Table of Contents

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

Abstract

This part of ISO 10993 describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and skin sensitization.

General Product Information

Published
Document Type	Standard
Status	Current
Publisher	International Organization for Standardization
Pages
ISBN
Committee	TC 194
Supersedes	ISO/DIS 10993-10 : 60.00 (2010)