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

Medical electrical equipment - 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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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.