This document specifies minimum 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 end adaptors supplied already assembled and to those supplied as components and assembled in accordance with the manufacturer’s instructions.
This document 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.
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: Examples of various types of breathing sets with patient end adaptors are depicted in Annex A.
This document is not applicable to breathing sets and breathing tubes for special purposes.
EXAMPLE 1: Ventilators having special compliance, pressure or breathing frequency requirements.
Requirements for breathing system components such as exhalation valves, exhaust valves, adjustable pressure-limiting (APL) valves, heat and moisture exchangers (HMEs), breathing filters, and reservoir bags, are not covered by this document but can be found in ISO 80601-2-12, ISO 80601-2-13, ISO 9360-1, ISO 23328-2, and ISO 5362. Requirements for heated breathing tubes can be found in ISO 80601-2-74.