*This International Standard specifies essential requirements for breathing sets and breathing circuits intended for use with anesthesia breathing systems, ventilator breathing systems, humidifiers and nebulizers. It applies to breathing sets and breathing tubes as well as to adapters at the patient end, which are either already assembled or supplied as components for assembly according to the manufacturer's instructions. This International Standard applies to breathing sets that contain special components (e.g. water separators) between the patient end and the machine end, which are supplied already assembled. This International Standard does not apply to breathing sets and breathing tubes for special purposes. EXAMPLE 1 Ventilators with specific compliance, pressure or respiratory rate requirements. EXAMPLE 2 High Frequency Oscillation Ventilation (HFOV) or High Frequency Jet Ventilation (HFJV). EXAMPLE 3 Breathing sets and breathing tubes with special connectors for ventilation of newborns. Specifications have been included for coaxial and associated breathing sets that are bifurcated, dual lumen, or have multiple lumens, as well as breathing tubes suitable for use with patient end adapters. NOTE 1 Examples of different types of breathing sets with patient end adapters are shown in Appendix A. Requirements for exhalation valves, exhaust valves, adjustable pressure relief valves (APL valve), heat and moisture exchangers (HMEs), breathing filters and reservoir bags, if any, are not covered by this International Standard. NOTE 2 ISO 80601-2-12, ISO 80601-2-13 and ISO 9360-1 [3], ISO 23328-2 [4] and ISO 5362 [1] cover this. NOTE 3 Certain aspects of heated breathing tubes are covered in ISO 8185 [2].
EN ISO 5367:2014 Referenced Document
EN 556-1:2001 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices*， 2024-04-20 Update
IEC 60601-1-6:2010 Medical electrical equipment - General requirements for basic safety and essential performance - Collateral Standard: Usability
IEC 60601-1:2005 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 62366:2007 Medical devices - Application of usability engineering to medical devices
ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
ISO 11607-1:2006 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
ISO 14971:2007 Medical devices - Application of risk management to medical devices
ISO 15223-1:2012 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
ISO 5356-1:2004 Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets
ISO 7000:2014 Graphical symbols for use on equipment - Registered symbols
ISO 80601-2-12:2011 Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
ISO 80601-2-13:2011 Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation
EN ISO 5367:2014 history
2023EN ISO 5367:2023 Anaesthetic and respiratory equipment - Breathing sets and connectors (ISO 5367:2023)
2014EN ISO 5367:2014 Anaesthetic and respiratory equipment - Breathing sets and connectors (ISO 5367:2014)