I.S. EN 50527-2-2:2018

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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)

Available format(s): Hardcopy, PDF

Language(s): English

Published date: 17-06-2018

Publisher: National Standards Authority of Ireland

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Table of Contents - (Show below) - (Hide below)

National Foreword
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

Abstract - (Show below) - (Hide below)

Describes the procedure for the specific assessment required in EN 50527-1:2016, Annex A, for workers with implanted cardioverter defibrillators (ICDs) and Cardiac Resynchronization Therapy devices with associated defibrillation functions (CRT-D).

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Document Type	Standard
ISBN
Pages
Product Note	The date of any NSAI previous adoption may not match the date of its original CEN/CENELECdocument.
Published
Publisher	National Standards Authority of Ireland
Status	Current

International Equivalents – Equivalent Standard(s) & Relationship - (Show below) - (Hide below)

Equivalent Standard(s)	Relationship
EN 50527-2-2:2018	Identical

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

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 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)
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
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

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