Tagasi

ISO 14708-5:2020

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

Üldinfo
Kehtiv alates 12.05.2020
Direktiivid või määrused
puuduvad
Standardi ajalugu
Staatus
Kuupäev
Tüüp
Nimetus
12.05.2020
Põhitekst
26.01.2010
Põhitekst
This document specifies requirements for safety and performance of active implantable circulatory support devices, including type tests, animal studies and clinical evaluation requirements. NOTE The device that is commonly referred to as an active implantable medical device can in fact be a single device, a combination of devices, or a combination of a device or devices and one or more accessories. Not all of these parts are required to be either partially or totally implantable, but there is a need to specify main requirements of non-implantable parts and accessories if they could affect the safety or performance of the implantable device. The tests that are specified in this document are type tests and are to be carried out on a sample of a device to assess device behavioural responses and are not intended to be used for the routine testing of manufactured products. Included in the scope of this document are: - ventricular assist devices (VAD), left or right heart support; - total artificial hearts (TAH); - biventricular assist devices (biVAD); - percutaneous assist devices; - paediatric assist devices.
*
*
*
PDF
196,60 € koos KM-ga
Paber
196,60 € koos KM-ga
Standardi monitooring