SIST EN 45502-2-2:2008

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Active implantable medical devices - Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)Dispositifs médicaux implantables actifs - Partie 2-2: Exigences particulières pour les dispositifs médicaux implantables actifs destinés au traitement des tachyarythmies (y compris les défibrillateurs implantables)Aktive implantierbare Medizingeräte - Teil 2-2: Besondere Festlegungen für aktive implantierbare medizinische Produkte zur Behandlung von Tachyarrhythmie (einschließlich implantierbaren Defibrillatoren)11.040.40Implantanti za kirurgijo, protetiko in ortetikoImplants for surgery, prosthetics and orthoticsICS:SIST EN 45502-2-2:2008en,fr,deTa slovenski standard je istoveten z:EN 45502-2-2:200801-junij-2008SIST EN 45502-2-2:2008SLOVENSKI
STANDARDSIST EN 50061:1995/A1:1998SIST EN 50061:19951DGRPHãþD







EUROPEAN STANDARD EN 45502-2-2 NORME EUROPÉENNE
EUROPÄISCHE NORM March 2008
CENELEC European Committee for Electrotechnical Standardization Comité Européen de Normalisation Electrotechnique Europäisches Komitee für Elektrotechnische Normung
Central Secretariat: rue de Stassart 35, B - 1050 Brussels
© 2008 CENELEC -
All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 45502-2-2:2008 E
ICS 11.040.40 Partially supersedes EN 50061:1988 + A1:1995
English version
Active implantable medical devices -
Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia
(includes implantable defibrillators)
Dispositifs médicaux implantables actifs - Partie 2-2: Exigences particulières
pour les dispositifs médicaux implantables actifs destinés au traitement des tachyarythmies
(y compris les défibrillateurs implantables)
Aktive implantierbare Medizingeräte -
Teil 2-2: Besondere Festlegungen
für aktive implantierbare medizinische Produkte zur Behandlung von Tachyarrhythmie
(einschließlich implantierbaren Defibrillatoren)
This European Standard was approved by CENELEC on 2007-05-01. 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.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, 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.



EN 45502-2-2:2008 - 2 - Foreword This European Standard was prepared by the CEN/CENELEC Joint Working Group on ACTIVE IMPLANTABLE MEDICAL DEVICES (CEN/CLC JWG AIMD).
The text of the draft was submitted to the formal vote and was approved by CENELEC as EN 45502-2-2 on 2007-05-01. This European Standard, together with EN 45502-2-1:2003, supersedes EN 50061:1988 + A1:1995 (+ corrigendum October 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)
2008-10-01 – latest date by which the national standards conflicting with the EN have to be withdrawn
(dow)
2010-05-01 The requirements of this Particular 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. 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 members of either CEN or CENELEC. 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 the essential requirements of Directive 90/385/EEC Council Directive of June 1990 on the approximation of the laws of the Member states relating to active implantable medical devices. Although both this Particular Standard and the Directive deal with the same products, the structure and purpose of the two documents are different. Annex AA of this Particular Standard correlates the requirements of the Directive with the subclauses of EN 45502-1:1997 and of this Particular Standard. Annex BB provides references in the other direction, from this European Standard to the Directive. Annex CC is a rationale providing some further explanation of the subclauses of this Particular Standard. __________



