BS EN ISO 10993-10:2013 PDF

1   Scope 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.