ISO 10993-10:2021 PDF Download
Standard EN Sample
Biological evaluation of medical devices - Part 10: Tests for skin sensitization
Also Known As:
SKU112646585
Published by
International Organization for Standardization
ISO
Publication Date2021-11
Pages CountPages56
This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to induce skin sensitization.
This document includes:
— details of in vivo skin sensitization test procedures;
— key factors for the interpretation of the results.
NOTE Instructions for the preparation of materials specifically in relation to the above tests are given in Annex A.
Details
History and complementary documents
History
| Edition | 4 |
| ICS Codes | 11.100.20 - Biological evaluation of medical devices |
| Language(s) | English |
| File Size | 901.1 KB |
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