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ISO 10993-10

Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization

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Organization: ISO
Publication Date: 1 August 2010
Status: active
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 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

February 14, 2020
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: —...
ISO 10993-10
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...
July 15, 2006
Biological evaluation of medical devices — Part 10: Tests for irritation and delayed-type hypersensitivity AMENDMENT 1
Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is...
September 1, 2002
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...
January 1, 1995
Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Sensitization
A description is not available for this item.

References

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