ISO 80369-1:2010

• Date: March 30, 2011
• Source: Admin

ISO 80369-1:2010 defines general requirements for small-bore connectors. These connectors carry liquids or gases in healthcare applications. They are used in medial devices or accessories planned for a patient’s use.

ISO 80369-1:2010 also specifies the healthcare fields in which these small-bore connectors are intended to be used.

These small-bore connectors are used in healthcare applications such as:

• Breathing systems and driving gases
• Enteral (feeding tube) and gastric applications
• Urethral and urinary tubing
• Limb cuff inflation or non-invasive blood pressure
• Neuraxial applications used in the delivery of medications to spinal fluid
• Intravascular or hypodermic applications

Small-bore connectors are non-interconnectable with:

• The cones and sockets of ISO 5356-1:2004 and ISO 5356-2:2006;
• The temperature sensor connector and mating ports specified in Annex DD of ISO 8185:2007; and
• The nipples of EN 13544-2:2002.

ISO 80369-1:2010 offers an approach to assess the 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. It also provides an approach to reduce the risk of misconnections between medical devices with 6 % Luer connectors, and all other non-Luer (6 %) connectors that will be developed in future under 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.

Regulations

ISO 80369-1:2010 provides regulations for manufacturers on how to create a connector for their device and how to prepare for the remaining standards in the series. Sometimes multiple lines are connected to patients to deliver medicine and nutrients. The main problem is that numerous devices use the universal luer lock connector, which is a type of small-bore connector.

Through this connector, a healthcare worker could connect one device used for one application by mistake, such as a feeding tube to another device used for another application such as an intravenous fluid.

The goal of this series is to create connectors that can be used only among devices used for the same clinical application.

This standard offers manufacturers information on how to design a safe connector for just their medical devices within a specific clinical application.

Source

http://www.iso.org/iso/iso_catalogue/catalogue_ics/catalogue_detail_ics.htm?csnumber=45976&ics1=11&ics2=040&ics3=10

http://www.aami.org/publications/aaminews/Jan2011/80369.html