NEN EN ISO 10993-10 : 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

Explains the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and skin sensitization.