1、BRITISH STANDARD BS EN 45502-2-1:2003 Active implantable medical devices Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers) The European Standard EN 45502-2-1:2003 has the status of a British Standard ICS 11.040.40 BS EN 45
2、502-2-1:2003 This British Standard was published under the authority of the Standards Policy and Strategy Committee on 20 January 2004 BSI 20 January 2004 ISBN 0 580 43280 7 National foreword This British Standard is the official English language version of EN 45502-2-1:2003. It supersedes BS 6902-1
3、:1990 and BS 6902-1:Supplement No. 1:1996 which are withdrawn. The UK participation in its preparation was entrusted by Technical Committee CH/150, Implants for surgery, to Subcommittee CH/150/6, Active implants, which has the responsibility to: A list of organizations represented on this subcommitt
4、ee can be obtained on request to its secretary. Cross-references The British Standards which implement international or European publications referred to in this document may be found in the BSI Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Sea
5、rch” facility of the BSI Electronic Catalogue or of British Standards Online. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard does not of itself confer immunity from legal o
6、bligations. aid enquirers to understand the text; present to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European developments and promulgate them in the UK. Summa
7、ry of pages This document comprises a front cover, an inside front cover, the EN title page, pages 2 to 95 and a back cover. The BSI copyright notice displayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No. Date CommentsEUROPEAN STANDARD EN
8、 45502-2-1 NORME EUROPENNE EUROPISCHE NORM December 2003 CEN/CENELEC Central Secretariat: rue de Stassart 35, B - 1050 Brussels 2003 CEN/CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CEN and CENELEC members. Ref. No. EN 45502-2-1:2003 E ICS 11.040.40 Partly
9、 supersedes EN 50061:1988 + A1:1995English version Active implantable medical devices Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers) Dispositifs mdicaux implantables actifs Partie 2-1: Rgles particulires pour les dispos
10、itifs mdicaux implantables actifs destins traiter la bradyarythmie (stimulateurs cardiaques) Aktive implantierbare medizinische Gerte Teil 2-1: Besondere Festlegungen fr aktive implantierbare medizinische Gerte zur Behandlung von Bradyarrhythmie (Herzschrittmacher) This European Standard was approve
11、d by CEN and CENELEC on 2003-09-01. 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 concern
12、ing such national standards may be obtained on application to the Central Secretariat 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 it
13、s 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, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ir
14、eland, Italy, Lithuania, Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and United Kingdom. EN 45502-2-1:2003 2 Foreword This European Standard has been prepared by the CEN/CENELEC Joint Working Group on Active Implantable Medical Devices (CEN/CLC JWG AIMD). M
15、embers of the Joint Working Group were nominated by one of the member bodies of either CEN or CENELEC. The text of the draft was submitted to the formal vote and was approved by CEN and CENELEC as EN 45502-2-1 on 2003-09-01. This European Standard, together with EN 45502-2-2, supersedes EN 50061:198
16、8 + A1:1995 + A1:1995/corrigendum Oct. 1995. 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) 2004-09-01 - latest date by which the national standards conflicting with the EN
17、 have to be withdrawn (dow) 2005-09-01 This European Standard has been prepared under mandates given to CEN and CENELEC by the Commission of the European Communities and the European Free Trade Association, and supports essential requirements of Directive 90/385/EEC. 3 EN 45502-2-1:2003 Contents Pag
18、e Introduction7 1 Scope8 2 Normative references .8 3 Definitions .9 4 Symbols and abbreviations (optional).13 5 General requirements for non-implantable parts 13 6 Measurement of implantable pulse generator and lead characteristics .13 7 General arrangement of the packaging 28 8 General markings for
19、 active implantable medical devices28 9 Markings on the sales packaging .28 10 Construction of the sales packaging.29 11 Markings on the sterile pack .29 12 Construction of the non-reusable pack.30 13 Markings on the active implantable medical device31 14 Protection from unintentional biological eff
