BS EN ISO 10993-10:2010 describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and skin sensitization.

BS EN ISO 10993-10:2010 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.



Cross References:
ISO 10993-1:2009
ISO 10993-2
ISO 10993-9
ISO 10993-12
ISO 10993-13
ISO 10993-14
ISO 10993-15
ISO 10993-18
ISO 14155-1
ISO 14155-2
88/379/EEC
ISO 9394
93/42/EEC
90/385/EEC


All current amendments available at time of purchase are included with the purchase of this document.