ISO 80369-1:2018

Overview

ISO 80369-1:2018 - Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements - defines the general requirements and methodology for designing and assessing small-bore connectors used with medical devices and accessories. Developed by ISO in collaboration with IEC, this part of the ISO 80369 series focuses on preventing hazardous misconnections by specifying the healthcare application fields (for example breathing systems, enteral, limb cuff inflation, neuraxial, intravascular/hypodermic) and the approach for demonstrating non‑interconnectable connector characteristics.

Key topics and technical requirements

• Scope and application fields: Describes the intended healthcare fields (breathing/delivery gases, enteral feeding, limb cuff inflation, neuraxial, intravascular/hypodermic and others).
• Non‑interconnectability methodology: Provides the methodology to assess connectors’ inherent design and dimensional features to reduce misconnections between different application families.
• Materials and safety: Addresses material considerations relevant to healthcare use (biocompatibility and suitability are referenced rather than device-specific performance).
• Test methods and assessment procedures: Includes normative annexes with test methods (Annex B) and CAD-based assessment procedures (Annex D) used to demonstrate non‑interconnectable characteristics.
• Marking, disclosure and alternative designs: Requirements for alternative connector designs and guidance for disclosure and marking to support safe implementation.
• Normative references and risk management: References ISO 14971 (risk management) and IEC 62366-1 (usability engineering) to integrate safety and usability into connector design.

Practical applications and who uses this standard

• Medical device manufacturers and component designers: Use ISO 80369-1 to design connectors that minimize risk of hazardous misconnections and to align with future device standards.
• Regulatory and quality teams: Reference the general requirements during conformity assessment, risk analysis, and standards alignment.
• Test laboratories and certification bodies: Apply the test methods and assessment procedures when evaluating connector non‑interconnectability.
• Healthcare providers and procurement: Use the standard’s application definitions to inform device selection and reduce clinical risk from inappropriate connections.

Related standards

• ISO 80369 series (Parts 2–7): Application‑specific connector dimensions and interfaces (enteral, limb cuff, neuraxial, intravascular, etc.).
• ISO 14971: Medical device risk management.
• IEC 62366-1: Usability engineering for medical devices.
• IEC/ISO collaborative publications cited in the standard.

Practical value / SEO keywords

By specifying general requirements and a robust methodology to demonstrate non‑interconnectability, ISO 80369-1 helps reduce patient harm from misconnections and supports consistent connector designs across medical devices. Relevant keywords: ISO 80369-1, small-bore connectors, non-interconnectable, misconnections, enteral connector, neuraxial connector, intravascular connector, medical device standards, risk management.