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1      Scope

The scope of this procedure is to provide a uniform approach to the CBTL and Manufacturer on how to assess and document compliance with the relevant clauses of IEC 60601 standard series related to the standard ISO 14971.

【该程序的范围是向CBTL和制造商提供统一的方法，以评估和记录与ISO 14971标准相关的IEC 60601标准系列的相关条款的合规性。】

2      Reference documents

IEC 60601-1:2005, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance【 IEC 60601-1：2005，医疗电气设备 - 第1部分：基本安全和基本性能的一般要求】

IEC 60601-1:2005 Incl. Am 1:2012, Medical equipment – Part 1: General requirements for basic safety and essential performance (Also known as IEC 60601-1:2005 + A1:2012)【IEC 60601-1：2005 包括 Am 1：2012，医疗设备 – 第 1 部分：基本安全和基本性能的一般要求（也称为 IEC 60601-1：2005 + A1：2012）】

IEC 60601-1-2:2007, Medical electrical equipment - Collateral standard: Electromagnetic compatibility - Requirements and tests

Note: The RM requirements are addressed through the IEC 60601-1:2005

【IEC 60601-1-2：2007，医疗电气设备 - 附带标准：电磁兼容性 - 要求和测试

注意：RM要求通过IEC 60601-1：2005解决】

IEC 60601-1-3:2008, Medical electrical equipment - Collateral Standard: Radiation protection in diagnostic X-ray equipment   【IEC 60601-1-3：2008，医疗电气设备 - 附属标准：诊断X射线设备中的辐射防护】

IEC 60601-1-6:2010, Medical electrical equipment - Collateral Standard: Usability

【IEC 60601-1-6：2010，医疗电气设备 - 辅助标准：可用性】

IEC 60601-1-8:2006, Medical electrical equipment - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems                         【IEC 60601-1-8：2006，医疗电气设备 - 附属标准：医疗电气设备和医疗电气系统中报警系统的一般要求，测试和指导】

IEC 60601-1-10:2007, Medical electrical equipment - Collateral Standard: Requirements for the development of physiologic closed-loop controllers

【IEC 60601-1-10：2007，医疗电气设备 - 附属标准：生理闭环控制器的开发要求】

IEC 60601-1-11:2010, Medical electrical equipment - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

【IEC 60601-1-11：2010，医疗电气设备 - 附属标准：家庭医疗保健环境中使用的医疗电气设备和医疗电气系统的要求】

IEC 62366:2007, Medical devices – Application of usability engineering to medical devices 【IEC 62366：2007，医疗器械 – 可用性工程在医疗器械中的应用】

IEC 62304:2006, Medical device software – Software life cycle processes 【IEC 62304：2006，医疗设备软件 – 软件生命周期流程】

ISO 14971:2000, Medical devices – Application of risk management to medical devices【 ISO 14971-2000 医疗器械 风险管理在医疗器械中的应用】

ISO 14971:2007, Medical devices – Application of risk management to medical devices【 ISO 14971-2007，医疗器械.风险管理在医疗器械中的应用】

IEC60601_1G, IECEE Test Report Form - IEC 60601-1: 2005 + CORR. 1(2006) + CORR 2 (2007) 【IEC60601_1G，IECEE 测试报告表 - IEC 60601-1：2005 + CORR. 1（2006） + CORR 2 （2007）】

IEC60601_1H, IECEE Test Report form - IEC 60601‑1: 2005 + AM1 (2012) 【 IEC60601_1H，IECEE 测试报告表 - IEC 60601 1： 2005 + AM1 （2012）】

3      Terms and definitions

For the purposes of this Operational Document, the terms and definitions of ISO 14971 standard and IEC  60601 standard series apply. 【就本操作文档而言，ISO 14971 标准和 IEC 60601 标准系列的术语和定义适用。】

For the purpose of this document, the Risk Management Process is a management system intended to address all activities related to ISO 14971. 【就本文档而言，风险管理流程是一个管理系统，旨在解决与ISO 14971相关的所有活动。】

For the purpose of this document, unless otherwise specified, the following conventions are used: 【出于本文档的目的，除非另有说明，否则将使用以下约定：】

·      IEC 60601-1:2005 or IEC 60601-1:2005 + A1:2012 designates "the general standard" alone;

·      IEC 60601-1 designates reference to IEC 60601-1:2005 and IEC 60601-1:2005 + A1:2012

·      IEC 60601-1-nn designates a specific collateral standard (this applies for all the collateral standards stated in this document where “nn” is the number of the collateral)

·      IEC 60601 series designates the combination of the general standard IEC 60601-1:2005/IEC  60601-1:2005 + A1:2012 and the collateral standards IEC 60601-1-nn.

