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.
Status: WithdrawnPublication date: 2010-02
Edition: 1Number of pages: 47
Technical Committee: ISO/TC 150/SC 6 Active implants