DIN EN 45502-2-3
; VDE 0750-10-3:2010-07
Active implantable medical devices - Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems; German version EN 45502-2-3:2010
Aktive implantierbare Medizingeräte - Teil 2-3: Besondere Festlegungen für Cochlea-Implantatsysteme und auditorische Hirnstammimplantatsysteme; Deutsche Fassung EN 45502-2-3:2010
Overview
This standard applies to 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 the requirements of this standard. This standard amends and supplements DIN EN 45502-1:(VDE 0750-10):1998-07. The responsible Committee is Joint Subcommittee GUK 812.5 "Aktiv betriebene Implantate" ("Active implantable medical devices") of the DKE (German Commission for Electrical, Electronic and Information Technologies) at DIN and VDE.
Document: references other documents
Document: referenced in other documents
Responsible national committee
DKE/GUK 812.5 - Aktiv betriebene Implantate
