1、BS EN45502-2-3:2010ICS 11.040.40NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDActive implantablemedical devicesPart 2-3: Particular requirementsfor cochlear and auditory brainstemimplant systemsThis British Standardwas published under theauthority of the Stand
2、ardsPolicy and StrategyCommittee on 31 March2010 BSI 2010ISBN 978 0 580 70990 6Amendments/corrigenda issued since publicationDate CommentsBS EN 45502-2-3:2010National forewordThis British Standard is the UK implementation of EN 45502-2-3:2010.The UK participation in its preparation was entrusted to
3、TechnicalCommittee CH/150/6, Active Surgical Implants.A list of organizations represented on this committee can be obtained onrequest to its secretary.This publication does not purport to include all the necessary provisionsof a contract. Users are responsible for its correct application.Compliance
4、with a British Standard cannot confer immunityfrom legal obligations.BS EN 45502-2-3:2010EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 45502-2-3 March 2010 ICS 11.040.40 English version Active implantable medical devices - Part 2-3: Particular requirements for cochlear and auditory brainstem
5、implant systems Dispositifs mdicaux implantables actifs - Partie 2-3: Exigences particulires pour les systmes dimplant cochlaire et les systmes dimplant auditif du tronc crbral Aktive implantierbare Medizingerte - Teil 2-3: Besondere Festlegungen fr Cochlea-Implantatsysteme und auditorische Hirnstam
6、mimplantatsysteme This European Standard was approved by CEN on 1 February 2010. 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
7、 lists and bibliographical references concerning such national standards may be obtained on application to the CEN Management Centre or to any CEN and CENELEC member. This European Standard exists in three official versions (English, French, German). A version in any other language made by translati
8、on under the responsibility of a CEN and CENELEC member into its own language and notified to the CEN Management Centre 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, Croa
9、tia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. CEN Management Centre: CENELEC C
10、entral Secretariat:Avenue Marnix 17, B-1000 Brussels Avenue Marnix 17, B-1000 Brussels 2010 CEN/CENELEC All rights of exploitation in any form and by any means reserved worldwide for CEN national Members and for CENELEC Members. Ref. No. EN 45502-2-3:2010 EBS EN 45502-2-3:2010EN 45502-2-3:2010 2 For
11、eword 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 se
12、cond 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 f
13、ollowing 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 requirement
14、s 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
15、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 do
16、cuments are different. Annex AA, BB, CC are rationales, providing some further explanation of particular subclauses of this European Standard. All three annexes are informative. _ BS EN 45502-2-3:2010 3 EN 45502-2-3:2010 Contents Introduction . 5 1 Scope . 6 2 Normative references . 6 3 Definitions
17、. 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
18、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 o
19、r 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 medic
20、al 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 im
21、plantable 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 im
22、plantable 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 do
23、cumentation .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 BS EN 45502-2-3:2010EN 45502-2-3
24、:2010 4 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
25、 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 HP25 Table 102 Peak elec
26、tric field strength EP. 26 Table CC.101 Peak net dipole power . 43 BS EN 45502-2-3:2010 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
27、 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 (externa
28、l 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 de
29、livered 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 455021:1997
30、, 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 o
31、f Part 1 are numbered starting from 101; additional annexes are lettered AA, BB, etc. BS EN 45502-2-3:2010EN 45502-2-3:2010 6 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 ele
32、ctrical 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. Thi
33、s 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
34、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 combinat
35、ion 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.
36、 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
37、is not printed in small capital letters unless the concept thus qualified is also defined. 2 Normative references This clause of Part 1 applies except as follows: Additional references: EN ISO 14971 1)2007 Medical devices - Application of risk management to medical devices (ISO 14971:2007) EN 1593 1
38、999 Non-destructive testing - Leak testing - Bubble emission techniques 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 5
39、5011 + A2 2007 2007 Industrial, scientific and medical (ISM) radio-frequency equipment - Electromagnetic disturbance characteristics - Limits and methods of measurement (CISPR 11:2003, mod. + A1:2004, mod. + A2:2006) EN 60068-2-27 2)1993 Basic environmental testing procedures - Part 2: Tests - Test
40、Ea and guidance: Shock (IEC 60068-2-27:1987) EN 60068-2-31 3)2008 Basic environmental testing procedures - Part 2: Tests - Test Ec: Drop and topple, primarily for equipment-type specimens (IEC 60068-2-31:1969 + A1:1982) 1)Superseded by EN ISO 14971:2009 “Medical devices - Application of risk managem
41、ent to medical devices” (ISO 14971:2007). 2)Will be superseded by EN 60068-2-27:2009 “Environmental testing - Part 2-27: Tests - Test Ea and guidance: Shock” (IEC 60068-2-27:2008) at the dow of the latter, i.e. 2012-05-01. BS EN 45502-2-3:2010 7 EN 45502-2-3:2010 EN 60068-2-47 2005 Environmental tes
42、ting - Part 2-47: Tests - Mounting of specimens for vibration, impact and similar dynamic tests (IEC 60068-2-47:2005) EN 60068-2-64 2008 Environmental testing - Part 2-64: Tests - Test Fh: Vibration, broadband random and guidance (IEC 60068-2-64:2008) EN 60068-2-75 1997 Environmental testing - Part
43、2-75: Tests - Test Eh: Hammer tests (IEC 60068-2-75:1997) EN 60118-6 1999 Hearing aids - Part 6: Characteristics of electrical input circuits for hearing aids (IEC 60118-6:1999) EN 60601-1 2006 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IE
44、C 60601-1:2005) EN 60601-1-2 2007 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests (IEC 60601-1-2:2007, mod.) EN 60801-2 4)1993 Electromagnetic compatibility for indu
45、strial-process measurement and control equipment - Part 2: Electrostatic discharge requirements (IEC 60801-2:1991) 3 Definitions This clause of Part 1 applies except as follows: Additional definitions: 3.3.1 cochlear implant system (CIS) active implantable medical device, comprising implantable and
46、NON-IMPLANTABLE PARTS, intended to treat hearing impairment via electrical stimulation of the cochlea 3.3.2 auditory brainstem implant system (BIS) ACTIVE IMPLANTABLE MEDICAL DEVICE, comprising implantable and NON-IMPLANTABLE PARTS, intended to treat hearing impairment via electrical stimulation of
47、the auditory brainstem 3.3.3 implant system either COCHLEAR IMPLANT SYSTEM or AUDITORY BRAINSTEM IMPLANT SYSTEM 3.3.4 non-implantable part external part of the IMPLANT SYSTEM NOTE Examples would include but are not limited to: sound processor, microphone, coil or power source. 3.3.5 stimulator impla
48、ntable part of the IMPLANT SYSTEM containing electronic circuitry required to produce electrical stimulation 3)Will be superseded by EN 60068-2-31:2008 “Environmental testing - Part 2-31: Tests - Test Ec: Rough handling shocks, primarily for equipment-type specimens” (IEC 60068-2-31:2008) at the dow
49、 of the latter, i.e. 2011-07-01. 4)Superseded by EN 61000-4-2:1995, “Electromagnetic compatibility (EMC) - Part 4-2: Testing and measurement techniques - Electrostatic discharge immunity test” (IEC 61000-4-2:1995). BS EN 45502-2-3:2010EN 45502-2-3:2010 8 3.3.6 body-worn NON-IMPLANTABLE PART of the IMPLANT SYSTEM and worn on the body (e.g. belt or ear level) 3.5.1 electrode contact electrically conducting part which is designed to form an interface with body tissue or body fluid 3.5.2 electrode array DISTAL part o
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