EUROLAB, together with its state-of-the-art accredited laboratories and expert team, provides precise and fast testing services within the scope of EN ISO 80601-2-74 testing. This standard, together with its accessories, is valid for the basic safety and basic performance of a humidifier, also referred to as ME equipment hereinafter. .
The standard in question describes the features of a humidifier, called medical system, in combination with medical equipment and device, along with accessories, for basic safety and required performance.
This part of the international 80601 standard also applies to accessories intended for connection to a humidifier device. The features of these accessories can affect the basic safety or basic performance of the humidifier. For example, heated breathing tubes or medical equipment designed to control these heated breathing tubes. Heated breathing tubes and control devices are considered medical devices and are subject to the requirements of the IEC 60601‑1 standard.
The standard also includes requirements for different medical uses of humidification, such as invasive ventilation, non-invasive ventilation, nasal high-flow therapy, obstructive sleep apnea therapy, and humidification therapy for tracheostomy patients.
Meanwhile, a humidifier can be integrated into other equipment. In this case, the requirements of other equipment are also considered valid for the humidifier.
The ISO 80601-2-74 standard also describes requirements for medical equipment used to increase the temperature and humidity level of the gas delivered to the patient.
EUROLAB assists manufacturers with EN ISO 80601-2-74 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.
To get an appointment, to get more detailed information or to request an evaluation, you can ask us to fill in our form and reach you.
EUROLABreporting and certification activities, United Accreditation Foundation (UAF), Turkish Accreditation Agency (TÜRKAK) ve Enterprise Accreditation Foundation (EAF) based on the accreditation provided by the accreditation body. The Enterprise Accreditation Foundation (EAF) accreditation body is also a signatory of the United Nations (UN GLOBAL COMPACT) organization.
