ISO 80369-1-2018 PDF

Full title and description

ISO 80369-1:2018 — Small-bore connectors for liquids and gases in healthcare applications — Part 1: General requirements. This part defines general interface and safety requirements, intended healthcare application areas, and the methodology to assess and reduce the risk of dangerous misconnections between medical devices and accessories that use small-bore connectors.

Abstract

This document specifies general requirements and assessment methods for small-bore connectors used to convey liquids or gases in healthcare applications (for example respiratory, enteral, limb cuff inflation, neuraxial and intravascular/hypodermic). It describes the intended fields of use, gives the principles for non-interconnectability to reduce misconnections, and clarifies that requirements for the medical devices that incorporate these connectors are given in the particular device standards.

General information

• Status: Withdrawn (replaced/revised by a later edition of ISO 80369-1).
• Publication date: November 2018 (ISO publication date: 2018-11).
• Publisher: International Organization for Standardization (ISO); national adoptions published by national bodies (for example BSI/EN adoptions).
• ICS / categories: 11.040.10; 11.040.20 (healthcare technology — anaesthetic/respiratory equipment and transfusion/infusion/injection equipment).
• Edition / version: Edition 2 (2018).
• Number of pages: ISO metadata lists 31 pages for the 2018 record; several national/adopted editions and resellers list the document as 41–42 pages (national publication formatting can vary).

Scope

Sets out the general interface requirements for small-bore connectors that are part of medical devices or accessories conveying liquids or gases to a patient. Identifies the healthcare application areas intended for the connectors (including but not limited to respiratory/breathing systems, enteral feeding, limb cuff inflation, neuraxial applications, and intravascular/hypodermic use) and provides a methodology to assess and specify non-interconnectable characteristics to reduce the risk of hazardous misconnections. The document does not set requirements for the medical devices that use these connectors — those are given in device-specific standards.

Key topics and requirements

• General interface and dimensional requirements for small-bore connectors used in healthcare applications.
• Identification of intended application areas (respiratory, enteral, limb cuff inflation, neuraxial, intravascular/hypodermic, and future parts).
• Methodology and criteria for assessing non-interconnectability (design features and dimensional tolerances intended to prevent misconnections).
• Guidance that particular medical device standards remain the normative source for device-level requirements; encourages manufacturers to adopt ISO 80369 connectors proactively.
• Reference to common test methods and to other parts of the ISO 80369 series for application-specific connector dimensions and tests.

Typical use and users

Primary users include medical device and connector manufacturers, design and product development engineers, regulatory and compliance teams, test laboratories, standards committees, hospital procurement and clinical safety officers, and clinical engineering groups who implement or evaluate connector interfaces for patient safety. Clinical specialties affected include anesthesia, critical care, infusion therapy, enteral nutrition, and regional/neuraxial procedures.

Related standards

ISO 80369-1 is Part 1 of the ISO 80369 series. Related parts and supporting documents include (examples): ISO 80369-2 (connectors for respiratory applications — recent revision 2024), ISO 80369-3 (connectors for enteral applications, 2016 with amendment), ISO 80369-5 (limb cuff inflation), ISO 80369-6 (connectors for neuraxial applications, originally 2016; later revisions published), ISO 80369-7 (intravascular/hypodermic connectors, 2021), and ISO 80369-20 (common test methods). For full list and current editions consult the ISO catalogue for the ISO 80369 series.

Keywords

small-bore connector, connector standard, misconnections, non-interconnectable, medical connector, ISO 80369, enteral, respiratory, neuraxial, intravascular, test methods, patient safety.

FAQ

Q: What is this standard?

A: ISO 80369-1:2018 is the general-requirements part of the ISO 80369 family; it defines the overall objectives, application areas, and the methodology for specifying small-bore medical connector interfaces to reduce hazardous misconnections.

Q: What does it cover?

A: It covers general interface requirements and assessment methods for small-bore connectors conveying liquids or gases in healthcare — identifies intended fields of use (respiratory, enteral, limb cuff, neuraxial, intravascular/hypodermic, etc.) and sets out the approach for ensuring connectors intended for different applications are not mutually connectable. It does not replace device-specific requirements in particular medical device standards.

Q: Who typically uses it?

A: Medical device and accessory manufacturers, design engineers, regulatory/compliance teams, testing laboratories, clinical engineering and hospital procurement, and standards bodies working on connector safety and implementation.

Q: Is it current or superseded?

A: The 2018 edition is recorded as withdrawn in ISO lifecycle metadata and has been revised by a later edition of ISO 80369-1 (a 2025 edition is listed in the ISO catalogue). Users should adopt or transition to the current published edition of ISO 80369-1 and to the relevant application-specific parts of the series; check the ISO catalogue or national standards bodies for the latest active edition.

Q: Is it part of a series?

A: Yes — ISO 80369 is a multipart series addressing small-bore connectors in healthcare; Part 1 provides general requirements and other parts (for example Parts 2, 3, 5, 6, 7 and 20) provide application-specific connector dimensions, performance requirements, and common test methods.

Q: What are the key keywords?

A: Small-bore connector, non-interconnectable, misconnections, connector interface, ISO 80369, enteral, neuraxial, respiratory, intravascular, test methods, patient safety.