The ISO 80601-2-74 standard, developed by the International Standards Organization (ISO), describes certain requirements and test methods for the safety and performance of respiratory humidifier equipment. This standard has also been published in our country by the Turkish Standards Institute (TSE) with the following title: TS EN ISO 80601-2-74 Electrical medical equipment - Part 2-74: Specific requirements for the basic safety and required performance of respiratory humidifier equipment. This standard replaced the abolished TS EN ISO 8185 standard.
This standard is referred to as a humidifier, medical system with accessories for its basic safety and basic performance. This standard also applies to accessories intended to be attached to a humidifier. The properties of these accessories can affect the basic safety or basic performance of the humidifier. For example, heated breathing tubes or equipment designed to control these heated breathing tubes. Heated breathing tubes and control devices are medical devices and are subject to the requirements of the IEC 60601‑1 standard. The ISO 5367 standard specifies other safety and performance requirements for breathing tubes.
If a humidifier is integrated into other medical equipment, the requirements of that equipment also apply to the humidifier. For example, a heated humidifier added to a critical care ventilator that complies with the ISO 80601-2-12 standard.
Hazards in the intended physiological function of medical devices or medical systems within the scope of the ISO 80601-2-74 standard are not covered by certain requirements in this document, except for the IEC 60601‑1 standard.
In short, the purpose of the ISO 80601-2-74 standard is to determine certain basic safety and basic performance requirements for a humidifier and its accessories. The combination of humidifier and accessories must be sufficiently safe and therefore accessories also fall within the scope of the standard.
Within the scope of laboratory services, our organization also provides testing services for the safety and performance of ISO 80601-2-74 respiratory humidifier equipment.
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