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BS EN ISO 10993-23:2021

BS EN ISO 10993-23:2021

$215.11

Biological evaluation of medical devices – Tests for irritation

Published By Publication Date Number of Pages
BSI 2021 80
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This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation. The tests are designed to predict and classify the irritation potential of medical devices, materials or their extracts according to ISO 10993-1 and ISO 10993-2.

This document includes:

  • pre-test considerations for irritation, including in silico and in vitro methods for dermal exposure;

  • details of in vitro and in vivo irritation test procedures;

  • key factors for the interpretation of the results.

PDF Catalog

PDF Pages PDF Title
2 National foreword
6 European foreword
8 Annex ZA (informative) Relationship between this European Standard and the essential requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered
10 Annex ZB (informative) Relationship between this European Standard and the essential requirements of Directive 90/385/EEC [OJ L 189] aimed to be covered
12 Annex ZC (informative) Relationship between this European standard and the General Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered
16 Foreword
17 Introduction
19 1 Scope
2 Normative references
20 3 Terms and definitions
21 4 General principles — Step-wise approach
22 5 Pre-test considerations
5.1 General
23 5.2 Types of material
5.2.1 Initial considerations
5.2.2 Ceramics, metals and alloys
5.2.3 Polymers
5.2.4 Biologically derived materials
5.3 Information on chemical composition
5.3.1 General
5.3.2 Existing data sources
24 6 In vitro irritation tests
6.1 General
6.2 In vitro reconstructed human epidermis model
6.2.1 Test system — Reconstructed human epidermis model
6.2.2 Principle of the method
25 6.2.3 Prediction model
26 6.3 Materials
6.3.1 Reconstructed human epidermis models — Product description
6.3.2 Preparation of medical device extracts
27 6.4 Methods
6.4.1 General
6.4.2 Test procedure
28 6.4.3 Media and end point solutions
6.4.4 Test sample and control preparation
29 6.5 Considerations for test performance
6.5.1 Receipt of the reconstructed human epidermis tissues
6.5.2 Preparation and pre-incubation
6.6 Application of the test sample and rinsing
6.6.1 General
30 6.6.2 Preparation
6.6.3 Test extract and controls exposure
31 6.7 MTT test for determination of RhE tissue viability after the exposure period
6.7.1 MTT incubation and Isopropanol extraction
6.7.2 Absorbance measurements
32 6.8 Test acceptance criteria
6.9 Data calculation steps
6.9.1 General
6.9.2 Isopropanol background control for OD in RhE assay
6.9.3 Negative DPBS or PBS treated controls
6.9.4 Positive control
33 6.9.5 Tested extract and VC samples (TTs)
6.10 Data interpretation — Prediction model
6.11 Method documentation sheet
34 6.12 Test report
7 In vivo irritation tests
7.1 General
35 7.2 Animal irritation test by skin exposure
7.2.1 Principle
7.2.2 Test materials
7.2.3 Animals and husbandry
7.2.4 Test procedure
37 7.2.5 Observation of animals
7.2.6 Evaluation of results
39 7.2.7 Test report
7.3 Animal irritation test by intracutaneous (intradermal) administration
7.3.1 Introduction
7.3.2 Exclusion from test
7.3.3 Test sample
40 7.3.4 Animals and husbandry
7.3.5 Test procedure
41 7.3.6 Observation of animals
7.3.7 Evaluation of results
7.3.8 Test report
42 8 Human skin irritation test
8.1 Introduction
8.2 Initial considerations
44 Annex A (normative) Preparation of materials for irritation testing
46 Annex B (informative) Test method check list for in vitro irritation testing using reconstructed human epidermis models
48 Annex C (informative) Example of method documentation sheet for reconstructed human epidermis models
54 Annex D (normative) Special irritation tests
70 Annex E (normative) Human skin irritation test
74 Annex F (informative) Background information on irritation tests
76 Bibliography

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BS EN ISO 10993-23:2021
$215.11