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AAMI ANSI/AAMI/ISO 10993-9:2009/(R)2014

Biological evaluation of medical devices—Part 9: Framework for identification and quantification of potential degradation products
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AAMI ANSI/AAMI/ISO 10993-9:2009/(R)2014

Biological evaluation of medical devices—Part 9: Framework for identification and quantification of potential degradation products

PUBLISH DATE 2010
AAMI ANSI/AAMI/ISO 10993-9:2009/(R)2014
AAMI/AAMI/ISO 10993-9 provides general principles for the systematic evaluation of the potential and observed biodegradation of medical devices and for the design and performance of biodegradation studies. Information obtained from these studies can be used in the biological evaluation described in the ISO 10993 series. Considers both non-resorbable and resorbable materials. Not applicable to: a) evaluation of degradation which occurs by purely mechanical processes; methodologies for the production of this type of degradation product are described in specific product standards, where available; b) leachable components which are not degradation products; c) medical devices or components that do not contact the patient's body directly or indirectly.
SDO AAMI: Assoc. for the Advancement of Medical Instrumentation
Document Number 10993-9
Publication Date May 17, 2010
Language en - English
Page Count 22
Revision Level
Supercedes
Committee
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