EN 60601-2-20 Electrical Medical Equipment, Part 2-20: Standard Test for Basic Safety and Required Performance of Infant Transport Incubators

EUROLAB laboratory provides testing and compliance services within the scope of EN 60601-2-20 standard. The EN 60601-2-20 standard describes specific rules for the basic safety and performance of baby transport incubators.

This specific standard describes the safety requirements for baby transport incubators. However, the application of this standard may be abandoned if the manufacturer has proved that the risks in the device are at an acceptable level compared to the benefit obtained from the treatment by showing the equivalent safety criteria in the risk management file it has prepared.

The products covered by this standard are:

• Blankets for medical use;
• Devices that provide heat through pads and beds (EN 80601-2-35 standard);
• Spot incubators without baby-carrying feature (EN 60601-2-19 standard);
• Baby radiant warmers (standard EN 60601-2-21);
• Baby photography (standard EN 60601-2-50).

The purpose of the EN 60601-2-20 standard is to establish certain essential safety and essential performance requirements for infant transport incubators that minimize hazards to patients and operators, and to specify test methods by which compliance with the requirements can be verified.

This special standard complements the IEC 60601-1 standard for medical electrical equipment.

The following standards referred to during the implementation of the 60601-2-20 standard are indispensable:

• EN 60601-1-2 (medical electrical equipment, general requirements for basic safety and basic performance, electromagnetic compatibility);
• EN 60601-1-10 (general requirements for medical electrical equipment, basic safety and basic performance);
• ISO 32 (gas cylinders for medical use);
• ISO 407 (small medical gas cylinders, valve connections).

EUROLAB assists manufacturers with EN 60601-2-20 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.