What is EN 60601-2-50: 2019 ?

EN 60601-1-2: 2020 is an essential safety standard for medical electrical equipment. It specifies the basic requirements and essential performance criteria to ensure the safety of patients, operators, and bystanders. The standard aims to address electromagnetic disturbances generated by medical electrical equipment, and to prevent any adverse effects on patients or users.

Key Requirements of EN 60601-1-2: 2020

EN 60601-1-2: 2020 establishes several key requirements for manufacturers to consider when designing, manufacturing, and testing their medical devices. These requirements include:

Medical device design: The standard requires manufacturers to ensure that their medical devices are designed to minimize the risk of electromagnetic interference and to avoid any potential hazards associated with the use of electromagnetic fields.

Electrical safety: The standard specifies essential requirements for electrical safety, including the use of appropriate materials for electrical components, the use of insulated materials for electrical connections, and the use of appropriate marking and labeling.

Performance testing: The standard requires manufacturers to perform thorough testing of their medical devices to ensure that they meet the essential performance criteria specified in the standard. This testing should include testing for electromagnetic interference, electrical safety, and performance.

Documentation: The standard requires manufacturers to maintain records of their medical devices, including tests, calculations, and any modifications made to the device.

Quality management: The standard requires manufacturers to have a quality management system in place to ensure that their medical devices meet the essential requirements specified in the standard.

Conclusion

EN 60601-1-2: 2020 is an essential safety standard for medical electrical equipment. It provides manufacturers with guidelines to design, manufacture, and test their medical devices while considering the potential hazards and risks associated with their use. By following the key requirements specified in this standard, manufacturers can ensure that their medical devices are safe and effective for use in healthcare environments, while also minimizing the risk of electromagnetic interference and electrical safety.