ISO/TS 10993-19:2020 医疗器械的生物学评价 第19部分：材料的物理化学、形态和地形特征

标准编号：ISO/TS 10993-19:2020

中文名称：医疗器械的生物学评价 第19部分：材料的物理化学、形态和地形特征

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

发布日期：2020-03

标准范围

本文件提供的参数和测试方法汇编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。本文件既不涉及降解产物的识别或量化，也不涉及ISO 10993-9、ISO 10993-13、ISO 10993-14和ISO 10993-15中所述降解材料的物理化学性质的评估。ISO 10993-18涵盖了材料的化学特性。当材料或设备未直接或间接与身体接触时，ISO 10993系列不适用。

This document provides a compilation of parameters and test methods that can be useful for the identification and evaluation of the physical, i.e. 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.This document does neither address the identification or quantification of degradation products nor the evaluation of the physico-chemical properties of the degraded materials, which are covered in ISO 10993？9, ISO 10993？13, ISO 10993？14 and ISO 10993？15.Chemical characterization of materials is covered by ISO 10993？18.The ISO 10993 series is not applicable when the material or device is not in contact with the body directly or indirectly.

标准预览图