This Part 2-3 of EN 45502 specifies requirements that are applicable to those ACTIVE IMPLANTABLE
MEDICAL DEVICES that are intended to treat hearing impairment via electrical stimulation of the auditory
pathways. Devices which treat hearing impairment via means other than electrical stimulation are not
covered by this European Standard.
The tests that are specified in EN 45502 are type tests and are to be carried out on samples of a device
to show compliance.
The electrical characteristics of the IMPLANTABLE PART shall be determined by either the appropriate
method detailed in this particular standard or by any other method demonstrated to have an accuracy
equal to, or better than, the method specified. In the case of dispute, the method detailed in this particular
standard shall apply.
BS EN 45502-2-3:2010 history
2010BS EN 45502-2-3:2010 Active implantable medical devices - Particular requirements for cochlear and auditory brainstem implant systems