been implemented and verified, the manufacturer shall evaluate the overall residualrisk posed by the medical device, taking into account the contributions of allresidual risks, in relation to the benefits of the intended use, using the method and the criteria for acceptability of the overall residual risk definedin the risk management plan [see 4.4 e)].
在实施并验证了所有风险控制措施之后,制造商应按风险管理计划规定的剩余风险可接受准则评估医疗器械的总体剩余风险,并考虑所有剩余风险的贡献,以及与预期用途的受益。[参见4.4 e)]

If the overall residual risk is judged acceptable, the manufacturer shall inform users of significant residual risksand shall include the necessary information in the accompanying documentationin order to disclose those residual risks.
如果总体剩余风险被认为是可以接受的,则制造商应将严重的剩余风险告知用户,并应在随附的文档中包括必要的信息,以披露这些剩余风险。
NOTE 1 The rationale for the disclosure of significant residual risks is givenin  A.2.8.
注1:重大剩余风险的披露理由在A.2.8中给出。

NOTE 2  See ISO/TR  24971[9] for guidance on the evaluation  of overall  residual  risk and  the  disclosure of
residual risks.

注2:关于评估总体剩余风险和披露剩余风险的指导见ISO / TR 24971 [9]。

If the overall residual risk is not judged acceptable in relation to the benefits of the intended use, the manufacturer may consider implementing additional risk control measures (go back to 7.1) or modifying the medical device or its intended use (go back to 5.2). Otherwise,the overall residual risk remains unacceptable.
如果相对于预期用途的利益而言,总剩余风险被判定为不可接受,则制造商可考虑实施其他风险控制措施(返回至7.1)或修改医疗器械或其预期用途(返回至5.2)。否则,总的剩余风险仍然不可接受。

The results of the evaluation of the overall residual risk shall be recorded in the risk management file.
整体剩余风险的评估结果应记录在风险管理文件中。
Compliance is checked by inspection of the risk management file and the accompanying documentation.
通过检查风险管理文件和随附的文档来检查其符合性。

9 Riskmanagement review
风险管理评审
Prior to release for commercial distribution of the medical device, the manufacturer shall review the executionof the risk management plan. This review shall at least ensure that:
在医疗器械销售放行之前,制造商应评审风险管理计划的执行情况。该评审应至少应确保:
—   the overall residual risk is acceptable; and
—   总的剩余风险是可以接受的;
— the risk management plan has been appropriately implemented;
风险管理计划已得到适当实施;
— appropriate methods are in place to collect and review information in the production andpost- production phases.
—   在生产和生产后阶段,采用适当的方法来收集和评审信息。
The results of this review shall berecorded and maintained as the risk management report and shall  be included in the risk management file.
评审结果应记录并保存为风险管理报告,并应包含在风险管理文档中。
The responsibility for review shall beassigned in the risk management plan to persons having the appropriate authority [see 4.4 b)].
风险管理计划中,宜赋予具有适当权限的人员以评审的责任。[见4.4 b)]。
Complianceis checked by inspection of the risk management file.
通过检查风险管理文件来检查符合性。

10 Production and post-production activities
生产及生产后活动

10.1 General
一般要求
The manufacturer shall establish, documentand maintain a system to actively collect and review information relevant to the medical device in the production and post-production phases. When establishing this system, the manufacturer shall consider appropriate methodsfor the collection and processing of information.
制造商应建立,形成文件并保持一个系统,以便收集和评审医疗器械生产及生产后阶段的信息。在建立该系统时,制造商应考虑收集和处理信息的适当方法。
NOTE 1  See also 7.3.3, 8.2.1, 8.4 and 8.5 of ISO 13485:2016[5].
注1:另见ISO 13485:2016 [5]的7.3.3、8.2.1、8.4和8.5。

NOTE 2 See ISO/TR 24971[9] for guidance on production and post-production activities.
注2:关于生产和后期生产活动的指南,请参见ISO / TR 24971 [9]。
Compliance is checked by inspection of the appropriate documents.
通过检查风险管理文件来检查符合性。

