Back

EVS-EN 45502-2-3:2010

Active implantable medical devices - Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems

General information
Valid from 06.04.2010
Base Documents
EN 45502-2-3:2010
Standard history
Status
Date
Type
Name
06.04.2010
Main
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.
*
*
*
PDF
16.10 €
Paper
16.10 €
Price: 2.00 €
Standard monitoring
Customers who bought this item also bought
Main

EVS-EN 45502-1:2015

Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
Newest version Valid from 08.06.2015
Main

EVS-EN ISO 20485:2018

Non-destructive testing - Leak testing - Tracer gas method (ISO 20485:2017)
Newest version Valid from 15.02.2018
Main

EVS-EN 45502-2-1:2004

Active implantable medical devices - Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (Cardiac pacemakers)
Newest version Valid from 09.09.2004
Main

EVS-EN 45502-2-2:2008

Active implantable medical devices -- Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)
Newest version Valid from 08.05.2008