Standard Svensk standard · SS-EN ISO 14708-5:2022

Kirurgiska implantat - Aktiva implanterbara medicintekniska produkter -Del 5: Cirkulationsstödjande anordningar (ISO 14708-5:2020)

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Standard Svensk standard · SS-EN ISO 14708-5:2022

Kirurgiska implantat - Aktiva implanterbara medicintekniska produkter -Del 5: Cirkulationsstödjande anordningar (ISO 14708-5:2020)
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Omfattning
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.

Ämnesområden

Kirurgiska implantat, proteser och ortoser (11.040.40)


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Standard Svensk standard · SS-EN ISO 14708-5:2022

Kirurgiska implantat - Aktiva implanterbara medicintekniska produkter -Del 5: Cirkulationsstödjande anordningar (ISO 14708-5:2020)
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Produktinformation

Språk: Engelska

Framtagen av: Implantat, SIS/TK 340/AG 03

Internationell titel: Implants for surgery - Active implantable medical devices - Part 5: Circulatory support devices (ISO 14708-5:2020)

Artikelnummer: STD-80037061

Utgåva: 1

Fastställd: 2022-08-01

Antal sidor: 88