- 3 - EN 45502-2-2:2008 Contents 1 Scope . 7 2 Normative references . 7 3 Definitions . 8 4 Symbols and abbreviations (optional) . 11 5 General requirements for non-implantable parts . 11 6 Measurement of IMPLANTABLE PULSE GENERATOR and LEAD characteristics . 12 7 General arrangement of the packaging . 14 8 General MARKINGS for ACTIVE IMPLANTABLE MEDICAL DEVICES . 14 9 MARKINGS on the SALES PACKAGING . 15 10 Construction of the SALES PACKAGING . 16 11 MARKINGS on the STERILE PACK . 16 12 Construction of the NON-REUSABLE PACK . 16 13 MARKINGS on the ACTIVE IMPLANTABLE MEDICAL DEVICE . 17 14 Protection from unintended biological effects being caused by the ACTIVE IMPLANTABLE MEDICAL DEVICE . 17 15 Protection from HARM to the patient or user caused by external physical features of the ACTIVE IMPLANTABLE MEDICAL DEVICE . 18 16 Protection from HARM to the patient caused by electricity . 18 17 Protection from HARM to the patient caused by heat . 21 18 Protection from ionizing radiation released or emitted from the ACTIVE IMPLANTABLE MEDICAL DEVICE . 21 19 Protection from unintended effects caused by the device . 21 20 Protection of the device from damage caused by external defibrillators . 23 21 Protection of the device from changes caused by high power electrical fields applied directly to the patient . 27 22 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from changes caused by miscellaneous medical treatments . 28 23 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from mechanical forces . 28 24 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from damage caused by electrostatic discharge . 33 25 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from damage caused by atmospheric pressure changes . 33 26 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from changes caused by temperature changes . 34 27 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from electromagnetic non-ionizing radiation . 34 28 Accompanying documentation . 56
Annex AA (informative)
Table of cross-references from 90/385/EEC to EN 45502-2-2 . 62 Annex BB (informative)
Relationship between the subclauses of EN 45502-2-2 and the essential requirements of 90/385/EEC listed in Annex AA. 70 Annex CC (informative)
Notes on EN 45502-2-2 . 72 Annex DD (informative)
Code for describing modes of IMPLANTABLE PULSE GENERATORS . 93 Annex EE (normative)
Interface circuits . 95



EN 45502-2-2:2008 - 4 - Annex FF (informative)
Selection of capacitor Cx . 99 Annex GG (normative)
Calibration of injection network (Figure EE.105); Test signal of inhibition generator (Figure GG.101) . 100 Annex HH (informative)
Defined terms . 102 Bibliography . 104
Figure 101 – Measurement of CD PULSE characteristics . 12 Figure 102 – Measurement of ICD OUTPUT VOLTAGE . 13 Figure 103 – Test set-up for measurement of electrical neutrality . 19 Figure 104 – Band pass filter for a.c. leakage current measurement . 20 Figure 105 – Test set up for measurement of a.c. leakage current . 20 Figure 106 – Test set-up for checking internal DEFIBRILLATION protection . 22 Figure 107 – Damped sinus DEFIBRILLATION waveform . 24 Figure 108 – RCL circuit for generating a damped sinus DEFIBRILLATION waveform . 24 Figure 109 – Timing sequence used for DEFIBRILLATION test . 25 Figure 110 – Resistor network for Test 1 and Test 2 . 25 Figure 111 – Test setup for truncated exponential DEFIBRILLATION waveform . 26 Figure 112 – Biphasic DEFIBRILLATION waveform for Test 2 . 26 Figure 113 – Test set up for proof of protection from high frequency
currents caused by surgical equipment . 28 Figure 114 – Conductor current integrity test fixture . 30 Figure 115 – Conductor flex test fixture . 31 Figure 116 – Connector flex test fixture . 32 Figure 117 – Test signal 2 . 35 Figure 118 – Test set-up for measurement of induced current flow . 36 Figure 119 - Common mode connection to multichannel bipolar PULSE generators . 36 Figure 120 – Differential mode connection to multichannel bipolar PULSE generators . 37 Figure 121 – Common mode connection for CARDIOVERSION/DEFIBRILLATION TERMINALS . 38 Figure 122 – Differential mode connection for CARDIOVERSION/DEFIBRILLATION TERMINALS . 38 Figure 123 – Test set-up to check for induced malfunction . 40 Figure 124 – Common mode connection to multichannel bipolar PULSE generators . 41 Figure 125 – Differential mode connection to multichannel bipolar PULSE generators . 41 Figure 126 – Test set-up to check for induced malfunction due to voltages induced on CARDIOVERSION/DEFIBRILLATION LEADS . 42 Figure 127 – Common mode connection for CARDIOVERSION/DEFIBRILLATION TERMINALS . 42 Figure 128 – Differential mode connection for CARDIOVERSION/DEFIBRILLATION TERMINALS . 43 Figure 129 – Test signal for frequencies between 10 MHz and 450 MHz . 43 Figure 130 – Test set-up to check for induced malfunction at high frequency . 44 Figure 131 – Connection of the PULSE generator . 45 Figure 132 – Test set-up to characterize performance while subject to interference . 46 Figure 133 – Modulation 1 . 48 Figure 134 – Modulation 2 (alternative) . 49 Figure 135 – Test signal for frequencies between 150 kHz and 10 MHz . 51 Figure 136 – Test set-up to check for malfunction at high frequency . 53 Figure 137 – Connection of the PULSE generator . 54 Figure 138 – Loop configuration for varying magnetic field test . 55 Figure CC.101 – Safe exposure times for adipose/skeletal muscle tissue at various temperatures . 76 Figure CC.102 – Average number of full shocks per year . 78



