ISO 10993-1-2003 医疗器械的生物学评价.第1部分_评价与试验.pdf

标准号：ISO 10993-1-2003
实施状态：作废
中文名称：医疗器械的生物学评价.第1部分:评价与试验
英文名称：Biological evaluation of medical devices - Part 1: Evaluation and testing
发布日期：2003-08
被替代标准：ISO 10993-1-2009
代替标准：ISO 10993-1-1997;ISO/FDIS 10993-1-2003
采用标准：DIN EN ISO 10993-1-2003,IDT;DIN EN ISO 10993-1-2009,IDT;ANSI/AAMI/ISO 10993-1-2003,IDT;BS EN ISO 10993-1-2003,IDT;BS EN ISO 10993-1-2009,IDT;EN ISO 10993-1-2003,IDT;EN ISO 10993-1-2009,IDT;FprEN ISO 10993-1-2009,IDT;NF S99-501-2004,IDT;NF S99-501-1-2009,IDT;S99-501PR,IDT;JIS T 0993-1-2005,IDT;SN EN ISO 10993-1-2003,IDT;OENORM EN ISO 10993-1-2003,IDT;OENORM EN ISO 10993-1-2009,IDT;OENORM EN ISO 10993-1-2009,IDT;UNE-EN ISO 10993-1-2004,IDT;GOST R ISO 9333-2008,MOD;GOST R ISO 22112-2008,MOD
起草单位：ISO/TC 194
标准简介：This part of ISO 10993 describes
a)   the general principles governing the biological evaluation of medical devices;
b)   the categorization of devices based on the nature and duration of their contact with the body;
c)   the selection of appropriate tests.
This part of ISO 10993 does not cover testing of materials and devices that do not come into direct or indirect contact with the patient's body, nor does it cover biological hazards arising from any mechanical failure.
NOTE   Other parts of ISO 10993 cover specific tests (see also the rationale in A.2).
文件格式：PDF
文件大小：484.72KB
文件页数：22
（以上信息更新时间为：2019-11-23）



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