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AAMI ANSI/AAMI/ISO 11658:2012

Cardiovascular implants and extracorporeal systems—Blood/tissue contact surface modifications for extracorporeal perfusion systems
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AAMI ANSI/AAMI/ISO 11658:2012

Cardiovascular implants and extracorporeal systems—Blood/tissue contact surface modifications for extracorporeal perfusion systems

PUBLISH DATE 2012
AAMI ANSI/AAMI/ISO 11658:2012
This standard will apply to components of heart-lung bypass equipment and of extracorporeal life support equipment that carry blood and have a coating on the blood contact surface of the device. While standards exist for the main components used in heart-lung bypass and extracorporeal life support equipment, many of these components are currently distributed with a surface coating that comes in contact with blood. This aspect of the design of these components was not addressed in the existing standard. Rather than rewrite the existing standards, a single standard will address the composition, the mechanical and biological characteristics, performance and safety of these coating for all the components.
SDO AAMI: Assoc. for the Advancement of Medical Instrumentation
Document Number 11658
Publication Date Oct. 1, 2012
Language en - English
Page Count 20
Revision Level
Supercedes
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