The ISO 80369 standard, published by the International Standards Organization (ISO), consists of the following subsections under the main title "Small-diameter connectors for liquids and gases in healthcare applications":
The ISO 80369-1 standard describes general requirements for small diameter connectors carrying liquids or gases in healthcare applications. These small diameter connectors are used in medical devices or accessories intended for use on a patient. This standard also identifies healthcare areas where these small diameter connectors are intended to be used. These health areas include, but are not limited to:
This standard provides methods in other parts of this standard to evaluate the non-connectable properties of small diameter connectors based on their structural design and dimensions in order to reduce the risk of misconnection between medical devices or between accessories for the different applications described in this standard. This standard does not specify requirements for medical devices or accessories that use these small diameter connectors. Such requirements are contained in other international standards for certain medical devices or accessories. The connectors specified in the ISO 80369 series of standards are intended for use only in their specified applications. Using these connectors for other applications increases the risk of a dangerous misconnection occurring.
The ISO/DIS 80369-2 standard describes the requirements for connectors used in respiratory applications and presents a test method. This standard is still in draft form.
The ISO 80369-3 standard describes dimensions and requirements for the design and functional performance of small bore connectors intended for connections in enteral medical devices and accessories. Enteral medical devices include enteral feeding sets, enteral drainage sets, enteral syringes, and patient interface devices including access ports. This standard does not include dimensions and requirements for medical devices or accessories using these connectors. Such requirements are contained in other international standards for certain medical devices or accessories. This standard does not specify requirements for small diameter connectors used in equipment such as:
The IEC 80369-5 standard describes the dimensions and requirements for the design and functional performance of small-hole connectors intended for use in limb cuff inflation applications of medical devices and accessories. Limb cuff inflation applications involve connections between a blood pressure monitor and its cuff.
The ISO 80369-6 standard describes requirements for small diameter connectors intended for use for connections in neural axis applications. Neuraxial applications include the use of medical devices for administering drugs to neuraxial sites, administering wound infiltration anesthesia and other regional anesthetic procedures, or for monitoring or removing cerebrospinal fluid for therapeutic or diagnostic purposes. This standard specifies the dimensions and requirements for the design and functional performance of these through-hole connectors intended for use with medical devices. It does not specify requirements for medical devices or accessories that use these connectors. Such requirements are contained in other international standards for certain medical devices or accessories.
The ISO 80369-7 standard describes the dimensions and requirements for the design and functional performance of small bore connectors intended for use for connections in intravascular applications or hypodermic connections in hypodermic applications of medical devices and accessories. It does not specify requirements for medical devices or accessories that use these connectors. Such requirements are contained in other international standards for certain medical devices or accessories.
The ISO 80369-20 standard describes test methods for evaluating performance requirements for small diameter connectors specified in the ISO 80369 series of standards.
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