EN 50527-2-2:2018
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 2-2: Specific assessment for workers with cardioverter defibrillators (ICDs)
11-05-2018
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 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 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) |
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