1 Scope
*This International Standard specifies basic requirements for breathing sets and breathing tubes intended to be used with anaesthetic breathing systems, ventilator breathing systems, humidifiers or nebulizers. It applies to breathing sets and breathing tubes and patient endadaptors supplied already assembled and to those supplied as components and assembled in accordance with the manufacturer’s instructions.
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.
EXAMPLE 1
Ventilators having special compliance, pressure or breathing frequency requirements.
EXAMPLE 2
High Frequency Oscillatory Ventilation, (HFOV) or High Frequency Jet Ventilation (HFJV).
EXAMPLE 3
Breathing sets and breathing tubes with special connectors for neonatal ventilation.
Provision is made for coaxial and related bifurcated, double-lumen, or multiple-lumen breathing sets and breathing tubes suitable for use with patient endadaptors.
NOTE 1
Examples of various types of breathing sets with patient endadaptors are depicted in Annex A.
Requirements for exhalation valves, exhaust valves, adjustable pressure-limiting (APL) valves, heat and moisture exchangers (HMEs), breathing filters, and reservoir bags, if provided, are not covered by this International Standard.
NOTE 2
ISO 80601-2-12, ISO 80601-2-13, ISO 9360-1[3], ISO 23328-2[4], and ISO 5362[1] cover these.
NOTE 3
Certain aspects of heated-wire breathing tubes are discussed in ISO 8185[2].