Implants for surgery — Active implantable medical devices — Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
手术植入物 - 有源植入式医疗器械 - 第1部分:制造商提供的安全 标记和信息的一般要求
发布日期:
2014-08-11
ISO 14708-1:2014规定了通常适用于主动植入式医疗设备的要求。
ISO 14708中规定的试验为型式试验,将在有源植入式医疗设备的样品上进行,以证明符合要求。
ISO 14708-1:2014不仅适用于电动的有源植入式医疗设备,也适用于由其他能源(如气压或弹簧)驱动的设备。
ISO 14708-1:2014也适用于主动植入式医疗设备的一些非植入式零件和附件。
ISO 14708-1:2014 specifies requirements that are generally applicable to active implantable medical devices.
The tests that are specified in ISO 14708 are type tests and are to be carried out on samples of an active implantable medical device to show compliance.
ISO 14708-1:2014 is applicable not only to active implantable medical devices that are electrically powered but also to those powered by other energy sources (for example by gas pressure or by springs).
ISO 14708-1:2014 is also applicable to some non-implantable parts and accessories of the active implantable medical devices.