GSO ISO 10993-10:2016
Gulf Standard
Current Edition
·
Approved on
22 December 2016
·
Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization
GSO ISO 10993-10:2016 Files
English
67 Pages
Current Edition
Reference Language
81.84 BHD
GSO ISO 10993-10:2016 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.
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