·      ISO 14971 designates references to ISO 14971:2000 and ISO 14971:2007

·      【IEC 60601-1：2005或IEC 60601-1：2005 + A1：2012仅指定“通用标准”;

·      IEC 60601-1 指定对 IEC 60601-1：2005 和 IEC 60601-1：2005 + A1：2012

·      IEC 60601-1-nn 的引用（这适用于本文档中所述的所有附属标准，其中“nn”是附属品编号）

·      IEC 60601 系列指定通用标准 IEC 60601-1：2005/IEC 60601-1：2005 + A1：2012 和附属标准

·      IEC 60601-1-nn.ISO 14971 指定对 ISO 14971：2000 和 ISO 14971 的引用】

4      Application of Risk Management Principle for IEC 60601 series CB Scheme investigations风险管理原则在IEC 60601系列CB计划调查中的应用

4.1       General

The third edition of IEC 60601-1:2005 is the primary standard in a series of standards that covers safety and essential performance of medical electrical equipment. It is the first IEC standard in the scope of the CB Scheme that incorporates risk management principles according to ISO 14971:2000. The introduction of Risk Management is the reason for this Operational Document. IEC 60601-1：2005的第三版是涵盖医疗电气设备安全【和基本性能的一系列标准中的主要标准。它是CB计划范围内的第一个IEC标准，根据ISO 14971：2000纳入风险管理原则。风险管理的引入是本操作文档的原因。】

The existence of a CB Test Certificate does not solely establish legal market entry. However, it could be used to help substantiate a request for legal market access.【 CB测试证书的存在并不仅仅确立合法的市场准入。但是，它可以用来帮助证实关于合法市场准入的请求。】

This Operational Document is related solely to the IECEE CB Scheme and is intended for use by those individuals with a working knowledge of risk management for medical electrical equipment and the provisions of the IEC 60601 series.【 本操作文档仅与IECEE CB计划相关，旨在供具有医疗电气设备风险管理和IEC 60601系列规定的工作知识的个人使用】

NOTE: IEC 60601-1:2005 + A1:2012 incorporates risk management principles according to ISO 14971:2007. 【注：IEC 60601-1：2005 + A1：2012 根据 ISO 14971：2007 纳入风险管理原则。】

5      Assessment of Risk Management principles in the IEC 60601 series CB Scheme investigations IEC 60601系列CB计划调查中的风险管理原则评估

5.1       General principles

There is a general requirement to perform the risk management process as specified in ISO 14971:2000 (IEC  60601-1:2005, Clause 4.2.) or ISO 14971:2007 (IEC 60601-1:2005 + A1:2012, Clause 4.2.2).

【执行 ISO 14971：2000（IEC 60601-1：2005，条款 4.2）或 ISO 14971：2007（IEC 60601-1：2005 + A1：2012，条款 4.2.2）中规定的风险管理流程有一般要求。】

The registration to ISO 13485 is not sufficient to demonstrate that a risk management process compliant with ISO 14971 requirements is performed. There can be no investigation to IEC 60601 series without the manufacturer’s Risk Management File being available, unless specifically permitted by the rules of the CB Scheme. 【ISO 13485的注册不足以证明执行了符合ISO 14971要求的风险管理流程。除非CB计划规则明确允许，否则如果没有制造商的风险管理文件，则无法对IEC 60601系列进行调查。】

The CB Test Report and Certificate confirms that there is a Risk Management Process performed which complies with the risk management requirements of IEC 60601 series and the applicable requirements of ISO 14971. This does not mean that a complete Risk Management System in compliance with ISO 14971 is in place. The CB Test Report is only a snapshot in time and does not necessarily assess all top management responsibilities.【 CB测试报告和证书确认执行的风险管理过程符合IEC 60601系列的风险管理要求和ISO 14971的适用要求。这并不意味着符合ISO 14971的完整风险管理体系已经到位。CB测试报告只是及时的快照，并不一定评估所有最高管理层的职责。】

Several clauses of ISO 14971 define the requirements for the application of the Risk Management Process to “the particular medical device being considered”. When those clauses of ISO 14971 are used to address Risk Management requirements in IEC 60601-1, the verification shall confirm whether the Risk Management Process is correctly applied to the particular Device Under Evaluation/Test. 【ISO 14971的几个条款定义了将风险管理流程应用于“正在考虑的特定医疗器械”的要求。当ISO 14971的这些条款用于解决IEC 60601-1中的风险管理要求时，验证应确认风险管理流程是否正确应用于正在评估/测试的特定设备。】

A separate certification of registration to ISO 14971 indicates that a risk management system conforming to ISO 14971 is in place, but does not necessarily provide the risk management device specific documentation to meet the requirements of IEC 60601 series. IEC 60601 series requires specific Risk Management activities to be done and the CB Test Report requires objective evidence that these activities have been performed for the Device Under Test. 【ISO 14971的单独注册认证表明符合ISO 14971的风险管理系统已经到位，但不一定提供风险管理设备特定的文档以满足IEC 60601系列的要求。IEC 60601系列要求进行特定的风险管理活动，CB测试报告要求客观证据证明这些活动已针对被测设备执行。】

A CB Scheme Test Certificate does not imply that an audit of the manufacturer’s Risk Management System was conducted. 【CB计划测试证书并不意味着对制造商的风险管理系统进行了审核。】

