SIST EN 45502-2-1:2004
(Main)Active implantable medical devices - Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)
Active implantable medical devices - Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)
EN 45502-2-1:2003 & EN 45502-2-2 will supersede EN 50061:1988 + A1:1995
Aktive implantierbare medizinische Geräte - Teil 2-1: Besondere Festlegungen für aktive implantierbare medizinische Geräte zur Behandlung von Bradyarrhythmie (Herzschrittmacher)
Dispositifs médicaux implantables actifs - Partie 2-1: Règles particulières pour les dispositifs médicaux implantables actifs destinés à traiter la bradyarythmie (stimulateurs cardiaques)
Aktivni medicinski pripomočki za vsaditev - 2-1. del: Posebne zahteve za vsadke, namenjene zdravljenju bradiaritmij (srčni spodbujevalniki)
General Information
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Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Aktive implantierbare medizinische Geräte - Teil 2-1: Besondere Festlegungen für aktive implantierbare medizinische Geräte zur Behandlung von Bradyarrhythmie (Herzschrittmacher)Dispositifs médicaux implantables actifs - Partie 2-1: Règles particulières pour les dispositifs médicaux implantables actifs destinés à traiter la bradyarythmie (stimulateurs cardiaques)Active implantable medical devices - Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)11.040.40Implantanti za kirurgijo, protetiko in ortetikoImplants for surgery, prosthetics and orthoticsICS:Ta slovenski standard je istoveten z:EN 45502-2-1:2003SIST EN 45502-2-1:2004en01-maj-2004SIST EN 45502-2-1:2004SLOVENSKI
STANDARDkSIST EN 45502-2-1:20041DGRPHãþD
SIST EN 45502-2-1:2004
EUROPEAN STANDARD
EN 45502-2-1 NORME EUROPÉENNE EUROPÄISCHE 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 supersedes EN 50061:1988 + A1:1995
English version
Active implantable medical devices Part 2-1: Particular requirements for active implantable
medical devices intended to treat bradyarrhythmia
(cardiac pacemakers)
Dispositifs médicaux implantables actifs Partie 2-1: Règles particulières
pour les dispositifs médicaux implantables actifs destinés à traiter la bradyarythmie (stimulateurs cardiaques)
Aktive implantierbare medizinische GeräteTeil 2-1: Besondere Festlegungen
für aktive implantierbare medizinische Geräte zur Behandlung
von Bradyarrhythmie
(Herzschrittmacher)
This European Standard was approved 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 concerning 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 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, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Lithuania, Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and United Kingdom.
SIST EN 45502-2-1:2004
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). Members 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 50061:1988 + 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 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. SIST EN 45502-2-1:2004
– 3 – EN 45502-2-1:2003 Contents Page Introduction.7 1 Scope.8 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 active implantable medical devices.28 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 device.31 14 Protection from unintentional biological effects 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 by heat.33 18 Protection from ionizing radiation released or emitted from the active implantable medical
device.33 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 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 implantable 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
changes.40 SIST EN 45502-2-1:2004
EN 45502-2-1:2003 – 4 – 27 Protection of the active implantable medical device from electromagnetic non-ionizing
radiation.40 28 Accompanying documentation.56
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 45502−2-1 and the essential
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 generators.84 Annex EE (informative) Symbols.88 AnnexFF (normative) Pulse forms.89 Annex GG (normative) Interface circuits.90 Annex HH (informative) Selection of capacitor CX.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 measurement.16 Figure 104 - Escape interval measurement.17 Figure 105 - Initial oscilloscope display, when measuring the escape interval.18 Figure 106 - Measurement of escape interval (te) in inhibited mode.18 Figure 107 - Measurements of escape interval (te) in triggered (synchronised) mode.18 Figure 108 - Refractory period measurement.19 Figure 109 - Initial oscilloscope display when measuring sensing and pacing refractory period.19 Figure 110 - Measurement of sensing refractory period in inhibited mode - A.20 Figure 111 - Measurement of sensing refractory period in Inhibited mode - B.20 Figure 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 measuring AV interval.22 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 - Oscilloscope display when measuring the AV interval after sensing.24 SIST EN 45502-2-1:2004
