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

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