PREN 50527-2-1 : DRAFT 2015
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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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
01-12-2016
03-03-2015
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
Defines the procedure for the specific assessment required in Annex A of EN 50527-1:2015 for workers with implanted pacemakers.
| Committee |
TC 106X
|
| DocumentType |
Draft
|
| PublisherName |
European Committee for Standards - Electrical
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| 15/30321270 DC : 0 | Identical |
| ANSI/AAMI/ISO 14708-3:2017 | IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 3: IMPLANTABLE NEUROSTIMULATORS |
| 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 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) |
| 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 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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