ISO 80369-3-2016 PDF

Full title and description

ISO 80369-3:2016 — Small-bore connectors for liquids and gases in healthcare applications — Part 3: Connectors for enteral applications. This International Standard specifies dimensions and performance requirements for small-bore connectors intended for use with enteral medical devices and accessories to reduce the risk of misconnections and improve patient safety.

Abstract

ISO 80369-3:2016 defines the geometric, material and functional requirements, and test methods for enteral small-bore connectors used on enteral feeding sets, enteral syringes, drainage sets and associated patient interfaces. The standard focuses on connector design and performance (including dimensional limits, mechanical strength, leakage and usability) and does not set requirements for the enteral medical devices themselves. An Amendment (Amd 1:2019) provides clarifications and updates to the original publication.

General information

• Status: Published (confirmed in periodic review).
• Publication date: July 2016 (ISO 80369-3:2016); Amendment 1 published February 2019.
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.040.25 (Medical equipment and supplies).
• Edition / version: Edition 1 (2016) with Amendment 1 (2019).
• Number of pages: Main publication: 39 pages (plus Amendment 1: 6 pages).

Scope

This standard applies to small-bore connectors intended for connections on enteral medical devices and accessories. It specifies dimensional and performance requirements for connectors to ensure safe, reliable enteral connections and to minimise the likelihood of misconnections with non-enteral devices. The standard does not prescribe requirements for the enteral devices themselves and excludes certain specific applications (for example gastric suction-only devices, oral-only devices, rectal devices, gastrointestinal endoscopy equipment and skin-level gastrostomy devices).

Key topics and requirements

• Dimensional and geometric specifications for enteral small-bore connectors (forms and tolerances to prevent incompatible connections).
• Mechanical performance: strength, retention, engagement and wear criteria.
• Leakage and pressure performance requirements for liquid flow and sealing integrity.
• Materials and biocompatibility considerations for connector components where applicable.
• Usability and human factors guidance to reduce risk of misconnection (including informative guidance annexes).
• Reference and test connector definitions and test methods for conformity assessment.
• Marking, identification and labelling expectations to support safe use.

Typical use and users

Primary users are medical device manufacturers (enteral feeding sets, enteral syringes, pumps and accessories), designers and product engineers, test and conformity assessment laboratories, hospital procurement and clinical engineering teams, regulators and standards committees. The standard is used when designing, testing, purchasing or certifying enteral connectors to ensure compatibility with the ISO enteral connector family and to reduce misconnection risk in clinical settings.

Related standards

ISO 80369-3 is part of the ISO 80369 series for small-bore connectors. Related parts include ISO 80369-1 (general requirements) and other application-specific parts addressing intravascular/hypodermic, neuraxial, limb cuff, breathing systems and more. Regional/adopted versions and industry-adopted variants (for example national adoptions or ANSI/AAMI publications) and amendments to ISO 80369-3 should be considered when implementing the standard.

Keywords

enteral, small-bore connector, feeding tube, enteral syringe, misconnection prevention, ISO 80369-3, connector dimensions, clinical connectors

FAQ

Q: What is this standard?

A: ISO 80369-3:2016 is the international standard specifying dimensional and performance requirements for small-bore connectors intended for enteral medical device applications (enteral feeding, syringes, drainage sets and related accessories).

Q: What does it cover?

A: It covers connector geometry, tolerances, mechanical and leakage performance, test methods, usability guidance, and marking for enteral small-bore connectors to prevent misconnections with non-enteral systems. It does not set requirements for the host medical devices themselves and excludes a number of specific enteral-related applications.

Q: Who typically uses it?

A: Device manufacturers, product designers and engineers, test laboratories, clinical engineers, procurement and regulatory bodies use this standard when designing, testing, buying or certifying enteral connectors and accessories.

Q: Is it current or superseded?

A: The original ISO 80369-3 was published in July 2016 and has an Amendment published in 2019. The standard was subject to periodic review and remains the current edition unless a later revision is published by ISO; users should check national adoption notices or ISO for any subsequent revisions or further amendments before relying on the text for compliance.

Q: Is it part of a series?

A: Yes — ISO 80369-3 is one part of the ISO 80369 family addressing small-bore connectors for different healthcare applications. ISO 80369-1 contains general requirements and other parts address application-specific connector types.

Q: What are the key keywords?

A: Enteral, small-bore connector, connector dimensions, misconnection prevention, enteral feeding, ISO 80369-3, usability, connector testing.