Medicinsk utrustning

Kommittébeteckning: SIS/TK 330 (Förbrukningsmaterial inom sjukvården)
Källa: CEN
Svarsdatum: den 25 jan 2019
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This ISO standard specifies requirements for enteral feeding systems comprising enteral giving sets, enteral giving set extensions, enteral syringes, enteral feeding catheters, enteral accessories and their connector systems.

Kommittébeteckning: SIS/TK 340 (Implantat och biologisk säkerhet)
Källa: CEN
Svarsdatum: den 14 mar 2019
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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 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 within 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.