EN ISO 5364:2026

Overview

EN ISO 5364:2026 - Anaesthetic and respiratory equipment – Oropharyngeal airways defines the requirements and specifications for oropharyngeal airways used during anesthesia and emergency airway management. Developed by CEN in collaboration with ISO, this standard addresses the critical performance and safety requirements of non-metallic oropharyngeal airways intended to maintain a patient airway through the mouth and pharynx.

This international standard is designed for use by manufacturers, clinicians, and regulatory bodies. It ensures that oropharyngeal airways used in clinical practice meet specific size, material, and performance criteria for effective and safe airway management.

Key Topics

• Scope and Exclusions

  • Applies exclusively to oropharyngeal airways made from materials other than metal.
  • Does not cover metal oropharyngeal airways or requirements concerning flammability.
  • Supralaryngeal airways are addressed separately under ISO 11712.

• Material and Design Requirements

  • Specifies resistance to deterioration from anaesthetic gases, cleaning, disinfection, and sterilization.
  • Focus on minimizing dental and soft tissue trauma during insertion and use.
  • Mandates smooth inner and outer surfaces for patient safety.

• Dimensions and Size Designation

  • Oropharyngeal airway sizes are designated by nominal length, marked clearly and color-coded for rapid identification.
  • Detailed dimensional tolerances for each size ensure compatibility and performance.
  • Edges and corners that contact tissue must have a minimum radius to reduce injury risk.

• Performance Testing

  • Test methods for assessing resistance to collapse and lumen patency at elevated temperatures, simulating emergency situations.
  • Reinforcement inserts must be securely attached and meet material requirements.

• Manufacturer Information and Marking

  • Requirements for device marking (size, manufacturer/trademark, latex indication).
  • Colour coding corresponding to airway size, especially important for quick selection in emergency settings.
  • Specifics for marking shelf or multi-unit packaging to ensure clarity for end users.

• Precedence of Requirements

  • Device-specific requirements in EN ISO 5364 take precedence over any conflicting clauses in the general airway device standard (ISO 18190).

Applications

• Clinical Use in Anaesthesia and Emergency

  • Oropharyngeal airways are essential in maintaining open airways during anesthesia, resuscitation, and emergency care.
  • Colour coding and clear labeling promote rapid, accurate airway selection in time-sensitive situations.

• Manufacturing and Compliance

  • Standards-driven design ensures consistent quality and safety of airway devices.
  • Following EN ISO 5364:2026 aids manufacturers in meeting regulatory and procurement requirements for medical devices.

• Healthcare Facilities

  • This standard supports hospital protocols for airway management equipment, emphasizing patient safety and device reliability.
  • Facilitates staff training and equipment management through standardized sizing and color coding.

• Regulatory and Quality Assurance

  • EN ISO 5364 provides a structured benchmark for assessing oropharyngeal airways during certification and quality audits.
  • National regulations and healthcare procurement specs reference these criteria to ensure compliance and interoperability.

Related Standards

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

By adhering to EN ISO 5364:2026, stakeholders ensure the safe, effective, and standardized use of oropharyngeal airways in various clinical environments, supporting patient safety, regulatory compliance, and best practice in airway management.