EN ISO 10993-10:2023現行
Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO 10993-10:2021)
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基本信息
標準編號： EN ISO 10993-10:2023
標準類別：Standard
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標準簡介
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 invivo 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 AnnexA.
