ISO 5364:2016

Overview

ISO 5364:2016 - Anaesthetic and respiratory equipment - Oropharyngeal airways - defines dimensional, performance, marking, packaging and sterility-related requirements for oropharyngeal airways made of plastics and/or rubber (including those with plastic or metal reinforcement inserts). The standard is focused on safe, traceable, readily identifiable oropharyngeal airways used to maintain an airway through the oral cavity and pharynx. It explicitly excludes solid metal airways, requirements for flammability mitigation, and supralaryngeal airways without an internal sealing mechanism.

Key topics and technical requirements

• Size designation and dimensions
  • Size is designated by nominal length in centimetres (commonly 3–12 cm). The standard specifies length tolerances and minimum inside lumen dimensions (e.g., approximately 2.5 mm to 5.5 mm depending on size) to ensure compatibility with adjunct devices such as suction catheters.
• Materials and biocompatibility
  • Devices must meet biological safety testing as indicated in ISO 10993-1 after any manufacturer-recommended preparation for use.
• Design features
  • Patient-contacting edges and corners require a minimum radius (0.5 mm) to reduce tissue trauma. Reinforcement inserts are permitted when specified.
• Performance
  • Resistance to collapse: the buccal portion must retain at least 75% of the minimum inside dimension under specified test conditions (Annex B).
  • Patency: lumen patency must be maintained under the test method in Annex C.
• Sterility and packaging
  • Sterile products must comply with EN 556-1 and packaging must meet ISO 11607-1 requirements for sterile barrier systems; individual sterile packs and multi-unit shelf packs are specified.
• Marking and colour coding
  • The flanged end must be clearly marked with the designated size, manufacturer name/trademark, and latex indication if applicable. Markings must be legible at specified viewing conditions.
  • A standardized colour code by size is mandated to support rapid identification in emergencies.
• Information to users
  • Packaging and instructions must include single-use/reprocessing guidance, sterilization method, batch number, and cleaning/sterilization instructions when reusable.

Applications and users

ISO 5364:2016 is used by:

• Medical device manufacturers designing and producing oropharyngeal airways
• Clinical procurement and sterile supply departments specifying devices for operating rooms, emergency departments, and prehospital care
• Regulatory and quality teams ensuring compliance with device marking, sterility and biocompatibility standards
• Clinicians and airway managers who rely on consistent sizing, colour coding and labelling for rapid selection during airway management

Related standards

• ISO 10993-1 (biological evaluation)
• ISO 11607-1 (packaging for terminally sterilized devices)
• ISO 15223-1 and ISO 7000 (symbols and graphical marks)
• EN 556-1 (sterilization requirements)
• EN 1041 (information supplied by manufacturer)

Keywords: ISO 5364:2016, oropharyngeal airways, airway size, colour code, sterility, anaesthetic and respiratory equipment, device marking, lumen patency.