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Non-Luers
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ISO 80369
There is a new standard in development known as ISO 80369, to minimize misconnections of small-bore connectors
used in liquid and gas healthcare applications. Qosina carries thousands of stock components including small-bore
connectors, and you may be affected by this new ISO 80369 standard. We would like to make you aware of the future
changes and are happy to talk to you about your concerns and help plan for the implementation.
Why is there a new ISO standard being developed?
Small-bore connectors convey liquids or gases in a patient-care setting. Such connectors are used in IV Access, enteral
feeding tubes, breathing systems, urinary catheters, and many other healthcare applications.
Patients often have multiple lines connected to them to deliver medicine and nutrients. Numerous devices and systems
use the universal luer lock connector, which is a type of small-bore connector. A small-bore connector is defined as
having an ID of less than 8.5 mm, and a luer is defined by the ISO 594-1 and ISO 594-2 standards as: “... a conical fitting
with a 6% taper for syringes, needles, and certain other medical equipment.”
Through this luer connector, a healthcare worker or patient could mistakenly connect one device used for one
application, such as enteral nutrition, to another device used for another application such as intravenous therapy. These
types of mistakes were highlighted in an FDA report from 2009 (AAMI News: Jan 2011: New Standard).
How does this affect you?
If you are currently using any small-bore connectors in a kit, set, or line, which drives gas or pressurized fluids to
patients or are using luers in non-IV applications, this may impact you. This standard will involve some key changes
from component suppliers, which may include designing new connectors or modifying existing connectors to meet the
specifications in the new standard.
What does the ISO 80369 standard cover?
The new standard ISO 80369-1, approved in the fall of 2010, is for medical device manufacturers and gives guidance
on how to create connectors for different applications to prevent accidental misconnections and how to prepare for the
remaining standards in the series.
ISO 80369-1 specifies the general requirements for small-bore connectors, which convey liquids or gases in healthcare
applications, and are part of medical devices intended for use with a patient. It also specifies the healthcare fields in
which these small-bore connectors are intended to be used. It basically will provide the structure for risk mitigation, and
how to validate the new design.
Each of the remaining standards in the series will focus on the specific healthcare fields, the clinical applications, and the
design requirements for each connector which must be used in the related delivery systems.
NEW ISO 80369 Small-Bore Connector Standards