EN ISO 10993-11 2018 is here! It’s the European adoption of the ISO-10993-11 issued in 2017. The title of the standard is Biological evaluation of medical devices. Tests for systemic toxicity. While the 2009 Edition of this standard is still part of the harmonized lists for 2007/47/EC, 90/385/EEC, and 93/42/EEC, acceptance of this new 2018 edition is expected.
Changes in the standard reflect the changes in the ISO 10993-11 from 2017. Here is a list of the guidance on them provided by ISO:
- Reduction in the group size for chronic toxicity testing (see Table 1)
- Annex F has been renamed Annex G and a new Annex F has been added
- Annex H was also added
- the Bibliography was updated.
Toxicity testing provides evidence that a medical device is safe to use for its intended purpose. This standard provides you with a framework for conducting a systemic toxicity study.
For this article, I reviewed the BS EN ISO 10993-11 2018 Edition. Although the European standard references the ZA and ZB Annexes, I don’t find them in this publication. We may be soon seeing an update to this particular national edition, as the European Annexes provide detailed information on how the standard relates to the 3 medical device directives.
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