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Small-bore connectors for liquids and gases in healthcare applications - General requirements

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1 Scope

NOTE    Clause A.2 contains guidance or rationale for this Clause.

This document specifies general interface requirements for small-boreconnectors that form part of a medical device or accessory that conveys liquids or gases to a patient.

This document also identifies the applications for which these small-boreconnectors are intended to be used, which include, but are not limited to:

  • respiratory;

  • enteral;

  • limb cuff inflation;

  • neural;

  • intravascular or hypodermic;

  • other use cases utilizing an ISO 80369‑7small-boreconnector.

This document provides the methodology to assess non-interconnectable characteristics of small-boreconnectors based on their inherent design in order to reduce the risk of misconnections between medical devices or between accessories for different applications as specified in this document as well as those that can be developed under future parts of the ISO and IEC 80369 series.