Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization
This standard was last reviewed and confirmed* in 2016.
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.
Document published on: 2010-08 Edition: 3 (Monolingual) ICS: 11.100.20 Status: Published Stage: 90.93 (2016-04-07) TC/SC: ISO/TC 194 Number of Pages: 67
Revises: ISO 10993-10:2002
Revises: ISO 10993-10:2002/Amd 1:2006
No corrigenda or amendments available