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
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.
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