Full Description

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 thoseproperties that are relevant to biological evaluation and the medical device's intended use (clinicalapplication and duration of use) even if such properties overlap with clinical effectiveness.

Cross References:
ISO 10993-1
ISO 10993-18
ASTM F 665
ISO 17853
ISO 13565-2
ASTM F 2081
ISO 13565-1
ISO 14971
ISO 4287
ASTM D 968
ISO 5436-2
ISO 22442-1
ISO 17190-5
ASTM G 174
ISO 18757
ISO 18754
ASTM F 754
EN 623-4
ASTM F 732
ASTM F 1854
EN 828
ISO 3274
ASTM D 1894
ISO 22442-3
ISO 13320
ASTM F 735
ISO 16610-21
ISO/TR 10993-22
ISO 22442-2
ISO 13565-3
ISO 4288
EN 725-5
ISO 13319
ASTM F 1877
ASTM D 4060
ISO 10993-9
ISO 12179
ASTM D 1044
EN 455-3
ISO 10993-14
ISO 10993-13
ISO 5832-1
ASTM F 1978
ISO 10993-15
ISO 5436-1


All current amendments available at time of purchase are included with the purchase of this document.

Product Details

Published: 03/16/2020 ISBN(s): 9780580997556 Number of Pages: 24 File Size: 1 file , 2.1 MB Product Code(s): 30372405, 30372405, 30372405