What is EN 60601-1-11:2019 ?

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 was developed in response to the growing concern about the potential interference between medical devices and other electronic devices in healthcare settings.

Key Requirements of EN 60601-1-2:2020

EN 60601-1-2:2020 has several key requirements that manufacturers must meet to ensure their medical devices are safe and reliable. These requirements include:

1. Essential Safety Requirements: The standard establishes essential safety requirements for medical electrical equipment, including requirements for design, manufacture, testing, and documentation.

2. Electrical Safety: The standard specifies electrical safety requirements for medical electrical equipment, including requirements for electrical isolation, grounding, and labeling.

3. Performance Requirements: The standard specifies performance requirements for medical electrical equipment, including requirements for performance, reliability, and stability.

4. Safety of the User: The standard specifies requirements for the safety of patients, operators, and bystanders, including requirements for adequate user control, emergency stop mechanisms, and labeling.

5. Environmental Requirements: The standard specifies environmental requirements for medical electrical equipment, including requirements for environmental robustness, durability, and resistance to interference.

6. Maintenance and Repairs: The standard specifies requirements for the maintenance and repairs of medical electrical equipment, including requirements for records, testing, and repair.

EN 60601-1-2:2020 is an essential standard for medical electrical equipment, ensuring the safety and reliability of medical devices while mitigating the risks associated with electromagnetic interference. It is widely recognized and adopted by many countries, making it a crucial standard for manufacturers of medical electrical equipment.