ISO 10993-10:2021
Biological evaluation of medical devices — Part 10: Tests for skin sensitization
- Standard No.
- ISO 10993-10:2021
- Release Date
- 2021
- Published By
- International Organization for Standardization (ISO)
- Latest
- ISO 10993-10:2021
- Scope
- 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.
ISO 10993-10:2021 Referenced Document
- ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- ISO 10993-2 Biological evaluation of medical devices — Part 2: Animal welfare requirements*， 2022-11-03 Update
ISO 10993-10:2021 history
- 2021 ISO 10993-10:2021 Biological evaluation of medical devices — Part 10: Tests for skin sensitization
- 2010 ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
- 2006 ISO 10993-10:2002/Amd 1:2006 Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity; Amendment 1
- 2002 ISO 10993-10:2002 Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity
- 1995 ISO 10993-10:1995 Biological evaluation of medical devices - Part 10: Tests for irritation and sensitization
