ISO/TS 10993-19:2006被替代
Biological evaluation of medical devices Part 19: Physico-chemical, morphological and topographical characterization of materials
出版：International Organization for Standardization
专家解读视频
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.
AAMI ISO TIR 10993-19:2006 - Identical
DD ISO/TS 10993-19:2006 - Identical
GB/T 16886.19-2011 - Identical
