Historical
ISO 14708-5:2010
Implants for surgery - Active implantable medical devices - Part 5: Circulatory support devices
ISO 14708-5:2010 specifies requirements for safety and performance of active implantable circulatory support devices. It is not applicable to extracorporeal perfusion devices, cardiomyoplasty, heart restraint devices and counter-pulsation devices, such as extra- or intra-aortic balloon pumps.
ISO 14708-5:2010 specifies type tests, animal studies and clinical evaluation requirements.
CONTENT PROVIDER
International Organization for Standardization [iso]
International Organization for Standardization [iso]