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AAMI ANSI/AAMI/ISO 10993-13-2010/(R)2019

Biological evaluation of medical devices—Part 13: Identification and quantification of degradation products from polymeric devices
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AAMI ANSI/AAMI/ISO 10993-13-2010/(R)2019

Biological evaluation of medical devices—Part 13: Identification and quantification of degradation products from polymeric devices

PUBLISH DATE 2019
AAMI ANSI/AAMI/ISO 10993-13-2010/(R)2019
This standard describes general requirements for the design of tests in a simulated environment for identifying and quantifying degradation products from finished polymeric medical devices ready for clinical use.
SDO AAMI: Assoc. for the Advancement of Medical Instrumentation
Document Number 10993-13
Publication Date Jan. 1, 2019
Language en - English
Page Count 28
Revision Level
Supercedes
Committee
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