ISO 5367 Anesthetic and Respiratory Equipment - Breathing Sets and Connectors

EUROLAB laboratory provides testing and compliance services within the scope of ISO 5367 standard. The ISO 5367 standard, developed by the International Standards Organization (ISO), specifies the basic requirements for breathing sets and breathing tubes intended for use with anesthetic breathing systems, ventilator breathing systems, humidifiers or nebulizers. Applies to breathing sets and breathing tubes and patient end adapters supplied already assembled, and those supplied as components and assembled according to the manufacturer's instructions.

ISO 5367 is applicable to breathing sets that contain special components (eg water traps) between the patient tip and the machine tip, which are supplied pre-assembled. Prepared for coaxial and associated bifurcated, double-lumen or multi-lumen breathing sets and breathing tubes suitable for use with patient-end adapters.

Requirements for exhalation valves, exhaust valves, adjustable pressure limiting (APL) valves, heat and moisture exchangers (HMEs), breathing filters and receptacle bags, if any, are not covered by this International Standard.

This International Standard contains requirements for breathing sets, breathing tubes and connectors intended to function as accessories for anesthetic and respiratory equipment. Breathing sets and breathing tubes are characterized by certain design requirements such as a means of connection and leakage limits.

The disclosure requirements for compatibility and flow resistance values ​​allow the user to make an informed choice when connecting these accessories to a breathing system. These design requirements are intended to allow anesthetic breathing systems and ventilator breathing systems that accessories are intended to work with to operate within the performance limits.

This International Standard contains requirements for breathing sets and breathing tubes, both disposable and reusable. Reusable breathing sets and breathing tubes are intended to comply with the requirements of this International Standard for the recommended service life.

Certain tests are performed under constant pressure to simplify the testing methodology. It is recognized that this does not reflect clinical use where pressure is intermittent and peak pressures occur for short periods of time. Limits in test methods take this into account. While such test methods do not address product variability, the required limits do take this into account as well.

Throughout this International Standard, all pressures are expressed in SI units of hPa, with the corresponding cmH₂O equivalent values ​​rounded up to the nearest whole cmH2O.

Among the services provided by our organization within the framework of material testing services, there are also ISO 5367 standard tests. Do not hesitate to contact our laboratory EUROLAB for your testing and certification requests.