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BS EN ISO 10993-10:2023-TC

BS EN ISO 10993-10:2023-TC

$245.79

Tracked changes. Biological evaluation of medical devices – Tests for skin sensitization

Published By Publication Date Number of Pages
BSI 2023 172
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This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to induce skin sensitization. This document includes: —     details of in vivo skin sensitization test procedures; —    key factors for the interpretation of the results. NOTE      Instructions for the preparation of materials specifically in relation to the above tests are given in Annex A.

PDF Catalog

PDF Pages PDF Title
110 undefined
115 Annex ZA (informative)Relationship between this European standard and the General Safety and Performance requirements of Regulation (EU) 2017/745 aimed to be covered
118 Blank Page
121 Foreword
122 Introduction
123 1 Scope
2 Normative references
3 Terms and definitions
125 4 General principles — Step-wise approach
126 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
127 5.3.2 Existing data sources
6 Skin sensitization tests
6.1 Choice of test methods
128 6.2 Murine local lymph node assay
6.2.1 Principle
6.2.2 Test sample preparation
6.2.3 Animals and husbandry
129 6.2.4 Test procedure
130 6.2.5 Treatment groups
6.2.6 Determination of cellular proliferation and tissue preparation
131 6.2.7 Results and interpretation
6.2.8 Test report
6.3 Guinea pig assays for the detection of skin sensitization
6.3.1 Principle
132 6.3.2 Choice of test sample concentrations
6.3.3 Induction
6.3.4 Challenge
6.4 Important factors affecting the outcome of the test
133 6.5 Guinea pig maximization test
6.5.1 Principle
6.5.2 Test sample preparation
6.5.3 Animals and husbandry
134 6.5.4 Test procedure
136 6.5.5 Observation of animals
6.5.6 ​Evaluation of results
137 6.5.7 Test report
6.6 Closed-patch test (Buehler test)
6.6.1 Principle
6.6.2 Test sample preparation
6.6.3 Animals and husbandry
138 6.6.4 Test procedure
139 6.6.5 Observation of animals
6.6.6 ​Evaluation of results
6.6.7 Test report
140 7 Key factors in interpretation of test results
141 Annex A (normative) Preparation of materials for skin sensitization testing
143 Annex B (informative) Method for the preparation of extracts from polymeric test materials
146 Annex C (informative) Non-animal methods for skin sensitization
159 Annex D (informative) Background information on sensitization tests for skin sensitization
162 Bibliography

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BS EN ISO 10993-10:2023-TC
$245.79