Сòòò½APP

In this white paper, Steve Hayes discusses manufacturer responsibilities under IEC 60601-1-2 for ongoing EMC compliance in the medical device industry. It emphasizes the need for continual updates to risk management files to address evolving electromagnetic disturbances, new wireless technologies, and emerging threats. Manufacturers are urged to maintain vigilance, conduct regular reviews, and take appropriate action to ensure product safety and compliance.

Understanding the Dynamic Landscape of EMC Compliance in Medical Device Manufacturing

Given the critical role of medical products, manufacturers of medical equipment have a responsibility to ensure that they continually update their risk management files with the latest, most up-to-date feedback from the real-world environment.

In the case of electromagnetic (EM) disturbances, this will always be a continuous process given the new and emerging wireless technologies that are released and deployed by electronic product manufacturers.

This paper is intended to highlight what manufacturers of medical products need to do to ensure that their product continues to meet the requirements of the applicable standard and hence regulations for medical devices and specifically electromagnetic influences that could affect the performance/safety of medical products.

The Background of EMC Safety Standards in Medical Device Manufacturing

IEC 60601-1-2:2014 +A1:2020 serves as the foundation for all assessments of electromagnetic disturbances for medical products. While commonly referred to as an EMC (electromagnetic compatibility) standard, it is more accurately described as an electromagnetic safety or resilience standard. Its primary purpose is to ensure that the product continues to function and provide its ‘essential performance’ and ‘basic safety’ in all foreseeable electromagnetic environments, including those that are not typical.

Supplementary to IEC 60601-1-2, specific types of medical products may have modified requirements outlined in Part 2 standards, which detail specific aspects of the equipment type. All these standards are linked to the risk assessments required by ISO 14971 and risk management. This is an essential aspect of assessing a product’s characteristics against the hazards and harm that could arise if potential hazards are not properly addressed.

In the case of electromagnetic (EM) hazards, many foreseeable risks have already been integrated into the requirements of the standard. A notable amendment to IEC 60601-1-2 was published in 2020, introducing additional tests to mitigate the threat posed by the widespread use of RFID (Radio Frequency Identification) systems. While this update addresses that specific threat to medical products, it does not encompass other emerging threats from Electronic Article Surveillance (EAS) systems, which are increasingly utilized.

The amendment to the standard introduced a dedicated Annex (Annex F) titled ‘Guidance on the application of Risk Management concerning electromagnetic disturbances…’ This annex assists manufacturers in understanding their responsibilities and the measures required to maintain the safety of their products in terms of EM hazards.

What Actions are Required by Medical Device Manufacturers for EMC Compliance under IEC 60601-1-2?

All manufacturers are required to maintain and keep their risk management files up to date. Given the new wireless services that are deployed and new threats, this activity should be addressed regularly. It is up to the manufacturer to determine this frequency however an annual review would seem appropriate in most circumstances (unless of course the product is being aimed at a new demographic or EM environment).

Below is a non-exhaustive list of hazards that have been introduced in the last few years that manufacturers may not have considered in their risk management file and only covered to a limited extent by the standard:-

• • Wireless Power Transfer (WPT) – high-power wireless charging of consumer devices but soon to be deployed, vehicles and higher power applications. Some of these devices operate at frequencies below the lowest assessed for immunity (i.e. <150 kHz)
• • Electronic Article Surveillance (EAS) – used in professional healthcare facilities, homes etc to track assets, patients etc.
• • 5G (New Radio) – new frequency bands being used for cellular communication as well as different modulation schemes. Some of these frequency bands are above 6 GHz, the higher frequency normally used for radiated immunity testing.
• • Wi-Fi 6E/7 – starting to be incorporated in everyday consumer goods from phones to routers etc. Like 5G, the upper Wi-Fi are higher than the upper frequency used for most EMC tests of 6 GHz.
• • Ultra-Wide Band (UWB) – used in phones, consumer goods, vehicles and the like to provide very accurate location information. These often operate > 6GHz.

Expert Guidance and Support for Continuous Risk Management in Medical Device Development

Maintaining a risk management file is a critical aspect of demonstrating and keeping a medical product safe. Regular reviews of the file and comparing it to the new technologies that have been deployed are needed to achieve this. 

Where significant new threats have been identified, the risk needs to be mitigated. This mitigation may require additional testing to demonstrate that the product is not susceptible and that it can continue to provide its essential performance against these new threats.

Сòòò½APP’s team of highly qualified engineers and scientists are available to help guide manufacturers through the requirements and help with the recording and mitigation that may be required. To ensure that these reviews are systemized, Сòòò½APP offers an annual check-up to review the Risk Management File in terms of EM hazards, recording the outcomes and action, where necessary the steps the manufacturer may take to bring their product back into conformity with the standard.