IEC TR 60601-4-3:2018-医用电气设备第4-3部分:指南和解释IEC 60601-1第三版中未提及的安全方面的考虑和新要求的建议-国家数字标准馆

现行 IEC TR 60601-4-3:2018

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Medical electrical equipment - Part 4-3: Guidance and interpretation - Considerations of unaddressed safety aspects in the third edition of IEC 60601-1 and proposals for new requirements 医用电气设备第4-3部分:指南和解释IEC 60601-1第三版中未提及的安全方面的考虑和新要求的建议

发布日期： 2018-12-13

IEC TR 60601-4-3:20 18作为IEC TR 60601-4-3:20 18 RLV提供，其中包含国际标准及其红线版本，显示了与上一版本相比技术内容的所有变化。IEC TR 60601-4-3:20 18包含IEC小组委员会62A的专家工作组针对IEC 60601-1:20 05和IEC 60601系列中相关附属标准的解释问题制定的一系列建议。IEC TR 60601-4-3:20 18主要用于:
-医疗电气设备制造商；
-测试实验室和其他负责评估是否符合IEC 60601 1:20 05，？IEC 60601-1:20 05/AMD1:2012、IEC 60601-1-8:20 06、IEC 60601-1-8:20 06/AMD1:2012、IEC 60601-1-11:20 10、IEC 60601 11:20 15和IEC 60601-1-12:20 14；
-开发IEC 60601后续版本的人员-1.
在编写IEC 60601-1第三版时考虑了IEC TR 62296第一版中的建议。同样，预计在准备IEC 60601-1和IEC 60601系列中相关附属标准的未来修订版时，将考虑IEC 60601-4-3中的这些建议。IEC TR 60601-4-3:20 18的目的是向对IEC 60601-1第三版和适用辅助标准的应用感兴趣的人员提供建议/解释。IEC TR 60601-4-3:20 18取消并取代2015年发布的第一版IEC 60601-4-3。本版构成技术修订版。IEC TR 60601-4-3:20 18相对于上一版本包括以下重大技术变更:增加了47项新建议。

IEC TR 60601-4-3:2018 is available as IEC TR 60601-4-3:2018 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.

IEC TR 60601-4-3:2018 contains a series of recommendations developed by an expert working group of IEC subcommittee 62A in response to questions of interpretation of IEC 60601-1:2005 and related collateral standards in the IEC 60601 series. IEC TR 60601-4-3:2018 is primarily intended to be used by:

– manufacturers of medical electrical equipment;

– test laboratories and others responsible for assessment of compliance with IEC 60601 1:2005,？ IEC 60601-1:2005/AMD1:2012, IEC 60601-1-8:2006, IEC 60601-1-8:2006/AMD1:2012, IEC 60601-1-11:2010, IEC 60601 1 11:2015 and IEC 60601-1-12:2014;

– those developing subsequent editions of IEC 60601-1.

The recommendations in the first edition of IEC TR 62296 were considered in preparing the third edition of IEC 60601-1. Similarly, it is expected that these recommendations within IEC 60601-4-3 will be considered when preparing future revisions of IEC 60601-1 and related collateral standards in the IEC 60601 series. The object of IEC TR 60601-4-3:2018 is to make the recommendations/interpretations available to those interested in the application of the third edition of IEC 60601-1 and applicable collateral standards. IEC TR 60601-4-3:2018 cancels and replaces the first edition of IEC 60601-4-3 published in 2015. This edition constitutes a technical revision. IEC TR 60601-4-3:2018 includes the following significant technical changes with respect to the previous edition: addition of 47 new recommendations.