Biological evaluation of medical devices - Tests for irritation and skin sensitization
Biological evaluation of medical devices - Tests for irritation and skin sensitization
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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.
Упомянутые в описании и другие стандарты BS