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  • EN 45502-2-2 : 2008 COR 2009

    Current The latest, up-to-date edition.

    ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 2-2: PARTICULAR REQUIREMENTS FOR ACTIVE IMPLANTABLE MEDICAL DEVICES INTENDED TO TREAT TACHYARRHYTHMIA (INCLUDES IMPLANTABLE DEFIBRILLATORS)

    Available format(s): 

    Language(s): 

    Published date:  30-04-2009

    Publisher:  European Committee for Standards - Electrical

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    Table of Contents - (Show below) - (Hide below)

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

    Abstract - (Show below) - (Hide below)

    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.

    General Product Information - (Show below) - (Hide below)

    Committee JWG AIMD
    Development Note Together with EN 45502-2-1, it supersedes EN 50061. (11/2008) Supersedes PREN 45502-2-2. (05/2009)
    Document Type Standard
    Publisher European Committee for Standards - Electrical
    Status Current
    Supersedes

    Standards Referenced By This Book - (Show below) - (Hide below)

    08/30191453 DC : DRAFT OCT 2008 BS EN 50527-1 - ASSESSMENT OF HUMAN EXPOSURE AT THE WORKPLACE FOR PERSONS BEARING ACTIVE IMPLANTABLE MEDICAL DEVICES (AIMD) IN ELECTRIC, MAGNETIC AND ELECTROMAGNETIC FIELDS WITH FREQUENCIES FROM 0 HZ TO 300 GHZ - PART 1: GENERAL
    ISO 14117:2012 Active implantable medical devices Electromagnetic compatibility EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
    NF 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)
    17/30359914 DC : 0 BS EN 50527-2-2 - PROCEDURE FOR THE ASSESSMENT OF THE EXPOSURE TO ELECTROMAGNETIC FIELDS OF WORKERS BEARING ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 2-2: SPECIFIC ASSESSMENT FOR WORKERS WITH CARDIOVERTER DEFIBRILLATORS (ICDS)
    I.S. EN 50527-1:2016 PROCEDURE FOR THE ASSESSMENT OF THE EXPOSURE TO ELECTROMAGNETIC FIELDS OF WORKERS BEARING ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL
    I.S. 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)
    AAMI ISO 27186 : 2010 ACTIVE IMPLANTABLE MEDICAL DEVICES - FOUR-POLE CONNECTOR SYSTEM FOR IMPLANTABLE CARDIAC RHYTHM MANAGEMENT DEVICES - DIMENSIONAL AND TEST REQUIREMENTS
    15/30321267 DC : DRAFT FEB 2015 BS EN 50527-1 - PROCEDURE FOR THE ASSESSMENT OF THE EXPOSURE TO ELECTROMAGNETIC FIELDS OF WORKERS BEARING ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL
    EN 50527-1:2016 Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices - Part 1: General
    08/30191626 DC : DRAFT OCT 2008 BS ISO 27186 - ACTIVE IMPLANTABLE MEDICAL DEVICES - FOUR-POLE CONNECTOR SYSTEM FOR IMPLANTABLE CARDIAC RHYTHM MANAGEMENT DEVICES - DIMENSIONAL AND TEST REQUIREMENTS
    10/30195946 DC : DRAFT DEC 2010 BS ISO 27185 - CARDIAC RHYTHM MANAGEMENT DEVICES - SYMBOLS TO BE USED WITH CARDIAC RHYTHM MANAGEMENT DEVICE LABELS, AND INFORMATION TO BE SUPPLIED - GENERAL REQUIREMENTS
    BS ISO 27186:2010 Active implantable medical devices. Four-pole connector system for implantable cardiac rhythm management devices. Dimensional and test requirements
    PREN 50527-2-2 : DRAFT 2017 PROCEDURE FOR THE ASSESSMENT OF THE EXPOSURE TO ELECTROMAGNETIC FIELDS OF WORKERS BEARING ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 2-2: SPECIFIC ASSESSMENT FOR WORKERS WITH CARDIOVERTER DEFIBRILLATORS (ICDS)
    BS EN 45502-2-1:2003 Active implantable medical devices Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)
    EN 50527-2-2:2018 Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices - Part 2-2: Specific assessment for workers with cardioverter defibrillators (ICDs)
    PREN 50527-1 : DRAFT 2015 PROCEDURE FOR THE ASSESSMENT OF THE EXPOSURE TO ELECTROMAGNETIC FIELDS OF WORKERS BEARING ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL
    BS EN 50527-1:2016 Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices General
    BS ISO 14117:2012 Active implantable medical devices. Electromagnetic compatibility. EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
    ISO 27186:2010 Active implantable medical devices Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements
    10/30208719 DC : 0
    AAMI ISO 14117 : 2012 ACTIVE IMPLANTABLE MEDICAL DEVICES - ELECTROMAGNETIC COMPATIBILITY - EMC TEST PROTOCOLS FOR IMPLANTABLE CARDIAC PACEMAKERS, IMPLANTABLE CARDIOVERTER DEFIBRILLATORS AND CARDIAC RESYNCHRONIZATION DEVICES
    AAMI ISO 27185 : 2012 CARDIAC RHYTHM MANAGEMENT DEVICES - SYMBOLS TO BE USED WITH CARDIAC RHYTHM MANAGEMENT DEVICE LABELS, AND INFORMATION TO BE SUPPLIED - GENERAL REQUIREMENTS
    ANSI/AAMI/ISO 14708-1:2014 IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND FOR INFORMATION TO BE PROVIDED BY THE MANUFACTURER
    ISO 27185:2012 Cardiac rhythm management devices — Symbols to be used with cardiac rhythm management device labels, and information to be supplied — General requirements
    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)
    ISO 14708-1:2014 Implants for surgery — Active implantable medical devices — Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
    UNE-EN 50527-1:2011 Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices - Part 1: General
    BS ISO 27185:2012 Cardiac rhythm management devices. Symbols to be used with cardiac rhythm management device labels, and information to be supplied. General requirements

    Standards Referencing This Book - (Show below) - (Hide below)

    AAMI PC69 : 2007
    IEC 60068-2-27:2008 Environmental testing - Part 2-27: Tests - Test Ea and guidance: Shock
    EN 60068-2-64:2008 ENVIRONMENTAL TESTING - PART 2-64: TESTS - TEST FH: VIBRATION, BROADBAND RANDOM AND GUIDANCE
    IEC 60068-2-64:2008 Environmental testing - Part 2-64: Tests - Test Fh: Vibration, broadband random and guidance
    EN 60068-2-27:2009 Environmental testing - Part 2-27: Tests - Test Ea and guidance: Shock
    IEC 60068-2-47:2005 Environmental testing - Part 2-47: Test - Mounting of specimens for vibration, impact and similar dynamic tests
    ISO 8601:2004 Data elements and interchange formats Information interchange Representation of dates and times
    ISO 5841-3:2013 Implants for surgery — Cardiac pacemakers — Part 3: Low-profile connectors (IS-1) for implantable pacemakers
    EN 45502-1 : 2015 IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND FOR INFORMATION TO BE PROVIDED BY THE MANUFACTURER
    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)
    EN 28601 : 1992 DATA ELEMENTS AND INTERCHANGE FORMATS - INFORMATION INTERCHANGE - REPRESENTATION OF DATES AND TIMES
    EN 980:2008 Symbols for use in the labelling of medical devices
    ISO 11318:2002 Cardiac defibrillators — Connector assembly DF-1 for implantable defibrillators — Dimensions and test requirements
    EN 60068-2-47:2005 Environmental testing - Part 2-47: Tests - Mounting of specimens for vibration, impact and similar dynamic tests
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