Tagasi

ISO 14708-5:2010

Implants for surgery -- Active implantable medical devices -- Part 5: Circulatory support devices

Üldinfo
Kehtetu alates 12.05.2020
Direktiivid või määrused
puuduvad

Standardi ajalugu

Staatus
Kuupäev
Tüüp
Nimetus
12.05.2020
Põhitekst
26.01.2010
Põhitekst
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.
*
*
*
PDF
79,98 € koos KM-ga
Paber
79,98 € koos KM-ga
Standardi monitooring