标准号：ISO 10993-4-2002
实施状态：作废
中文名称：医疗器械的生物评定.第4部分:与血液相互作用的试验的选择
英文名称：Biological evaluation of medical devices - Part 4: Selection of test for interactions with blood
发布日期：2002-10
被替代标准：ISO 10993-4-2017
代替标准：ISO 10993-4-1992;ISO/FDIS 10993-4-2002
采用标准：DIN EN ISO 10993-4-2003,IDT;DIN EN ISO 10993-4-2007,IDT;DIN EN ISO 10993-4-2009,IDT;ANSI/AAMI/ISO 10993-4-2002,IDT;BS EN ISO 10993-4-2002,IDT;BS EN ISO 10993-4-2010,IDT;GB/T 14233.2-2005,NEQ;GB/T 16886.4-2003,IDT;EN ISO 10993-4-2002,IDT;EN ISO 10993-4-2009,IDT;prEN ISO 10993-4-2008,IDT;NF S99-501-4-2009,IDT;NF S99-504-2004,IDT;SN EN ISO 10993-4-2002,IDT;SN EN ISO 10993-4-2009,IDT;OENORM EN ISO 10993-4-2003,IDT;OENORM EN ISO 10993-4-2006,IDT;OENORM EN ISO 10993-4-2009,IDT;OENORM EN ISO 10993-4-2009,IDT;OENORM EN ISO 10993-4/A1-2005,IDT;PN-EN ISO 10993-4-2003,IDT;PN-EN ISO 10993-4-2009,IDT;SS-EN ISO 10993-4-2003,IDT;SS-EN ISO 10993-4-2009,IDT;UNE-EN ISO 10993-4-2003,IDT;UNE-EN ISO 10993-4-2009,IDT;SANS 10993-4-2004,IDT;GOST ISO 10993-4-2011,IDT;GOST R ISO 10993-4-2009,IDT;TS EN ISO 10993-4-2009,IDT;TS EN ISO 10993-4-2014,IDT;DS/EN ISO 10993-4-2003,IDT;DS/EN ISO 10993-4-2009,IDT;UNI EN ISO 10993-4-2008-2008,IDT;UNI EN ISO 10993-4-2009-2009,IDT;STN EN ISO 10993-4-2003,IDT;STN EN ISO 10993-4-2004,IDT;STN EN ISO 10993-4-2009,IDT;SANS 10993-4-2004,IDT;SANS 10993-4-2004-2004,IDT;CSN EN ISO 10993-4-2003,IDT;CSN EN ISO 10993-4-2009,IDT;DS/EN ISO 10993-4-2003,IDT;DS/EN ISO 10993-4-2009,IDT;NEN-EN-ISO 10993-4-2002 en-2002,IDT;NEN-EN-ISO 10993-4-2009 en-2009,IDT;SANS 10993-4-2004-2004,IDT
起草单位：ISO/TC 194
标准简介：This part of ISO 10993 provides general requirements for evaluating the interactions of medical devices with blood. It describes
a) a classification of medical and dental devices that are intended for use in contact with blood, based on the intended use and duration of contact as defined in ISO 10993-1,
b) the fundamental principles governing the evaluation of the interaction of devices with blood,
c) the rationale for structured selection of tests according to specific categories, together with the principles and scientific basis of these tests.
Detailed requirements for testing cannot be specified because of limitations in the knowledge and precision of tests for interactions of devices with blood. This part of ISO 10993 describes biological evaluation in general terms and may not necessarily provide sufficient guidance for test methods for a specific device.
文件格式：PDF
文件大小：685.07KB
文件页数：42
（以上信息更新时间为：2019-11-23）
ISO 10993-4-2002 医疗器械的生物评定.第4部分_与血液相互作用的试验的选择.pdf
(685.07 KB)
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