ISO 80369-1:2018
Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements
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About This Item
ISO 80369-1:2018 defines general requirements for small-bore connectors used for liquids and gases in healthcare applications, making it a relevant technical document for teams involved in design review, procurement, verification activities, and compliance preparation. As the primary reference in the ISO 80369 series, it supports a structured approach to connector safety and operational consistency where unintended misconnections can create clinical risk. Organizations often use it during technical assessment, documented evaluation, and conformity assessment planning.
ISO 80369-1:2018 standard overview
ISO 80369-1:2018 provides the general requirements framework for the ISO 80369 family, which addresses small-bore connectors intended for liquids and gases in healthcare settings. The title indicates a focus on connector interface requirements rather than a specific device type, so it is typically used as a baseline compliance reference across product development and validation workflows. For engineering and quality teams, it can support design controls, risk management review, and verification planning when assessing whether connector-related features align with intended clinical use.
Applications of ISO 80369-1:2018
This document is commonly relevant in healthcare product engineering, laboratory evaluation, and procurement review for systems that transfer fluids or gases through small-bore connector interfaces. It may be used when assessing reusable or single-use components, selecting compatible connector solutions, or preparing technical documentation for regulatory submission. Teams working on device integration, product evaluation, and test protocols often consult ISO 80369-1:2018 to help maintain consistent technical requirements across development, quality workflows, and supplier assessment activities.
Why ISO 80369-1:2018 matters
ISO 80369-1:2018 matters because connector compatibility is a practical safety and compliance issue, not just a design detail. A clear general-requirements reference can help reduce the likelihood of misconnections, improve interoperability control, and support repeatable testing and engineering validation. It is also useful in conformity assessment preparation, where documented evidence of technical compliance and risk reduction is often needed. For procurement and quality teams, the standard can provide a common basis for product review and specification alignment.
- General requirements framework for small-bore connectors used with liquids and gases in healthcare applications
- Useful for design verification, interface review, and technical documentation control
- Supports risk management activities aimed at reducing connector misconnections
- Provides a compliance reference for laboratory evaluation and conformity assessment planning
- Relevant to procurement checks when comparing connector-related specifications across suppliers
- Publication Date: 2018-05-11
- Standard Status: Original
- Publisher: IEC
- Edition: 2
- This Version: ISO 80369-1:2018 (2018-05-11)
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