20、ects being caused by the active implantable medical device 32 15 Protection from harm to the patient or user caused by external physical features of the active implantable medical device 32 16 Protection from harm to the patient caused by electricity.32 17 Protection from harm to the patient caused
21、by heat.33 18 Protection from ionizing radiation released or emitted from the active implantable medical device33 19 Protection from unintended effects caused by the device 34 20 Protection of the device from damage caused by external defibrillators 35 21 Protection of the device from changes caused
22、 by high power electrical fields applied directly to the patient.35 22 Protection of the active implantable medical device from changes caused by miscellaneous medical treatments.35 23 Protection of the active implantable medical device from mechanical forces. .36 24 Protection of the active implant
23、able medical device from damage caused by electrostatic discharge 40 25 Protection of the active implantable medical device from damage caused by atmospheric pressure changes.40 26 Protection of the active implantable medical device from damage caused by temperature changes40 EN 45502-2-1:2003 4 27
24、Protection of the active implantable medical device from electromagnetic non-ionizing radiation40 28 Accompanying documentation56 Annex AA (informative) Table of cross-references from 90/385/EEC to EN 45502-2-1 .61 Annex BB (informative) Relationship between the clauses of EN 455022-1 and the essent
25、ial requirements of 90/385/EEC listed in Annex AA .72 Annex CC (informative) Notes on EN 45502-2-1 74 Annex DD (informative) Code for describing modes of implantable pulse generators84 Annex EE (informative) Symbols.88 AnnexFF (normative) Pulse forms.89 Annex GG (normative) Interface circuits .90 An
26、nex HH (informative) Selection of capacitor C X .93 Annex II (normative) Calibration of the injection network, Figure GG.104 94 Figures Figure 101 - Measurement of pulse amplitude, pulse duration, pulse interval and pulse rate 15 Figure 102 - Sensitivity measurement .16 Figure 103 - Input impedance
27、measurement 16 Figure 104 - Escape interval measurement.17 Figure 105 - Initial oscilloscope display, when measuring the escape interval18 Figure 106 - Measurement of escape interval (t e ) in inhibited mode .18 Figure 107 - Measurements of escape interval (t e ) in triggered (synchronised) mode18 F
28、igure 108 - Refractory period measurement19 Figure 109 - Initial oscilloscope display when measuring sensing and pacing refractory period.19 Figure 110 - Measurement of sensing refractory period in inhibited mode - A20 Figure 111 - Measurement of sensing refractory period in Inhibited mode - B20 Fig
29、ure 112 - Measurement of sensing refractory period in triggered (synchronous) mode - A 20 Figure 113 - Measurement of sensing refractory period in triggered (synchronous) mode - B .21 Figure 114 - Measurement of pacing refractory period in inhibited mode .21 Figure 115 - Oscilloscope display when me
30、asuring AV interval22 Figure 116 - Post ventricular atrial refractory period (PVARP) measurement.23 Figure 117 - Initial oscilloscope display when measuring PVARP.23 Figure 118 - Oscilloscope display when measuring PVARP .23 Figure 119 - AV INTERVAL after sensing measurement .24 Figure 120 - Oscillo
31、scope display when measuring the AV interval after sensing 24 5 EN 45502-2-1:2003 Figure 121 - Determination of the lead pacing impedance of a unipolar lead .25 Figure 122 - Determination of the lead pacing impedance of a bipolar lead .26 Figure 123 - Determination of the lead sensing impedance of a
32、 unipolar lead .27 Figure 124 - Determination of the lead sensing impedance of a bipolar lead .27 Figure 125 - Test set-up for measurement of electrical neutrality.33 Figure 126 - Test set-up for proof protection from high frequency currents caused by surgical equipment35 Figure 127 - Conductor flex
33、 test fixture .38 Figure 128 - Connector flex test fixture .39 Figure 129 - Test signal 242 Figure 130 - Test set-up for measurement of induced current flow 42 Figure 131 - Connection to a single channel unipolar pulse generator .43 Figure 132 - Connection to a multichannel unipolar pulse generator
34、43 Figure 133 - Common mode connection to single channel bipolar pulse generator .43 Figure 134 - Differential mode connection to single channel bipolar pulse generator.43 Figure 135 - Common mode connection to multichannel bipolar pulse generator44 Figure 136 - Differential mode connection to multi
