DIN EN ISO 10993-10
Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010)
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| Organization: | DIN |
| Publication Date: | 1 October 2014 |
| Status: | active |
| Page Count: | 77 |
| ICS Code (Biological evaluation of medical devices): | 11.100.20 |
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.
Document History
April 1, 2023
Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO 10993-10:2021)
A description is not available for this item.
April 1, 2020
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
A description is not available for this item.
DIN EN ISO 10993-10
October 1, 2014
Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010)
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...
December 1, 2010
Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010)
A description is not available for this item.
August 1, 2009
Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity (ISO 10993-10:2002, including Amd 1:2006)
A description is not available for this item.
February 1, 2009
Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity (ISO 10993-10:2002, including Amd 1:2006); English version prEN ISO 10993-10:2008, Amendment 2
A description is not available for this item.
June 1, 2007
Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity (ISO 10993-10:2002+Amd.1:2006) (includes Amendment A1:2006)
A description is not available for this item.
February 1, 2003
Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity (ISO 10993-10:2002)
A description is not available for this item.
February 1, 1996
Biological evaluation of medical devices - Tests for irritation and sensitization (ISO 10993-10:1995)
A description is not available for this item.