New ISO/TR 15499 standard available on Biological evaluation of medical devices — Guidance on the conduct of biological evaluation within a risk management process

ISO/TR 15499:2012, “Biological evaluation of medical devices — Guidance on the conduct of biological evaluation within a risk management process,” has just been released and is now available from Document Center Inc.  The new Technical Report provides guidance on conduct of biological evaluation of medical devices according to the requirements of ISO 10993-1.

This document can be used to better understand the requirements of ISO 10993-1 and to illustrate some of the variety of methods and approaches available for meeting the requirements of ISO 10993-1.  Biological evaluation is a design verification activity which is set in the context of broader risk management processes. This means ISO/TR 15499 includes guidance on the application of ISO 10993-1 in the context of risk management processes conducted according to the requirements of ISO 14971.

Guidance contained in this Technical Report can also be useful as background information for those representing risk management process assessors, conformity assessment bodies and regulatory enforcement bodies.

ISO standards are sold by Document Center Inc. under license agreement at our webstore,  Or contact us by phone (650-591-7600), fax (650-591-7617) or email (  We can assist you with the standards questions and requirements that affect your business.

New BS EN ISO 14971 Medical devices. Application of risk management to medical devices Corregendum 1 for 2009 Edition

BS EN ISO 14971:2009 has been reissued with a new Corrigendum 1 as of February 2011.  The document is titled “Medical devices. Application of risk management to medical devices.”  It’s available for purchase from Document Center Inc.

The EN Corrigenda are corrections that are interfiled directly into the standard they modify.  For example, the Corrigendum 1 for  the BS EN ISO 14971:2009 corrects the pagination of the document.  So, there is no page within the document that describes the change.  It is just included by correcting the way the pages are numbered.

The EN ISO 14971 is a major European medical devices standard.  The BS EN ISO 14971 is the official English language edition.  It continues to adopt the ISO-14971:2007 Edition.

The standard 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.

The requirements of ISO 14971:2007 and its various adoptions are applicable to all stages of the life-cycle of a medical device.

The EN ISO 14971 is one of the “harmonised” standards for the Medical Devices Directive (93/42/eec), which means that by meeting the requirements of the standard there is the presumption of conformity with the essential requirements of the directive.

Both ISO 14971 and BS EN ISO 14971 are available for purchase from Document Center Inc.  Check out our website at or send us an email at, phone us at 650-591-7600 or send a fax to 650-591-7617.  We’re happy to help you with all your Standards Requirements.

Is BS-EN-ISO-14971 identical to ISO-14971?

Here at Document Center Inc. we have bought in to the concept of “One Standard, One Test, Accepted everywhere”, the theme of World Standards Day 2002.

So when BSI, the British Standards Institute,  states that BS-EN-ISO-14971 (Medical devices. Application of risk management to medical devices) is identical to both EN ISO 14971:2009 and  ISO 14971:2007, we believe it.

However, we’ve heard of a couple of cases where auditors at customer sites have not accepted the ISO-14971 2007 Edition as being equal to the BS-EN-ISO-14971 2009 Edition for use in certifying to the EU Medical Device Directive.

We are putting out a call to the auditors themselves to see if we can get clarification on why the documents are not interchangeable for purposes of meeting the EU Directive requirements.

Having to purchase multiple copies of a single  ISO standard to meet certification requirements for different jurisdictions is problematic.  The costs can rise rapidly and references to multiple versions of a document can be cumbersome and difficult to manage when updates are made.

Do you have an opinion on this?  Are you an auditor who can speak with authority on this issue?  We ‘d love to hear from you.

Claudia Bach, President, Document Center Inc (

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

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,, and by phone at +650-591-7600 or fax at +650-591-7617.