标准摘要
[中文适用范围]： 本文件规定了医疗器械及其组成材料诱发皮肤过敏潜力的评估程序。 本文件包括： ——体内皮肤致敏测试程序的详细信息； ——解释结果的关键因素。 注：附录 A 中给出了与上述测试相关的材料准备说明。 [外文原描述]： 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.
英文名称Biological evaluation of medical devices — Part 10: Tests for skin sensitization