EN 50527-2-1:2016

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

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 1This 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 2The rationale for limiting the observation range to 3 GHz can be found in ISO 14117:2012, Clause 5.