ISO 80369-3:2016
Small-bore connectors for liquids and gases in healthcare applications -- Part 3: Connectors for enteral applications
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About This Item
ISO 80369-3:2016 addresses small-bore connectors for liquids and gases in healthcare applications, with a specific focus on connectors for enteral applications. It is relevant for teams evaluating connector compatibility, patient safety, and product conformity where misconnection risks must be controlled. For engineering, testing, procurement, and regulatory preparation, ISO 80369-3:2016 provides a focused technical reference for documenting requirements and supporting consistent product evaluation within healthcare device workflows.
Overview of ISO 80369-3:2016
The official title indicates a technical framework for enteral connectors used in healthcare applications, where connector design and interface control are important to avoid unintended connections with other systems. In practical terms, the document is useful during design review, risk management, and verification activities for devices that handle liquids or gases through small-bore connectors. ISO 80369-3:2016 can support technical assessment, engineering documentation, and conformity assessment planning where enteral connection safety is a core requirement.
Compliance applications of ISO 80369-3:2016
Organizations may use this reference when evaluating enteral feeding systems, related accessories, and connector interfaces that must remain consistent across manufacturing and procurement workflows. It is also relevant in laboratory evaluation, supplier qualification, and testing workflows that check connector fit, interchangeability, and documented compliance expectations. For quality teams, the standard can help structure verification activities and technical review steps for products intended for healthcare use where operational consistency and controlled connection design are important.
Importance of compliance with ISO 80369-3:2016
Compliance with ISO 80369-3:2016 matters because connector errors in healthcare can create avoidable safety risks and complicate regulatory preparation. Using a clear technical reference supports engineering validation, product evaluation, and more consistent conformity assessment preparation across development and procurement stages. It can also improve testing consistency and quality assurance by giving teams a defined basis for reviewing connector-related requirements, which helps reduce ambiguity in technical documentation and supports safer clinical use.
- Enteral connector design and interface control for healthcare applications
- Risk reduction for unintended or unsafe misconnections
- Support for engineering validation, verification activities, and laboratory evaluation
- Useful reference for procurement review, supplier documentation, and conformity assessment
- Publication Date: 2016-01-07
- Standard Status: Original
- Publisher: IEC
- Edition: 1
- New Version Available: ISO 80369-3:2016 (2019-12-02)
- This Version: ISO 80369-3:2016 (2016-01-07)
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