The International Electrotechnical Commission (IEC) has recently released a new version of the standard EN 60601-1-2, titled 'Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance'. This standard addresses the electromagnetic compatibility (EMC) requirements for medical devices, aiming to ensure their safe operation in various environments.
Why is EMC important in medical devices?
Electromagnetic interference (EMI) can significantly impact the performance of medical devices, compromising patient safety and generating erroneous results. With the increased use of electronic equipment both inside and outside healthcare facilities, the risk of EMI-induced malfunctions becomes more critical. Compliance with EMC standards like EN 60601-1-2 is crucial to mitigate these risks.
Key changes in the 2020 version
The latest version of EN 60601-1-2 introduces several updates to improve the standard's efficacy. These changes include:
Wider frequency range: The previous version covered frequencies up to 2.5 GHz, while the new edition extends the range to 6 GHz, aligning with modern wireless communication technologies such as Wi-Fi and Bluetooth.
Enhanced test levels: The updated standard defines higher immunity test levels, ensuring that medical devices are more resistant to electromagnetic disturbances present in real-world scenarios.
Risk management process: The 2020 version emphasizes the importance of employing a comprehensive risk management process when addressing EMC issues, helping manufacturers to proactively identify and mitigate potential risks.
Compliance and certification
Manufacturers of medical devices must ensure their products comply with EN 60601-1-2:2020 in order to meet regulatory requirements and obtain necessary certifications. Compliance involves conducting rigorous EMC testing and documenting the test results. Additionally, manufacturers should establish a quality management system that includes proper risk assessment and control measures related to electromagnetic compatibility.
In conclusion, EN 60601-1-2:2020 plays a crucial role in ensuring the safety and reliability of medical electrical equipment. By addressing electromagnetic compatibility concerns, this standard helps protect patients from potential hazards associated with electromagnetic interference. Manufacturers should embrace the changes introduced in the latest version and strive for compliance to provide medical devices that deliver optimal performance without compromising patient well-being.
Nina She