What is EN 60601-1-2: 2016 ?

Title: Understanding EN 60601-1-2: 2016 and EN 60601-1: 2020 for Medical Electrical Equipment

The healthcare industry has been one of the most important sectors for the application of electrical and electronic technologies. With the growing reliance on electronic systems and wireless technologies in healthcare facilities, it is essential to establish safety measures to prevent conflicts or disruptions in medical environments. The international standard for medical electrical equipment, EN 60601-1-2: 2016, provides requirements and guidelines for the basic safety and essential performance of equipment used in healthcare facilities.

EN 60601-1-2: 2016 is an essential standard for medical electrical equipment, as it aims to ensure that medical electrical equipment does not interfere with other devices and systems, and are immune to electromagnetic disturbances. The purpose of EN 60601-1-2: 2016 is to establish safety measures for medical electrical equipment to prevent interference and ensure the essential performance of the equipment.

Key Requirements of EN 60601-1-2: 2016

EN 60601-1-2: 2016 provides several key requirements for medical electrical equipment. These requirements are essential for ensuring the safety and performance of the equipment. The key requirements of EN 60601-1-2: 2016 are as follows:

No interference: The equipment should not interfere with other devices and systems.

Immunity to electromagnetic interference: The equipment should be immune to electromagnetic interference that may cause a failure or malfunction.

Limited risk of electrical shock: The equipment should have a limited risk of electrical shock.

No: The equipment should not pose a risk of fire or ignition.

No risk of electrical fires: The equipment should not pose a risk of electrical fires.

Compliance with relevant parts of other international standards: The equipment should comply with relevant parts of other international standards, such as IEC 60601-1-2: 2006.

What is EN 60601-1: 2020?

EN 60601-1: 2020 is an international standard for medical electrical equipment that provides guidelines for the safety and essential performance of equipment used in healthcare facilities. It is designed to ensure the safety of both patients and healthcare professionals.

The primary objective of EN 60601-1: 2020 is to establish safety measures for medical electrical equipment to prevent interference and ensure the essential performance of the equipment. It takes into account advancements in technology, emerging risks, and changes in regulatory requirements. EN 60601-1: 2020 provides manufacturers with guidelines to design, manufacture, and test their medical devices while considering the potential hazards and risks associated with their use.

Conclusion

EN 60601-1-2: 2016 and EN 60601-1: 2020 are two essential standards for medical electrical equipment. They provide requirements and guidelines for the basic safety and essential performance of equipment used in healthcare facilities. By ensuring that medical electrical equipment meets these standards, healthcare facilities can provide a safe and effective environment for their patients and staff.