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About This Item
Full Description
This part of ISO 10993 includes:
- a) pretest considerations for irritation, including in silico and in vitro methods for dermal exposure;
- b) details of in vivo (irritation and sensitization) test procedures;
- c) key factors for the interpretation of the results.
Instructions are given in Annex A for the preparation of materials specifically in relation to the above tests. In Annex B several special irritation tests are described for application of medical devices in areas other than skin.
Document History
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ISO 10993-10:2021
Biological evaluation of medical devices - Part 10: Tests for skin sensitization- Most Recent
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ISO 10993-10:2010
viewing
Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization- Historical Version
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ISO 10993-10:2002
Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity- Historical Version