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EN 50527-2-1:2016

Current
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
Published date

12-02-2016

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

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 1This 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 2The rationale for limiting the observation range to 3 GHz can be found in ISO 14117:2012, Clause 5.

Committee
CLC/TC 106X
DevelopmentNote
Supersedes PREN 50527-2-1. (12/2016)
DocumentType
Standard
PublisherName
European Committee for Standards - Electrical
Status
Current
Supersedes

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)
PREN 12895 : DRAFT 2013 INDUSTRIAL TRUCKS - ELECTROMAGNETIC COMPATIBILITY
PREN 50499 : DRAFT 2017 PROCEDURE FOR THE ASSESSMENT OF THE EXPOSURE OF WORKERS TO ELECTROMAGNETIC FIELDS
CEI EN 50647 : 1ED 2018 BASIC STANDARD FOR THE EVALUATION OF WORKERS' EXPOSURE TO ELECTRIC AND MAGNETIC FIELDS FROM EQUIPMENT AND INSTALLATIONS FOR THE PRODUCTION, TRANSMISSION AND DISTRIBUTION OF ELECTRICITY
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)
EN 50647:2017 Basic standard for the evaluation of workers' exposure to electric and magnetic fields from equipment and installations for the production, transmission and distribution of electricity
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)
13/30257892 DC : 0 BS EN 12895 - INDUSTRIAL TRUCKS - ELECTROMAGNETIC COMPATIBILITY
BS EN 50527-1:2016 Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices General
I.S. 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)
I.S. EN 50496:2018 DETERMINATION OF WORKERS' EXPOSURE TO ELECTROMAGNETIC FIELDS AND ASSESSMENT OF RISK AT A BROADCAST SITE
17/30365898 DC : 0 BS EN 50499 - PROCEDURE FOR THE ASSESSMENT OF THE EXPOSURE OF WORKERS TO ELECTROMAGNETIC FIELDS
ISO 14708-3:2017 Implants for surgery — Active implantable medical devices — Part 3: Implantable neurostimulators
BS EN 50647:2017 Basic standard for the evaluation of workers\' exposure to electric and magnetic fields from equipment and installations for the production, transmission and distribution of electricity
I.S. EN 50647:2017 BASIC STANDARD FOR THE EVALUATION OF WORKERS' EXPOSURE TO ELECTRIC AND MAGNETIC FIELDS FROM EQUIPMENT AND INSTALLATIONS FOR THE PRODUCTION, TRANSMISSION AND DISTRIBUTION OF ELECTRICITY
EN 50496:2018 Determination of workers' exposure to electromagnetic fields and assessment of risk at a broadcast site

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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