IEC/TR 60601-4-3 Ed. 2.0 en:2018

Current Revision
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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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

PUBLISH DATE 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.

IEC TR 60601-4-3:2018 is available as IEC TR 60601-4-3:2018 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.

IEC TR 60601-4-3:2018 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.

IEC TR 60601-4-3:2018 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 IEC TR 60601-4-3:2018 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.

IEC TR 60601-4-3:2018 cancels and replaces the first edition of IEC 60601-4-3 published in 2015.

This edition constitutes a technical revision. IEC TR 60601-4-3:2018 includes the following significant technical changes with respect to the previous edition: addition of 47 new recommendations.

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