CUSTOM ENGINEERING CUSTOM SOLUTIONS EXCEPTIONAL VALUE
(1.8” x .95” x .60”)
( 3. 2” x 1.9” x .90”)
( 5. 5” x 3. 5” x 2. 7”)
( 2. 2” x .91” x 1.8”)
influenced by state legislation.
ISO 80369-7 states that the existing Luer
connector will be maintained only for vascular
access in the form of intravascular and hypodermic applications.
The AAMI/ISO working group for small bore
connectors for liquids and gases in healthcare
applications (ISO 80369) met at the DIN office
in Berlin, Germany between March 17 and
March 21, 2014. The agenda of this meeting
included reviewing the recent ballot results
and arriving at a resolution of the following
committee drafts: ISO/CD 80369-1 general
requirements, ISO 80369-20 common test
methods, ISO 80369-3 enteral feeding, and
ISO 80369-7 intravascular. Updates were
also provided by the task groups leading ISO
80369-5 limb cuff inflation, ISO 80369-6
neuraxial, and ISO 80369-2 respiratory.
Highlights from the Berlin working group
• ISO 80369-1 General Requirements – The
current version is already released and avail-
able to the general public. A new version is
being worked on by the committee and is
expected to be released in 2016.
• ISO 80369-2 Connectors for Breathing
Systems and Driving Gases Applications –
The committee facilitated the creation of
a task (sub) group that will be trusted with
building tools, molding connectors, and
completing the functional tests as per ISO
80369-20. The standard is expected to be
released in 2015.
• ISO 80369-3 Connectors for Enteral Applications – The committee decided that the
proposed E1 connector design is applicable
for both adult and pediatric applications.
• ISO 80369-5 Connectors for Limb-Cuff
Applications – Functional testing of parts
conforming to the CAD designs are scheduled to start now. This standard is expected
to be released in late 2014 or early 2015.
• ISO 80369-6 Connectors for Neuraxial Ap-
plications – Functional testing of parts con-
forming to the CAD designs is in progress.
It was discovered that in certain situations,
the parts could misconnect with luers. The
CAD committee offered options during the
meeting session, such as modified thread
designs and revised specifications, to miti-
gate these misconnections. This standard is
expected to be released between late 2014
and early 2015.
• ISO 80369-7 Connectors with 6% (Luer)
Taper for Intravascular or Hypodermic
Applications – The committee is now preparing a Final Draft International Standard
(FDIS) draft. This standard is expected to be
published late in 2014.
• ISO 80369-20 Common Test Methods –
This standard is now expected to be
released in late 2014.
The unique driving force about the ISO 80369
standard that is pushing the unilateral participation and collaboration by so many different
manufacturers, healthcare providers, organizations, and regulatory bodies is patient safety.
These medical devices, and the small-bore connectors that facilitate their application, are used
to interface directly with patients in hospitals
and healthcare facilities.
From the device manufacturer to the healthcare provider to the patient, it is a win-win situation of improved and safer medical care. MDT
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