BS EN 60601-2-19:2009+A1:2016

What is this standard about? 

BS EN 60601-2-19 is part of a series of international standards on medical electrical equipment, covering basic safety and essential performance for both equipment and systems.It is a collateral standard – its objective is to specify requirements that are in addition to those of the general standard. BS EN 60601-2-19 covers the safety of infant incubator equipment. It complements BS EN 60601-1.

Who is this standard for?

• Manufacturers, suppliers and users of infant incubator equipment and components
• All healthcare facilities/hospitals/intensive care units• Health and safety professionals
• Regulatory bodies and technical committees 

Why should you use this standard?

This collateral standard ensures that infant incubators are manufactured and operated in a way that prevents accidents and ensures the optimum safety of children. It specifies performance requirements and basic safety for areas such as temperature and oxygen control, warnings and safety notices, sound levels, audible alarms and air velocity.

It also specifies tests by which compliance with requirements can be verified. 

What’s changed since the last update?

BS EN 60601-2-19 has been systematically reviewed by experts, who have taken into consideration technological developments and changes to clinical practice. 

• The normal load for an infant is reduced to 10kg
• The temperature of the surfaces in contact with a patient shall not exceed 40⁰ C
• Skin temperature sensors on baby controlled operators, which include a displayed value, are not considered as a clinical thermometer
• Amendments have been made to conditions surrounding ambient temperature, humidity and atmospheric pressure
• Additional warning and safety notices relating to use plus extra operating instructions
• Manufacturers shall specify on accompanying documents the maximum CO2 concentration (subclause 201.12.4.2.101)