What is EN 60601-1-3:2020?

EN 60601-1-3:2020 is an international standard that addresses the safety requirements and essential performance of medical electrical equipment. It focuses specifically on radiation protection in diagnostic radiology devices. This latest edition, published in 2020, replaces the previous version from 2013. The standard was developed by technical committees from the International Electrotechnical Commission (IEC) and covers a wide range of medical applications, including X-ray machines, computed tomography (CT) scanners, and mammography systems.

Importance of EN 60601-1-3:2020

Radiation is a powerful tool in medical diagnosis, but it also poses risks to both patients and healthcare professionals. EN 60601-1-3:2020 plays a crucial role in ensuring the safety of medical electrical equipment used in radiology procedures. By complying with this standard, manufacturers can minimize the potential for harmful exposure to ionizing radiation and protect the well-being of patients and operators.

Main Requirements of EN 60601-1-3:2020

EN 60601-1-3:2020 sets forth several important requirements to ensure radiation protection in medical electrical equipment. One key aspect is the establishment of radiation reference levels (RRLs), which define the acceptable range of radiation doses for specific diagnostic or interventional procedures. Manufacturers must calibrate their devices accordingly and provide accurate dose information to users. In addition, the standard requires effective control measures, such as shielding, collimation, and beam limitation, to be implemented in equipment design to reduce unnecessary radiation exposure.

Compliance and Certification

To meet the requirements of EN 60601-1-3:2020, medical equipment manufacturers must perform comprehensive risk assessments and conduct tests to ensure their devices comply with the standard. They also need to provide evidence of this compliance through technical documentation and certification. Regulatory bodies, such as the Food and Drug Administration (FDA) in the United States, may require proof of conformity with EN 60601-1-3:2020 before allowing the sale and use of medical electrical equipment in their respective jurisdictions.