ISO 5367:2014
Anaesthetic and respiratory equipment - Breathing sets and connectors

Standard No.

ISO 5367:2014

Release Date

2014

Published By

International Organization for Standardization (ISO)

Status

Be replaced 2023-07

Replace By

ISO 5367:2023

Latest

ISO 5367:2023

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 end adaptors 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. EXAMPLE 1 EXAMPLE 2 EXAMPLE 3 Ventilators having special compliance, pressure or breathing frequency requirements. High Frequency Oscillatory Ventilation, (HFOV) or High Frequency Jet Ventilation (HFJV). 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 end adaptors. NOTE 1 Examples of various types of breathing sets with patient end adaptors are depicted in Annex A. NOTE 2 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 3 Certain aspects of heated-wire breathing tubes are discussed in ISO 8185[2].

ISO 5367:2014 Referenced Document

• EN 1041:2008 Information supplied by the manufacturer of medical devices
• 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 60417:1973 Graphical symbols for use on equipment. Index, survey and compilation of the single sheets.
• 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
• 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 23328-2:2002 Breathing system filters for anaesthetic and respiratory use - Part 2: Non-filtration aspects
• ISO 4135:2001 Anaesthetic and respiratory equipment - Vocabulary
• ISO 5356-1:2004 Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets
• ISO 5362:2006 Anaesthetic reservoir bags
• ISO 7000:2014 Graphical symbols for use on equipment - Registered symbols
• ISO 8185:2007 Respiratory tract humidifiers for medical use - Particular requirements for respiratory humidification systems
• ISO 9360-1:2000 Anaesthetic and respiratory equipment - Heat and moisture exchangers (HMEs) for humidifying respired gases in humans - Part 1: HMEs for use with minimum tidal volumes of 250 ml

ISO 5367:2014 history

• 2023 ISO 5367:2023 Anaesthetic and respiratory equipment — Breathing sets and connectors
• 2014 ISO 5367:2014 Anaesthetic and respiratory equipment - Breathing sets and connectors
• 2000 ISO 5367:2000 Breathing tubes intended for use with anaesthetic apparatus and ventilators
• 1991 ISO 5367:1991 Breathing tubes intended for use with anaesthetic apparatus and ventilators
• 1985 ISO 5367:1985 Breathing tubes used with anaesthetic apparatus and ventilators
• 1980 ISO 5367:1980 Title missing - Legacy paper document