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 byThis 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 inThis 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 inThis particular standard shall apply. NOTE 1 The device that is commonly referred to as an active implantable medical device can in fact be a single device, a combination of devices, or a combination of a device or devices and one or more accessories. Not all of these parts are required to be either partially or totally implantable, but there is a need to specify some requirements of NON-IMPLANTABLE PARTS and accessories if they could affect the safety or performance of the implantable part. NOTE 2 The terminology used inThis European Standard is intended to be consistent with the terminology of Directive 90/385/EEC. NOTE 3 InThis European Standard, terms printed in small capital letters are used as defined in Clause 3. Where a defined term is used as a qualifier in another term, it is not printed in small capital letters unless the concept thus qualified is also defined.
EN 45502-2-3:2010 Referenced Document
EN 13185:2001 Non-destructive testing - Leak testing - Tracer gas method
EN 45502-1:1997 Active Implantable Medical Devices - Part 1: General Requirements for Safety, Marking and Information to Be Provided by the Manufacturer
EN 55011:2007 Industrial@ scientific and medical (ISM) radio-frequency equipment - Electromagnetic disturbance characteristics - Limits and methods of measurement (Incorporates Amendments A2: 2007; Remains Current)
EN 60068-2-27:1993 Basic Environmental Testing Procedures Part 2: Tests Test Ea and Guidance: Shock
EN 60068-2-31:1993 Basic Environmental Testing Procedures Part 2: Tests Test Ec: Drop and Topple@ Primarily for Equipment- Type Specimens
EN 60068-2-47:2005 Environmental testing Part 2-47: Tests - Mounting of specimens for vibration, impact and similar dynamic tests
EN 60068-2-64:2008 Environmental testing - Part 2-64: Tests - Test Fh: Vibration, broadband random and guidance
EN 60068-2-75:1997 Environmental Testing Part 2: Tests - Test Eh: Hammer Tests (Remains Current)
EN 60118-6:1999 Hearing aids Part 6: Characteristics of electrical input circuits for hearing aids
EN 45502-2-3:2010 history
2010EN 45502-2-3:2010 Active implantable medical devices - Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems