Glossary of equivalent standards
Committee representation
Background of ANSI/AAMI adoption of ISO 10993-10:2002 and
rationale for minor technical deviation
ANSI/AAMI deviation from ISO 10993-10:2002
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
5.2.1 Initial considerations
5.2.2 Ceramics, metals, and alloys
5.2.3 Polymers
5.2.4 Biologically derived materials
5.3 Information on chemical composition
5.3.1 General
5.3.2 Existing data sources
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
6.3.1 Principle
6.3.2 Test material
6.3.3 Animals and husbandry
6.3.4 Test procedure
6.3.5 Observation of animals
6.3.6 Evaluation of results
6.3.7 Test report
6.4 Human skin irritation test
6.4.1 Introduction
6.4.2 Initial considerations
6.4.3 Principle
6.4.4 Description of the method
6.4.5 Data and reporting
7 Delayed hypersensitivity tests
7.1 Choice of test
7.2 Choice of test sample concentrations
7.2.1 General
7.2.2 Induction
7.2.3 Challenge
7.3 Other important factors affecting the
outcome of the test
7.4 Maximization test for delayed hypersensitivity
7.4.1 Principle
7.4.2 Test sample preparation
7.4.3 Animals and husbandry
7.4.4 Test procedure
7.4.5 Observation of animals
7.4.6 Evaluation of results
7.4.7 Test report
7.5 Closed-patch test for delayed hypersensitivity
7.5.1 Principle
7.5.2 Test sample preparation
7.5.3 Animals and husbandry
7.5.4 Test procedure
7.5.5 Observation of animals
7.5.6 Evaluation of results
7.5.7 Test report
8 Key factors in interpretation of test results
Annexes
A Preparation of materials for irritation/sensitization
testing
B Additional irritation tests
C Background information
Bibliography