What is EN 60601-1-13:2020 ?

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. Some of these key requirements include:

Electrical Safety: The standard requires manufacturers to ensure that their medical devices are electrically safe and do not pose any risk of electrical shock or other injuries to patients or users.

Performance: The standard specifies the essential performance criteria for medical electrical equipment, including limits on the amount of electrical energy that can be passed through the device, the maximum voltage and current that can be accepted, and the duration of the device's performance.

Environmental Protection: The standard requires manufacturers to ensure that their medical devices can withstand the environmental conditions in which they will be used, including temperature, humidity, and moisture.

Emissions and Interference: The standard specifies the maximum level of electromagnetic interference that can be generated by the medical device, and the measures that manufacturers must take to minimize the impact of electromagnetic interference on other electronic devices.

User Interface: The standard requires manufacturers to ensure that their medical devices have a user-friendly interface that is easy for healthcare professionals to use.

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 ensuring that their medical devices meet the necessary safety requirements, manufacturers can help to minimize the risk of electrical shock, fires, and other adverse effects on patients and users.