EN 45502-2-3:2010

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

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. 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 in this European Standard is intended to be consistent with the terminology of Directive 90/385/EEC. NOTE 3 In this 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.

Aktive implantierbare Medizingeräte - Teil 2-3: Besondere Festlegungen für Cochlea-Implantatsysteme und auditorische Hirnstammimplantatsysteme

Dispositifs médicaux implantables actifs - Partie 2-3: Exigences particulières pour les systèmes d'implant cochléaire et les systèmes d'implant auditif du tronc cérébral

Aktivni medicinski vsadki (za implantacijo) - 2-3. del: Posebne zahteve za sisteme s polžkovim vsadkom

Ta del 2-3 EN 45502 določa zahteve, ki veljajo za AKTIVNE MEDICINSKE VSADKE (ZA IMPLANTACIJO), ki so namenjeni zdravljenje slušnih okvar z električno stimulacijo slušnih poti. Naprave, ki ne zdravijo slušne okvare z električno stimulacijo, temveč na druge načine, niso zajete v tem evropskem standardu. Preskusi, ki so določeni v EN 45502, so tipski preskusi in so izvedeni na vzorcih naprave za dokaz skladnosti.

General Information

• Status: Published
• Publication Date: 18-Feb-2010
• Withdrawal Date: 31-Jan-2013
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• ICS: 13.320 - Alarm and warning systems
• Technical Committee: CEN/CLC/JTC 16 - CEN/CENELEC Joint Working Group on Active Implantable Medical Devices
• Drafting Committee: IEC/SC 62D - IEC_SC_62D
• Parallel Committee: IEC/SC 62D - IEC_SC_62D
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 19-Feb-2010
• Completion Date: 19-Feb-2010
• Directive: 90/385/EEC - Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices
• Mandate: BC/CLC/02-89 - BC/CLC/02-89
• Mandate: M/432 - Standardisation Mandate addressed to CEN and CENELEC within the framework of Directive 2007/47/EC amending Directive 90/385/EEC and Directive 93/42/EEC relating to Medical Devices
• Mandate: M/BC/CEN/89/9 - Joint Standardization request to CEN/CENELEC concerning harmonized standards relating to horizontal aspects in the field of medical devices
• Ref Project: SIST EN 45502-2-3:2010 - Active implantable medical devices - Part 2-3: Particular requirements for cochlear implant systems

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 45502-2-3:2010
01-april-2010
Aktivni medicinski vsadki (za implantacijo) - 2-3. del: Posebne zahteve za sisteme
s polžkovim vsadkom
Active implantable medical devices - Part 2-3: Particular requirements for cochlear
implant systems
Aktive implantierbare Medizingeräte - Teil 2-3: Besondere Festlegungen für Cochlea-
Implantate
Dispositifs médicaux implantables actifs - Partie 2-3: Exigences particulières pour les
systèmes d'implant cochléaire
Ta slovenski standard je istoveten z: EN 45502-2-3:201
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
SIST EN 45502-2-3:2010 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 45502-2-3:2010

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SIST EN 45502-2-3:2010

EUROPEAN STANDARD
EN 45502-2-3

NORME EUROPÉENNE
February 2010
EUROPÄISCHE NORM

ICS 13.320


English version


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



Dispositifs médicaux implantables actifs - Aktive implantierbare Medizingeräte -
Partie 2-3: Exigences particulières Teil 2-3: Besondere Festlegungen
pour les systèmes d'implant cochléaire für Cochlea-Implantatsysteme
et les systèmes d'implant auditif und auditorische
du tronc cérébral Hirnstammimplantatsysteme





This European Standard was approved by CEN and CENELEC on 2010-02-01. CEN and CENELEC members
are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration.

Up-to-date lists and bibliographical references concerning such national standards may be obtained on
application to the CEN-CENELEC Management Centre or to any CENELEC member

This European Standard exists in three official versions (English, French, German). A version in any other
language made by translation under the responsibility of a CENELEC member into its own language and notified
to the Central Secretariat has the same status as the official versions.

CEN and CENELEC members are the national standards bodies and national electrotechnical committees of
Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany,
Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland,
Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom.

CEN/CENELEC




CEN-CENELEC Management Centre: Avenue Marnix 17, B - 1000 Brussels



Ref. No. EN 45502-2-3:2010 E

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SIST EN 45502-2-3:2010
EN 45502-2-3:2010 – 2 –
Foreword
This European Standard was prepared by the CEN/CENELEC Joint Working Group AIMD, Active
Implantable Medical Devices. Members of the Joint Working Group were nominated by one of the
members of either CEN or CENELEC. The lead has been given to CENELEC.
The text of the draft was submitted to a second formal vote and was approved by CEN and CENELEC as
EN 45502-2-3 on 2010-02-01.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN and CENELEC shall not be held responsible for identifying any or all such patent
rights.
The following dates were fixed:
– latest date by which the EN has to be implemented

at national level by publication of an identical

national standard or by endorsement
(dop) 2011-02-01

– latest date by which the national standards conflicting

with the EN have to be withdrawn
(dow) 2013-02-01
The requirements of this particular standard supplement or modify those of the General Standard
EN 45502-1:1997, Active implantable medical devices – Part 1: General requirements for safety, marking
and information to be provided by the manufacturer.
This European Standard has been prepared under a mandate given to CEN and CENELEC by the
European Commission and the European Free Trade Association and covers essential requirements of
EC Directive 90/385/EEC. See Annexes AA and BB.
Although both this European Standard and the Directive deal with the same range of products, the
structure and purpose of the two documents are different. Annex AA, BB, CC are rationales, providing
some further explanation of particular subclauses of this European Standard. All three annexes are
informative.
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SIST EN 45502-2-3:2010
– 3 – EN 45502-2-3:2010
Contents
Introduction . 5
1 Scope .
...