English -- 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 - Edition 2.0

Abstract

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.