What is EN 60601-2-47: 2018 ?

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 establishes several key requirements that manufacturers must meet to ensure their medical electrical equipment meets the necessary safety requirements. These key requirements include:

1. Essential Performance Requirements: The standard specifies the essential performance criteria for medical electrical equipment. including requirements for electrical safety. immunity to environmental interference. and performance under various conditions.

2. Safety Integrity and Reliability: The standard outlines the principles for ensuring the safety integrity and reliability of medical electrical equipment. including the use of design-based safety and failure modes and effects analysis.

3. Electrical Safety: The standard provides requirements for electrical safety. including the use of appropriate circuit breakers. fuses. and other electrical protection devices.

4. Environmental Interference: The standard specifies the requirements for mitigating environmental interference. including the use of shielded cables and grounded equipment.

5. Performance: The standard specifies the requirements for the performance of medical electrical equipment. including the use of appropriate test methods and the performance of equipment under various conditions.

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 medical electrical equipment meets the necessary safety requirements. EN 60601-1-2: 2020 helps to ensure the safety of both patients and healthcare professionals.