PREN 50527-2-1 : DRAFT 2015

Superseded

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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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Superseded date: 01-12-2016

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Published date: 03-03-2015

Publisher: European Committee for Standards - Electrical

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

1 Scope
2 References
3 Terms and definitions
4 Specific assessment
5 Documentation
Annex A (normative) - Pacemaker specific replacement
        of EN 50527-1:2015, 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

Abstract - (Show below) - (Hide below)

Defines the procedure for the specific assessment required in Annex A of EN 50527-1:2015 for workers with implanted pacemakers.

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Comment Closes On
Committee	TC 106X
Document Type	Draft
ISBN
Pages
Published
Publisher	European Committee for Standards - Electrical
Status	Superseded
Superseded By	EN 50527-2-1:2016

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Equivalent Standard(s)	Relationship
15/30321270 DC : 0	Identical

Standards Referenced By This Book - (Show below) - (Hide below)

ANSI/AAMI/ISO 14708-3:2017	IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 3: IMPLANTABLE NEUROSTIMULATORS

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

ISO 14155-2:2003	Clinical investigation of medical devices for human subjects Part 2: Clinical investigation plans
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 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)
EN 50527-1:2016	Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices - Part 1: General
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 ISO 14155-1:2009	Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 14155-1:2003)
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

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