– 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 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 equipment.35 Figure 127 - Conductor flex test fixture.38 Figure 128 - Connector flex test fixture.39 Figure 129 - Test signal 2.42 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.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 generator.44 Figure 136 - Differential mode connection to multichannel bipolar pulse generator.44 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 bipolar pulse generator.46 Figure 141 - Differential mode connection to a single channel bipolar pulse generator.46 Figure 142 - Common mode connection to a multi channel bipolar pulse generator.47 Figure 143 - Differential mode connection to a multi channel bipolar pulse generator.47 Figure 144 - Test set-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 frequency.52 Figure 148 - Connection to a unipolar 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 - Measurement of pulse duration.89 SIST EN 45502-2-1:2004
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 measurements.90 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 determine the value of CX.93 Tables Table 101 - Overall measurement accuracy limits.14 Table 102 - Overall measurement accuracy limits.25 Table 103 - Settings for determining the projected service life.34 Table 104 - Spurious injection current limits.44 Table 105 - Peak to peak amplitudes Vpp in the range 16,6 Hz to 150 kHz.50 Table 106 - Peak to peak amplitudes Vpp in 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 scheme.84 Table DD.102 - Examples of mode code.85 Table EE.101 - Conventional 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 – Calibration signal amplitude.95
SIST EN 45502-2-1:2004
– 7 – EN 45502-2-1:2003 Introduction 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 sealed, 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, 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 45502-1:1997, 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 Part 2-1 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. 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 with 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 the accompanying documentation in multiple languages. Annex FF defines reference points for measurements of PULSE AMPLITUDE and PULSE DURATION, and the form of test signal used to determine SENSITIVITY. Annex GG defines the tissue equivalent interface circuits, signal injection network and low pass filter required for some compliance tests. Annex HH describes a method for selecting the filter capacitor used in the tissue equivalent interface circuits defined by Annex GG. Annex II defines the method of calibrating the injection network defined by Annex GG.
All annexes except Annex FF, GG and II are informative. SIST EN 45502-2-1:2004
EN 45502-2-1:2003 – 8 – 1 Scope This Part 2-1 specifies requirements that are applicable to those ACTIVE IMPLANTABLE MEDICAL DEVICES intended to treat bradyarrhythmias.
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 2-1 is also applicable to some non-implantable parts and accessories of the devices (see Note 1).
The characteristics of the IMPLANTABLE PULSE GENERATOR or LEAD shall be determined by either the appropriate method detailed in this Part 2-1 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 Part 2-1 shall apply. Any features of an ACTIVE IMPLANTABLE MEDICAL DEVICE intended to treat tachyarrhythmias are covered by EN 45502–2-2. NOTE 1 The device that is commonly referred to as an active implantable medical device may 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 device. 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. 2 Normative references This clause of Part 1 applies except as follows. Additional references: EN 28601:1992 Data elements and interchange formats – Information interchange –Representation of dates and times (ISO 8601:1988 + technical corrigendum 1:1991) EN 45502-1:1997 Active implantable medical devices - Part 1: General requirements for safety, marking and information to be provided by the manufacturer
EN 45502-2-2 1) Active implantable medical devices – Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators) EN 60068–2–27:1993 Basic environmental testing procedures – Part 2: Tests – Test Ea and guidance: Shock (IEC 60068–2–27:1987)
1) At draft stage. SIST EN 45502-2-1:2004
– 9 – EN 45502-2-1:2003 EN 60068–2–47:1999 Environmental testing – Part 2-47: Test methods – Mounting of components, equipment and other articles for vibration, impact and similar dynamic tests (IEC 60068-2-47:1999) EN 60068–2–64:1994 Environmental testing – Part 2: Test methods – Test Fh: Vibration, broad-band random (digital control) and guidance
(IEC 60068-2-64:1993 + corr. Oct. 1993)
ISO 5841-3:1992 Low profile connectors (IS1) for implantable pacemakers
ISO 11318:1993 Cardiac defibrillators – Connector assembly DF-1 for implantable defibrillators – Dimensions and test requirements
ANSI/AAMI PC69-2000 Active implantable medical devices – Electromagnetic compatibility – EMC test protocols for implantable cardiac pacemakers and implantable cardioverter defibrillators 3 Definitions
This clause of Part 1 applies.
