EN 45502-2-3:2010

SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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
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.
__________
– 3 – EN 45502-2-3:2010
Contents
Introduction . 5
1 Scope . 6
2 Normative references . 6
3 Definitions . 7
4 Symbols and abbreviations (optional) . 9
5 General requirements for non-implantable parts. 9
6 Inspection and measurement . 9
7 General arrangement of the packaging .10
8 General markings for active implantable medical devices .10
9 Markings on the SALES PACKAGING .10
10 Construction of the SALES PACKAGING .11
11 Markings on the sterile pack.11
12 Construction of the non-reusable pack .12
13 Markings on the active implantable medical device .12
14 Protection from unintentional biological effects being caused by the active implantable medical
device .12
15 Protection from harm to the patient or user caused by external physical features of the active
implantable medical device .13
16 Protection from harm to the patient caused by electricity .13
17 Protection from harm to the patient caused by heat .13
18 Protection from ionizing radiation released or emitted from the active implantable medical device 14
19 Protection from unintended effects caused by the device .14
20 Protection of the device from damage caused by external defibrillators .15
21 Protection of the device from changes caused by high power electrical fields applied directly to
the patient .15
22 Protection of the active implantable medical device from changes caused by miscellaneous
medical treatments .16
23 Protection of the active implantable medical device from mechanical forces .18
24 Protection of the active implantable medical device from damage caused by electrostatic
discharge .23
25 Protection of the active implantable medical device from damage caused by atmospheric
pressure changes .24
26 Protection of the active implantable medical device from damage caused by temperature
changes .24
27 Protection of the active implantable medical device from electromagnetic non-ionising radiation .24
28 Accompanying documentation .27
Annex AA (informative) Notes on EN 45502-2-3 .30
Annex BB (informative) Notes on theoretical modelling to demonstrate compliance to Clause 27 .38
Annex CC (informative) Notes on EMI measurements to demonstrate compliance to Clause 27 .40
Bibliography .44

Figures
Figure 101 – Measurement of output signal amplitude and load impedance . 10
Figure 102 – Test set-up for proof of protection from high frequency currents caused by surgical
equipment . 15
Figure 103 – Test set-up for proof of protection from harmful output during MRI scanning . 17
Figure 104 – Stimulator drop test . 20
Figure 105 – Flex test fixture . 21
Figure 106 – Interference signal at 16 Hz and 50 Hz . 26
Figure 107 – Interference signal at frequencies above 1 kHz . 26
Figure CC.101 – Head simulator for EMI measurements . 41
Tables
Table 101 – Peak magnetic field strength H . 25
P
Table 102 – Peak electric field strength E . 26
P
Table CC.101 – Peak net dipole power . 43

– 5 – EN 45502-2-3:2010
Introduction
This European Standard specifies particular requirements for those ACTIVE IMPLANTABLE MEDICAL DEVICES
that are intended to treat hearing impairment via electrical stimulation (for EXAMPLE COCHLEAR IMPLANT
SYSTEMS or AUDITORY BRAINSTEM IMPLANT SYSTEMS), to provide basic assurance of safety for both patients
and users.
A COCHLEAR IMPLANT SYSTEM or AUDITORY BRAINSTEM IMPLANT SYSTEM is an ACTIVE IMPLANTABLE MEDICAL
DEVICE comprising implantable and NON-IMPLANTABLE PARTS (external parts). The power source may be
externally derived or from an internal battery. The IMPLANT SYSTEM is designed to restore hearing via
electrical stimulation of the auditory pathways. Externally or internally processed acoustic information is
converted to electrical stimulation signals which are delivered via one or more electrodes. The working
parameters of the device may be adjusted via a non-implantable accessory.
This European Standard is relevant to all parts of IMPLANT SYSTEMS, including accessories.
The requirements of this European Standard supplement or modify those of EN 45502–1:1997, Active
implantable medical devices – Part 1: General requirements for safety, marking and information to be
provided by the manufacturer, hereinafter referred to as Part 1. The requirements of this European
Standard take priority over those of Part 1.
Figures or tables that are additional to those of Part 1 are numbered starting from 101; additional annexes
are lettered AA, BB, etc.
1 Scope
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 def
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