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)

Published date

11-05-2018

Publisher

European Committee for Standards - Electrical

European foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Specific assessment
5 Documentation
Annex A (normative) - Device specific replacement of
        EN 50527-1:2016, Table 1
Annex B (informative) - Clinical investigation methods
Annex C (informative) - in vitro testing/measurements
Annex D (informative) - Modelling - Field modelling or
        calculations
Annex E (informative) - Interference from Low-Frequency
        Magnetic and Electric Fields (1 Hz to 10 MHz)
        Including Application to 50 Hz Power-Frequency
Annex F (informative) - Determination of minimum immunity
        for radio-frequency fields
Annex G (informative) - Obtaining the device immunity
        and guidelines provided by device manufacturers
Bibliography

This European Standard provides the procedure for the specific assessment required in Annex A of EN 50527 1:2015 for workers with implanted cardioverter defibrillators. It offers different approaches for doing the risk assessment. The most suitable one shall be used. If the worker has other Active Implantable Medical Devices (AIMDs) implanted additionally, they have to be assessed separately.

Committee	CLC/TC 106X
DevelopmentNote	Supersedes PREN 50527-2-2. (05/2018)
DocumentType	Standard
PublisherName	European Committee for Standards - Electrical
Status	Current

Standards	Relationship
I.S. EN 50527-2-2:2018	Identical
NF EN 50527-2-2 : 2018	Identical
NEN-EN 50527-2-2:2018	Identical
PN-EN 50527-2-2:2018	Identical
SS-EN 50527-2-2:2019	Identical
SN EN 50527-2-2 : 2018	Identical
UNE-EN 50527-2-2:2018	Identical
VDE 0848-527-2-2:2019-11	Identical
DIN EN 50527-2-2:2019	Identical
BS EN 50527-2-2:2018	Identical

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)
IEC 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 ISO 14155:2011/AC:2011	CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - GOOD CLINICAL PRACTICE (ISO 14155:2011)
EN 45502-2-2 : 2008 COR 2009	ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 2-2: PARTICULAR REQUIREMENTS FOR ACTIVE IMPLANTABLE MEDICAL DEVICES INTENDED TO TREAT TACHYARRHYTHMIA (INCLUDES IMPLANTABLE DEFIBRILLATORS)
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
ISO 27186:2010	Active implantable medical devices Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements
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)
ISO/TS 10974:2012	Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device
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 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 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
IEC 62226-3-1:2007+AMD1:2016 CSV	Exposure to electric or magnetic fields in the low and intermediatefrequency 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
EN 50527-2-1:2016	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
EN 45502-2-2 : 2008 COR 2009	ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 2-2: PARTICULAR REQUIREMENTS FOR ACTIVE IMPLANTABLE MEDICAL DEVICES INTENDED TO TREAT TACHYARRHYTHMIA (INCLUDES IMPLANTABLE DEFIBRILLATORS)