ISO 10993-23:2021 医疗器械的生物学评价 第23部分：刺激试验

标准编号：ISO 10993-23:2021

中文名称：医疗器械的生物学评价 第23部分：刺激试验

英文名称：Biological evaluation of medical devices — Part 23: Tests for irritation

发布日期：2021-01

标准范围

本文件规定了评估医疗器械及其组成材料产生刺激性的可能性的程序。这些试验旨在根据ISO 10993对医疗器械、材料或其提取物的潜在刺激性进行预测和分类？1和ISO 10993？2.本文件包括:-对刺激的测试前考虑，包括皮肤暴露的计算机和体外方法；-体外和体内刺激试验程序的细节；-解释结果的关键因素。

This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation. The tests are designed to predict and classify the irritation potential of medical devices, materials or their extracts according to ISO 10993？1 and ISO 10993？2.This document includes:— pre-test considerations for irritation, including in silico and in vitro methods for dermal exposure;— details of in vitro and in vivo irritation test procedures;— key factors for the interpretation of the results.

标准预览图