EVS-EN 45502-2-3:2010

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. This Part of EN 45502 is also applicable to NON-IMPLANTABLE PARTS and accessories of the devices (see NOTE 1). 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.