I.S. EN ISO 10993-23:2021
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021)
Hardcopy , PDF
English
18-04-2021
09-09-2025
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.
Dates of withdrawal of national standards are available from NSAI.
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 |
ISO/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 |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| EN ISO 10993-23:2021 | Identical |
| ISO 10993-23:2021 | Identical |
| ISO 9394:2012 | Ophthalmic optics — Contact lenses and contact lens care products — Determination of biocompatibility by ocular study with rabbit eyes |
Access your standards online with a subscription
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.
Important note : Users cannot be edited or removed once added to your Multi user PDF.