ISO 80369-7:2021
Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
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About This Item
ISO 80369-7:2021 defines requirements for small-bore connectors for liquids and gases in healthcare applications, with a specific focus on connectors for intravascular or hypodermic use. It is relevant to teams evaluating connector compatibility, safety risks, and documented conformity within medical device workflows. For engineering, procurement, and quality functions, the document supports technical review of connector selection, verification activities, and regulatory preparation where controlled connection design is essential.
What is ISO 80369-7:2021?
ISO 80369-7:2021 is the primary technical reference for small-bore connectors intended for intravascular or hypodermic applications. Its scope is generally associated with connector design expectations that help reduce misconnections between different medical delivery systems. In practice, the document is used during technical assessment, product evaluation, and compliance workflows to support consistent interpretation of connector intent, interface control, and conformity assessment planning for healthcare-related fluid and gas applications.
Applications of ISO 80369-7:2021
This document is commonly used in the design and evaluation of medical tubing assemblies, syringes, infusion-related connectors, and other small-bore interfaces where intravascular or hypodermic connection safety is a concern. It may also support laboratory evaluation, supplier qualification, and testing workflows for healthcare products that require controlled connector performance. Organizations often use ISO 80369-7:2021 alongside engineering documentation and quality workflows when reviewing product compatibility and connection-related risk management.
Why is ISO 80369-7:2021 important?
The document matters because connector misconnection can create serious safety and operational risks in healthcare environments. Using ISO 80369-7:2021 helps organizations align technical validation, procurement decisions, and conformity assessment preparation around a defined connector reference. It can also improve testing consistency and support documented evaluation of product interfaces, which is important for quality assurance, interoperability checks, and reducing ambiguity during compliance reviews and regulatory submission activities.
- Supports review of small-bore connector design for intravascular and hypodermic applications
- Helps structure verification activities and technical validation for connector-related interfaces
- Useful for procurement and supplier assessment where compatibility and safety are key criteria
- Assists with documented evaluation, quality workflows, and regulatory preparation
- Provides a compliance reference for reducing misconnection risk in healthcare delivery systems
- Publication Date: 2021-04-05
- Standard Status: Original
- Publisher: IEC
- Edition: 2
- This Version: ISO 80369-7:2021 (2021-04-05)
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