PREN 50527-2-2 : DRAFT 2017
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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)
01-05-2018
22-08-2017
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Superseded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 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 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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