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EN 45502-2-1:2003

(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)

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.

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

Status
Published
Publication Date
21-Dec-2003
ICS
11.040.40 - Implants for surgery, prosthetics and orthotics
Technical Committee
CEN/CLC/JTC 16 - CEN/CENELEC Joint Working Group on Active Implantable Medical Devices
Drafting Committee
IEC/SC 62D - IEC_SC_62D
Parallel Committee
CENCLC/JWG AIMD - CENCLC_JWG_AIMD
Current Stage
6060 - Document made available - Publishing
Start Date
22-Dec-2003
Completion Date
22-Dec-2003
Directive
90/385/EEC - Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices
Mandate
BC/CLC/02-89 - BC/CLC/02-89
M/432 - Standardisation Mandate addressed to CEN and CENELEC within the framework of Directive 2007/47/EC amending Directive 90/385/EEC and Directive 93/42/EEC relating to Medical Devices
M/BC/CEN/89/9 - Joint Standardization request to CEN/CENELEC concerning harmonized standards relating to horizontal aspects in the field of medical devices
Ref Project
SIST EN 45502-2-1:2004 - Active implantable medical devices - Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)

Relations

Replaces
EN 50061:1988/A1:1995 - Safety of implantable cardiac pacemakers
Effective Date
07-Jun-2022
Replaces
EN 50061:1988 - Safety of implantable cardiac pacemakers
Effective Date
07-Jun-2022
EN 45502-2-1:2004EN 45502-2-1:2004
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EN 45502-2-1:2004
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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

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.
– 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

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 ge
...

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