Tag: EN-ISO-14971:2009

European Risk Management Standards center on Medical Devices

Looking for European Standards on risk management?  If you’re interested in EN standards specific to the region, you’ll find most are focused on medical devices and laboratories.  And they’re almost all adoptions of ISO and IEC standards as well!

Here’s a list with links to the existing Official English language editions of the EN standards on Risk Management:

EN 31010:2010 Risk management – Risk assessment techniques,

CEN ISO/TS 22367:2010 Medical laboratories – Reduction of error through risk management and continual improvement (ISO/TS 22367:2008, including Cor 1:2009),

EN ISO 10993-1:2009 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009) – Includes Corrigendum 1,

EN ISO 22442-1:2007 Medical devices utilizing animal tissues and their derivatives – Part 1: Application of risk management (ISO 22442-1:2007),

EN ISO 14971:2009 Medical devices – Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01),

EN 80001-1:2011 Application of risk management for IT-networks incorporating medical devices – Part 1: Roles, responsibilities and activities,

EN ISO 17666:2003 Space systems – Risk management (ISO 17666:2003),

EN ISO 15743:2008 Ergonomics of the thermal environment – Cold workplaces – Risk assessment and management (ISO 15743:2008),

EN 15975-1:2011 Security of drinking water supply – Guidelines for risk and crisis management – Part 1: Crisis management, and

EN 62305-2:2006 Protection against lightning – Part 2: Risk management.

EN standards are not available as stand-alone items, but only as reprints by each country in the European Union, released as the EN is adopted.  The official English language editions and other national issues are all available from Document Center Inc. at our website, www.document-center.com.  You may prefer to contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’re here from 8 am to 5 pm Monday through Friday California time to help you with your standards requirements and questions.

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 (www.document-center.com)