EN 45502-2-2:2008
(Main)Active implantable medical devices - Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)
Active implantable medical devices - Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)
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.
Aktive implantierbare Medizingeräte -- Teil 2-2: Besondere Festlegungen für aktive implantierbare medizinische Produkte zur Behandlung von Tachyarrhythmie (einschließlich implantierbaren Defibrillatoren)
Der vorliegende Teil 2 2 legt die für IMPLANTIERBARE KARDIOVERTER-DEFIBRILLATOREN geltenden Anforderungen und die Funktionen von aktiven implantierbaren medizinischen Geräten fest, die zur Behandlung von Tachyarrhythmie vorgesehen sind. Die in EN 45502 festgelegten Prüfungen sind Typprüfungen und sind an Prüflingen eines Gerätes durchzuführen, um die Einhaltung der Anforderungen nachzuweisen. Dieser Teil von EN 45502 gilt auch für einige nicht implantierbaren Teile und Zubehörteile der Geräte (siehe ANMERKUNG 1). Die Eigenschaften des IMPLANTIERBAREN IMPULSGENERATORS oder der ELEKTRODE müssen entweder dem jeweilig zutreffenden der in der vorliegenden Besonderen Norm beschriebenen Verfahren oder nach einem anderen Verfahren, für das nachgewiesen ist, dass dessen Präzision gleich dem festgelegten Verfahren oder besser ist, bestimmt werden. Im Zweifelsfall muss das in dieser Besonderen Norm beschriebene Verfahren angewendet werden. Jeglicher Aspekt bezüglich aktiver implantierbarer medizinischer Geräte, die zum Behandeln von Bradyarrhythmien vorgesehen sind, wird in EN 45502 2 1, Besondere Festlegungen für aktive implantierbare medizinische Geräte zur Behandlung von Bradyarrhythmie (Herzschrittmacher), behandelt. ANMERKUNG 1 Geräte, die allgemein als aktive implantierbare medizinische Geräte bezeichnet werden, können in der Realität Einzelgeräte, eine Kombination von Geräten oder eine Kombination eines Gerätes bzw. mehrerer Geräte mit einem oder mehreren Zubehörteilen darstellen. Nicht alle dieser Teile müssen entweder teilweise oder vollständig implantierbar sein, jedoch besteht die Notwendigkeit, einige Anforderungen an nicht implantierbare Teile und Zubehör festzulegen, wenn sie die Sicherheit oder Leistung des implantierbaren Gerätes beeinflussen können. ANMERKUNG 2 Die in dieser Europäischen Norm verwendete Terminologie soll derjenigen in der Richtlinie 90/385/EWG entsprechen. ANMERKUNG 3 In dieser Europäischen Norm werden die in Abschnitt 3 definierten Begriffe in Kapitälchen gedruckt. Wenn ein definierter Begriff als Merkmal eines anderen Begriffs dient, wird dieser nicht in Kapitälchen gedruckt, es sei denn, der somit näher bestimmte Begriff ist ebenfalls definiert. ANMERKUNG 4 Besondere Anforderungen an Geräte für kongestive Herzinsuffizienz (Stauungsinsuffizienz) werden derzeit erwogen. Diese Arten von Geräten werden in dieser Norm nicht berücksichtigt.
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)
La présente Partie 2-2 de l’EN 45502 spécifie les exigences qui sont applicables aux DEFIBRILLATEURS CARDIOVERTEURS IMPLANTABLES et aux fonctions des DISPOSITIFS MÉDICAUX IMPLANTABLES ACTIFS pour le traitement de la tachyarythmie. Les essais qui sont spécifiés dans l’EN 45502 sont des essais de type et doivent être réalisés sur des échantillons d’un dispositif afin d’en démontrer la conformité. La présente partie de l’EN 45502 est également applicable aux éléments non-implantables et aux accessoires de ces dispositifs (voir la Note 1). Les caractéristiques du GÉNERATEUR D’IMPULSIONS IMPLANTABLE ou de la DÉRIVATION doivent être déterminées soit par la méthode appropriée détaillée dans la présente Norme Particulière, soit par toute autre méthode connue pour avoir une précision égale ou supérieure à la méthode spécifiée. En cas de litige, c'est la méthode détaillée dans la présente Norme Particulière qui doit s'appliquer. Tout aspect d’un DISPOSITIF MÉDICAL IMPLANTABLE ACTIF destiné à traiter les bradyarythmies est couvert par l’EN 45502–2-1 Exigences particulières pour les DISPOSITIFS MÉDICAUX IMPLANTABLES ACTIFS destinés au traitement de la bradyarythmie (STIMULATEURS). NOTE 1 Les dispositifs qui sont couramment désignés sous le terme « DISPOSITIFS MÉDICAUX IMPLANTABLES ACTIFS » peuvent en fait être des dispositifs individuels, une combinaison de dispositifs ou une combinaison d'un dispositif ou plusieurs dispositifs avec un ou plusieurs accessoires. Ces parties ne sont pas nécessairement toutes implantables, en partie ou en totalité, mais il est nécessaire de spécifier certaines exigences pour les parties et accessoires non implantables s’ils peuvent affecter la sécurité ou les performances du dispositif implantable. NOTE 2 La terminologie utilisée dans la présente Norme Européenne est cohérente avec celle de la Directive 90/385/CEE. NOTE 3 Dans la présente Norme Européenne, les termes imprimés en petites majuscules sont utilisés tels qu’ils sont définis à l’Article 3. Lorsqu’un terme défini est utilisé comme qualificatif d’un autre terme, il n’est pas imprimé en petites majuscules sauf si la notion ainsi qualifiée est elle-même également définie. NOTE 4 Des exigences particulières pour les dispositifs de traitement des insuffisances cardiaques congestives sont à l’étude. Ces types de dispositifs ne sont pas couverts par la présente norme.
Aktivni vsadljivi medicinski elementi - 2-2. del: Posebne zahteve za aktivne vsadljive medicinske elemente, namenjene za zdravljenje tahiaritmije (vključuje vsadljive defribilatorje)
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Standards Content (Sample)
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.
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
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
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