ISO 80369-1:2025

Overview

ISO 80369-1:2025 - "Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements" defines the general interface and risk-reduction framework for small-bore connectors used in medical devices and accessories that convey liquids or gases to patients. The standard sets out application scope (respiratory, enteral, limb cuff inflation, neural, intravascular/hypodermic and other use cases using ISO 80369-7) and a methodology to demonstrate non-interconnectable characteristics to reduce misconnections and wrong-route administration.

Key topics and requirements

• General interface requirements for small-bore connectors forming part of medical devices or accessories.
• Non-interconnectable requirement: criteria and process to ensure connectors intended for different clinical applications cannot be mistakenly mated.
• Methodology for assessment: normative processes (including Annex B and Annex C) for demonstrating and testing non-interconnectability and performance.
• Application-specific listings: identification of clinical use-cases (respiratory, enteral, limb cuff inflation, neural, intravascular/hypodermic, etc.) and guidance on which connector families are intended for each.
• Risk management alignment: references to ISO 14971 and IMDRF essential principles for risk control, emphasizing safe design to eliminate or reduce misconnection hazards.
• Supporting normative and informative annexes: rationale, test procedures, design-assessment summaries and references to common test methods used across the ISO/IEC 80369 series.

Applications and who uses this standard

• Medical device manufacturers and designers - to develop connector interfaces that are application-specific and demonstrably non-interconnectable with other connector types.
• Regulatory bodies and conformity assessors - to evaluate connector safety claims, test evidence and compliance with international risk-management expectations.
• Clinical engineers, procurement teams and hospital safety officers - to specify or source compatible, safer connector systems to reduce wrong-route errors.
• Standards committees and test laboratories - to implement the assessment procedures and harmonize connector specifications across products.

Practical benefits include reduced risk of misconnections, clearer device labelling and harmonized requirements for connector design across respiratory, enteral, neural, intravascular and other clinical applications.

Related standards

• ISO 80369 series (Parts 2, 3, 5, 6, 7, 20, etc.) - application-specific connector dimensions, material and performance requirements.
• ISO 14971 - medical device risk management.
• ISO 20417 - manufacturer information requirements.
• Relevant IEC 80369 parts and IMDRF guidance referenced for regulatory alignment.

Keywords: ISO 80369-1:2025, small-bore connectors, non-interconnectable, misconnections, Luer replacement, medical device connectors, respiratory connectors, enteral connectors, risk management.