EUROLAB laboratory provides testing and compliance services within the scope of EN ISO 8185 standard. EN ISO 8185 contains requirements for essential safety and essential performance of humidification systems.
It also includes requirements for individual devices specified for use in humidification systems, such as heated breathing tubes (heated-wire breathing tubes) and devices for controlling these heated breathing tubes (heated breathing tube controllers). ISO 5367 specifies other safety and performance requirements for breathing tubes.
EN ISO 8185 also contains requirements for active HME (heat and moisture exchanger) devices that actively add heat and moisture to increase the humidity level of the gas delivered from the HME to the patient.
It does not apply to passive HMEs that return some of the moisture and heat exhaled by the patient to the airway during inspiration without adding heat and humidity. ISO 9360-1 and ISO 9360-2 specify security and performance requirements for passive HMEs and describe methods for testing performance.
Respiratory humidifiers can be gas powered, electrically powered, or both. However, EN ISO 8185 has been prepared as a specific standard based on IEC 60601-1; This standard gives general requirements for all aspects of safety, not just electrical safety, and therefore most of the requirements are applicable to non-electrical humidifiers.
EN ISO 8185 does not apply to devices commonly referred to as "room humidifiers" or humidifiers used in heating, ventilation and air conditioning systems, or humidifiers included in baby incubators.
EUROLAB assists manufacturers with EN ISO 8185 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.
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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.
