ISO 80369-1:2025 PDF

Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements

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Title (English):

ISO 80369-1:2025

Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements

Document status:: Active
Format:: Electronic (PDF)
Number of pages:: 41
Publication date:: October 10, 2025
Edition:: IEC IS 80369 edition 3 version 1
ICS:: 11.040.10

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Description (English):

This document specifies general interface requirements for small-bore connectors that form part of a medical device or accessory that conveys liquids or gases to a patient. This document also identifies the applications for which these small-bore connectors are intended to be used, which include, but are not limited to: - respiratory; - enteral; - limb cuff inflation; - neural; - intravascular or hypodermic; - other use cases utilizing an ISO 80369-7 small-bore connector. This document provides the methodology to assess non-interconnectable characteristics of small-bore connectors based on their inherent design in order to reduce the risk of misconnections between medical devices or between accessories for different applications as specified in this document as well as those that can be developed under future parts of the ISO and IEC 80369 series. NOTE Clause A.2 contains guidance or rationale for this Clause.

Technical details

Technical committee: SC 62D - Particular medical equipment, software, and systems
SKU: ISO 80369-1:2025

Abstract

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.

Related standards

Standards mentioned in the description

Abstract

Overview

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.

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.

ISO 80369-1:2025 PDF

Technical details

Abstract

Overview

Key topics and requirements

Applications and who uses this standard

Related standards

Related standards

Abstract

Overview

Key topics and requirements

Applications and who uses this standard

Related standards

Related standards

Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular…

Medical devices - Application of risk management to medical devices (ISO 14971:2019)

Small bore connectors for liquids and gases in healthcare applications - Connectors for neuraxial applications

Medical devices - Information to be supplied by the manufacturer (ISO 20417:2026)

Corrigendum 2 - Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors f…