DS/EN ISO 10993-10
Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity
| Organization: | DS |
| Publication Date: | 7 November 2002 |
| Status: | inactive |
| Page Count: | 62 |
| ICS Code (Biological evaluation of medical devices): | 11.100.20 |
scope:
This standard describes the procedure for the assessment of devices and their constituent materials with regard to their potential to produce irritation and delayed-type hypersensitivity. This standard includes: a) pretest considerations b) details of the test procedures, and 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.
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