ISO 10993-10:2010 PDF

Scope: This part of ISO 10993 describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and skin sensitization. This part of ISO 10993 includes: a) pretest considerations for irritation, including in silico and in vitro methods for dermal exposure; b) details of in vivo (irritation and sensitization) test procedures; 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. In Annex B several special irritation tests are described for application of medical devices in areas other than skin.

ISO 10993-10:2010 Referenced Document

ISO 10993-1:2009 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 10993-9 Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products*， 2019-11-26 Update
ISO 14155-1 Clinical investigation of medical devices for human subjects - Part 1: General requirements
ISO 14155-2 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plants

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