scope:

This part of the series of International Standards specifies general requirements, by application, for the smallbore connectors used in medical devices and accessories that contain or convey liquids or gases to or from a patient or via intermediate systems. These applications include, but are not limited to connections for breathing systems and driving gases, enteral, urethral and urinary, cuff inflation and neuraxial. See also Annex B. It provides the methodology to assess non-interchangeability of small-bore connectors based on their inherent design and dimensions in order to minimise the risk of misconnections between medical devices or between accessories for different applications. It does not specify requirements for the medical devices or accessories that use these connectors. Such requirements are given in particular International Standards for specific medical devices or accessories. Note 1 It is intended that new designs of small-bore connectors are included in this series of standards after they have been assessed according to the procedure given in Clause 6. Note 2 Manufacturers are encouraged to incorporate the small-bore connectors specified in this series of Standards into medical devices or medical systems, even if currently not required by the particular medical device standards. It is expected that when the particular medical device standards are revised, requirements for small-bore connectors as specified in the series of standards will be included. Note 3 Manufacturers and responsible organizations are encouraged to report their experience with the small-bore connectors specified in this series of standards to the relevant committee to consider this feedback during the revision of the relevant part of this series of Standards.