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B51-14 (R2019) – Boiler, pressure vessel, and pressure piping code

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ISO 10993:2021

ISO 10993:2021 Biological evaluation of medical devices – Part 10: Tests for skin sensitization

CDN $376.00

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Description

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.

Edition

4

Published Date

2021-11-16

Status

PUBLISHED

Pages

48

Language Detail Icon

English

Format Secure Icon

Secure PDF

Abstract

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.

Previous Editions

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