ISO 10993-23:2021
Biological evaluation of medical devices — Part 23: Tests for irritation
This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation. The tests are designed to predict and classify the irritation potential of medical devices, materials or their extracts according to ISO 10993‑1 and ISO 10993‑2.
This document includes:
— pre-test considerations for irritation, including in silico and in vitro methods for dermal exposure;
— details of in vitro and in vivo irritation test procedures;
— key factors for the interpretation of the results.
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General principles — Step-wise approach
5 Pre-test 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
6 In vitro irritation tests
6.1 General
6.2 In vitro reconstructed human epidermis model
6.2.1 Test system — Reconstructed human epidermis model
6.2.2 Principle of the method
6.2.3 Prediction model
6.3 Materials
6.3.1 Reconstructed human epidermis models — Product description
6.3.2 Preparation of medical device extracts
6.4 Methods
6.4.1 General
6.4.2 Test procedure
6.4.3 Media and end point solutions
6.4.4 Test sample and control preparation
6.5 Considerations for test performance
6.5.1 Receipt of the reconstructed human epidermis tissues
6.5.2 Preparation and pre-incubation
6.6 Application of the test sample and rinsing
6.6.1 General
6.6.2 Preparation
6.6.3 Test extract and controls exposure
6.7 MTT test for determination of RhE tissue viability after the exposure period
6.7.1 MTT incubation and Isopropanol extraction
6.7.2 Absorbance measurements
6.8 Test acceptance criteria
6.9 Data calculation steps
6.9.1 General
6.9.2 Isopropanol background control for OD in RhE assay
6.9.3 Negative DPBS or PBS treated controls
6.9.4 Positive control
6.9.5 Tested extract and VC samples (TTs)
6.10 Data interpretation — Prediction model
6.11 Method documentation sheet
6.12 Test report
7 In vivo irritation tests
7.1 General
7.2 Animal irritation test by skin exposure
7.2.1 Principle
7.2.2 Test materials
7.2.3 Animals and husbandry
7.2.4 Test procedure
7.2.5 Observation of animals
7.2.6 Evaluation of results
7.2.7 Test report
7.3 Animal irritation test by intracutaneous (intradermal) administration
7.3.1 Introduction
7.3.2 Exclusion from test
7.3.3 Test sample
7.3.4 Animals and husbandry
7.3.5 Test procedure
7.3.6 Observation of animals
7.3.7 Evaluation of results
7.3.8 Test report
8 Human skin irritation test
8.1 Introduction
8.2 Initial considerations
Annex A (normative) Preparation of materials for irritation testing
Annex B (informative) Test method check list for in vitro irritation testing using reconstructed human epidermis models
Annex C (informative) Example of method documentation sheet for reconstructed human epidermis models
Annex D (normative) Special irritation tests
Annex E (normative) Human skin irritation test
Annex F (informative) Background information on irritation tests
Bibliography
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Related Information
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General principles — Step-wise approach
5 Pre-test 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
6 In vitro irritation tests
6.1 General
6.2 In vitro reconstructed human epidermis model
6.2.1 Test system — Reconstructed human epidermis model
6.2.2 Principle of the method
6.2.3 Prediction model
6.3 Materials
6.3.1 Reconstructed human epidermis models — Product description
6.3.2 Preparation of medical device extracts
6.4 Methods
6.4.1 General
6.4.2 Test procedure
6.4.3 Media and end point solutions
6.4.4 Test sample and control preparation
6.5 Considerations for test performance
6.5.1 Receipt of the reconstructed human epidermis tissues
6.5.2 Preparation and pre-incubation
6.6 Application of the test sample and rinsing
6.6.1 General
6.6.2 Preparation
6.6.3 Test extract and controls exposure
6.7 MTT test for determination of RhE tissue viability after the exposure period
6.7.1 MTT incubation and Isopropanol extraction
6.7.2 Absorbance measurements
6.8 Test acceptance criteria
6.9 Data calculation steps
6.9.1 General
6.9.2 Isopropanol background control for OD in RhE assay
6.9.3 Negative DPBS or PBS treated controls
6.9.4 Positive control
6.9.5 Tested extract and VC samples (TTs)
6.10 Data interpretation — Prediction model
6.11 Method documentation sheet
6.12 Test report
7 In vivo irritation tests
7.1 General
7.2 Animal irritation test by skin exposure
7.2.1 Principle
7.2.2 Test materials
7.2.3 Animals and husbandry
7.2.4 Test procedure
7.2.5 Observation of animals
7.2.6 Evaluation of results
7.2.7 Test report
7.3 Animal irritation test by intracutaneous (intradermal) administration
7.3.1 Introduction
7.3.2 Exclusion from test
7.3.3 Test sample
7.3.4 Animals and husbandry
7.3.5 Test procedure
7.3.6 Observation of animals
7.3.7 Evaluation of results
7.3.8 Test report
8 Human skin irritation test
8.1 Introduction
8.2 Initial considerations
Annex A (normative) Preparation of materials for irritation testing
Annex B (informative) Test method check list for in vitro irritation testing using reconstructed human epidermis models
Annex C (informative) Example of method documentation sheet for reconstructed human epidermis models
Annex D (normative) Special irritation tests
Annex E (normative) Human skin irritation test
Annex F (informative) Background information on irritation tests
Bibliography