DIN EN ISO 10993-10:2003-02

National foreword
National Annex NA (informative) - Bibliography
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General principles - Step-wise approach
5 Pretest considerations
6 Irritation tests
7 Skin sensitization tests
8 Key factors in interpretation of test results
Annex A (normative) - Preparation of materials for
        irritation/sensitization testing
Annex B (normative) - Special irritation tests
Annex C (normative) - Human skin irritation test
Annex D (informative) - In vitro tests for skin
        irritation
Annex E (informative) - Method for the preparation of
        extracts from polymeric test materials
Annex F (informative) - Background information
Annex ZA (informative) - Relationship between this
         European Standard and the Essential
         Requirements of EU Directive 93/42/EEC
         on Medical Devices
Annex ZB (informative) - Relationship between this
         European Standard and the Essential
         Requirements of EU Directive 90/385/EEC
         on Active Implantable Medical Devices
Bibliography

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