NEN EN ISO 10993-10 : 2013
Current
The latest, up-to-date edition.
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND SKIN SENSITIZATION
12-01-2013
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
5.3 Information on chemical composition
5.4 Material characterization
6 Irritation tests
6.1 In vitro irritation tests
6.2 Factors to be considered in design and selection
of in vivo tests
6.3 Animal skin irritation test
6.4 Human skin irritation test
7 Delayed hypersensitivity tests
7.1 Choice of test
7.2 Choice of test sample concentrations
7.3 Other important factors affecting the outcome
of the test
7.4 Maximization test for delayed hypersensitivity
7.5 Closed-patch test for delayed hypersensitivity
8 Key factors in interpretation of test results
Annex A (normative) Preparation of materials for
irritation/sensitization testing
Annex B (informative) Additional irritation tests
Annex C (informative) Background information
Bibliography
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