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现行 IEC TR 60601-4-3:2018 RLV
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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 RLV包含IEC官方国际标准及其红线版本。Redline版本不是官方文档,它只有英文版本,为您提供了一种快速简单的方法来比较IEC官方标准与其以前版本之间的所有变化。 IEC TR 60601-4-3:20 18包含由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 60601-1后续版本的人员。 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 RLV contains both the official IEC International Standard and its Redline version. The Redline version is not an official document, it is available in English only and provides you with a quick and easy way to compare all the changes between the official IEC Standard and its 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.
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归口单位: TC 62/SC 62A
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现行
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IEC TR 60601-4-5-2021
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IEC TR 60601-4-4-2017
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IEC TR 60601-4-3-2018
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IEC TS 60601-4-6-2024
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