本文件提供了参数和测试方法的汇编，可用于识别和评估物理，即物理化学、形态和地形 （PMT）成品医疗器械中材料的特性。这种评估仅限于那些 与生物学评估和医疗器械预期用途（临床）相关的特性 即使这些特性与临床效果重叠，应用和使用期限也不例外。交叉引用:ISO 10993-1ISO 10993-18ASTM F 665ISO 17853ISO 13565-2ASTM F 2081ISO 13565-1ISO 14971ISO 4287ASTM D 968ISO 5436-2ISO 22442-1ISO 17190-5ASTM G 174ISO 18757ISO 18754ASTM F 754EN 623- 4ASTM F 732ASTM F 1854EN 828ISO 3274ASTM D 1894ISO 22442-3ISO 13320ASTM F 735ISO 16610-21ISO/TR 10993-22ISO 22442-2ISO 13565-3ISO 4288EN 725-5ISO 13319ASTM F 1877ASTM D 4060ISO 10993-9ISO 12179ASTM D 1044EN 455-3ISO 10993-13ISO 5832-1ASTM F 1978ISO 10993-15ISO 5436-1购买本文件时可提供的所有现行修订版。

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.Cross References:ISO 10993-1ISO 10993-18ASTM F 665ISO 17853ISO 13565-2ASTM F 2081ISO 13565-1ISO 14971ISO 4287ASTM D 968ISO 5436-2ISO 22442-1ISO 17190-5ASTM G 174ISO 18757ISO 18754ASTM F 754EN 623-4ASTM F 732ASTM F 1854EN 828ISO 3274ASTM D 1894ISO 22442-3ISO 13320ASTM F 735ISO 16610-21ISO/TR 10993-22ISO 22442-2ISO 13565-3ISO 4288EN 725-5ISO 13319ASTM F 1877ASTM D 4060ISO 10993-9ISO 12179ASTM D 1044EN 455-3ISO 10993-14ISO 10993-13ISO 5832-1ASTM F 1978ISO 10993-15ISO 5436-1All current amendments available at time of purchase are included with the purchase of this document.