ISO 80369-7:2016 Small-bore connectors for liquids and gases in healthcare applications -- Part 7: Connectors for intravascular or hypodermic applications – specifies dimensions and requirements for the design and functional performance of small bore connectors for use in intravascular or hypodermic applications of medical devices and accessories.
Scott Colburn, Convenor of the joint working group ISO/TC 210/JWG 4 said: ‘In the past, many delivery devices such as those for intravenous delivery used a universal system of connectors. But when a patient had several different tubes around them, there was an elevated risk of misconnections between two separate clinical applications, which, of course, could be disastrous. Now there are specific connectors for each type of delivery that medical devices can incorporate into their design. This new series of standards helps to reduce the risk of misconnection by defining the different connectors within each clinical application, thus reducing the risk of being connected inadvertently to the wrong application.”
This standard together with the others in the ISO 80369 series replaces two previous ISO standards (ISO 594 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment – Parts 1 and 2), that described more interchangeable connectors which could inadvertently result in misconnections by health care workers. Key changes between the ISO 594 standards and ISO 80369 include new terms of conditions, to better define the types of connectors and a change whereby the new standard outlines the requirements for connectors rather than the requirements for the fitting of these connectors.
Other standards in the ISO 80369 series include:
- ISO 80369-1 General requirements;
- ISO 80369-2 : Connectors for breathing systems and driving gases applications*
- ISO 80369-3, Connectors for enteral applications;
- IEC 80369-5 Connectors for limb cuff inflation applications;
- ISO 80369-6 Connectors for neuraxial applications; and
- ISO 80369-20 Common test methods