ISO/TS 10993-19:2006 医疗器械的生物评定-第19部分：评价和试验.

标准编号：ISO/TS 10993-19:2006

中文名称：医疗器械的生物评定-第19部分：评价和试验.

英文名称：Biological evaluation of medical devices — Part 19: Physico-chemical, morphological and topographical characterization of materials

发布日期：2006-06

标准范围

ISO/TS 10993-19:2006提供了一系列参数和测试方法，可用于识别和评估成品医疗器械中材料的物理化学、形态和地形（PMT）特性。此类评估仅限于与生物评估和医疗器械预期用途（临床应用和使用期限）相关的属性，即使此类属性与临床有效性重叠。

ISO/TS 10993-19:2006 provides a compilation of parameters and test methods that can be useful for the identification and evaluation of the physico-chemical, morphological and topographical (PMT) properties of materials in finished medical devices. Such an assessment is limited to those properties that are relevant to biological evaluation and the medical device's intended use (clinical application and duration of use) even if such properties overlap with clinical effectiveness.

标准预览图