Study type: Law/recommendation/guideline

[Active implantable medical devices - Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems; German version EN 45502-2-3:2010]. guideline

Aktive implantierbare Medizingeräte - Teil 2-3: Besondere Festlegungen für Cochlea-lmplantatsysteme und auditorische Hirnstammimplantatsysteme; Deutsche Fassung EN 45502-2-3:2010.

German Commission for Electrical, Electronic & Information Technologies in DIN and VDE (DKE)
2010, DIN EN 45502-2-3 VDE 0750-10-3:2010-07

Summary

The standard establishes particular requirements for active implantable medical devices for the treatment of hearing impairments by applying electric stimulation (e.g., cochlear and auditory brainstem implant systems) to provide safety for the patients as well as for the operators.

General information

Exposure

Original texts