Numerous publications have reported severe harm and death when medical devices and their associated connecting tubing, intended to deliver medication via a particular route of administration into the body, are connected to devices intended to deliver medication via a different route. The risk of this occurring is increased when devices involved are fitted with the ‘universal’ Luer connector.

Examples of this include the administration of medicines intended to be given intravenously being given intrathecally (into the spinal fluid), and the unintended intravenous delivery of enteral feed.

ISO has developed the multi-part 80369 standard, which includes parts specifying the designs for a series of small-bore connectors. Each connector within this series is assigned a specified medical application usage. A list of parts of the standard is included in the bibliography section. The connectors have been designed to ensure that dissimilar ones are non interconnectable, thus minimizing cross-connection risks.

The ISO 80369-1 standard describes General Requirements for small–bore connectors for liquids and gases in health care applications. Universal implementation of ISO 80369-1 will minimize the likelihood of misconnections between connectors fitted to devices used for the specified medical applications, by introducing a series of engineering controls and manufacturing design guidelines.

A small-bore connector is a connector with an inner diameter of less than 8.5mm used to connect medical devices, components and accessories for the purposes of delivering fluids or gases. 

The ISO standards will provide design and performance specifications for a range of connectors which can be used on different medical devices, intended for different applications (or routes -neuraxial, enteral, intravascular etc) and  which have been shown to reduce the risks of cross-connections between applications.

The following table shows which standard relates to which application area:

As each part is developed, laboratory testing and human factors/usability studies have been undertaken when necessary and appropriate to ensure that the designs are acceptable for health care workers, patients and the medical device industry.