60601-1 Third Edition Overview Outlines Adoption in U.S., Canada & EU

by admin on Oct.21, 2011, under Medical, Product Safety

Last week, MET Labs hosted a 60601-1 Third Edition Overview webinar.  The webinar was very popular, so we are following up with a transcription of many of the key points.

About half of the presentation was devoted to regional acceptance.

United States
In the U.S., the current standard is UL 60601-1 First Edition, with revisions through April 26, 2006.

  • Based on IEC 60601-1 Second Edition with Amendment 1 and Amendment 2
  • Requires use of Particular Standards or Part 2s
  • Collateral standards are optional

AAMI ES60601-1:2005 incorporates Amendment 2: 2010

  • Based on IEC 60601-1 3rd Edition
  • FDA will accept now as well as previous version
  • FDA has stated they will mandate acceptance by July 1, 2013
  • OSHA has not yet recognized this edition

OSHA, which governs the NRTL program, is concerned with the new concepts of risk-based hazard analysis and the Risk Management File.  It does not yet recognize it nor endorse certification bodies to certify to it.  It may be prudent to consider obtaining current edition and 3rd edition certification.

Canada
In Canada, the current standard is CSA C22.2 601.1-M90 First Edition, revised through November 2003.

  • Based on IEC 60601-1 Second Edition
  • Requires use of Particular Standards or Part 2s
  • Collateral standards are required

Canada also recognizes CSA C22.2 No. 60601-1-08, which is based on the Third Edition.

Switchover date from 2nd edition to 3rd edition is June 2012.

European Union
In Europe, the current standard is EN 60601-1, with amendments through January 1996.

  • Based on IEC 60601-1 Second Edition
  • Requires use of Particular Standards or Part 2s
  • Collateral standards are required

EU also recognizes EN 60601-1, incorporating corrigendum March 2010, which is based on IEC 60601-1 Third Edition.

Switchover date from 2nd edition to 3rd edition is June 2012.

CB Scheme
For the CB Scheme, the current standard is IEC 60601-1 Second Edition, with amendment 1.

  • Requires use of Particular Standards or Part 2s
  • Collateral standards may be required

CB Scheme also recognizes IEC 60601-1 Third Edition.  Participating countries determine which edition they accept.

Stay tuned.  Next week we will cover the other half of the webinar: Key changes in the 3rd edition of 60601-1.

Find out more about product safety testing and certification of electrical medical equipment.

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2 Comments for this entry

  • Dan

    If I have a product that I tested in 2nd edition (year ago), should I retest the product to comply with 3rd edition?
    Thanks,
    Dan

    • admin

      Definitely Europe, possibly Canada. Traditionally Canada (and the U.S.) have allowed previously certified products to continue to ship as-is and remain certified to the previous edition as long as no technical changes are made to it. We haven’t seen anything official yet. Safe bet is to recertify. For a free project review, contact MET: info@metlabs.com or 410.354.3300

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