Safety and reliability are top priorities in the development of medical devices and systems. Electromagnetic compatibility (EMC) plays a decisive role here. At seleon GmbH, we have made it our mission not only to design our medical devices to be efficient in accordance with requirements, but also to design them to be safe and interference-free. This blog post looks at the importance of EMC compliance for medical devices and how seleon GmbH ensures that its product developments comply with the latest standards.
What is EMC?
Electromagnetic compatibility (EMC) refers to the ability of electronic devices to operate in their environment without disturbing other devices through electromagnetic interference (EMI) and without being disturbed by them. EMC is therefore crucial for the reliability and safety of medical devices and systems.
Why is EMC so important for medical devices?
Medical devices are used in sensitive environments such as hospitals, where they must operate reliably and without interference. Disturbances caused by electromagnetic interference can lead to malfunctions that can have serious consequences for patient safety or for the user. Compliance with EMC standards for medical devices is therefore not only a legal requirement, but also an essential quality feature.
Current EMC standards
The EMC standards for medical devices are regularly updated to take account of the latest technical developments. The most important standards include
EN 60601-1-2: This standard specifies the EMC requirements for medical electrical equipment. It covers both emissions and immunity to electromagnetic disturbances.
EN 60601-2-2: This standard specifies the EMC requirements for medical electrical equipment, especially for high-frequency surgical equipment.
Further standards are referred to in it:
EN 55011: This standard concerns the radio interference requirements for industrial, scientific and medical equipment.
ISO 14971: This standard describes risk management for medical devices, including the consideration of EMC risks.
CISPR 11: International standards for radio interference from industrial, scientific, medical and IT equipment.
Implementation of EMC compliance at seleon GmbH
At seleon GmbH, we attach great importance to ensuring that our products fulfil the highest EMC standards. Our process for ensuring EMC compliance comprises several steps:
Design phase:
As early as the design phase, EMC stability requirements are derived from system requirements. We ensure that potential sources of interference are minimised and the highest possible interference immunity is achieved. The advantage for you as a customer and essential for the successful implementation of EMC requirements is the many years of experience of seleon GmbH employees who work on the realisation of such EMC-stable devices and systems. The biggest challenge here is selecting the most efficient EMC measures and optimising them. One step towards the optimal dimensioning of the defined EMC measures, and a further advantage for our customers, is the use of simulation tools, with the help of which the selected EMC measures are calculated, evaluated and optimised. This optimises development time and reduces development costs.
In addition, methods are used, such as carrying out the design risk analysis, especially the EMC risk analysis in accordance with 60601-1-2, for the devices and systems to be developed in order to identify possible sources of interference or weak points and to take appropriate countermeasures.
Functional sample tests:
Our functional samples essentially correspond to set-ups that contain all the electrical and electronic functionalities of the final medical device or system. These functional models are thoroughly tested in the EMC laboratory of our long-standing partners. Both emissions and interference immunity are tested. In the event of anomalies, suitable countermeasures are taken directly in the laboratory and checked again immediately.
In preparation for these tests, they must be specified. This is done by drawing up the EMC test plan, which is carried out using and adhering to the seleon processes. This ensures that all aspects in accordance with EN 60601-1-2 and applicable particulate standards are complied with. The various device states and modes that are relevant for carrying out the tests are queried. Real operating cases are simulated, which must be checked. The pass/fail criteria are created in close cooperation with our customer. The primary objective here is to guarantee safe use of the device/system under all relevant conditions.
Prototype tests:
Our prototypes correspond to the series device with full functionality. They also contain all modifications from the findings of the functional sample tests and have therefore achieved their final EMC stability. The prototype tests correspond to the formally required EMC tests in accordance with EN 60601-1-2 for the system and are therefore part of the device certification. For the formal tests, you benefit from our many years of co-operation with independent accredited testing institutes.
The future of EMC
The rapid development of technology is constantly bringing new challenges in the field of EMC. In particular, the use of wireless technologies and IoT devices, including in medical technology, requires new approaches and innovations in EMC. As one of the leading service providers in the development of medical devices and systems, we strive to continuously expand our expertise and processes. To this end, seleon has installed processes that result in immediate adaptation of the corresponding processes in the event of changes in the regulatory environment. This ensures that our customers’ development results always comply with all applicable EMC regulations.
Conclusion
Compliance with EMC standards is not just a duty for seleon, but a promise to our customers. We do everything we can to ensure that our product developments are safe and reliable and fulfil the highest quality standards. In this way, we help to ensure that the medical devices and systems developed by seleon will function efficiently and without interference in the future.
Please note that all details and listings do not claim to be complete, are without guarantee and are for information purposes only.
