标准编号：ISO 10993-10:2010
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 irritation and skin sensitization
发布日期：2010-08
标准范围
This part of ISO 10993 describes the procedure for the assessment of medical devices and their constituentmaterials with regard to their potential to produce irritation and skin sensitization.This part of ISO 10993 includes:a) pretest considerations for irritation, including in silico and in vitro methods for dermal exposure;b) details of in vivo (irritation and sensitization) test procedures;c) key factors for the interpretation of the results.Instructions are given in Annex A for the preparation of materials specifically in relation to the above tests. InAnnex B several special irritation tests are described for application of medical devices in areas other than skin.
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