The IEC 60601-2-19 standard, prepared by the International Electrotechnical Commission (IEC), an organization affiliated to the International Standards Organization (ISO), describes the safety and performance criteria and test methods that should be addressed in the design and production of baby incubators (incubators).
This standard has been published in our country by the Turkish Standards Institute with the following title: TS EN 60601-2-19 Electrical medical equipment - Part 2-19: Specific features for the basic safety and required performance of baby incubators.
This specific standard describes the safety requirements for infant incubators. However, if the manufacturer has proved that the risks in the device are at an acceptable level according to the benefit obtained from the use by showing the equivalent safety criteria in the risk management file it has prepared, the application of this standard may be abandoned.
Medical equipment excluded from the scope of the IEC 60601-2-19 standard are: Devices that provide heat through blankets, pads and mattresses used for medical purposes within the scope of IEC 80601-2-35, baby radiant heaters within the scope of IEC 60601-2-21, IEC 60601 Infant transport incubators covered by -2-20 and infant phototherapy equipment covered by IEC 60601-2-50.
A few standards that are indispensable and referred to during the implementation of the IEC 60601-2-19 standard are: IEC 60601-1-2 (assurance standard: electromagnetic compatibility) and IEC 60601-1-10 (assurance standard: requirements for the development of physiological closed loop controllers. ).
Baby incubators are used to keep the baby's body temperature at 37 degrees. Today, these medical devices are used in maternity wards, neonatal units and birth centers of all hospitals. These devices It provides babies with a suitable environmental condition and a closed and controlled environment. Essentially, it circulates the heated air over the baby skin.
Tests in accordance with IEC 60601-2-19 standard are also carried out by our organization within the scope of medical device tests.
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