31 Oct 2011

This blog has explored a number of topic areas as it relates to Third Edition. Intertek expert and technical lead for North America, Todd Konieczny, has provided insight into these topics and answered incoming questions on this matter.

Today, Todd addresses the compliance specifics for Third Edition. Recently, there has been much discussion from medical device manufacturers on the specific standards that they need to meet in order to be compliant with Third Edition. More specifically, this discussion will most likely increase as companies work with third-party organizations to meet the Third Edition deadline of June 2012.

“Completing risk management to ISO 14971 is nothing new for medical device manufacturers in the US or the EU,” said Todd K Konieczny, North American Technical Lead for Intertek. “With the release of the new 60601-1, Third Edition, compliance with ISO 14971 is also now required for product certification. There are four main standards that medical device manufacturers need to meet for this Edition.”

These four standards include the following:

  1. ANSI/AAMI ES60601-1: 2005
  2. CAN/CSA-C22.2 No. 60601-1: 2008
  3. CENELEC EN 60601-1: 2006
  4. IEC 60601-1: 2005

If you and/or your company would like to know more about how to meet compliance for the Third Edition deadline (June 2012) or would like to speak with Todd about your upcoming project, please send an e-mail to ThirdEdition@intertek.com.
To learn more on this subject matter, please visit www.intertek.com/medical.

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