In view of the above and similar to the second edition, the CB Test Report according to IEC 60601-1 is not necessarily a guarantee of certification by an accepting NCB. 【鉴于上述情况，与第二版类似，根据IEC 60601-1的CB测试报告不一定保证接受NCB的认证。】

A certificate of registration may be requested for local or regional certification to IEC 60601 series as it relates to follow-up services. There may be differences in requirements that are the subject of local legal market entry requirements. 【IEC 60601系列的本地或区域认证可能会要求注册证书，因为它与后续服务有关。在当地合法市场进入要求的要求方面可能存在差异。】

5.2      Implementation of ISO 14971 into the IEC 60601 series【在 IEC 60601 系列中实施 ISO 14971】

In the clauses of IEC 60601-1 series there are three types of references to ISO 14971 Risk Management requirements: 【在IEC 60601-1系列的条款中，有三种类型的ISO 14971风险管理要求参考：】

a)   Direct reference to Risk Management Process as specified by ISO 14971 (for example clause 4.2 or 4.2.2). 【直接引用ISO 14971规定的风险管理流程（例如条款4.2或4.2.2）。】

b)   Test related references to give appropriate alternative to the application of laboratory testing with specific pass/fail criteria or to select appropriate tests to be performed on the specific product (for example clause 5.7).【测试相关参考文献，以适当的替代方案来应用具有特定通过/未通过标准的实验室测试，或选择对特定产品进行的适当测试（例如条款5.7）。】

c)   Indirect reference to offer additional elements to be considered in the implementation of the Risk Management Process specified by ISO 14971 for the specific product. (for example clause 14.1) 【间接参考，提供在实施ISO 14971为特定产品指定的风险管理流程时要考虑的其他要素。（例如条款 14.1）】

The manufacturer can also identify alternative means to provide an equivalent safety level to IEC 60601 series. The manufacturer may implement new and original approaches to developing effective means of protection against unacceptable risks. The manufacturer must verify that the residual risks that result from applying the alternative means are equal to or less than the residual risks that result from applying the requirements of IEC 60601 series. All these activities must be performed in accordance with the requirements of ISO 14971. 【制造商还可以确定替代方法，以提供与IEC 60601系列等效的安全等级。制造商可以实施新的和原始的方法来开发有效的保护手段，以防止不可接受的风险。制造商必须验证应用替代方法产生的残余风险等于或小于应用IEC 60601系列要求所产生的残余风险。所有这些活动必须按照ISO 14971的要求进行。】

Clause 4.2 of IEC 60601-1:2005 and Clause 4.2.2 of IEC 60601-1:2005 + A1:2012 do not require post market monitoring (e.g. clause 9 of ISO 14971) of the effectiveness of the risk control measures IEC 60601-1：2005 【第 4.2 条和 IEC 60601-1：2005 + A1：2012 第 4.2.2 条不要求对风险控制措施的有效性进行上市后监控（例如 ISO 14971 第 9 条）】

Tables appended in Clause 6 of this Operational Document provide mapping with all the clauses of IEC  60601-1 and the IEC collaterals standards which require risk management, and the applicable clauses in ISO 14971. These tables provide guidance and considerations for application and assessment of RM criteria. 【本操作文档第6条所附的表格提供了IEC 60601-1和IEC附属标准中所有需要风险管理的条款以及ISO 14971中适用条款的映射。这些表为RM标准的应用和评估提供了指导和注意事项。】

5.3       ISO 14971:2000 (1^st edition) and ISO 14971:2007 (2^nd edition) 【ISO 14971：2000（第1版）和ISO 14971：2007（第2版）】

The process of standards development progresses over a significant length of time. The IEC 60601 series of standards to which this Operational Document refers were published between 2005 and 2010. When IEC 60601-1:2005 was published and consequentially its collateral standards published, the risk management standard used as reference was the ISO 14971:2000.【标准制定过程在很长一段时间内进行。本操作文档所指的IEC 60601系列标准于2005年至2010年间发布。当IEC 60601-1：2005发布并因此发布其附属标准时，用作参考的风险管理标准是ISO 14971：2000。】

This situation is not valid when referring to IEC 60601-1-6:2010 which includes a direct link to IEC 62366:2007. The IEC 62366:2007 also refers directly to ISO 14971:2007.  This situation is also not valid when referring to IEC 60601-1:2005 + A1:2012 which also makes a direct reference to ISO 14971:2007. 【当引用 IEC 60601-1-6：2010（包括与 IEC 62366：2007 的直接链接）时，这种情况无效。IEC 62366：2007 还直接参考了 ISO 14971：2007。 当参考IEC 60601-1：2005 + A1：2012时，这种情况也无效，这也直接引用了ISO 14971：2007。】

For this reason, in the tables appended that provide mapping with all the clauses of IEC 60601 series, the following references have been made: 【因此，在附加的表中，提供了IEC 60601系列所有条款的映射，并进行了以下参考：】

·     ISO 14971:2000 clauses are used to address the risk management process required by IEC 60601-1 series aligned with IEC 60601-1:2005;【ISO 14971：2000条款用于解决IEC 60601-1系列与IEC 60601-1：2005一致的风险管理流程;】

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