BS EN 50527-2-1:2016 – TC:2020 Edition
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Tracked Changes. Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices – Specific assessment for workers with cardiac pacemakers
| Published By | Publication Date | Number of Pages |
| BSI | 2020 | 168 |
This European Standard provides the procedure for the specific assessment required in EN 50527-1:2016, Annex A, for workers with implanted pacemakers. It offers different approaches for doing the risk assessment. The most suitable one will be used. If the worker has other Active Implantable Medical Devices (AIMDs) implanted additionally, they need to be assessed separately. The purpose of the specific assessment is to determine the risk for workers with implanted pacemakers arising from exposure to electromagnetic fields at the workplace. The assessment includes the likelihood of clinically significant effects and takes account of both transient and long-term exposure within specific areas of the workplace. NOTE 1 This standard does not address risks from contact currents. The techniques described in the different approaches may also be used for the assessment of publicly accessible areas. The frequency range to be observed is from 0 Hz to 3 GHz. Above 3 GHz no interference with the pacemaker occurs when the exposure limits are not exceeded. NOTE 2 The rationale for limiting the observation range to 3 GHz can be found in ISO 14117:2012, Clause 5.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 98 | Contents Page |
| 101 | European foreword |
| 102 | 1 Scope 2 Normative references 3 Terms and definitions |
| 104 | 4 Specific assessment 4.1 Description of the assessment process 4.1.1 General |
| 105 | Figure 1 — Overview of the assessment process |
| 106 | Figure 2 — Pacemaker specific assessment process |
| 107 | 4.1.2 Equipment consideration 4.1.3 Patient warning consideration 4.1.4 Cases for additional investigation |
| 109 | Figure 3 — Additional investigation process |
| 110 | 4.1.5 Choice of investigative method 4.1.5.1 General 4.1.5.2 Considerations in choosing a clinical method |
| 111 | 4.1.5.3 Considerations in choosing a non-clinical method 4.2 Clinical investigation 4.3 Non-clinical investigation 4.3.1 General |
| 112 | 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 |
| 113 | 4.3.3 Non-clinical investigation by comparative study 4.3.3.1 General |
| 114 | Figure 4 — Comparison process |
| 115 | 4.3.3.2 Determination of the induced voltages on the leads 4.3.3.3 Determination of the voltage immunity |
| 116 | 4.3.3.4 Comparison of induced voltages to voltage immunity and conclusion 5 Documentation |
| 117 | Annex A (normative) Pacemaker specific replacement of EN 50527-1:2016, Table 1 Table A.1 — Compliant workplaces and equipment with exceptions |
| 123 | Annex B (informative) Clinical investigation methods B.1 External ECG monitoring B.2 Assessment of pacemaker compatibility using stored data and diagnostic features B.3 Real time event monitoring by telemetry |
| 125 | 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 |
| 126 | C.2.2.2 Commercial phantoms C.2.2.3 Custom made phantoms C.3 Basic procedure for cardiac pacemaker in vitro testing |
| 127 | Figure C.1 — Example of in vitro procedure for EM interference at low frequency using planar electrodes, bipolar lead and ECG and data recording C.4 References |
| 128 | C.5 Literature |
| 129 | Annex D (informative) Modelling D.1 General D.2 Analytical techniques D.3 Numerical techniques D.4 Field modelling or calculations |
| 130 | D.5 Modelling the human body and implant D.6 References |
| 131 | Annex E (informative) Derived worst case conversions for frequencies below 450 MHz E.1 Introduction E.2 Functionality of implanted pacemaker leads |
| 132 | Figure E.1 — Typical implantations of cardiac pacemakers (abdominal implantation with prolonged lead is used in clinical environment only) E.3 Conversion based on known field strength E.3.1 General E.3.2 Low frequency range (below 5 MHz) |
| 133 | E.3.3 Pure magnetic field (16 Hz to 5 MHz) Figure E.2 — Effective induction area of an open wire loop inside a conductive medium |
| 135 | Figure E.3 — Schematic representation of bipolar pickup of interference in an infinitely extended homogeneous conducting medium E.3.4 Pure electric field (16 Hz to 150 kHz) E.3.4.1 Frequency range 16 Hz to 60 Hz |
| 137 | Figure E.4 — Induced voltage on the implanted lead in a pure E field |
| 138 | E.3.4.2 Frequency range 60 Hz to 150 kHz E.3.5 Field with electric component (16 Hz to 150 kHz) E.3.5.1 Frequency range 16 Hz to 60 Hz |
| 139 | E.3.5.2 Frequency range 60 Hz to 150 kHz E.3.6 Field with electric and magnetic component (150 kHz to 5 MHz) Figure E.5 — Schematic graphs of the same voltage on the lead for different layouts |
| 140 | E.3.7 Range between low and high frequency ranges (5 MHz to 30 MHz) E.3.8 High frequency range (above 30 MHz) |
| 142 | E.4 Conversion based on known compliance with basic restrictions E.4.1 General E.4.2 Short survey on the direct effects of human exposure (induced current density) |
| 143 | Figure E.6 — Eddy-current inside a conductive medium induced by varying magnetic flux |
| 144 | E.4.3 Short survey on induced voltages on an implanted lead Figure E.7 — Voltage induced on a lead inside conductive body tissue E.4.4 A simple model to analyse the possible voltages at pacemaker terminations generated from induced current density equivalent the basic restrictions of Council Recommendation 1999/519/EC |
| 146 | Figure E.8 — Voltages on an implanted lead E.5 References |
| 148 | Annex F (informative) Interference from power-frequency magnetic and electric fields from transmission, distribution and use of electricity F.1 Sensitivity of pacemakers to interference F.2 Immunity requirements |
| 149 | Table F.1 — Amplitude of the immunity test signal applied F.3 Voltage induced in the leads by magnetic fields |
| 150 | F.4 Voltage induced in the leads by electric fields |
| 152 | F.5 Values of 50 Hz magnetic and electric field that may cause interference Table F.2 — Values of 50 Hz electric and magnetic field (r.m.s.) that might, under unfavourable circumstances, cause interference in a pacemaker |
| 153 | F.6 Factors that affect the immunity from interference F.6.1 Reasons for improved immunity |
| 154 | F.6.2 Adjustment for pacemaker sensitivity Figure F.1 — How the immunity ratio affects magnetic field that may result in interference |
| 155 | Figure F.2 — How the immunity ratio affects electric field that may result in interference F.7 Application to exposure situations F.7.1 Public exposures F.7.2 Beneath high voltage power lines |
| 156 | Table F.3 — Summary of typical maximum field values beneath high-voltage overhead lines at 1 m above ground F.7.3 Occupational settings |
| 157 | F.7.4 Temporary exposure above the interference levels F.8 References |
| 158 | Annex G (informative) Determination of the pacemaker immunity and guidelines provided by pacemaker manufacturers – Determination method G.1 Introduction G.2 EMC and pacemakers – General guidelines |
| 161 | G.3 Induced voltages, fields and zones G.3.1 Induced voltage test levels Figure G.1 — Induced voltage test levels G.3.2 Magnetic field amplitudes producing test limits |
| 162 | Figure G.2 — Magnetic field amplitudes, for frequencies below 5 000 kHz, producing test limits in unipolar configurations |
| 163 | G.3.3 Induced voltage zones Figure G.3 — Induced voltage zones for unipolar configurations G.3.4 Magnetic field zones |
| 164 | Figure G.4 — Magnetic field zones, for frequencies below 5 000 kHz and for unipolar configurations G.4 References |
| 165 | G.5 Literature |
| 166 | Bibliography |
