ANSI/AAMI/ISO 25539-1 2017 Released

ANSI/AAMI/ISO 25539-1 has just been updated.  The new 2017 Edition is available from Document Center Inc. in both paper format and for pdf download.  The title is Cardiovascular implants – Endovascular devices – Part 1: Endovascular prostheses.  It is the U.S. national adoption of ISO 25539-1 from 2017.

What is a national adoption of an ISO standard?  It is an authorized reprint of an international standard.  It may be a translation from the original ISO text.  For U.S. adoptions, the spelling is modified to support American conventions from the original British.  In the case of AAMI, these national editions are possible because AAMI is the U.S. TAG (Technical Advisory Group) participation in the writing of ISO and IEC standards for medical devices.  Many times national adoptions are less expensive, since all the proceeds go only to the publisher and do not have to be shared with ISO.

Where is the ANSI/AAMI/ISO 25539-1 an authorized edition?  Normally national adoptions are for use in the country where they are published.  With medical device standards, there are other regulatory concerns.  Many of these AAMI adoptions are called out for FDA compliance.  So the use of the U.S. adoptions may be required for medical devices manufactured and/or sold in the U.S.

How do I know if ANSI/AAMI/ISO 25539-1 is required by the FDA?  This publication has just been released.  It will take a while for the FDA to review it and determine if there are national differences necessary for U.S. compliance.  To find out the status for a document in the U.S., go to the FDA Recognized Consensus Standards Search Page.  Put the document number only in the standard designation search field.  The results of the search will show you what document editions are authorized by the FDA.

In the case of the 25539-1, currently the previous ISO edition is in force.  This means that right now, the FDA requires you to meet the ISO 25539-1 1st Edition (2001) with Amendment 1 (2005).  I would expect this to be updated with information on either the ISO 25539-1 2nd Edition (2017), the ANSI/AAMI/ISO adoption (2017) or both.

To get a full run-down on the changes in the new 2017 Edition, take a look at the Introduction on Page viii.  Here the committee has provided you with an “executive summary” of the updates.

To get your copy, use Document Center Inc.  We’ve been selling standards since 1982 and we are an authorized AAMI distributor.  Go to our webstore at www.document-center.com or directly to the order page for ANSI/AAMI/ISO 25539-1.

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