What is EN 60601-1-2:2016?

EN 60601-1-2:2016 is an international standard for the electromagnetic compatibility (EMC) of medical devices. It provides specific requirements and tests to ensure that medical equipment can function safely and effectively in the presence of electromagnetic disturbances. This standard, also known as the EMC standard, is part of a series of standards developed by the International Electrotechnical Commission (IEC) for medical electrical equipment.

Importance of EN 60601-1-2:2016 Compliance

Compliance with EN 60601-1-2:2016 is crucial for manufacturers and users of medical devices. It ensures that these devices are not affected by electromagnetic disturbances, such as radio frequency signals or electromagnetic radiations, which can potentially interfere with their proper functioning and compromise patient safety. By adhering to the requirements outlined in the standard, manufacturers can demonstrate the safety and reliability of their medical devices.

The Requirements of EN 60601-1-2:2016

EN 60601-1-2:2016 establishes a comprehensive set of requirements for medical electrical equipment regarding electromagnetic compatibility. These requirements include testing methods, performance criteria, and limits for emissions and immunity against electromagnetic disturbances. The standard covers various aspects, including radiated and conducted emissions, electrostatic discharge, radiated and conducted immunity, as well as voltage dips and interruptions.

Complying with EN 60601-1-2:2016

To ensure compliance with EN 60601-1-2:2016, manufacturers must conduct rigorous testing throughout the development and production stages of medical devices. Testing should cover all relevant aspects mentioned in the standard, including emissions and immunity against electromagnetic disturbances. It is essential to evaluate the performance of medical devices under various environmental conditions and potential interference scenarios.

Manufacturers should also maintain proper documentation, including test reports and certificates, to demonstrate compliance with the standard. Compliance with EN 60601-1-2:2016 is not only a legal requirement in many countries but also an indication of product quality and safety. When purchasing medical devices, healthcare institutions and professionals should ensure that they are compliant with this standard to minimize the risk of equipment malfunction and potential harm to patients.