ISO 5366:2016

Overview

ISO 5366:2016 - Anaesthetic and respiratory equipment - Tracheostomy tubes and connectors - defines essential requirements for adult and paediatric tracheostomy tubes and connectors. The standard covers both cuffed and uncuffed designs and applies to many specialized tubes (e.g., reinforced walls, metal components, suction or monitoring ports). ISO 5366:2016 is intended for devices used in anaesthesia, artificial ventilation and other respiratory support, and focuses on safe design, materials, testing, labelling and sterile supply.

Key Topics

• Scope and definitions: Clear terminology for tracheostomy components (outer/inner tube, neck-plate, cuff, inflating tube, inflation indicator, introducer, machine/patient end).
• Design requirements: Guidance on connector interfaces, neck-plate features, inner tubes, patient-end bevels and tube geometry to assist clinical selection.
• Size designation and dimensions: Specifies how to indicate designated size, outside dimension and nominal length, helping clinicians choose tubes that match airway anatomy and airflow resistance needs.
• Cuffs and inflation systems: Requirements for cuff designs, inflating tubes, inflation indicators (pilot balloons) and associated markings.
• Materials and safety: Material selection guidance and informative annex for design and risk assessment; flammability management is acknowledged as a clinical hazard (outside the standard’s scope).
• Performance tests: Normative test methods for connector attachment security, cuff diameter and herniation, and kink resistance to ensure airway patency under bending.
• Sterility and packaging: Requirements for tracheostomy tubes supplied sterile, including sterility assurance and protective packaging.
• Information and labelling: Mandatory markings on neck-plates, inflation indicators and unit packs, plus additional labelling requirements to support safe use.

Applications

ISO 5366:2016 is used by:

• Medical device manufacturers to design, test and certify tracheostomy tubes and connectors for regulatory compliance.
• Clinical engineers and quality teams to develop product specifications, perform risk assessments and validate kink resistance and cuff integrity.
• Hospitals and procurement professionals when selecting compatible, properly labelled tracheostomy devices for adult and paediatric care.
• Test laboratories and regulators for conformity assessment and verification of packaging, sterility and performance tests.

Practical benefits include improved device compatibility with breathing systems, clearer size selection, enhanced patient safety through standardized testing, and predictable labelling for clinical use.

Related Standards

• ISO 4135 - Anaesthetic and respiratory equipment - Vocabulary
• ISO 5356-1 - Conical connectors (cones and sockets)
• ISO 18190 - General requirements for airways and related equipment
• ISO 80369-7, ASTM F2052, ASTM F2503, and ISO/TR 11991 (guidance on airway fire avoidance) are also referenced for connector safety, MR environment and flammability considerations.

Keywords: ISO 5366:2016, tracheostomy tubes, connectors, cuffed tracheostomy tubes, paediatric tracheostomy, design requirements, kink resistance, sterility, labelling.