scope:

This part of the series of International Standards specifies general requirements, by application, for small bore connectors used in medical devices and accessories that contain or convey liquids or gases to or from a patient. These applications include, but are not limited to connections for breathing systems and driving gases, and enteral, urethral and urinary limb cuff inflation and neuraxial devices. Small-bore connectors as specified in this International Standards are non-interconnectable with: . the cones and sockets of ISO 5356-1:2004 and ISO 5356-2:2006; and . the nipples of EN 13544-2:2002. It provides the methodology to assess non-interconnectable characteristics of small-bore connectors based on their inherent design and dimensions in order to reduce the risk of misconnections between medical devices or between accessories for different applications and to reduce the risk of misconnections between medical devices with 6 % Luer connectors, and all other non-Luer (6 %) connectors that will be developed under future parts of this series of standards. It does not specify requirements for the medical devices or accessories that use these small-bore 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 will be 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, medical systems or accessories, even if currently not required by the relevant particular medical device standards. It is expected that when the relevant particular medical device standards are revised, requirements for small-bore connectors as specified in the series of standards will be included. 153 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 Secretariat of ISO/TC 210 to consider this feedback during the revision of the relevant part of this series of Standards.