What is EN 60601-1-2:2015?

EN60601-1-2:2015 is an international standard that deals with the essential performance and safety requirements for medical electrical equipment (ME equipment). It is one of the standards set by the International Electrotechnical Commission (IEC) specifically for medical devices.

Scope of EN60601-1-2:2015

This standard provides guidance on how to manage the electromagnetic compatibility (EMC) of ME equipment. It ensures that medical devices are not affected by, or do not interfere with, other electronic devices and systems in their intended environment.

The scope of EN60601-1-2:2015 includes both intentional and unintentional electromagnetic phenomena that could pose risks to patients or operators of ME equipment. Intentional phenomena include electromagnetic disturbances caused by other devices or systems intentionally designed to operate in the same environment as the medical device. Unintentional phenomena refer to electromagnetic disturbances that occur incidentally and may affect the performance of ME equipment.

Main Requirements of EN60601-1-2:2015

EN60601-1-2:2015 specifies various tests and limits to ensure the EMC of ME equipment. These tests evaluate a device's immunity to external electromagnetic disturbances and its emissions of electromagnetic disturbances that might interfere with other devices.

The standard prescribes test methods to assess the immunity of ME equipment against electromagnetic disturbances, such as radiated and conducted disturbances. It also sets limits on electromagnetic emissions produced by ME equipment. Compliance with these limits helps to minimize the risk of interference with other devices.

Additionally, EN60601-1-2:2015 requires manufacturers to provide relevant documentation that demonstrates compliance with the standard. This documentation should include test reports, technical descriptions, and instructions for the correct use of ME equipment to ensure electromagnetic compatibility in its intended environment.

Benefits of EN60601-1-2:2015 Compliance

Complying with EN60601-1-2:2015 offers several benefits. First and foremost, it helps to ensure patient and operator safety, as well as the proper functioning of ME equipment in environments where other electronic devices are present.

Furthermore, compliance increases the confidence of users, healthcare providers, and regulatory authorities in the reliability and performance of medical devices. It also facilitates international trade by providing a common standard that harmonizes EMC requirements for ME equipment across different countries.

In conclusion, EN60601-1-2:2015 is an essential standard that ensures the electromagnetic compatibility of medical electrical equipment. By complying with this standard, manufacturers can enhance the safety and effectiveness of their products, while also meeting regulatory requirements in various markets.