ISO 5364:2026

Overview

ISO 5364:2026 is an international standard published by ISO that specifies requirements for oropharyngeal airways used in anaesthetic and respiratory equipment. The standard outlines essential aspects relating to design, dimensions, materials, safety, and marking of oropharyngeal airways intended to maintain a gas pathway through the oral cavity and pharynx during airway management. It is important to note that ISO 5364:2026 does not apply to metal oropharyngeal airways or to issues concerning flammability, and it excludes supralaryngeal airways (covered by ISO 11712) and general requirements now addressed in ISO 18190.

Complying with ISO 5364:2026 helps ensure that oropharyngeal airways are safe, effective, and easily identifiable, supporting patient safety in both routine and emergency settings.

Key Topics

• Scope and Exclusions

  • Applies to oropharyngeal airways made from non-metallic materials
  • Excludes metal airways, flammability requirements, and supralaryngeal devices

• Design and Dimension Requirements

  • Specifies size designation by nominal length in centimetres
  • Prescribes minimum internal dimensions to allow passage of suction catheters
  • Mandates radiused edges to minimize tissue trauma

• Material Selection

  • Materials must resist deterioration from anaesthetic gases and cleaning procedures
  • If reusable, devices must withstand disinfection and sterilization

• Safety Considerations

  • Focus on minimizing dental and soft tissue trauma during use
  • Requirements for reinforcement inserts (secure attachment, material compatibility)

• Identification and Marking

  • Flanged end must be marked with size and manufacturer information
  • Mandatory size-based colour coding for quick identification in emergencies

• Manufacturer Information

  • Requirements for packaging and labelling on individual and multi-unit packs

Applications

ISO 5364:2026 is relevant for:

• Medical Device Manufacturers: Ensures consistency in design, safety, and labelling of oropharyngeal airways, supporting regulatory approvals and access to global markets.
• Healthcare Providers: Supports proper selection and rapid identification of airway sizes in clinical and emergency situations, reducing the risk of improper airway management.
• Procurement and Quality Assurance: Guides product specification, purchasing, and acceptance criteria for hospitals and clinics.
• Regulatory Bodies and Auditors: Provides a benchmark for evaluating conformance in clinical practice and medical device approvals.

By adhering to ISO 5364:2026, stakeholders help achieve higher standards of patient safety, product quality, and interoperability within anaesthetic and respiratory care settings.

Related Standards

• ISO 18190:2025 - Anaesthetic and respiratory equipment - General requirements for airway devices and related equipment. This general standard complements ISO 5364, with the device-specific requirements of ISO 5364 taking precedence in case of conflict.
• ISO 11712 - Anaesthetic and respiratory equipment - Supralaryngeal airways and connectors. Covers supralaryngeal airway devices not included within the scope of ISO 5364.
• ISO 4135:2022 - Anaesthetic and respiratory equipment - Vocabulary. Provides standardized terminology used throughout ISO 5364 and related documents.

Practical Value

Implementing ISO 5364:2026 improves patient safety and clinical outcomes by ensuring oropharyngeal airways reliably maintain airway patency and are clearly identified during urgent procedures. Standardization supports streamlined procurement, facilitates international trade, and simplifies compliance assessment for manufacturers and regulators.

For more information, visit ISO's official website.