DS/IEC TR 60601-4-3

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

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Organization: DS
Publication Date: 18 December 2018
Status: active
Page Count: 148
ICS Code (Medical equipment in general): 11.040.01
scope:

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.

Document History

DS/IEC TR 60601-4-3
December 18, 2018
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
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...
May 19, 2015
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
IEC TR 60601-4-3:2015(E) is intended to convey the results of WG 14's work to interested parties such as manufacturers and test laboratories while retaining the informative nature of the material....
IEC TR 60601-4-3 ED2: 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
This document contains a series of recommendations developed by an expert working group of IEC subcommittee 62A in response to questions of interpretation of the third edition of IEC 60601-1 and...
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