ISO 80369-3:2016

Overview

ISO 80369-3:2016 - Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications (published 2016). Developed by ISO in collaboration with IEC/SC 62D, this standard specifies the design dimensions, material and functional requirements, and performance tests for small-bore connectors used on enteral medical devices and accessories. The goal is to reduce hazardous misconnections (e.g., enteral feed delivered intravenously or into the airway) by making enteral connectors dimensionally incompatible with connectors from other medical application categories.

Key topics and technical requirements

• Scope: Applies to connectors for enteral feeding sets, enteral drainage sets, enteral syringes, access ports and patient interface devices. It does not cover device-specific requirements or certain enteral-related items (e.g., gastric suction-only, oral-only devices, rectal devices, gastrointestinal endoscopy, skin-level gastrostomy, or balloon inflation ports).
• Design and dimensions: Detailed dimensional drawings and tolerances for enteral small-bore connectors are provided (see normative Annex B and C for reference connectors).
• Materials: Guidance and requirements on materials suitable for enteral connectors to ensure biocompatibility and mechanical integrity.
• Performance requirements and tests (aligned with ISO 80369-1 and ISO 80369-20):
  • Fluid leakage (pressure-decay and positive-pressure leakage tests)
  • Stress cracking resistance
  • Resistance to separation from axial loads, unscrewing, and overriding
  • Controlled disconnection behavior
• Usability and risk management: Informative annexes (D–G) summarize usability requirements, design assessment, and rationale. Risk management referencing ISO 14971 is required.
• Non-interconnectability: Connectors are designed so they cannot mate with connectors intended for other clinical applications, reducing misconnection risk.

Applications

• Use when designing, manufacturing, testing, or procuring components of enteral feeding systems and accessories:
  • Enteral feeding sets and tubing
  • Enteral syringes and administration devices
  • Patient access ports and enteral connectors on devices
• Helps hospitals and procurement teams choose safer connectors to mitigate misconnection incidents.
• Useful for regulatory submissions, quality systems, and conformity assessment for enteral device connectors.

Who should use this standard

• Medical device designers and manufacturers
• Regulatory and quality managers (compliance with device standards)
• Clinical engineers, procurement officers, and hospital safety officers
• Test labs performing connector performance and compatibility testing

Related standards

• ISO 80369-1 (General requirements)
• ISO 80369-20 (Common test methods)
• Other ISO 80369 parts (e.g., Part 2, Part 6, Part 7)
• ISO 14971 (Risk management)
• ISO 18250-3 (enteral reservoir connectors)

Keywords: ISO 80369-3:2016, small-bore connectors, enteral connectors, enteral feeding, misconnection prevention, connector dimensions, medical device standards.