Tag: EN ISO 10993-1:2009

Change to EN ISO 10993-1

EN ISO 10993-1, Biological evaluation of medical devices. Evaluation and testing within a risk management process, has been released with a correction.  The error was introduced in 2010 when the document was released with Corrigendums 2 and 3.  This new corrected edition (with Corrigendum 4) solves the problem.

The correction is a missing word in table A.1.  The word was present in the original release of the standard, but omitted in the 2010 update.  Someone must have finally spotted it, as this edition reinserts the word!  It just goes to show you that when you are working with a standard and a minor revision is issued, you will likely focus on the correction and not review the balance of the publication.  It has taken 6 1/2 years for someone to notice…

However, standards developers must insist on complete and correct information.  So if you use the EN ISO 10993-1, you will need a copy of this corrected release.  Good news for you if you purchased your copy of the standard from Document Center Inc.  You will be able to get the update for a nominal service charge.  Just let us know you need it.  We will confirm that you purchased the original 2009 Edition from us and send you off your corrected copy.

Two things to note:  Many other standards distributors do not notify you when these types of minor corrections occur.  If you want to have complete notification services from your vendor, then purchase your standards from Document Center Inc.  We have been selling standards since 1982 and understand the challenges you face when working with compliance documents.

We have a full range of options for you, including reporting, notification, and access services.  We can tailor a standards solution to meet the needs of your organization.  Contact our staff by phone (650-591-7600) or email (info@document-center.com) for more information.  Or browse our catalog of over 1 million documents.  You can find them by number or by topic at www.document-center.com.

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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.