标准摘要
[中文适用范围]: 本文件适用于用于中枢或外周神经系统的可电活性刺激的植入式医疗器械。在本文件中指定的试验是对设备行为反应进行评估的型式试验,应在设备样品上进行,而不是用于对生产的常规测试。 [外文原描述]: ISO 14708-3:2017 is applicable to active implantable medical devices intended for electrical stimulation of the central or peripheral nervous system. 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.
英文名称Implants for surgery — Active implantable medical devices — Part 3: Implantable neurostimulators