ISO 80369-3:2016/AMD1:2019
Amendment 1 - 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/AMD1:2019 is a supporting amendment to the parent document on small-bore connectors for liquids and gases in healthcare applications, specifically for enteral applications. It is relevant for teams reviewing connector compatibility, patient-safety risks, and technical documentation tied to enteral systems. For engineering, procurement, and compliance workflows, ISO 80369-3:2016/AMD1:2019 helps clarify how the parent requirements should be interpreted or updated, supporting more consistent technical assessment and documented evaluation.
ISO 80369-3:2016/AMD1:2019 standard overview
This amendment is linked to ISO 80369-3:2016, which addresses small-bore connectors used for enteral applications in healthcare. As a modifying reference, ISO 80369-3:2016/AMD1:2019 should be read together with the parent document rather than treated as a standalone technical specification. It is most useful where organizations need to maintain current compliance records, align engineering documentation, or confirm the latest published wording for connector-related requirements in enteral delivery systems.
Applications of ISO 80369-3:2016/AMD1:2019
Organizations may use this amendment during product evaluation, supplier review, and conformity assessment for enteral connectors and associated healthcare components. It can support quality workflows in design verification, regulatory preparation, and laboratory evaluation where connector fit, interchangeability, and risk management are being documented. The document is also relevant for teams maintaining controlled technical files, procurement specifications, or test plans that reference the parent standard and need to reflect the most current amendment status.
Why ISO 80369-3:2016/AMD1:2019 matters
For healthcare device programs, keeping the referenced amendment in view can improve safety, consistency, and compliance readiness. In enteral applications, connector errors can create serious operational risk, so maintaining an up-to-date technical reference helps support validation, verification activities, and audit preparation. ISO 80369-3:2016/AMD1:2019 is therefore important for organizations that need traceable documentation, stable procurement requirements, and a reliable basis for technical review across design, testing, and conformity assessment workflows.
- Supporting amendment to the parent enteral connector document
- Useful for technical review of small-bore connector requirements
- Helps maintain compliance records and controlled engineering documentation
- Relevant to verification, testing workflows, and conformity assessment preparation
- Supports risk reduction and operational consistency in enteral healthcare applications
- Publication Date: 2019-12-02
- Standard Status: Amendment
- Publisher: IEC
- Edition: 1
- This Version: ISO 80369-3:2016 (2019-12-02)
- Previous Version: ISO 80369-3:2016 (2016-01-07)
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