DIN EN ISO 10993-10:2007 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 delayed-type hypersensitivity. This part of ISO 10993 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. Supplementary tests which are required specifically for devices used intradermally and in the ocular,oral,rectal,penile and vaginal areas are given in annex B.

DIN EN ISO 10993-10:2007 history

2023 DIN EN ISO 10993-10:2023-04 Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO 10993-10:2021); German version EN ISO 10993-10:2023
2023 DIN EN ISO 10993-10:2023 Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO 10993-10:2021)
1970 DIN EN ISO 10993-10 E:2020-04 Biological evaluation of medical devices Part 10: Tests for irritation and delayed-type hypersensitivity reactions (draft)
2020 DIN EN ISO 10993-10 E:2020 Draft Document - Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO/DIS 10993-10:2020); German and English version prEN ISO 10993-10:2020
2014 DIN EN ISO 10993-10:2014 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010); German version EN ISO 10993-10:2013
2010 DIN EN ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010); German version EN ISO 10993-10:2010
0000 DIN EN ISO 10993-10:2009
2007 DIN EN ISO 10993-10:2007 Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity (ISO 10993-10:2002+Amd.1:2006); German version EN ISO 10993-10:2002+A1:2006