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    I.S. EN 50527-2-1:2016

    Current The latest, up-to-date edition.

    PROCEDURE FOR THE ASSESSMENT OF THE EXPOSURE TO ELECTROMAGNETIC FIELDS OF WORKERS BEARING ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 2-1: SPECIFIC ASSESSMENT FOR WORKERS WITH CARDIAC PACEMAKERS

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  01-01-2016

    Publisher:  National Standards Authority of Ireland

    For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
    Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

    Dates of withdrawal of national standards are available from NSAI.

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

    National Foreword
    European foreword
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Specific assessment
    5 Documentation
    Annex A (normative) - Pacemaker specific replacement of
            50527-1:2016, Table 1
    Annex B (informative) - Clinical investigation methods
    Annex C (informative) - in vitro testing/measurements
    Annex D (informative) - Modelling
    Annex E (informative) - Derived worst case conversions
            for frequencies below 450 MHz
    Annex F (informative) - Interference from power-frequency
            magnetic and electric fields from transmission,
            distribution and use of electricity
    Annex G (informative) - Determination of the pacemaker
            immunity and guidelines provided by
            pacemaker manufacturers - Determination method
    Bibliography

    Abstract - (Show below) - (Hide below)

    Defines the procedure for the specific assessment required in EN 50527-1:2016, Annex A, for workers with implanted pacemakers.

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

    Document Type Standard
    Publisher National Standards Authority of Ireland
    Status Current

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

    AAMI PC69 : 2007
    IEC 62209-2:2010 Human exposure to radio frequency fields from hand-held and body-mounted wireless communication devices - Human models, instrumentation, and procedures - Part 2: Procedure to determine the specific absorption rate (SAR) for wireless communication devices used in close proximity to the human body (frequency range of 30 MHz to 6 GHz)
    EN ISO 14155:2011/AC:2011 CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - GOOD CLINICAL PRACTICE (ISO 14155:2011)
    EN 62226-3-1:2007/A1:2017 EXPOSURE TO ELECTRIC OR MAGNETIC FIELDS IN THE LOW AND INTERMEDIATE FREQUENCY RANGE - METHODS FOR CALCULATING THE CURRENT DENSITY AND INTERNAL ELECTRIC FIELD INDUCED IN THE HUMAN BODY - PART 3-1: EXPOSURE TO ELECTRIC FIELDS - ANALYTICAL AND 2D NUMERICAL MODELS (IEC 62226-3-1:2007/A1:2016)
    ISO 14117:2012 Active implantable medical devices Electromagnetic compatibility EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
    IEEE 1528-2013 REDLINE IEEE Recommended Practice for Determining the Peak Spatial-Average Specific Absorption Rate (SAR) in the Human Head from Wireless Communications Devices: Measurement Techniques
    EN 62209-1:2016 Measurement procedure for the assessment of specific absorption rate of human exposure to radio frequency fields from hand-held and body-mounted wireless communication devices - Part 1: Devices used next to the ear (Frequency range of 300 MHz to 6 GHz)
    EN 50527-1:2016 Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices - Part 1: General
    ISO 14155:2011 Clinical investigation of medical devices for human subjects Good clinical practice
    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 50413 : 2008 AMD 1 2013 BASIC STANDARD ON MEASUREMENT AND CALCULATION PROCEDURES FOR HUMAN EXPOSURE TO ELECTRIC, MAGNETIC AND ELECTROMAGNETIC FIELDS (0 HZ - 300 GHZ)
    EN 50499:2008 Procedure for the assessment of the exposure of workers to electromagnetic fields
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