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ČSN EN ISO 14708-5 (853010)
Implants for surgery - Active implantable medical devices - Part 5: Circulatory support devices
Translate name
STANDARD published on 1.1.2023
The information about the standard:
Designation standards: ČSN EN ISO 14708-5
Classification mark: 853010
Catalog number: 515975
Publication date standards: 1.1.2023
SKU: NS-1097972
The number of pages: 84
Approximate weight : 283 g (0.62 lbs)
Country: Czech technical standard
Category: Technical standards ČSN
The category - similar standards:
Annotation of standard text ČSN EN ISO 14708-5 (853010):
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
Preview of the standard ČSN EN ISO 14708-5 (853010)
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