This standard specifies requirements that are applicable to those active implantable medical devices intended to treat hearing impairment via electrical stimulation of the auditory pathways. Externally or internally processed acoustic information is converted to electrical stimulation signals which are delivered via one or more electrodes. The working parameters of the device may be adjusted via a non-implantable accessory. The power source may be externally derived or from an internal battery. Devices, which treat hearing impairment via means other than electrical stimulation are not covered by this European Standard. This standard amends and supplements DIN EN 45502-1 (VDE 0750-10):1998-07.

Standard:

DIN EN ISO 14708-7 VDE 0750-20-7:2022-12

Implants for surgery – Active implantable medical devices

Part 7: Particular requirements for cochlear and auditory brainstem implant systems

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