IEC TR 60601-4-3 REDLINE

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: IEC
Publication Date: 1 December 2018
Status: active
Page Count: 304
ICS Code (Medical equipment in general): 11.040.01
scope:

This part of IEC 60601, which is a Technical Report, 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.

This document 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 this document 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.

NOTE There might be other acceptable solutions which are not reflected in this document. The reader is reminded that, although a majority of the National Committee members of IEC/SC 62A have approved publication of this document, the contents remain the opinion of the expert members having participated in the drafting of the document. These recommendations/interpretations are the result of considerations by this group of nominated experts and have not been formally adopted through any National Committee voting procedure. Distribution is only for information.

Document History

IEC TR 60601-4-3 REDLINE
December 1, 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
This part of IEC 60601, which is a Technical Report, contains a series of recommendations developed by an expert working group of IEC subcommittee 62A in response to questions of interpretation of...

References

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