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ISO-14971 – A guide to the document and it’s many reprints

Kyle Bach

ISO-14971:2007,  Medical devices — Application of risk management to medical devices, is a critical component to any medical device manufacturers core standards collection. However, many users get confused by the many adoptions and reprints of this standard.

According to ISO, the document itself “specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.”

It is an integral part of the Medical Device Quality Management System outlined by ISO-13485, Medical devices — Quality management systems — Requirements for regulatory purposes.

But the fact that the document is essential to a Medical Devices Quality system has meant that the document has been adopted and reprinted the world over.  The existence of many documents with “ISO-14971” in the document number but with differing dates makes choosing the right document difficult for some.

The reason for the many adoptions is the very popularity of the document itself.  For example, the European union has a scheme in place (harmonized standards) so that the requirements of legislation translate into regulation based on EN standards.   These standards have been produced under a mandate from the European Commission and adopted by Member States under the “New Approach” Directive.  And the EU is partial to the use of ISO standards whenever possible.

When legislation requires risk management to be adopted by companies selling medical devices in Europe, the use of the ISO-14971 is promptly identified as the standard to use.  However, the administrative process requires the ISO document to be adopted by the EU as an EN standard and then made publicly available as adoptions by the various countries of the EU as they are being put into use.  The BS-EN-ISO-14971 is the official English language edition, DIN-EN-ISO-14971 is the official German language edition, and so on.

Unfortunately, administrative activities have caused the issuance of 2009 Editions of the EN adoptions, out of sync with the current 2007 Edition of the ISO source document.  Customers do not realize that the ISO itself is stable in both the EN-14971:2007 and EN-14971:2009 Editions.  Only the administrative EN information has changed.

Another factor in the widespread reissuing of this document is the fact that when a country participates in the development of an ISO standard, they receive the right to reprint the standard in a national translation.  So, because AAMI is the U.S. “tag” (participant) for this committee, we have an American release of this standard, ANSI/AAMI/ISO-14971 2007 Edition.  The document has administrative information particular to the U.S. in the opening pages, much like the EN adoption.   Then the ISO edition is reprinted verbatim, except where English spelling conventions have been translated into the U.S. format (like “colour” vs. “color”).

You will find similar adoptions in Canada, Russia, Japan, and so on.

Our only comment to our customers is that the higher up the food chain you go, the “fresher” your information will be.  That is, the source document, ISO-14971, changes first and is released first.  Then each organization that issues a reprint of the item must go through the administrative formalities of adopting the new information.

However, many times the national translations of the ISO documents can be less expensive than the source material.  So if cost is a concern, you may want to check out the AAMI/ISO edition of the 14971.

Of course, to purchase ISO-14971 or the other documents mentioned above, they’re available from Document Center Inc. at www.document-center.com, info@document-center.com, and by phone at +650-591-7600 or fax at +650-591-7617.