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- 2018-09-22 发布于四川
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- 已被新标准代替,建议下载标准 GB/T 16886.10-2017
- | 2005-03-23 颁布
- | 2005-12-01 实施
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GBT16886.10-2005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 ·····
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