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
18-04-2021
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Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
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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
This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation.
| Committee |
TC 194
|
| DocumentType |
Standard
|
| Pages |
84
|
| ProductNote |
THIS STANDARD IS ALSO REFERES TO OECD 404, OECD 439
The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document. |
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Standards | Relationship |
| EN ISO 10993-23:2021 | Identical |
| ISO 10993-23:2021 | Identical |
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