- 5 - EN 45502-2-2:2008 Figure CC.103 – Reference test coil . 83 Figure CC.104 – Amplitude at point D and C of the Tissue Interface
in Annex EE (Cx selected for 5 kHz corner frequency) . 87 Figure CC.105 – Test signal amplitudes for 27.3 to 27.5.3 . 88 Figure CC.106 – Expected induced current during test according to 27.3 . 90 Figure EE.101 – Tissue equivalent interface circuit for current measurements . 95 Figure EE.102 – Tissue equivalent interface circuit to check for malfunction due to voltage induced on the sense/pace LEADS . 96 Figure EE.103 – Tissue equivalent interface circuit to check for malfunction due to voltages induced on the CD LEADS . 97 Figure EE.104 – Low pass filter used to attenuate the 500 kHz component of test signal . 97 Figure EE.105 – Injectionnetwork . 98 Figure FF.101 – Test to check for spurious low frequency
noise and to determine the value of CX . 99 Figure GG.101 – Form of signal from a test signal generator used for
determination of SENSITIVITY (SENSING THRESHOLD) and for inhibition . 101
Table 101 – Connection sequence . 23 Table 102 – Component values for resistor network shown in Figure 110 . 25 Table 103 – Timing parameters of test signal for Test 2 . 26 Table 104 – Spurious injection current limits for sense/pace TERMINALS . 39 Table 105 – Spurious injection current limits for CARDIOVERSION/DEFIBRILLATION TERMINALS . 39 Table 106 – Peak-to-peak amplitudes Vpp in the range 16,6 Hz to 10 MHz . 39 Table 107 – Peak-to-peak amplitudes Vpp in the range 16,6 Hz to 150 kHz (Common Mode Test) . 48 Table 108 – Peak-to-peak amplitudes Vpp in the range 150 kHz to 10 MHz . 50 Table 109 – Sinusoidally modulated magnetic field strengths . 56 Table DD.101 – Basic defibrillator code scheme . 93 Table DD.102 – Examples of the defibrillator code . 94 Table EE.101 – Component values for Figure EE.101 (A) . 95 Table EE.102 – Component values for Figure EE.101 (B) . 95 Table EE.103 – Component values for Figure EE.102 . 96 Table EE.104 – Component values for Figure EE.103 . 97 Table EE.105 – Component values for Figure EE.104 . 98 Table EE.106 – Component values for Figure EE.105 . 98 Table GG.101 – Calibration signal amplitude . 101



