DANSK DS/ISO 14708-3 PDF

This part of ISO 14708 specifies particular requirements for active implantable medical devices intended for electrical stimulation of the central or peripheral nervous system, to provide basic assurance of safety for both patients and users. This part of ISO 14708 is also applicable to all non-implantable parts and accessories of the devices (see clause 3). The tests that are specified in this part of ISO 14708 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. NOTE – This part of ISO 14708 is not intended to apply to non-implantable neurostimulation devices. However, it does apply to devices intended to be used as trial screeners because of their close affiliation with implantable neurostimulators.