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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