EN 45502-2-2:2008 - 6 - Introduction This Particular Standard specifies particular requirements for IMPLANTABLE CARDIOVERTER DEFIBRILLATORS and the functions of ACTIVE IMPLANTABLE MEDICAL DEVICES intended to treat tachyarrhythmia, to provide basic assurance of safety for both patients and users. An external defibrillator is a MEDICAL DEVICE used, in the emergency setting, to deliver a high-energy shock to the heart, by means of ELECTRODES applied to the external chest wall, in patients suffering ventricular fibrillation (a rapid, disorganized and potentially lethal heart rhythm abnormality), to restore normal heart action. External defibrillators may also be used, in emergency or elective settings, to terminate other ventricular or atrial tachyarrhythmias by delivery of a high-energy shock, synchronised to the intrinsic cardiac rhythm, a procedure known as CARDIOVERSION. In patients known to be at risk of such arrhythmias, due to the occurrence of previous episodes or the presence of specific pre-disposing cardiac conditions, an IMPLANTABLE CARDIOVERTER DEFIBRILLATOR may be implanted to perform similar functions. The implantable device, which is much smaller than an external defibrillator, is contained within a sealed, encapsulating enclosure. It generates high voltage PULSES from an enclosed, miniature, electrical battery. The PULSES are transmitted to the heart by means of implanted, insulated conductors with ELECTRODES (LEADS) The IMPLANTABLE CARDIOVERTER DEFIBRILLATOR may also incorporate other sensing and pacing functions, such as rate support for bradycardia and ANTITACHYCARDIA PACING (ATP) to terminate certain tachyarrhythmias without the need of a high-energy shock. The defibrillator may be adjusted non-invasively by means of an electronic device, known as a programmer.
This Particular Standard is relevant to all parts of ACTIVE IMPLANTABLE MEDICAL DEVICES intended to treat tachyarrythmia other than pacing functions to control bradyarrhythmia. Typical examples are IMPLANTABLE PULSE GENERATORS, LEADS, ADAPTORS, ACCESSORIES, programmers and the related software. (Bradyarrhythmia pacing functions are dealt with in EN 45502-2-1). The requirements of this Particular Standard supplement or modify those of EN 45502-1:1997, Active Implantable Medical Devices – Part 1: General requirements for safety, marking and for the information to be provided by the manufacturer, hereinafter referred to as the General Standard. The requirements of this particular standard take priority over those of the General Standard. Figures or tables that are additional to those of the General Standard are numbered starting from 101; additional annexes are lettered AA, BB, etc. Annex DD describes a coding system that may be used to designate tachyarrhythmia therapy modes. Annex EE defines the tissue equivalent interface circuits and low pass filter required for some compliance tests. Annex FF describes a method for selecting the filter capacitor used in the tissue equivalent interface circuits defined by Annex EE. Annex GG defines the method of calibrating the injection network defined by Annex EE. All annexes except Annex EE and Annex GG are informative.



- 7 - EN 45502-2-2:2008 1 Scope This Part 2-2 of EN 45502 specifies requirements that are applicable to IMPLANTABLE CARDIOVERTER DEFIBRILLATORS and the functions of ACTIVE IMPLANTABLE MEDICAL DEVICES intended to treat tachyarrhythmia. 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 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 particular standard or by any other method demonstrated to have accuracy equal to, or better than, the method specified. In the case of dispute, the method detailed in this Particular Standard shall apply. Any aspect of an ACTIVE IMPLANTABLE MEDICAL DEVICE intended to treat bradyarrhythmias is covered by EN 45502–2-1 Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (Pacemakers). 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. NOTE 4 Particular requirements for congestive heart failure devices are under consideration. These types of devices are not covered by this standard. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. This clause of the General Standard aplies except as follows: Additional references: Publication Year Title EN 980
Graphical symbols for use in the labelling of medical devices EN 28601
Data elements and interchange formats – Information interchange –Representation of dates and times (ISO 8601 + technical corrigendum 1) EN 45502-1
Active implantable medical devices – Part 1: General requirements for safety, marking and information to be provided by the manufacturer
EN 45502-2-1
Active implantable medical devices – Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)



