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.<\/p>\n
| PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
|---|---|---|---|---|---|---|---|
| 2<\/td>\n | undefined <\/td>\n<\/tr>\n | ||||||
| 8<\/td>\n | 1 Scope 2 Normative references <\/td>\n<\/tr>\n | ||||||
| 9<\/td>\n | 3 Terms and definitions <\/td>\n<\/tr>\n | ||||||
| 10<\/td>\n | 4 Specific assessment 4.1 Description of the assessment process 4.1.1 General <\/td>\n<\/tr>\n | ||||||
| 13<\/td>\n | 4.1.2 Equipment consideration 4.1.3 Patient warning consideration 4.1.4 Cases for additional investigation <\/td>\n<\/tr>\n | ||||||
| 16<\/td>\n | 4.1.5 Choice of investigative method 4.1.5.1 General 4.1.5.2 Considerations in choosing a clinical method <\/td>\n<\/tr>\n | ||||||
| 17<\/td>\n | 4.1.5.3 Considerations in choosing a non-clinical method 4.2 Clinical investigation <\/td>\n<\/tr>\n | ||||||
| 18<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 21<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 22<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 23<\/td>\n | Annex A (normative)Device specific replacement of EN 50527-1:2016, Table 1 <\/td>\n<\/tr>\n | ||||||
| 29<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 30<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 31<\/td>\n | C.2.2.2 Commercial phantoms C.2.2.3 Custom made phantoms C.3 Basic procedure for device in vitro testing <\/td>\n<\/tr>\n | ||||||
| 33<\/td>\n | Annex D (informative)Modelling \u2014 Field modelling or calculations <\/td>\n<\/tr>\n | ||||||
| 34<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 35<\/td>\n | E.3 Sensitivity of devices to interference E.4 Immunity requirements <\/td>\n<\/tr>\n | ||||||
| 36<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 37<\/td>\n | E.5.2.3 For bipolar leads <\/td>\n<\/tr>\n | ||||||
| 38<\/td>\n | E.5.3 Voltage induced in leads E.6 Voltage induced in the leads by electric fields <\/td>\n<\/tr>\n | ||||||
| 40<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 41<\/td>\n | E.8.2 Adjustment for device sensitivity setting <\/td>\n<\/tr>\n | ||||||
| 43<\/td>\n | E.8.3 Adjustment for lead tip to ring spacing <\/td>\n<\/tr>\n | ||||||
| 44<\/td>\n | E.9 Application to Power Frequency Exposure Situations E.9.1 Public exposures E.9.2 Beneath high voltage power lines <\/td>\n<\/tr>\n | ||||||
| 45<\/td>\n | E.9.3 Occupational settings E.9.4 Temporary exposure above the interference levels <\/td>\n<\/tr>\n | ||||||
| 46<\/td>\n | E.9.5 Induced voltages at occupational exposure limit values E.10 Conversion based on known compliance with basic restrictions E.10.1 General <\/td>\n<\/tr>\n | ||||||
| 47<\/td>\n | E.10.2 Relationship between magnetic fields and induced current density <\/td>\n<\/tr>\n | ||||||
| 48<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 51<\/td>\n | 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) <\/td>\n<\/tr>\n | ||||||
| 52<\/td>\n | F.1.3 High frequency (above 30 MHz) <\/td>\n<\/tr>\n | ||||||
| 53<\/td>\n | F.2 References <\/td>\n<\/tr>\n | ||||||
| 54<\/td>\n | Annex G (informative)Determining device immunity G.1 Introduction G.2 EMC and devices \u2013 General guidelines, hazards and harms <\/td>\n<\/tr>\n | ||||||
| 57<\/td>\n | G.3 Induced voltages, fields and zones G.3.1 Induced voltage test levels G.3.2 Magnetic field amplitudes producing test limits <\/td>\n<\/tr>\n | ||||||
| 59<\/td>\n | G.3.3 Induced voltage zones <\/td>\n<\/tr>\n | ||||||
| 60<\/td>\n | G.3.4 Magnetic field zones <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" 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)<\/b><\/p>\n |