In the regulatory landscape for medical devices and in vitro diagnostic (IVD) equipment, electromagnetic compatibility (EMC) is an essential requirement to ensure patient safety, device functionality, and compliance with applicable standards. Each device must be capable of operating correctly in electromagnetically complex environments, without causing or being critically affected by interference.
Essential Requirements and Regulatory Obligations
To be placed on the European market, medical devices and IVDs must comply with the general safety and performance requirements set by:
- Regulation (EU) 2017/745 (MDR) for medical devices
- Regulation (EU) 2017/746 (IVDR) for in vitro diagnostic devices
Both regulations require EMC assessment as an integral part of the conformity demonstration. This necessitates EMC testing in accordance with internationally recognized harmonized standards.
Electromagnetic Compatibility: A Key Compliance Criterion
Electromedical and diagnostic devices operate in complex environments saturated with electromagnetic sources—Wi-Fi systems, mobile phones, radiological equipment, electrosurgical units, and even household devices. In this context, every device must:
- Be sufficiently immune to external interference
- Not emit electromagnetic disturbances that could affect other devices
Reference Standards
EN/IEC 60601-1-2
Within the framework of regulatory compliance for electromedical devices, EN/IEC 60601-1-2 is the key standard for electromagnetic compatibility. It is Part 1-2 of the IEC 60601 series and defines EMC performance requirements to ensure the basic safety and essential performance of electromedical equipment and systems.
The 2021 version (Edition 5.0) introduced significant updates compared to the previous 2014 Edition 4.0, including:
- Stricter immunity testing
- New operating conditions for wearable or portable equipment
- Greater emphasis on the home environment and wireless technologies
Scope of Application
The standard applies to:
- Electrically powered medical devices or those with active electronic circuits
- Electromedical systems, including those with wireless components
- Devices intended for use in professional, home, portable, or patient-proximate environments
EMC Testing According to EN/IEC 60601-1-2
Conformity involves a complete suite of EMC tests, divided into two main categories:
- Electromagnetic Emission Tests
These assess whether the device stays within emission limits to prevent interference with other equipment.
- Electromagnetic Immunity Tests
These ensure that the device maintains its essential performance even when exposed to external disturbances.
IEC 61326-2-6:2021
In the field of in vitro diagnostics (IVD), electromagnetic compatibility is crucial for analytical reliability and functional safety. IEC 61326-2-6:2021 applies specifically to electrical and electronic instruments used for the analysis of biological samples outside the human body, i.e., IVD devices. It defines dedicated EMC requirements for this product category.
This standard is a sector-specific extension of IEC 61326-1 and provides specifications for instruments intended for use in light industrial or controlled environments such as clinical labs, hospital labs, and research settings.
Its EMC protocol includes emission and immunity tests tailored to the specific operating environments of IVD devices.
Analytical’s Support
Our laboratory is equipped with a semi-anechoic chamber for compliance and pre-compliance testing up to 18 GHz, with a maximum EUT–antenna distance of 3 meters. We provide specialized personnel and updated instrumentation to conduct EMC tests on medical and IVD devices, issuing accredited test reports.
Ensure your devices meet EMC requirements before entering the market.
Fill in the form at the bottom of the page to request technical support or book a test session with our specialists.