EN 45502-2-2:2008 - 8 - EN 60068-2-27
Environmental testing – Part 2-27: Tests – Test Ea and guidance: Shock (IEC 60068–2–27) EN 60068-2-47
Environmental testing – Part 2-47: Tests – Mounting of specimens for vibration, impact and similar dynamic tests (IEC 60068-2-47) EN 60068-2-64
Environmental testing – Part 2: Test methods – Test Fh: Vibration, broad-band random (digital control) and guidance
(IEC 60068-2-64)
IEC 60878
Graphical symbols for electrical equipment in medical practice ISO 5841-3 + corr. 1
Implants for surgery - Cardiac pacemakers - Part 3: Low-profile connectors (IS-1) for implantable pacemakers ISO 11318
Cardiac defibrillators – Connector assembly DF-1 for implantable defibrillators – Dimensions and test requirements ANSI/AAMI PC69
Active implantable medical devices – Electromagnetic compatibility – EMC test protocols for implantable cardiac pacemakers and implantable cardioverter defibrillators 3 Definitions This clause of the General Standard applies except as follows: Additional definitions: 3.3.1 adaptor special connector used between an otherwise incompatible IMPLANTABLE PULSE GENERATOR and a LEAD 3.3.2 implantable cardioverter defibrillator (ICD) ACTIVE IMPLANTABLE MEDICAL DEVICE comprising an IMPLANTABLE PULSE GENERATOR and LEAD(S) that is intended to detect and correct tachycardias and fibrillation by application of CARDIOVERSION/-DEFIBRILLATION PULSE(S) to the heart 3.3.3 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 Particular Standard, the term IMPLANTABLE PULSE GENERATOR describes any ACTIVE IMPLANTABLE MEDICAL DEVICE that incorporates functions intended to treat tachyarrhythmias. 3.3.4 sensitivity (sensing threshold) minimum signal required to control consistently the function of the IMPLANTABLE PULSE GENERATOR
[see 6.1.5] 3.3.5 sensor special part of an IMPLANTABLE PULSE GENERATOR that is designed to detect signals for the purpose of RATE MODULATION or other control purposes 3.5.1 electrode electrically conducting part (usually the termination of a LEAD), which is designed to form an interface with body tissue or body fluid



- 9 - EN 45502-2-2:2008 3.5.2 endocardial lead LEAD with an ELECTRODE designed to make a contact with the endocardium, or inner surface of the heart 3.5.3 epicardial lead LEAD with an ELECTRODE designed to make a contact with the epicardium, or outer surface of the heart 3.5.4 transvenous approach to the heart through the venous system 3.5.5 insertion diameter (of a lead) minimum bore of a rigid cylindrical tube into which the LEAD (not including the connector) may be inserted 3.5.6 lead conductor resistance Rc ohmic resistance between the ELECTRODE and the corresponding LEAD connector TERMINAL
[see 6.2.1 of EN 45502-2-1] 3.5.7 lead pacing impedance Zp impedance that is formed by the ratio of a voltage PULSE to the resulting current [see 6.2.2 of EN 45502-2-1]. The impedance is composed of the ELECTRODE/tissue interface and the LEAD CONDUCTOR RESISTANCE 3.5.8 lead sensing impedance Zs source impedance of a LEAD as seen by an IMPLANTABLE PULSE GENERATOR
[see 6.2.3 of EN 45502-2-1] 3.9.1 model designation name and/or a combination of letters and numbers used by a manufacturer to distinguish, by function or type, one device from another 3.9.2 serial number unique combination of letters and/or numbers, selected by the manufacturer, intended to distinguish a device from other devices with the same MODEL DESIGNATION 3.20.1 beat ordered spontaneous activity of the heart 3.20.2 pulse electrical output of an IMPLANTABLE PULSE GENERATOR other than CD PULSE [see 3.3.5] intended to stimulate the myocardium 3.20.3 pulse amplitude amplitude of the PULSE measured according to the procedure in 6.1.1 of EN 45502-2-1



EN 45502-2-2:2008 - 10 - 3.20.4 pulse duration duration of the PULSE, measured between two reference points specified in this Particular Standard
[see 6.1.1 of EN 45502-2-1] 3.20.5 pulse interval interval between equivalent points of two consecutive PULSES
[see 6.1.1 of EN 45502-2-1] 3.20.6 basic pulse interval PULSE INTERVAL in absence of sensed cardiac or other electrical influence 3.20.7 automatic sensitivity control automatic adjustment of the SENSITIVITY in response to available physiological signals 3.21.1 beginning of service; BOS when an individual IMPLANTABLE PULSE GENERATOR is first released by the manufacturer as fit for being placed on the market 3.21.2 end of service; EOS when the PROLONGED SERVICE PERIOD has elapsed and no further pacing function is specified nor can be expected 3.21.3 prolonged service period; PSP period beyond the RECOMMENDED REPLACEMENT TIME during which th
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