ISO 10993-10:2010
Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization
ISO 10993-10:2010 describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and skin sensitization.
ISO 10993-10:2010 includes:
- pretest considerations for irritation, including in silico and in vitro methods for dermal exposure;
- details of in vivo (irritation and sensitization) test procedures;
- key factors for the interpretation of the results.
Instructions are given for the preparation of materials specifically in relation to the above tests and several special irritation tests are described for application of medical devices in areas other than skin.
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Scope
Normative references
Terms and definitions
General principles — Step-wise approach
Pretest considerations
General
Types of material
Initial considerations
Ceramics, metals and alloys
Polymers
Biologically derived materials
Information on chemical composition
General
Existing data sources
Irritation tests
In vitro irritation tests
In vivo irritation tests — Factors to be considered in desig
Animal irritation test
Principle
Test material
Animals and husbandry
Test procedure
Preparation of animals
Application of test sample
Application of powder or liquid sample
Application of extracts and extract vehicle
Application of solid sample
Observation of animals
General
Single-exposure test
Repeated-exposure test
Evaluation of results
Test report
Animal intracutaneous (intradermal) reactivity test
Introduction
Exclusion from test
Test sample
Animals and husbandry
Test procedure
Observation of animals
Evaluation of results
Test report
Human skin irritation test
Introduction
Initial considerations
Skin sensitization tests
Choice of test methods
Murine Local Lymph Node Assay (LLNA)
Principle
Test sample preparation
Animals and husbandry
Test procedure
Treatment groups
Determination of cellular proliferation and tissue preparati
Results and interpretation
Test report
Guinea pig assays for the detection of skin sensitization
Principle
Choice of test sample concentrations
Induction
Challenge
Important factors affecting the outcome of the test
Guinea pig maximization test (GPMT)
Principle
Test sample preparation
Animals and husbandry
Test procedure
Preparation
Preliminary tests
Main test
Intradermal induction phase
Topical induction phase
Challenge phase
Observation of animals
Evaluation of results
Test report
Closed-patch test (Buehler test)
Principle
Test sample preparation
Animals and husbandry
Test procedure
Preparation
Preliminary tests
Main test
Induction phase
Challenge phase
Observation of animals
Evaluation of results
Test report
Key factors in interpretation of test results
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Scope
Normative references
Terms and definitions
General principles — Step-wise approach
Pretest considerations
General
Types of material
Initial considerations
Ceramics, metals and alloys
Polymers
Biologically derived materials
Information on chemical composition
General
Existing data sources
Irritation tests
In vitro irritation tests
In vivo irritation tests — Factors to be considered in desig
Animal irritation test
Principle
Test material
Animals and husbandry
Test procedure
Preparation of animals
Application of test sample
Application of powder or liquid sample
Application of extracts and extract vehicle
Application of solid sample
Observation of animals
General
Single-exposure test
Repeated-exposure test
Evaluation of results
Test report
Animal intracutaneous (intradermal) reactivity test
Introduction
Exclusion from test
Test sample
Animals and husbandry
Test procedure
Observation of animals
Evaluation of results
Test report
Human skin irritation test
Introduction
Initial considerations
Skin sensitization tests
Choice of test methods
Murine Local Lymph Node Assay (LLNA)
Principle
Test sample preparation
Animals and husbandry
Test procedure
Treatment groups
Determination of cellular proliferation and tissue preparati
Results and interpretation
Test report
Guinea pig assays for the detection of skin sensitization
Principle
Choice of test sample concentrations
Induction
Challenge
Important factors affecting the outcome of the test
Guinea pig maximization test (GPMT)
Principle
Test sample preparation
Animals and husbandry
Test procedure
Preparation
Preliminary tests
Main test
Intradermal induction phase
Topical induction phase
Challenge phase
Observation of animals
Evaluation of results
Test report
Closed-patch test (Buehler test)
Principle
Test sample preparation
Animals and husbandry
Test procedure
Preparation
Preliminary tests
Main test
Induction phase
Challenge phase
Observation of animals
Evaluation of results
Test report
Key factors in interpretation of test results