This part of ISO 10993 describes the procedure for the assessment of medical devices and their constituent
materials with regard to their potential to produce irritation and skin sensitization.
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.
BS EN ISO 10993-10:2010 history
2023BS EN ISO 10993-10:2023 Biological evaluation of medical devices. Tests for skin sensitization
2014BS EN ISO 10993-10:2013 Biological evaluation of medical devices. Tests for irritation and skin sensitization
2010BS EN ISO 10993-10:2010 Biological evaluation of medical devices. Tests for irritation and skin sensitization
0000 BS EN ISO 10993-10:2009
2002BS EN ISO 10993-10:2002 Biological evaluation of medical devices - Tests for irritation and delayed-type hypersensitivity