What is en 60601 1 2 2015 2021 ?

EN 60601-1-2:2020 is an essential safety standard for medical electrical equipment. It specifies the essential 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 establish guidelines for mitigating the risks associated with electromagnetic interference, ensuring the safe operation of medical equipment, and preventing any adverse effects on patients or users.

EN 60601-1-2:2020 provides manufacturers with a framework for designing, manufacturing, and testing medical electrical equipment while considering the potential hazards and risks associated with their use. It also gives them the guidance to ensure that their products meet the necessary safety requirements and can be used safely in healthcare environments.

The standard is divided into two parts, EN 60601-1:2020 and EN 60601-2:2020. EN 60601-1:2020 is focused on the safety and essential performance requirements of medical electrical equipment and systems, while EN 60601-2:2020 deals with the electromagnetic interference and related risks.

EN 60601-1-2:2020 is widely recognized as the global standard for medical electrical equipment. It is crucial to ensure that medical devices meet the necessary safety requirements, and can be used safely in healthcare environments. The standard provides manufacturers with guidelines to design, manufacture, and test their medical devices while considering the potential hazards and risks associated with their use.

In conclusion, EN 60601-1-2:2020 is an essential safety standard for medical electrical equipment. It provides manufacturers with guidelines to ensure the safety of patients, operators, and bystanders while mitigating the risks associated with electromagnetic interference. It is widely recognized as the global standard for medical electrical equipment, and it is crucial to ensure that medical devices meet the necessary safety requirements.