EN ISO 14708-5:2022
外科植入物.有源可植入医疗装置.第5部分:循环支撑装置

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

作废

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标准号

EN ISO 14708-5:2022

发布

2022年

发布单位

欧洲标准化委员会

当前最新

EN ISO 14708-5:2022

 

 

适用范围

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.

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