scope:

This International Standard specifies basic requirements for antistatic and non-antistatic breathing sets, breathing tubes, and breathing tubes supplied to be cut to length, intended to be used with anaesthetic apparatus and ventilators, humidifiers and nebulizers. It also applies to breathing sets and breathing tubes and patient end adaptors supplied already assembled and to those supplied as components and assembled in accordance with the manufacturers' instructions. This International Standard is applicable to breathing sets and breathing tubes having ends incorporating adaptors with conical connectors (assembled ends) or with plain ends (either cylindrical or tapered). This International Standard is applicable to breathing sets which include special components (e.g. water traps) between the patient end and machine end which are supplied already assembled. This International Standard is not applicable to breathing sets and breathing tubes for special purposes, such as those used with ventilators having special compliance, pressure, or breathing frequency requirements. NOTE 1 Examples of these breathing sets may include High Frequency Oscillatory Ventilation, (HFOV), or High Frequency Jet Ventilation (HFJV). Provision is made for coaxial and related bifurcated, double lumen, or multiple lumen breathing sets and breathing tubes suitable for use with patient end adaptors. NOTE 2 Examples of various types of breathing sets with patient end adaptors are depicted in Annex A. Requirements for exhalation valves, exhaust valves, and adjustable pressure-limiting (APL) valves and reservoir bags, if provided, are not covered by this standard. NOTE 3 ISO 80601-2-12, ISO 80601-2-13 and ISO 5362 cover these. NOTE 4 Certain aspects of heated wire breathing tubes are discussed in ISO 8185 [1].