What is EN 60601-2-20:2020?

EN 60601-2-20:2020 is a technical standard that specifies the safety and essential performance requirements for the basic safety and essential performance of infant transport incubators. This standard is applicable to both electrically powered and non-electrically powered neonatal transport incubators. It provides guidelines for manufacturers, sellers, and users to ensure the safety and effectiveness of these medical devices.

Scope and Purpose

The scope of EN 60601-2-20:2020 includes requirements related to electrical safety, protection against mechanical hazards, and performance testing of infant transport incubators. The main purpose of this standard is to minimize the risks associated with the use of these devices, such as electric shocks, overheating, and discomfort for the infants during transportation.

Evolutions in EN 60601-2-20

The latest edition of EN 60601-2-20 was published in 2020, and it introduces several notable updates compared to previous versions. These changes primarily aim at improving the safety aspects and aligning the standard with the advancements in technology and medical practices.

One of the significant evolutions is the requirement for manufacturers to perform risk management activities throughout the lifecycle of the infant transport incubators. This includes identifying hazards, assessing risks, implementing necessary risk control measures, and monitoring their effectiveness.

An emphasis is also placed on user interaction and ergonomics. The standard now contains specific requirements regarding the accessibility and ease of use of various functions and controls in the incubators. Design considerations for cleaning and disinfection have been expanded to promote better hygiene and infection control.

Compliance and Certification

Medical device manufacturers must ensure that their infant transport incubators comply with the requirements of EN 60601-2-20:2020 before they can market them in countries where this standard is applicable. Compliance with the standard is typically assessed through conformity assessment procedures, which may involve testing, inspection, and documentation review by authorized certification bodies.

Healthcare facilities and professionals should also familiarize themselves with the requirements specified in EN 60601-2-20 to ensure the proper selection, use, and maintenance of infant transport incubators. By adhering to the guidelines provided in the standard, they can contribute to the overall safety and well-being of newborns during transportation.