SN-ISO/TS 10993-19:2020
医疗器械生物学评价 第19部分：材料的物理化学、形态和形貌表征

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

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标准号

SN-ISO/TS 10993-19:2020

发布

2020年

发布单位

SCC

当前最新

SN-ISO/TS 10993-19:2020

 

 

适用范围

  Full Description ADOPTED_FROM:ISO/TS 10993-19:2020 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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