What is BS EN 50527‑2‑3 about?
BS EN 50527‑2‑3 is a part of the BS EN 50527 multi-series on procedures for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices. This European standard aims to improve the safety of patients with implantable medical devices. BS EN 50527‑2‑3 provides the procedure for the specific assessment needed for workers with implanted neurostimulator systems (NS), specifically of the type used for spinal cord stimulation (SCS).
The purpose of the BS EN 50527‑2‑3 is to find the risk for workers with implanted SCS devices arising from exposure to electromagnetic fields (EMF) at the workplace.
NOTE 1: If the worker has other Active Implantable Medical Devices (AIMDs) implanted additionally, they are assessed separately according to EN 50527-1 or other standards within the EN 50527 series.
NOTE 2: BS EN 50527‑2‑3 does not address risks from contact currents, or the effects upon any associated non-implantable devices (e.g., Patient Programmers).
NOTE 3: The rationale for limiting the observation range to 3 GHz can be found in ISO 14708-3.
Who is BS EN 50527‑2‑3 for?
BS EN 50527‑2‑3 on procedures for workers implanted medical devices in an electromagnetic field is useful for:
- Technical and medical experts as necessary, e.g., manufacturer of the device
- Health and safety experts
Why should you use BS EN 50527‑2‑3?
Medical electronic devices and metallic implants are found in an increasing number of workers. Industrial applications requiring intense electromagnetic fields (EMF) are growing and the potential risk of injurious interactions arising from EMF affecting devices or implants needs to be managed.
BS EN 50527‑2‑3 helps users by providing the procedure for the specific assessment needed for workers with implanted medical devices, specifically of the type used for spinal cord stimulation (SCS). BS EN 50527‑2‑3 provides guidance for risk identification, risk assessment and risk control procedures to be followed by the employees implanted with medical devices.
Overall, the assessment guidelines given in BS EN 50527‑2‑3 enable you to improve the safety of workers with implanted medical devices by assessing the risks it can face from EMFs in its operational lifecycle.