What is EN 60601-1-2?

EN 60601-1-2 is a technical standard that specifies the basic safety and essential performance requirements for medical electrical equipment, taking into account the electromagnetic compatibility (EMC) of the equipment. It ensures that medical electrical devices are safe to use and will not interfere with other electrical equipment in their vicinity.

The Purpose of EN 60601-1-2

The main purpose of EN 60601-1-2 is to harmonize the EMC requirements for medical electrical equipment across Europe. This standard ensures that medical devices meet specific safety and performance requirements in order to provide enhanced patient safety and to minimize risks associated with electromagnetic interference. Compliance with this standard is mandatory for most medical electrical devices sold in the European Union.

Key Requirements of EN 60601-1-2

EN 60601-1-2 sets out several key requirements for medical electrical equipment. These include immunity requirements (the ability to withstand external electromagnetic disturbances), emissions requirements (the amount of electromagnetic energy emitted by the equipment), and the requirement for appropriate labeling and user instructions. The standard also covers the testing methods and procedures that manufacturers must follow to ensure compliance with these requirements.

How to Ensure Compliance with EN 60601-1-2

To ensure compliance with EN 60601-1-2, manufacturers of medical electrical equipment must conduct comprehensive testing and risk assessments. They need to identify potential sources of electromagnetic disturbances and evaluate the device's susceptibility to such disturbances. Manufacturers also need to implement appropriate control measures to minimize electromagnetic emissions from their products.