• BS 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 Specific assessment for workers with cardiac pacemakers

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  31-01-2017

    Publisher:  British Standards Institution

    Add To Cart

    Scope - (Show below) - (Hide below)

    This European Standard provides the procedure for the specific assessment required in EN 50527-1:2016, Annex A, for workers with implanted pacemakers. It offers different approaches for doing the risk assessment. The most suitable one will be used. If the worker has other Active Implantable Medical Devices (AIMDs) implanted additionally, they need to be assessed separately. The purpose of the specific assessment is to determine the risk for workers with implanted pacemakers arising from exposure to electromagnetic fields at the workplace. The assessment includes the likelihood of clinically significant effects and takes account of both transient and long-term exposure within specific areas of the workplace. NOTE 1 This standard does not address risks from contact currents. The techniques described in the different approaches may also be used for the assessment of publicly accessible areas. The frequency range to be observed is from 0 Hz to 3 GHz. Above 3 GHz no interference with the pacemaker occurs when the exposure limits are not exceeded. NOTE 2 The rationale for limiting the observation range to 3 GHz can be found in ISO 14117:2012, Clause 5.

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

    Committee GEL/106
    Development Note 2011 Edition is still active & will be withdrawn on 04/07/2019. Supersedes 15/30321270 DC. (01/2017)
    Document Type Standard
    Publisher British Standards Institution
    Status Current
    Supersedes

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

    AAMI PC69 : 2007
    EN ISO 14155:2011/AC:2011 CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - GOOD CLINICAL PRACTICE (ISO 14155:2011)
    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 62209-2:2010 HUMAN EXPOSURE TO RADIO FREQUENCY FIELDS FROM HAND-HELD AND BODYMOUNTED 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 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
    IEC 60118-4:2014+AMD1:2017 CSV Electroacoustics - Hearing aids - Part 4: Induction-loop systems for hearing aid purposes - System performance 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)
    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
    • Access your standards online with a subscription

      Features

      • Simple online access to standards, technical information and regulations
      • Critical updates of standards and customisable alerts and notifications
      • Multi - user online standards collection: secure, flexibile and cost effective