SS ISO 10993-10:2017
Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitisation
OVERVIEW
Describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and skin sensitisation. Includes:
– pre-test considerations for irritation, including in silico and in vitro methods for dermal exposure;
– details of in vivo (irritation and sensitisation) test procedures;
– key factors for the interpretation of the results.
COMMENTS
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PRODUCT DETAILS
| Status | Current |
|---|---|
| Edition | 2017 |
| No. of Pages | 80 |
| ICS Classification | 11.100.20 Biological evaluation of medical devices |
| Committee | Biomedical and Health Standards Committee |
| Available for Purchase | Global |
| Adoption | ISO 10993-10 : 2010 IDT |