The IEC 60601-2-21 standard prepared by the International Electrotechnical Commission (IEC), an affiliate of the International Standards Organization (ISO), is a special standard and describes the safety requirements for baby radiant heaters. However, 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 application of this standard is waived.passable.
This standard has been published in our country by the Turkish Standards Institute with the following title: TS EN 60601-2-21 Electrical medical equipment - Part 2-21: Specific features for the basic safety and required performance of radiant baby warmers.
The purpose of the IEC 60601-2-21 standard is to establish specific basic safety and performance requirements for baby radiant heaters that minimize patient and operator risks, and to explain test methods by which compliance with the requirements can be verified.
Radiant baby warmers are electrical medical devices that are used for newborn babies and provide the necessary support for the baby to receive the same temperature that the baby feels in the womb. This medical equipment is a baby care unit used in hospitals, newborn and infant wards, neonatal intensive care units, maternity rooms and operating rooms. There is a homogeneous heat distribution system and stable temperature control on this unit. When the baby is born, it is taken under radiant warmer and reviewed in terms of respiratory and circulatory adequacy. In addition, different designs of radiant baby warmers allow the necessary interventions to be made to the baby in intensive care, postnatal and surgical interventions. Usually the radiant baby warmer is used only to warm the bed. The baby is laid naked on it and warms up.
Tests in accordance with IEC 60601-2-21 standard are also carried out by our organization within the scope of medical device tests.
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