Electrical Safety, EMC, Usability and Connectors
ISO 80369 Series: Small-Bore Connectors for Liquids and Gases in Healthcare
The ISO 80369 series addresses small-bore connectors used to carry liquids and gases in healthcare. Its purpose is misconnection prevention: a connector for one application, such as an enteral feeding set, should not physically fit a connector for another, such as an intravenous line, where a wrong connection could cause serious harm.
At a Glance
- Standard
- ISO 80369 Series
- Subject
- Small-Bore Connectors for Liquids and Gases in Healthcare
- Group
- Electrical Safety, EMC, Usability and Connectors
- Industries
- 1 industry guides reference it
A plain-language summary of scope, not the standard itself. Buy the current edition from the publisher and check which edition your auditor or market expects.
What It Covers
The series is organized by application. A general part sets the overall requirements and the approach to evaluating misconnection, a test methods part describes common performance tests, and application parts define connector designs for uses including enteral feeding, limb cuff inflation, neuraxial access, and intravascular or hypodermic use.
For manufacturers, conformity is largely a design and supplier question. Connector geometry and dimensions come from the relevant part, and performance testing covers properties such as leakage, resistance to separation and resistance to overriding. Many firms buy connectors from specialist suppliers, so supplier controls and incoming inspection carry much of the burden.
Moving from legacy connectors to dedicated designs affects the whole supply chain and the clinical site, because adapters and older stock coexist for a time. Device makers need a plan for labeling, customer communication and compatibility with mating devices from other manufacturers.
Who It Applies To
- Makers of enteral feeding sets, syringes, catheters and tubing with small-bore connectors
- Manufacturers of neuraxial, intravascular and hypodermic devices
- Equipment with limb cuff inflation connections, such as blood pressure monitors
- Contract manufacturers and component suppliers producing molded connectors
What Auditors Check
Connector Specifications
Drawings and specifications that reference the applicable part of the series for each connector, with the intended application stated.
Performance Test Records
Verification of connector performance using the series' test methods, covering leakage, separation and related properties.
Misconnection Risk Analysis
Risk analysis addressing misconnection with other small-bore connectors, including legacy connectors still in clinical use.
Supplier and Incoming Controls
Supplier qualification, dimensional inspection and change notification agreements for purchased connectors.
Mating Compatibility
Evidence the connector works with mating devices from other manufacturers, not only with the firm's own components.
Related Services
Supplier Audits and Supplier Controls
Risk-based supplier selection, quality agreements, monitoring and supplier audits that hold up under QMSR.
AI-Assisted QMS Gap Assessment
An AI-assisted first pass over the QMS documents you already have, with every result reviewed by an advisor.
Submission Readiness (510(k), De Novo, PMA, Pre-Sub, 513(g))
The design, risk and V&V evidence behind a 510(k), De Novo or PMA, organized and gap-checked.
Industry Guides That Reference ISO 80369 Series
ISO 80369 Series
Check Your Quality System Against ISO 80369 Series
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