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PREN 50527-2-2 : DRAFT 2017

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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)
Superseded date

05-01-2018

Published date

08-22-2017

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

Gives the procedure for the specific assessment required in EN 50527-1:2016, Annex A, for workers with implanted cardioverter defibrillators (ICDs) and Cardiac Resynchronization.

Committee
TC 106X
DocumentType
Draft
PublisherName
European Committee for Standards - Electrical
Status
Superseded

Standards Relationship
NEN EN 50527-2-2 : DRAFT 2017 Identical
17/30359914 DC : 0 Identical

PREN 50499 : DRAFT 2017 PROCEDURE FOR THE ASSESSMENT OF THE EXPOSURE OF WORKERS TO ELECTROMAGNETIC FIELDS
EN 50527-1:2016 Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices - Part 1: General
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 50527-1:2016 PROCEDURE FOR THE ASSESSMENT OF THE EXPOSURE TO ELECTROMAGNETIC FIELDS OF WORKERS BEARING ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL
17/30365898 DC : 0 BS EN 50499 - PROCEDURE FOR THE ASSESSMENT OF THE EXPOSURE OF WORKERS TO ELECTROMAGNETIC FIELDS

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 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

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