The IEC 60601-2-20 standard, prepared by the International Electrotechnical Commission (IEC), an affiliate of the International Organization for Standardization (ISO), describes specific rules for the basic safety and performance of infant carrying incubators (incubators). This standard has been published in our country by the Turkish Standards Institute with the following title: TS EN 60601-2-20 Electrical medical equipment - Part 2-20: Specific features for the basic safety and required performance of baby carrying 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: medical-use blankets, pads and devices that provide heat through mattresses (IEC 80601-2-35 standard), spot incubators without baby carrying (IEC 60601-2-19 standard), baby radiant warmers ( IEC 60601-2-21 standard) and baby photography (IEC 60601-2-50 standard).
The purpose of the IEC 60601-2-20 standard is to establish certain basic safety and basic performance requirements for baby 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 is for medical electrical equipment. It complements the IEC 60601-1 standard.
The following standards referenced during the implementation of the 60601-2-20 standard are indispensable: IEC 60601-1-2 (medical electrical equipment, general requirements for basic safety and basic performance, electromagnetic compatibility), IEC 60601-1-10 (medical electrical equipment, general requirements for basic safety and basic performance), ISO 32 (medical use gas cylinders) and ISO 407 (small medical gas cylinders, valve connections).
Tests in accordance with IEC 60601-2-20 standard are also carried out by our organization within the scope of medical device tests.
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