NEN-EN-ISO 10993-10
Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity
inactive
| Organization: | NEN |
| Publication Date: | 1 May 2009 |
| Status: | inactive |
| Page Count: | 74 |
| 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 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 in the ocular, oral, rectal, penile and vaginal areas are given in annex B.
Document History
March 1, 2023
Biological evaluation of medical devices - Part 10: Tests for skin sensitization
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:
—...
September 1, 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 skin sensitization. This...
August 1, 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...
NEN-EN-ISO 10993-10
May 1, 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...
August 1, 2008
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...
August 1, 2006
Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity
A description is not available for this item.
March 1, 2005
Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity
A description is not available for this item.
October 1, 2002
Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity
Describes the procedure for the assessment of devices and their constituent materials to produce: a) irritation, and b) delayed type hypersensitivity. This standard includes: a) pretest...
April 1, 2000
Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity
Describes the procedure for the assessment of devices and their constituent materials to produce: a) irritation, and b) delayed type hypersensitivity. This standard includes: a) pretest...
January 1, 1996
Biological evaluation of medical devices - Part 10: Tests for irritation and sensitization
Describes test methods to evaluate the potential of devices and their constituents materials to produce irritation and to produce sensitization. Also gives guidance for the preparation of materials...