What is EN 60601-1-7:2020?

EN 60601-1-7:2020 is an international standard that sets forth requirements for the safety and effectiveness of medical electrical equipment used in healthcare facilities. This standard, titled "Medical electrical equipment - Part 1-7: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of alarm systems", was published by the International Electrotechnical Commission (IEC) on December 17, 2020. It replaces the previous version, EN 60601-1-7:2006+A11:2011, and aims to address technological advancements and emerging challenges in alarm system development.

The Purpose of EN 60601-1-7:2020

This standard specifically focuses on alarm systems used in medical electrical equipment, aiming to ensure their reliability and safety in a healthcare environment. The primary goal is to minimize false alarms while ensuring timely and accurate alerts for potential risks or emergencies. By providing specific guidelines and requirements for alarm system development, EN 60601-1-7:2020 aims to decrease alarm fatigue and enhance patient safety in various healthcare settings such as hospitals, clinics, and home care.

Main Requirements of EN 60601-1-7:2020

EN 60601-1-7:2020 introduces several key requirements that manufacturers and developers need to follow while designing alarm systems for medical electrical equipment:

Identification of intended use and alarm conditions: The standard requires manufacturers to identify the intended use of the equipment and determine the alarm conditions based on relevant clinical practices and risk management processes.

Designing effective alarm signals: Alarm signals should be easily recognizable, distinguishable from other equipment sounds, and provide sufficient information to facilitate appropriate actions by the healthcare provider.

Minimizing false alarms: The standard emphasizes the importance of minimizing false alarms to avoid disturbing healthcare professionals and patients. It provides guidelines for setting alarm thresholds and implementing algorithms that can differentiate between real alarms and non-emergency events.

Alarm system documentation: Manufacturers are required to provide comprehensive documentation related to alarm system design, configuration, testing, and maintenance. This documentation should be easily accessible to users and service personnel.

The Impact of EN 60601-1-7:2020

EN 60601-1-7:2020 brings significant changes and improvements in the development and usage of alarm systems in medical electrical equipment. By addressing the issues of alarm fatigue and false alarms, this standard enhances patient safety and improves the overall quality of care. Healthcare providers benefit from more reliable alarm systems, enabling them to respond promptly to critical situations while minimizing unnecessary interruptions. Manufacturers and developers are guided by clear requirements that promote the development of effective and user-friendly alarm systems, contributing to safer healthcare environments.