What is EN 60601-1-12:2020 ?

EN 60601-1-12:2020 is an international standard that outlines the requirements for the safety and effectiveness of medical electrical equipment used in healthcare facilities. This standard, which replaces EN 60601-1-7:2006+A11:2011, is developed by the International Electrotechnical Commission (IEC) and focuses on the safety and essential performance requirements of medical electrical equipment and systems.

The primary objective of EN 60601-1-12:2020 is to ensure the safety of both patients and healthcare professionals. The latest version of this standard, which was published on December 17, 2020, takes into account advancements in technology, emerging risks, and changes in regulatory requirements.

EN 60601-1-12:2020 provides manufacturers with guidelines to design, manufacture, and test their medical devices while considering the potential hazards and risks associated with their use. It also sets out the main requirements for alarm systems used in medical electrical equipment, aimed at minimizing false alarms while ensuring timely and accurate alerts for potential risks or emergencies.

EN 60601-1-12:2020 is applicable to a wide range of medical electrical equipment, including pacemakers, implantable cardioverter-defibrillators, blood glucose monitors, and other similar devices. It is essential for manufacturers to comply with the requirements of this standard in order to ensure the safety and effectiveness of their medical devices.

In conclusion, EN 60601-1-12:2020 is an essential standard for the medical devices industry, providing manufacturers with guidelines to design, manufacture, and test their medical devices while considering the potential hazards and risks associated with their use. The standard aims to ensure the safety of both patients and healthcare professionals while advancements in technology and emerging risks are taken into account.