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BS EN 50527-2-2:2018

BS EN 50527-2-2:2018

$198.66

Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices – Specific assessment for workers with cardioverter defibrillators (ICDs)

Published By Publication Date Number of Pages
BSI 2018 66
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This European Standard provides the procedure for the specific assessment required in Annex A of EN 50527 1:2015 for workers with implanted cardioverter defibrillators. It offers different approaches for doing the risk assessment. The most suitable one shall be used. If the worker has other Active Implantable Medical Devices (AIMDs) implanted additionally, they have to be assessed separately.

PDF Catalog

PDF Pages PDF Title
2 undefined
8 1 Scope
2 Normative references
9 3 Terms and definitions
10 4 Specific assessment
4.1 Description of the assessment process
4.1.1 General
13 4.1.2 Equipment consideration
4.1.3 Patient warning consideration
4.1.4 Cases for additional investigation
16 4.1.5 Choice of investigative method
4.1.5.1 General
4.1.5.2 Considerations in choosing a clinical method
17 4.1.5.3 Considerations in choosing a non-clinical method
4.2 Clinical investigation
18 4.3 Non-clinical investigation
4.3.1 General
4.3.2 Non-clinical investigation by in vitro testing
4.3.2.1 Determination of in vitro testing feasibility
4.3.2.2 Requirements for in vitro testing
21 4.3.3 Non-clinical investigation by comparative study
4.3.3.1 General
4.3.3.2 Levels of device immunity
4.3.3.3 Determination of fields in the workplace
22 4.3.3.4 Determination of the immunity to fields
4.3.3.5 Manufacturer Assessment of field surveys, induced voltages and specific device immunity
5 Documentation
23 Annex A (normative)Device specific replacement of EN 50527-1:2016, Table 1
29 Annex B (informative)Clinical investigation methods
B.1 Assessment of device compatibility using stored data and diagnostic features
B.2 Real time event monitoring by telemetry
30 Annex C (informative)in vitro testing/measurements
C.1 Introduction
C.2 EM phantom
C.2.1 General
C.2.2 EM phantom design
C.2.2.1 General
31 C.2.2.2 Commercial phantoms
C.2.2.3 Custom made phantoms
C.3 Basic procedure for device in vitro testing
33 Annex D (informative)Modelling ā€” Field modelling or calculations
34 Annex E (informative)Interference from Low-Frequency Magnetic and Electric Fields (1 Hz to 10 MHz) Including Application to 50 Hz Power-Frequency
E.1 Introduction
E.2 Implanted devices and leads
35 E.3 Sensitivity of devices to interference
E.4 Immunity requirements
36 E.5 Voltage induced in the leads by magnetic fields
E.5.1 Induction in a loop
E.5.2 Inductive loop area for bipolar leads
E.5.2.1 General
E.5.2.2 For unipolar leads
37 E.5.2.3 For bipolar leads
38 E.5.3 Voltage induced in leads
E.6 Voltage induced in the leads by electric fields
40 E.7 Values of 50 Hz magnetic and electric field that can cause interference
E.8 Factors that affect the immunity from interference
E.8.1 Reasons for improved immunity
41 E.8.2 Adjustment for device sensitivity setting
43 E.8.3 Adjustment for lead tip to ring spacing
44 E.9 Application to Power Frequency Exposure Situations
E.9.1 Public exposures
E.9.2 Beneath high voltage power lines
45 E.9.3 Occupational settings
E.9.4 Temporary exposure above the interference levels
46 E.9.5 Induced voltages at occupational exposure limit values
E.10 Conversion based on known compliance with basic restrictions
E.10.1 General
47 E.10.2 Relationship between magnetic fields and induced current density
48 E.10.3 Relationship between magnetic fields and induced voltages on an implanted lead
E.10.4 A simple model to analyse the possible voltages at device terminations generated from induced current density equivalent the basic restrictions of Council Recommendation 1999/519/EC
51 Annex F (informative)Determination of minimum immunity for radio-frequency fields
F.1 Determination of immunity from the field
F.1.1 General
F.1.2 Intermediate frequencies (5 MHz to 30 MHz)
52 F.1.3 High frequency (above 30 MHz)
53 F.2 References
54 Annex G (informative)Determining device immunity
G.1 Introduction
G.2 EMC and devices ā€“ General guidelines, hazards and harms
57 G.3 Induced voltages, fields and zones
G.3.1 Induced voltage test levels
G.3.2 Magnetic field amplitudes producing test limits
59 G.3.3 Induced voltage zones
60 G.3.4 Magnetic field zones

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BS EN 50527-2-2:2018
$198.66