标准号：ISO 10993-10-2002
实施状态：作废
中文名称：医疗器械的生物评定.第10部分:刺激与持续型过敏症试验
英文名称：Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity
发布日期：2002-09
被替代标准：ISO 10993-10-2010
代替标准：ISO 10993-10-1995;ISO/DIS 10993-10-2000;ISO/FDIS 10993-10-2002
采用标准：DIN EN ISO 10993-10-1996,IDT;DIN EN ISO 10993-10-2003,IDT;DIN EN ISO 10993-10-2007,IDT;DIN EN ISO 10993-10-2009,IDT;BS EN ISO 10993-10-2002,IDT;BS EN ISO 10993-10-2010,IDT;GB/T 14233.2-2005,NEQ;GB/T 16886.10-2005,IDT;EN ISO 10993-10-2002,IDT;EN ISO 10993-10-2009,IDT;prEN ISO 10993-10-2008,IDT;NF S99-501-10-2009,IDT;NF S99-510-2003,IDT;SN EN ISO 10993-10-2002,IDT;SN EN ISO 10993-10-2009,IDT;OENORM EN ISO 10993-10-2003,IDT;OENORM EN ISO 10993-10-2006,IDT;OENORM EN ISO 10993-10-2010,IDT;OENORM EN ISO 10993-10-2009,IDT;OENORM EN ISO 10993-10/A1-2005,IDT;PN-EN ISO 10993-10-2003,IDT;PN-EN ISO 10993-10-2007,IDT;PN-EN ISO 10993-10-2009,IDT;UNE-EN ISO 10993-10-2003,IDT;UNE-EN ISO 10993-10-2009,IDT;GOST R ISO/TC 10993-20-2009,MOD;GOST R ISO 10993-7-2009,MOD;GOST R ISO 10993-10-2009,IDT
起草单位：ISO/TC 194
标准简介：This part of ISO 10993 describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and delayed-type hypersensitivity.
This part of ISO 10993 includes
a) pretest considerations,
b) details of the test procedures, and
c) key factors for the interpretation of the results.
Instructions are given in annex A for the preparation of materials specifically in relation to the above tests.
Supplementary tests which are required specifically for devices used intradermally in the ocular, oral, rectal, penile and vaginal areas are given in annex B.
文件格式：PDF
文件大小：518.54KB
文件页数：64
（以上信息更新时间为：2019-11-23）
ISO 10993-10-2002 医疗器械的生物评定.第10部分_刺激与持续型过敏症试验.pdf
(518.54 KB)
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