BS EN 50527-2-3:2021

Procedure for the Assessment of the Exposure to Electromagnetic Fields of Workers Bearing Active Implantable Medical Devices Specific Assessment for Workers with Implantable Neurostimulators

Standard Number: BS EN 50527-2-3:2021

Pages: 110

Released: 2021-11-02

ISBN: 978 0 539 06560 2

Status: Standard

Overview

The BS EN 50527-2-3:2021 standard provides a comprehensive procedure for assessing the exposure to electromagnetic fields (EMF) of workers who bear active implantable medical devices (AIMDs), with a specific focus on those with implantable neurostimulators. This standard is essential for ensuring the safety and well-being of workers who rely on these critical medical devices while performing their professional duties.

Key Features

• Detailed Assessment Procedure: The standard outlines a meticulous procedure for evaluating EMF exposure, ensuring that all potential risks are identified and mitigated.
• Specific Focus on Neurostimulators: While applicable to all AIMDs, this standard provides specific guidelines for workers with implantable neurostimulators, addressing their unique needs and challenges.
• Comprehensive Coverage: Spanning 110 pages, the standard covers all aspects of EMF exposure assessment, from initial evaluation to ongoing monitoring and risk management.
• Up-to-Date Information: Released on November 2, 2021, this standard incorporates the latest research and technological advancements in the field of EMF exposure and AIMDs.
• Internationally Recognized: As a BS EN standard, it is recognized and respected globally, ensuring compliance with international safety and health regulations.

Why This Standard is Important

Workers with active implantable medical devices, such as neurostimulators, are at a higher risk of adverse effects from EMF exposure. This standard is crucial for several reasons:

• Health and Safety: It ensures that the health and safety of workers with AIMDs are prioritized, reducing the risk of device malfunction or health complications due to EMF exposure.
• Regulatory Compliance: Adhering to this standard helps organizations comply with national and international regulations regarding workplace safety and EMF exposure.
• Risk Management: By following the procedures outlined in this standard, employers can effectively manage and mitigate risks associated with EMF exposure, protecting both their employees and their business.
• Enhanced Productivity: Ensuring a safe working environment for employees with AIMDs can lead to improved productivity and job satisfaction, as workers feel secure and supported in their roles.

Who Should Use This Standard?

This standard is designed for a wide range of professionals and organizations, including:

• Occupational Health and Safety Professionals: Those responsible for ensuring workplace safety and compliance with health regulations.
• Medical Device Manufacturers: Companies that produce AIMDs, particularly neurostimulators, can use this standard to inform their product design and safety protocols.
• Employers: Organizations with employees who have AIMDs need this standard to create safe working environments and comply with legal requirements.
• Healthcare Providers: Medical professionals who manage the care of patients with AIMDs can use this standard to advise on safe working conditions and EMF exposure limits.

Content Breakdown

The BS EN 50527-2-3:2021 standard is divided into several key sections, each addressing a critical aspect of EMF exposure assessment:

• Introduction: Provides an overview of the standard's purpose, scope, and applicability.
• Definitions and Terminology: Clarifies key terms and concepts related to EMF exposure and AIMDs.
• Assessment Procedure: Outlines the step-by-step process for evaluating EMF exposure, including initial assessment, detailed analysis, and ongoing monitoring.
• Risk Management: Discusses strategies for identifying, assessing, and mitigating risks associated with EMF exposure.
• Specific Considerations for Neurostimulators: Provides detailed guidelines for assessing and managing EMF exposure for workers with implantable neurostimulators.
• Case Studies and Examples: Includes real-world examples and case studies to illustrate the application of the standard's procedures.
• References and Further Reading: Lists additional resources and references for those seeking more in-depth information on EMF exposure and AIMDs.

Conclusion

The BS EN 50527-2-3:2021 standard is an invaluable resource for anyone involved in the assessment and management of EMF exposure for workers with active implantable medical devices, particularly those with neurostimulators. By following the comprehensive procedures and guidelines outlined in this standard, organizations can ensure the safety and well-being of their employees, comply with regulatory requirements, and effectively manage risks associated with EMF exposure.

With its detailed assessment procedures, specific focus on neurostimulators, and up-to-date information, this standard is a must-have for occupational health and safety professionals, medical device manufacturers, employers, and healthcare providers. Ensure the safety and productivity of your workforce by incorporating the BS EN 50527-2-3:2021 standard into your EMF exposure assessment and risk management practices.

BS EN 50527-2-3:2021

This standard BS EN 50527-2-3:2021 Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices is classified in these ICS categories:

• 17.240 Radiation measurements
• 11.040.40 Implants for surgery, prosthetics and orthotics

This document provides the procedure for the specific assessment required in EN 50527‑1:2016, Annex A, for workers with implanted neurostimulator systems (NS), specifically of the type used for spinal cord stimulation (SCS).

It is recognized that implantable neurostimulators have been developed for a wide variety of clinical applications, however the SCS devices within the scope of this document represent the largest segment of the implantable neurostimulator applications thus far.

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 particular standards within the EN 50527 series .

The purpose of the specific assessment is to determine the risk for workers with implanted SCS devices arising from exposure to electromagnetic fields (EMF) at the workplace. The assessment includes the likelihood of clinically significant effects.

NOTE 2 This document does not address risks from contact currents, or the effects upon any associated non-implantable devices (e.g. Patient Programmers).

The techniques described in the different approaches can 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 devices within the scope of this document is expected to occur.

NOTE 3 The rationale for limiting the observation range to 3 GHz can be found in ISO 14708‑3 [1].

NOTE 4 Further information concerning the functions of neurostimulator systems can be found at https://www.aans.org/Patients/Neurosurgical-Conditions-and-Treatments/Spinal-Cord-Stimulation.

This document provides the procedure for the specific assessment required in EN 50527‑1:2016, Annex A, for workers with implanted neurostimulator systems (NS), specifically of the type used for spinal cord stimulation (SCS).

It is recognized that implantable neurostimulators have been developed for a wide variety of clinical applications, however the SCS devices within the scope of this document represent the largest segment of the implantable neurostimulator applications thus far.

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 particular standards within the EN 50527 series .

The purpose of the specific assessment is to determine the risk for workers with implanted SCS devices arising from exposure to electromagnetic fields (EMF) at the workplace. The assessment includes the likelihood of clinically significant effects.

NOTE 2 This document does not address risks from contact currents, or the effects upon any associated non-implantable devices (e.g. Patient Programmers).

The techniques described in the different approaches can 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 devices within the scope of this document is expected to occur.

NOTE 3 The rationale for limiting the observation range to 3 GHz can be found in ISO 14708‑3 [1].

NOTE 4 Further information concerning the functions of neurostimulator systems can be found at https://www.aans.org/Patients/Neurosurgical-Conditions-and-Treatments/Spinal-Cord-Stimulation.