This part of ISO 10993 describes the procedure for the assessment of medical devices and their components for their potential to cause irritation and skin sensitization. This part of ISO 10993 contains: a) pre-test considerations regarding irritation, including in silico and in vitro dermal exposure methods; b) Details on the performance of in vivo tests (irritation and sensitization); c) Key factors for interpreting the results. Appendix A provides instructions for the specific preparation of materials related to the tests noted above. Several specific tests for irritation when using medical devices on areas other than the skin are described in Appendix B.
EN ISO 10993-10:2013 history
2023EN ISO 10993-10:2023 Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO 10993-10:2021)
2013EN ISO 10993-10:2013 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
2010EN ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
2009EN ISO 10993-10:2009 Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity
2002EN ISO 10993-10:2002 Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity
1995EN ISO 10993-10:1995 Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Sensitization (ISO 10993-10 : 1995)