Medical and Healthcare

IEC 60601-1 Standards for Medical Device EMC and Safety Testing

Medical devices are subject to rigorous regulatory approval processes across the globe, which often require testing by accredited laboratories. For active medical devices, compliance is governed by the IEC 60601 series of standards, which provide a harmonized framework for safety and performance requirements.

The IEC 60601-1 3rd Edition serves as the cornerstone for the approval of medical electrical equipment in most regulatory systems worldwide. In the European Union, the EN 60601 family of standards aligns with the Medical Device Regulation (MDR) 2017/745, ensuring that devices meeting IEC 60601-1 are presumed to conform to EU regulatory requirements.

IEC 60601-1-2: Electromagnetic Compatibility (EMC) Requirements

The IEC 60601-1-2 standard focuses on the electromagnetic compatibility (EMC) of medical devices, ensuring they operate safely and effectively in the presence of electromagnetic disturbances. It defines both emission limits and immunity levels to protect against interference that could compromise essential performance or safety.

The 4th Edition of IEC 60601-1-2 introduced risk management principles and categorized immunity test levels based on the intended use environment.

The 4th Edition also emphasizes risk analysis and management, requiring manufacturers to assess and mitigate potential risks related to electromagnetic interference (EMI).

Medical EMC/RF Testing

Many new medical devices can now operate wirelessly. Wireless issues with medical devices are getting increasingly complex. Some device regulators are expecting the manufacture to address “Wireless Coexistence” when they submit the application for device approval. Modern wireless communication technologies, including Wi-Fi, short-range radio connections, ultra-wideband (UWB), radio-frequency identification (RFID), and near-field communication (NFC), have the potential to significantly improve the functionality of healthcare equipment. However, these advancements also introduce significant challenges related to signal interference and compatibility issues. Many directives mandate that if a medical device includes wireless functionality, it therefore becomes radio equipment.