IEC - TR 60601-4-3 (REDLINE + STANDARD)
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
|Publication Date:||1 December 2018|
|ICS Code (Medical equipment in general):||11.040.01|
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/AMD1:20
- 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/inte
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/inte