BS EN ISO 10993-10, “Biological evaluation of medical devices. Tests for irritation and skin sensitization,” has just been updated and the new 2013 Edition is available from Document Center Inc. now. The new revision replaces the previous EN ISO 10993-10 2010 Edition with Corrigendum 1 (correction sheet). You’ll want to get this new copy if you export your medical devices to Europe.
Of course, you may be confused when you learn that the new EN ISO 10993-10 2013 Edition is actually the adoption of ISO 10993-10, 3rd Edition from 2010. The previous edition of the EN adoption was the ISO 10993-10 3rd edition too! So what changed to generate this release of a completely new revision?
As we’ve discussed in this blog before, when in doubt with these “out-of-sync” adoptions of ISO standards by the European Union, look to the Annexes! These informative sections are often the culprits that cause the republication of EN adoptions of ISO standards in a different time frame from the ISO originals.
This is especially true for those EN adoptions that relate to the medical device directives. Clarification of the relationship between adoptions of specific ISO standards and the Directives that they are “harmonized” to is causing almost a churning effect, with the EN adoptions being reissued more frequently than normal.
For the BS EN ISO 10993-10, this is completely the case. The qualifying remarks/notes area of the tables of both Annex ZA and ZB have been changed, and if you use this standard, you’ll want to take note. In ZA, Clauses 4, 5, 6, 7, 8 and Annexes A, B, and C are still covered. However, the relationship to 3 Essential Requirements (ER) in the 93/42/eec have changed – ER 7.1, ER 7.2, and ER 7.5. For the directive 90/385/eec, the presumptions of conformity are impacted for ER 9.
Yes, it is a challenge for the medical device community. When the ISO standards for medical devices were originally issued, it was felt that the EN adoptions would lead to compliance and that would be the end of it. But during the last few years, a number of concerns have been raised by the regulators at the European Union. You can trace these concerns in the history of these Annexes that have been added to the standards in the EN editions only.
Of course, it would be nice if there was some other method of communicating these issues rather than forcing users to continually re-purchase the documents to get the latest Annex information. But, unfortunately, that’s not the case. If you certify to the standard, you need to purchase each new edition as it is released.
All of these BS EN ISO standards are available from Document Center, an authorized dealer of the BS Official English Language editions of the EN documents. You can order at our webstore, www.document-center.com. Or you can contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com). One thing you can be sure of — When you want to know what has occurred to generate a new revision like this one, Document Center is one of the few resources at your disposal that can actually offer you an explanation.
That’s why so many standards users prefer Document Center Inc. We have a complete range of standards services that support your use of this compliance information. And our knowledgeable staff are able to respond to your requirements quickly and competently. Make us your Standards Experts!
