ISO 10993-10:2021
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:
— details of in vivo skin sensitization test procedures;
— key factors for the interpretation of the results.
NOTE Instructions for the preparation of materials specifically in relation to the above tests are given in Annex A.
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General principles — Step-wise approach
5 Pretest considerations
5.1 General
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
6 Skin sensitization tests
6.1 Choice of test methods
6.2 Murine local lymph node assay
6.2.1 Principle
6.2.2 Test sample preparation
6.2.3 Animals and husbandry
6.2.4 Test procedure
6.2.5 Treatment groups
6.2.6 Determination of cellular proliferation and tissue preparation
6.2.7 Results and interpretation
6.2.8 Test report
6.3 Guinea pig assays for the detection of skin sensitization
6.3.1 Principle
6.3.2 Choice of test sample concentrations
6.3.3 Induction
6.3.4 Challenge
6.4 Important factors affecting the outcome of the test
6.5 Guinea pig maximization test
6.5.1 Principle
6.5.2 Test sample preparation
6.5.3 Animals and husbandry
6.5.4 Test procedure
6.5.5 Observation of animals
6.5.6 Evaluation of results
6.5.7 Test report
6.6 Closed-patch test (Buehler test)
6.6.1 Principle
6.6.2 Test sample preparation
6.6.3 Animals and husbandry
6.6.4 Test procedure
6.6.5 Observation of animals
6.6.6 Evaluation of results
6.6.7 Test report
7 Key factors in interpretation of test results
Annex A (normative) Preparation of materials for skin sensitization testing
Annex B (informative) Method for the preparation of extracts from polymeric test materials
Annex C (informative) Non-animal methods for skin sensitization
Annex D (informative) Background information on sensitization tests for skin sensitization
Bibliography
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General principles — Step-wise approach
5 Pretest considerations
5.1 General
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
6 Skin sensitization tests
6.1 Choice of test methods
6.2 Murine local lymph node assay
6.2.1 Principle
6.2.2 Test sample preparation
6.2.3 Animals and husbandry
6.2.4 Test procedure
6.2.5 Treatment groups
6.2.6 Determination of cellular proliferation and tissue preparation
6.2.7 Results and interpretation
6.2.8 Test report
6.3 Guinea pig assays for the detection of skin sensitization
6.3.1 Principle
6.3.2 Choice of test sample concentrations
6.3.3 Induction
6.3.4 Challenge
6.4 Important factors affecting the outcome of the test
6.5 Guinea pig maximization test
6.5.1 Principle
6.5.2 Test sample preparation
6.5.3 Animals and husbandry
6.5.4 Test procedure
6.5.5 Observation of animals
6.5.6 Evaluation of results
6.5.7 Test report
6.6 Closed-patch test (Buehler test)
6.6.1 Principle
6.6.2 Test sample preparation
6.6.3 Animals and husbandry
6.6.4 Test procedure
6.6.5 Observation of animals
6.6.6 Evaluation of results
6.6.7 Test report
7 Key factors in interpretation of test results
Annex A (normative) Preparation of materials for skin sensitization testing
Annex B (informative) Method for the preparation of extracts from polymeric test materials
Annex C (informative) Non-animal methods for skin sensitization
Annex D (informative) Background information on sensitization tests for skin sensitization
Bibliography