I.S. EN 50527-2-1:2016
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 2-1: SPECIFIC ASSESSMENT FOR WORKERS WITH CARDIAC PACEMAKERS
Hardcopy , PDF
English
01-01-2016
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Dates of withdrawal of national standards are available from NSAI.
Important note : Users cannot be edited or removed once added to your Multi user PDF.
National Foreword
European foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Specific assessment
5 Documentation
Annex A (normative) - Pacemaker specific replacement of
50527-1:2016, 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 EN 50527-1:2016, Annex A, for workers with implanted pacemakers.
| DocumentType |
Standard
|
| Pages |
76
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Standards | Relationship |
| EN 50527-2-1:2016 | Identical |
| AAMI PC69 : 2007 | |
| 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) |
| 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 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 |
| 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 |
Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.