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.

Other parts of this product are listed below:

Implants for surgery -- Active implantable medical devices -- Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
Implants for surgery - Active implantable medical devices - Part 2: Cardiac pacemakers
Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators
Implants for surgery - Active implantable medical devices - Part 4: Implantable infusion pumps
Implants for surgery - Active implantable medical devices - Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators)