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 of 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.
German version of the European standard EN 45502-2-3:2010.

General information

Publishing organizations:
- German Commission for Electrical, Electronic & Information Technologies of DIN and VDE (DKE)
Origin: Germany
Publication type: standard
Scope: Germany
Pertains: patients with active implantable medical devices

Exposure

- 16.6 Hz–3 GHz
- 16 2/3 Hz (train)
- 50/60 Hz
- 2.45 GHz
- electric field
- magnetic field
- low frequency
- intermediate frequency
- RF field
- also other exposures without EMF
- signals/pulses
- therapeutic/medical device
- MRI

Available languages

German

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