What is EN 60601-1-2:2013?

EN60601-1-2:2013, also known as "Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests," is an international standard that outlines the basic safety and performance requirements for medical electrical equipment to ensure their protection against electromagnetic disturbances.

Scope of EN60601-1-2:2013

This standard applies to all medical electrical equipment and systems where the inherent electromagnetic compatibility (EMC) characteristics have a direct impact on patient safety. It covers a wide range of medical devices, including diagnostic equipment, therapeutic machines, patient monitoring systems, and more.

The scope of EN60601-1-2:2013 includes both emissions and immunity, addressing the potential interference of electromagnetic fields emitted by the equipment, as well as its ability to withstand external electromagnetic disturbances without compromising its functionality or patient safety.

Evaluating Compliance with EN60601-1-2:2013

Manufacturers must ensure that their medical electrical equipment complies with the requirements defined in EN60601-1-2:2013. This involves conducting comprehensive EMC testing during the design and manufacturing process.

The standard defines various test levels and criteria for both emissions and immunity. Emission tests evaluate the amount of electromagnetic energy radiated by the equipment and set limits to avoid interfering with other equipment or networks. Immunity tests, on the other hand, determine the equipment's resilience to external electromagnetic disturbances.

By meeting the standards specified in EN60601-1-2:2013, manufacturers can provide healthcare facilities with safe and reliable equipment that won't cause or be affected by electromagnetic interference, ensuring the well-being and accuracy of medical procedures.