PD IEC/TR 60601-4-3:2015 - Page 2

Medical electrical equipment. Guidance and interpretation. Considerations of unaddressed safety aspects in the third edition of IEC 60601-1 and proposals for new requirements | Status: Superseded, Withdrawn

1 Scope and object

1.1 Scope

This technical report 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. This technical report 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 and IEC 60601-1:2005/AMD1:2012, and
• — 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 a future revision of IEC 60601-1.