DSF/prEN ISO 10993-10
Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO/DIS 10993-10:2008)
inactive
| Organization: | DS |
| Status: | inactive |
| Page Count: | 83 |
| ICS Code (Laboratory medicine): | 11.100 |
| 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, 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. In Annex B several special irritation tests are described for application of medical devices in areas other than skin.
Document History
February 14, 2023
Biological evaluation of medical devices – Part 10: Tests for skin sensitization (ISO 10993-10:2021)
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: – ...
October 16, 2013
Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization
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...
September 3, 2010
Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
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...
June 11, 2009
Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity
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...
October 13, 2006
Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity
Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity AMENDMENT 1
November 7, 2002
Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity
This standard describes the procedure for the assessment of devices and their constituent materials with regard to their potential to produce irritation and delayed-type hypersensitivity. This...
January 17, 1996
Biological evaluation of medical devices - Part 10: Tests for irritation and sensitization
This part of the standard describes test methods: a) to evaluate the potential of devices and their constituent materials to produce irritation; and b) to evaluate the potential of devices and their...
Biological evaluation of medical devices – Part 10: Tests for skin sensitization (ISO/DIS 10993-10:2020)
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: –...
Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO/FDIS 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...
Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity (ISO 10993-10:2002, including Amd 1:2006)
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...
DSF/prEN ISO 10993-10
Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO/DIS 10993-10:2008)
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...
Biological evaluation of medical devices – Part 10: Tests for skin sensitization (ISO/FDIS 10993-10:2021)
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: –...