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SS EN ISO 10993-3 Ed. 1 (2004)被替代

Biological Evaluation Of Medical Devices - Part 3: Tests For Genotoxicity, Carcinogenicity And Reproductive Toxicity

出版：Standardiserings-Kommissionen I Sverige

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基本信息

标准编号： SS EN ISO 10993-3 Ed. 1 (2004)

发布时间：2004/2/6 0:00:00

标准类别：Standard

出版单位：Standardiserings-Kommissionen I Sverige

标准页数：23

标准简介

Gives strategies for hazard identification and tests on medical devices for the following biological aspects: genotoxicity, carcinogenicity, and reproductive and developmental toxicity. Applicable for evaluation of a medical device whose potential for genotoxicity, carcinogenicity or reproductive toxicity has been identified. Also provides guidance on selection of tests.

标准备注

Supersedes SS EN 30993-3. (04/2004)

本标准替代的旧标准

SS EN 30993-3 Ed. 1 (1994)

替代本标准的新标准

SS EN ISO 10993-3 Ed. 2 (2009)

等同采用的国际标准

ISO 10993-3:2003 - Identical

ONORM EN ISO 10993-3:2004 - Identical

NEN EN ISO 10993-3:2003 - Identical

UNE EN ISO 10993-3:2004 - Identical

NS EN ISO 10993-3 Ed. 1 (2003) - Identical