DIN EN ISO 10993-10 E : 2003
Current
The latest, up-to-date edition.
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND SKIN SENSITIZATION (ISO 10993-10:2010)
Hardcopy , PDF
English
01-01-2003
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
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