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Deletion of the reference to EU Directive 80/778/EEC of July
quality control and improvement using cusum techniques - Part 3: Cusum methods for process/quality control using measured data
2 specifies a 1
For an overview of ISO 14617
in a controlled manner
Cardiovascular implants and extracorporeal systems. Blood/tissue contact surface modifications for extracorporeal perfusion systems has-digital Deletion of the reference to1 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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