BS 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
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
Bibliography
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

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