New IEC 62353 Edition 2.0 – Medical Equipment Testing

Once medical electrical equipment leaves the manufacturing floor, there is still the question of routine testing to assure correct performance over time.  And this can include the question of putting a piece of equipment back into use after repair as well.  The IEC 62353 was developed to assist equipment designers and users develop processes for this type of testing to complement the IEC 60601-1 standard.  Titled “Medical electrical equipment – Recurrent test and test after repair of medical electrical equipment,” the new IEC 62353 Edition 2.0 updates and  replaces the original first edition from 2007.

What does the IEC 62353 contain?  It covers the general requirements for testing prior to putting into service, after modifications, after repair, and as part of a recurrent testing protocol.  It gives you  the tests that should be performed under these circumstances.  And it discusses the reporting of the results of your testing and how to evaluate your findings.

Who should be using this standard?  It is intended for use by equipment manufacturers, testing equipment manufacturers, regulatory authorities, equipment suppliers, service personnel and organizational equipment users.

What are the changes in the new 2014 Edition?  As a technical revision, you’ll find important changes in the new revision.  The major changes are:

  • clarification of clause 5.3.4.1 on the measurement of leakage currents (plus more information in Annex A)
  • revision of the protective earth resistance requiprements
  • the addition of expected minimum insulation resistance values in Table 2 and
  • the reordering of the testing sequence found in Annex B.

This document is full of information to assist the user set up and maintain a testing plan for medical electrical equipment.  The 8 Annexes cover a wide range of topics that you’ll want to review, from testing intervals to examples of test documentation.  There’s no shortage of tables illustrating important points and values.  And a 12 item bibliography completes the document.

You’ll want to get a copy of the new edition and you can order it online at the Document Center webstore, www.document-center.com.  Or contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  You’ll be able to get the IEC 62353 in paper format, for pdf download, or as part of our multi-user online subscription service.  It will come with our best-in-class notification service.  And we have a wide array of additional services that can help you use and maintain your standards more effectively.

Document Center Inc. has been serving customers like you since 1982 from our Silicon Valley location.  We have the experience you need for optimizing your compliance documentation.  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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