ISO 10993-10:2021 医疗器械的生物学评价 第10部分：刺激和皮肤敏化试验

标准编号：ISO 10993-10:2021

中文名称：医疗器械的生物学评价 第10部分：刺激和皮肤敏化试验

英文名称：Biological evaluation of medical devices — Part 10: Tests for skin sensitization

发布日期：2021-11

标准范围

本文件规定了医疗器械及其组成材料诱发皮肤致敏的可能性评估程序。本文件包括:-？体内皮肤致敏试验程序的详细信息；-？解释结果的关键因素。注？附录A中给出了与上述试验相关的材料制备说明。

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.

标准预览图