ISO 14708-3:2008 外科植入物 有源植入性医疗器械 第3部分:植入式神经刺激器

标准编号:ISO 14708-3:2008

中文名称:外科植入物 有源植入性医疗器械 第3部分:植入式神经刺激器

英文名称:Implants for surgery — Active implantable medical devices — Part 3: Implantable neurostimulators

发布日期:2008-11

标准范围

ISO 14708-3:2008适用于用于电刺激中枢或周围神经系统的主动植入式医疗设备。ISO 14708-3:2008也适用于设备的所有非植入零件和附件。ISO 14708-3:2008中规定的试验是在装置样品上进行的型式试验,以证明符合性,不用于制造产品的常规试验。

ISO 14708-3:2008 is applicable to active implantable medical devices intended for electrical stimulation of the central or peripheral nervous system.ISO 14708-3:2008 is also applicable to all non-implantable parts and accessories of the devices.The tests that are specified in ISO 14708-3:2008 are type tests intended to be carried out on a sample of a device to show compliance, and are not intended to be used for the routine testing of manufactured products.

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