ISO/TS TECHNICAL SPECIFICATION 10993-19 Second edition 2020-03 Biological evaluation of medical devices- Part 19: Physico-chemical, morphological and topographical characterization of materials Referencenumber IS0/TS10993-19:2020(E) iso IS02020 IS0/TS10993-19:2020(E) Contents Page Foreword iv Introduction. ..V 1 Scope.. .1 2 Normativereferences .1 3 Terms and definitions .1 4 General principles. .2 5 Characterizationprocedure. .3 5.1 General .3 5.2 Qualitativeinformation 3 5.3 Material equivalence 3 5.4 Quantitativeassessment. 4 6 Characterizationparametersandmethods .4 7 Reportingofdataobtained. .5 Annex A (informative)Principles for judging material equivalence .6 Bibliography .10 @IS0 2020-All rights reserved ii

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