标准号:ISO 10993-3-2003
实施状态:作废
中文名称:医疗器械的生物评定.第3部分:遗传毒性、致癌性和生殖毒性的试验
英文名称:Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
发布日期:2003-10
被替代标准:ISO 10993-3-2014
代替标准:ISO 10993-3-1992;ISO/FDIS 10993-3-2003
采用标准:DIN EN ISO 10993-3-2004,IDT;DIN EN ISO 10993-3-2009,IDT;ANSI/AAMI/ISO 10993-3-2003,IDT;BS EN ISO 10993-3-2003,IDT;BS EN ISO 10993-3-2009,IDT;GB/T 16886.3-2008,IDT;EN ISO 10993-3-2003,IDT;EN ISO 10993-3-2009,IDT;prEN ISO 10993-3-2008,IDT;NF S99-501-3-2009,IDT;S99-501-3PR,IDT;NF S99-503-2004,IDT;SN EN ISO 10993-3-2003,IDT;SN EN ISO 10993-3-2009,IDT;OENORM EN ISO 10993-3-2004,IDT;OENORM EN ISO 10993-3-2009,IDT;OENORM EN ISO 10993-3-2009,IDT;PN-EN ISO 10993-3-2004,IDT;PN-EN ISO 10993-3-2008,IDT;PN-EN ISO 10993-3-2009,IDT;UNE-EN ISO 10993-3-2004,IDT;UNE-EN ISO 10993-3-2009,IDT;GOST R ISO 10993-3-2009,IDT
起草单位:ISO/TC 194
标准简介:This part of ISO 10993 specifies strategies for hazard identification and tests on medical devices for the following biological aspects:
— genotoxicity,
— carcinogenicity, and
— reproductive and developmental toxicity.
This part of ISO 10993 is applicable for evaluation of a medical device whose potential for genotoxicity, carcinogenicity or reproductive toxicity has been identified.
NOTE Guidance on selection of tests is provided in ISO 10993-1.
文件格式:PDF
文件大小:234.62KB
文件页数:24
(以上信息更新时间为:2019-11-22)
ISO 10993-3-2003 医疗器械的生物评定.第3部分_遗传毒性、致癌性和生殖毒性的试验.pdf
(234.62 KB)
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