I.S. EN ISO 10993-23:2021
Current
The latest, up-to-date edition.
Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021)
Hardcopy , PDF
English
04-18-2021
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General principles — Step-wise approach
5 Pre-test considerations
6 In vitro irritation tests
7 In vivo irritation tests
8 Human skin irritation test
Annex A (normative) Preparation of materials for irritation testing
Annex B (informative) Test method check list for in vitro irritation testing using reconstructed human epidermis models
Annex C (informative) Example of method documentation sheet for reconstructed humanepidermis models
Annex D (normative) Special irritation tests
Annex E (normative) Human skin irritation test
Annex F (informative) Background information on irritation tests
Bibliography
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