ISO/TS 10993-19:2020,Biological evaluation of medical devices — Part 19: Physico-chemical, morphological and topographical characterization of materials.The size of this pdf file is 5.07M.
ISO/TS 10993-19:2020 provides a compilation of parameters and test methods that can be useful for the identification and evaluation of the physical.
ISO/TS 10993-19:2020 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.
4 General principles
Consideration of the PMT characterization of the materials from which a medical device is made, like chemical characterization of materials (addressed in ISO 10993-18), is a necessary step in assessingthe biological safety and clinical effectiveness of the device. Both types of characterization are also important in judging equivalence of
a) a proposed material to a clinically established material,
b) a prototype device to a final device,
c) a material or device after a process or manufacturing change, or
d) a real-time and or accelerated device and the non-aged device.
ISO/TS 10993-19:2020 introduction
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