95.99 Withdrawal of Standard Nov 16, 2021
ISO
ISO/TC 194 Biological and clinical evaluation of medical devices
International Standard
11.100.20 Biological evaluation of medical devices
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.
ISO 10993-10:2010 includes:
pretest considerations for irritation, including in silico and in vitro methods for dermal exposure;
details of in vivo (irritation and sensitization) test procedures;
key factors for the interpretation of the results.
Instructions are given for the preparation of materials specifically in relation to the above tests and several special irritation tests are described for application of medical devices in areas other than skin.
WITHDRAWN
ISO 10993-10:2010
95.99
Withdrawal of Standard
Nov 16, 2021
PUBLISHED
ISO 10993-10:2021