Additional definitions:
3.3.1 implantable pulse generator (IPG) part of the ACTIVE IMPLANTABLE MEDICAL DEVICE, including the power supply and electronic circuit, that produces an electrical output NOTE For purposes of this Part 2-1, the term implantable pulse generator describes any ACTIVE IMPLANTABLE MEDICAL DEVICE that incorporates functions intended to treat bradyarrhythmias. 3.3.2 pacemaker ACTIVE IMPLANTABLE MEDICAL DEVICE intended to treat bradyarrhythmias, comprising an IMPLANTABLE PULSE GENERATOR and LEAD(S) 3.3.3 sensor special part of a PACEMAKER that is designed to detect signals for the purpose of RATE MODULATION or other control purposes 3.3.4 terminal electrically separate conductive device connection 3.3.5 adaptor special connector used between an otherwise incompatible IMPLANTABLE PULSE GENERATOR and a LEAD 3.3.6 pulse electrical output of an IMPLANTABLE PULSE GENERATOR intended to stimulate the myocardium SIST EN 45502-2-1:2004
EN 45502-2-1:2003 – 10 – 3.3.7 pulse amplitude the time integral over current or voltage, as appropriate, divided by the PULSE DURATION [see 6.1.1] 3.3.8 pulse duration duration of the PULSE, measured between two reference points specified in Part 2-1 [see 6.1.1] 3.3.9 pulse interval interval between equivalent points of two consecutive PULSES [see 6.1.1] 3.3.10 basic pulse interval PULSE INTERVAL in the absence of sensed cardiac or other electrical influence 3.3.11 escape interval time elapsing between the sensing of a spontaneous BEAT and the succeeding non-triggered PULSE of an IMPLANTABLE PULSE GENERATOR [see 6.1.4] 3.3.12 hysteresis characteristic of an IMPLANTABLE PULSE GENERATOR defined by the difference between the ESCAPE INTERVAL and the BASIC PULSE INTERVAL NOTE The ESCAPE INTERVAL is normally longer than the BASIC PULSE INTERVAL — this is “positive” HYSTERESIS. 3.3.13 AV interval; atrioventricular interval delay between an atrial PULSE or the sensing of an atrial depolarisation and the subsequent ventricular PULSE or the sensing of a ventricular depolarisation [see 6.1.7] 3.3.14 test pulse interval PULSE INTERVAL of an IMPLANTABLE PULSE GENERATOR when directly influenced by a testing device 3.3.15 pulse rate number of PULSES per minute [see 6.1.1] 3.3.16 basic rate PULSE RATE of an IMPLANTABLE PULSE GENERATOR, either atrial or ventricular, unmodified by sensed cardiac or other electrical influence 3.3.17 interference pulse rate PULSE RATE with which the IMPLANTABLE PULSE GENERATOR responds when it senses electrical activity other than that from the myocardium that it recognises as interference 3.3.18 maximum tracking rate maximum PULSE RATE at which the IMPLANTABLE PULSE GENERATOR will respond on a 1:1 basis to a triggering signal SIST EN 45502-2-1:2004
– 11 – EN 45502-2-1:2003 3.3.19 rate modulation altering of the PULSE RATE as a function of a control parameter other than a sensed BEAT 3.3.20 test pulse rate PULSE RATE of an IMPLANTABLE PULSE GENERATOR when directly influenced by a testing device 3.3.21 input impedance; Zin (of an IMPLANTABLE PULSE GENERATOR) electrical impedance presented at an input TERMINAL [see 6.1.3] and taken as equal to the electrical loading presented to a sensed BEAT 3.3.22 sensitivity; sensing threshold minimum signal required to control consistently the function of the IMPLANTABLE PULSE GENERATOR [see 6.1.2] 3.3.23 refractory period period during which an IMPLANTABLE PULSE GENERATOR will not respond to a BEAT [see 6.1.5 and 6.1.6] 3.5.1 electrode electrically conducting part (usually the termination of a
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