ISO 10993-9:2009 医疗器械的生物学评价 第9部分：潜在降解产物的定性和定量框架

标准编号：ISO 10993-9:2009

中文名称：医疗器械的生物学评价 第9部分：潜在降解产物的定性和定量框架

英文名称：Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products

发布日期：2009-12

标准范围

ISO 10993-9:2008为系统评估医疗器械的潜在和观察到的生物降解以及生物降解研究的设计和性能提供了一般原则。从这些研究中获得的信息可用于ISO 10993系列中描述的生物评估。ISO 10993-9:2008考虑了不可再吸收和可再吸收材料。

ISO 10993-9:2008 provides general principles for the systematic evaluation of the potential and observed biodegradation of medical devices and for the design and performance of biodegradation studies. Information obtained from these studies can be used in the biological evaluation described in the ISO 10993 series. ISO 10993-9:2008 considers both non-resorbable and resorbable materials.

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