35、channel bipolar pulse generator44 Figure 137 - Test set-up to check for induced malfunction .45 Figure 138 - Connection to a single channel unipolar pulse generator .45 Figure 139 - Connection to a multichannel unipolar pulse generator 46 Figure 140 - Common mode connection to a single channel bipol
36、ar pulse generator 46 Figure 141 - Differential mode connection to a single channel bipolar pulse generator46 Figure 142 - Common mode connection to a multi channel bipolar pulse generator47 Figure 143 - Differential mode connection to a multi channel bipolar pulse generator47 Figure 144 - Test set-
37、up to characterise performance while subject to interference 48 Figure 145 - Test signal for frequencies in the range 16,6 Hz - 150 kHz 49 Figure 146 - Test signal for frequencies 150 kHz - 450 MHz 51 Figure 147 Test set-up to check for malfunction at high frequency52 Figure 148 - Connection to a un
38、ipolar pulse generator .52 Figure 149 - Connection to a bipolar pulse generator .53 Figure 150 - Test set-up for magnetostatic measurements 54 Figure 151 - Loop configuration for varying magnetic field test.55 Figure CC.101 - Measurement of x .74 Figure CC.102 - Reference test coil 78 Figure FF.101
39、- Measurement of pulse duration .89 EN 45502-2-1:2003 6 Figure FF.102 - Measurement of pulse amplitude.89 Figure FF.103 - Form of signal from a test signal generator used for the exact determination of sensitivity (sensing threshold).89 Figure GG.101 - Tissue equivalent interface circuit for current
40、 measurements90 Figure GG.102 - Tissue equivalent interface circuit to check for malfunction .90 Figure GG.103 - Low pass filter used to attenuate the 500 kHz component of the test signal .91 Figure GG.104 - Injection network.91 Figure HH.101 - Test to check for spurious low frequency noise and to d
41、etermine the value of C X 93 Tables Table 101 - Overall measurement accuracy limits 14 Table 102 - Overall measurement accuracy limits 25 Table 103 - Settings for determining the projected service life34 Table 104 - Spurious injection current limits44 Table 105 - Peak to peak amplitudes V ppin the r
42、ange 16,6 Hz to 150 kHz 50 Table 106 - Peak to peak amplitudes V ppin the range 150 kHz to 10 MHz 51 Table 107 - Sinusoidally modulated magnetic field strengths .55 Table AA.1 .61 Table BB.1 .72 Table DD.101 - Basic mode code scheme84 Table DD.102 - Examples of mode code 85 Table EE.101 - Convention
43、al symbols.88 Table GG.101 - Component values for Figure GG.101.92 Table GG.102 - Component values for Figure GG.102.92 Table GG.103 - Component values for Figure GG.103.92 Table GG.104 - Component values for Figure GG.104.92 Table II.101 Calibrati on signal amplitude95 7 EN 45502-2-1:2003 Introduct
44、ion This Part 2-1 specifies particular requirements for those ACTIVE IMPLANTABLE MEDICAL DEVICES intended to treat bradyarrhythmias (PACEMAKERS), to provide basic assurance of safety to both patients and users. An implantable cardiac PACEMAKER is essentially a powered electronic device within a seal
45、ed, encapsulating enclosure (an IMPLANTABLE PULSE GENERATOR). The device can stimulate heart beats by generating electrical impulses which are transmitted to the heart along implanted, insulated conductors with ELECTRODES (LEADS). The PACEMAKER may be adjusted non-invasively by an electronic device,
46、 known as a programmer. This Part 2-1 is relevant to all parts of implantable PACEMAKERS, including all accessories. Typical examples are IMPLANTABLE PULSE GENERATORS, LEADS, ADAPTORS, pro-grammers and the related software. The requirements of this Part 2-1 supplement or modify those of EN 45502-1:1
47、997, Active implantable medical devicesPart 1: General requirements for safety, marking and information to be provided by the manufacturer, hereinafter referred to as Part 1. The requirements of this Part 2-1 take priority over those of Part 1. Figures or tables that are additional to those of Part
48、1 are numbered starting from 101; additional annexes are lettered AA, BB, etc. Although both this Part 2-1 and the Directive 90/385/EEC deal with the same products, the structure and purpose of the two documents are different. Annex AA of this Part 2-1 correlates the requirements of the Directive wi
49、th the subclauses of EN 45502-1:1997 and this Part 2-1. Annex BB provides reference in the other direction, from this European Standard to the Directive. Annex CC is a rationale providing further explanation of the subclauses of this Part 2-1. Annex DD describes a coding system that may be used to designate bradyarrhythmia pacing modes. Annex EE provides optional symbols that may be used to reduce the need for translation of MARKINGS and information in
