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BS EN ISO 10993-10:2023

BS EN ISO 10993-10:2023

$198.66

Biological evaluation of medical devices – Tests for skin sensitization

Published By Publication Date Number of Pages
BSI 2023 64
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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
2 undefined
7 Annex ZA (informative)Relationship between this European standard and the General Safety and Performance requirements of Regulation (EU) 2017/745 aimed to be covered
10 Blank Page
13 Foreword
14 Introduction
15 1 Scope
2 Normative references
3 Terms and definitions
17 4 General principles — Step-wise approach
18 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
19 5.3.2 Existing data sources
6 Skin sensitization tests
6.1 Choice of test methods
20 6.2 Murine local lymph node assay
6.2.1 Principle
6.2.2 Test sample preparation
6.2.3 Animals and husbandry
21 6.2.4 Test procedure
22 6.2.5 Treatment groups
6.2.6 Determination of cellular proliferation and tissue preparation
23 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
24 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
25 6.5 Guinea pig maximization test
6.5.1 Principle
6.5.2 Test sample preparation
6.5.3 Animals and husbandry
26 6.5.4 Test procedure
28 6.5.5 Observation of animals
6.5.6 ​Evaluation of results
29 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
30 6.6.4 Test procedure
31 6.6.5 Observation of animals
6.6.6 ​Evaluation of results
6.6.7 Test report
32 7 Key factors in interpretation of test results
33 Annex A (normative) Preparation of materials for skin sensitization testing
35 Annex B (informative) Method for the preparation of extracts from polymeric test materials
38 Annex C (informative) Non-animal methods for skin sensitization
51 Annex D (informative) Background information on sensitization tests for skin sensitization
54 Bibliography

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BS EN ISO 10993-10:2023
$198.66