10.2 Information collection
信息收集   
The manufacturer shall collect, where applicable:
制造商应在适用的情况下收集:
a) information generated during production and monitoring of the production process;
生产过程中的信息以及对监视生产过程的信息;
b)  information generated by the user;
用户提供的信息
c) information generated by those accountable for the installation, use and maintenance of the medical device;
由负责安装,使用和维护医疗器械的人员提供的信息;
d)  information generated by the supply chain;
供应链产生的信息
e)  publicly available information; and
公共可获得的信息
f) information related to the generally acknowledged state of the art.
关于现有新技术水平

NOTE Information related to the generally acknowledged state of the art can include  new  or revised  standards, published validated data specific to the application of the medical device under consideration, the availability of alternative medical devices and/ortherapies, and other information (see also ISO/TR 24971[9]).
注:与公认的最新技术水平有关的信息可以包括新的或修订的标准,针对正在考虑中的医疗设备的应用而发布的经过验证的数据,替代性医疗器械和/或疗法的可用性信息以及其他信息(另请参见ISO / TR 24971 [9])。

The manufacturer shall also consider the need to actively collect and review publicly available information about similar medical devices and similar other products on the market.
制造商还应考虑积极收集和评审有关市场上同类医疗器械和同类其他医疗器械公开信息的需要。
Compliance is checked by inspection of the appropriate documents.
通过检查相关的文件来检查符合性。

10.3 Informationreview
信息评审
The manufacturer  shall  review the  information  collected for possible  relevance  to safety, especially
whether:
制造商应评审所收集的信息是否与安全有关,尤其是:
—   previously unrecognised hazards or hazardous situations are present;
—   存在以前无法识别的危害或危害处境;
—   anestimated risk arising from a hazardous situation is no longer acceptable;
—   由危害处境引起的估计风险不再可接受;
—   the overall residual risk is no longer acceptable in relation to the benefits ofthe intended use; or
—   就预期用途的受益,总的剩余风险已不再可以接受;
—   the generally acknowledged state of the art has changed.
—   现有技术水平已经改变。
The results of the review shall be recordedin the risk management file.
评审结果应记录在风险管理文件中。
Compliance is checked by inspection of therisk management file.
通过检查风险管理文档检查符合性

10.4 Actions
行动
If the collected information is determined to be relevant to safety, the following actions apply.
如果确定收集到的信息与安全有关,则将采取以下措施。

1)   Concerning the particular medical device,
关于特定的医疗设备,

—   the manufacturer shall review the risk management file and determine ifreassessment of risks and/or assessment of new risks isnecessary;
—制造商应审查风险管理文件,并确定是否有必要重新评估风险和/或评估新的风险;

— if a residual risk is no longer acceptable, the impact on previously implemented risk control measures shall beevaluated and should be considered as an input for modification of the medical device;
如果剩余风险不再可接受,则应评估对先前实施的风险控制措施的影响,并应将其视为   医疗器械的输入;

—   the  manufacturer  should consider  the  need for  actions  regarding medical  devices  on  the market; and
制造商应考虑对市场上医疗器械采取行动的必要性;

—   any decisions and actions shall be recorded in the risk management file.
任何决定和行动均应记录在风险管理文件中。

2)   Concerning the risk management process,
2)关于风险管理流程,

—  the manufacturer shall evaluate  the  impact on  previously  implemented risk management activities; and
—制造商应评估对先前实施的风险管理活动的影响;

— the results of this evaluation shall be considered as an input for thereview of the suitability of the risk management process by topmanagement (see 4.2).
评估的结果应被视为最高管理者对风险管理过程的适用性进行审查的输入(见4.2)

NOTE Some aspects of  post-production  monitoring are the  subject  of some  national  regulations. In such cases, additional measures might be required (e.g. prospective post-production evaluations).
注:生产后监控的某些方面是某些国家法规的要求。在这种情况下,可能需要采取其他措施(例如,预期的生产后评估)。

Compliance is checked by inspection of therisk management file and other appropriate document
通过检查风险管理文档和其他适用的检查。

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发表于 2022-3-8 21:55:58 | 显示全部楼层
本帖最后由 逝去的耐0vd 于 2022-4-26 15:49 编辑

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