SIST EN ISO 5364:2026

Overview

SIST EN ISO 5364:2026 specifies the requirements for oropharyngeal airways used in anaesthetic and respiratory equipment. These essential medical devices are designed to maintain an open airway by holding the tongue away from the posterior pharyngeal wall during anaesthesia and emergency interventions. The standard ensures the safety, quality, and performance of oropharyngeal airways, excluding devices made from metal and excluding flammability requirements. It does not apply to supralaryngeal airways, which are addressed in ISO 11712, nor does it duplicate requirements now covered in the general airway device standard, ISO 18190.

This international standard, developed by the Technical Committee ISO/TC 121 and adopted as a Slovenian national standard (SIST), plays a crucial role for manufacturers, healthcare providers, and regulatory bodies concerned with respiratory and resuscitation equipment.

Key Topics

• Scope and Exclusions

  • Applies to non-metal, reusable or disposable oropharyngeal airways
  • Excludes metal airways and flammability considerations
  • Not applicable to supralaryngeal airway devices

• Terminology

  • Defines key anatomical and component terms: oropharyngeal airway, pharyngeal end, flanged end

• Materials and Construction

  • Requirements for materials that resist deterioration from anaesthetic gases, cleaning, disinfection, and sterilization
  • Design must minimize risk of dental and soft tissue trauma
  • Reinforcement inserts, if used, must be securely attached and corrosion-resistant

• Design and Size Specification

  • Size indicated by nominal length (in cm), corresponding to patient anatomy
  • Dimensions and tolerances specified for each size
  • Inside lumen dimension must allow passage of suction catheters

• Marking and Colour Coding

  • Marked with size, manufacturer’s name or trademark, indication of latex if present
  • Colour coding by size for rapid identification in clinical emergencies

• Performance and Safety Tests

  • Resistance to collapse under compression at elevated temperature
  • Lumen patency under simulated clinical use conditions

• Packaging and Information

  • Shelf and multi-unit packs must be clearly labelled with size and relevant information for safe selection and use

Applications

Oropharyngeal airways standardized by SIST EN ISO 5364:2026 are vital in:

• Hospitals and surgical suites for general anaesthesia
• Emergency departments for airway management
• Pre-hospital and ambulance care settings
• Intensive care, resuscitation, and critical care units

The standard provides assurance of device safety and functionality, minimizing risk for patients and aiding clinicians in rapid, accurate device selection. Adherence to ISO 5364:2026 simplifies procurement, supports compliance with international regulations, and promotes harmonization of respiratory and anaesthetic equipment worldwide.

Related Standards

For comprehensive airway device regulation and compatibility, consider these closely associated standards:

• ISO 18190: Anaesthetic and respiratory equipment - General requirements for airways and related equipment
• ISO 11712: Anaesthetic and respiratory equipment - Supralaryngeal airways and connectors
• ISO 4135: Anaesthetic and respiratory equipment - Vocabulary
• ISO/TR 11991: Guidance on airway management during laser surgery of the upper airway

Summary

SIST EN ISO 5364:2026 elevates patient safety and clinical effectiveness in airway management by setting rigorous and harmonized requirements for oropharyngeal airways. Its provisions enable healthcare professionals and manufacturers to achieve high standards of quality, reliability, and interoperability for anaesthetic and respiratory devices in varied medical environments. For any organization seeking to market or use oropharyngeal airways, compliance with this standard signifies a commitment to the highest levels of patient care and product excellence.