ISO 10993-12-2002 医疗器械的生物评定.第12部分_样品制备和标准样品.pdf

标准号：ISO 10993-12-2002
实施状态：作废
中文名称：医疗器械的生物评定.第12部分:样品制备和标准样品
英文名称：Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
发布日期：2002-12
被替代标准：ISO 10993-12-2007
代替标准：ISO 10993-12-1996;ISO/DIS 10993-12-2001
采用标准：DIN EN ISO 10993-12-2005,IDT;DIN EN ISO 10993-12-2004,IDT;ANSI/AAMI/ISO 10993-12-2002,IDT;BS EN ISO 10993-12-2004,IDT;EN ISO 10993-12-2004,IDT;prEN ISO 10993-12-2004,IDT;NF S99-512-2005,IDT;OENORM EN ISO 10993-12-2005,IDT;OENORM EN ISO 10993-12-2004,IDT;OENORM EN ISO 10993-12/A1-2005,IDT;UNE-EN ISO 10993-12-2005,IDT
起草单位：ISO/TC 194
标准简介：This part of ISO 10993 specifies requirements and gives guidance on the procedures to be followed in the preparation of samples and the selection of reference materials for medical devices testing in biological systems in accordance with one or more parts of the ISO 10993 series.
Specifically, this part of ISO 10993 addresses:
—  test material selection;
—  selection of representative portions from a device;
—  test sample preparation;
—  experimental controls;
—  selection of and requirements for reference materials; and
—  preparation of extracts.
The applicability of this part of ISO 10993 to absorbable materials, materials that polymerize in situ, tissue-engineered medical products and materials of biological origin should be carefully evaluated.
文件格式：PDF
文件大小：751.82KB
文件页数：22
（以上信息更新时间为：2019-11-23）



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