Cardiovascular implants and extracorporeal systems. Blood/tissue contact surface modifications for extracorporeal perfusion systems Ingestion-build-61878 NOTE The general conditions defined
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Description
NOTE The general conditions defined in existing vehicle dynamics standards are valid up until the point when a respective reference to this part of ISO 15037 is included
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Cardiovascular implants and extracorporeal systems. Blood/tissue contact surface modifications for extracorporeal perfusion systems Ingestion-build-61878 NOTE The general conditions defined1 Scope This International Standard specifies requirements for the physical, biological and performance testing of biocompatible modifications on extracorporeal devices. This International Standard is applicable to components of heart lung bypass equipment and of extracorporeal life support equipment that carry blood and have modifications on the blood and tissue contacting surfaces of the device. The assumption is that these devices will be used at
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