《GBT 16886.10-2016 医疗器械生物学评价 第10部分》.pdf

ICS 11.040 C 30 1J8 中 华 人 民 共 和 国 国 家 标 准 GB/T 16886.10-2005/ISO10993-10:2002 代替GB/T16886.10-2000 医疗器械生物学评价 第 to部分: 刺激与迟发型超敏反应试验 Biologicalevaluationofmedicaldevices-Part10:Testsforirritationand delayed-typehypersensitivity (ISO 10993-10:2002,IDT) 2005-03-23发布 2005-12-01实施 中华人民共和国国家质量监督检验检疫总局 发 布 中 国 国家 标 准 化 管 理 委 员 会 GB/T16886.10-2005/ISO 10993-10:2002 目 次 前言 ··················································································································…… 扭 引言 ·················································································································…… V 1 范围 .·1 2 规范性引用文件 ·············································································.··.·，··.…… 1 3 术语和定义 ····································································································…… 1 4 总则与评价程序 ······················································.·············.·.···…… 3 5 试验前的考虑 ···································································································…… 3 6 刺激试验 ·········································································································…… 4 7 迟发型超敏反应试验 ································································.········.·.·.…… n 8解释试验结果的关键因素··································································.·… … 16 附录A (规范性附录) 刺激和致敏试验用材料的制备 ···················································…… 17 A.1 总则 ·········································································································…… 17 A.2 直接接触材料 ······