IEC TR 60601-4-3 Released – Recommendations for IEC 60601-1

IEC TR 60601-4-3, “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,” has just been released.  This new Technical Report provides the user with insight into areas in the existing edition of IEC 60601-1 that expert users feel need to be updated.  For manufacturers of medical electrical equipment, the testing labs they use, and the developers of the next edition of the IEC 60601-1 standard, this represents an early review of questions on interpretation that have come up and the working group’s recommendations for each.

This is a lengthy document, numbering 100 pages, with tabular information for 93 recommendations.  Each item is presented in the same format, a grid with the following fields on the left and the committee’s data on the right:

  • Recommendation number
  • Requirement, clause/subclause numbering from the IEC 60601-1
  • Source/problem as submitted to the working group (WG 14)
  • Discussion/comment from the submitter of the initial question
  • Submitter proposed recommendation when available
  • The working group final recommendation

Annex A provides you with a table that is sorted by the IEC 60601-1 clauses in numerical order, so that you can easily find any recommendations for a specific clause in the original document.  A 5-page bibliography completes the report.  It looks like only Clauses 1, 6, and 12 have managed to squeak by without suggested changes!

Why would you care about these recommendations?  One critical issue for medical electrical equipment manufacturers is meeting new requirements within the “grace period” for transitioning from one edition of a standard to the next.  Gap analysis can be extensive and changes to products, assembly lines, and required tests take time.  A document like the IEC TR 60601-4-3 provides you with a preliminary review of the areas where changes are possible and the likely outcomes.  Further, if there are recommendations that you feel are not “best practices,” you now have time to contact the TAG (technical advisory group) in your country that participates in the development of the IEC 60601-1 with your concerns.  This is a proactive stance that has come to be known as strategic standardization.

Meantime, you’ll want to get a copy of IEC TR 60601-4-3 from an authorized distributor and Document Center Inc. is your answer!  Head to our webstore at www.document-center.com and order online in both paper and pdf format.  Or contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com) to learn more about our Standards Online multi-user subscription service.  We have the tools for you to use to manage your standards in a cost-effective and compliant way.  Make us your Standards Experts!

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Claudia Bach

Claudia Bach is the President of Document Center Inc. and a world-wide recognized expert on Standards and Standards Distribution. You can connect with her on Google+

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