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What is ISO 80369
Hospitals and other healthcare facilities depend on a variety
of catheters, tubing and syringes to deliver medications
and other substances to patients through vascular, enteral,
respiratory, epidural and intrathecal delivery systems.
These delivery systems frequently employ fittings called
luer connectors to link various system components.
Unfortunately, because luer connectors are ubiquitous,
easy-to-use, and compatible between different delivery
systems, end users can inadvertently connect the incorrect
systems together. These misconnections can cause
medication or other fluids to be delivered through the wrong
route, resulting in serious patient injuries and even death. In
an effort to reduce the occurrence of these misconnections,
the FDA is actively participating internationally to develop
and implement standards for the non-interconnectability
of small bore medical connectors. A joint working
group established by the International Organization for
Standardization (ISO) and the International Electrotechnical
Commission (IEC) leads this effort to develop a series
of standards for incompatible connectors. ISO 80369-1
is the first in the series of standards and establishes the
applications specified below that will have their own unique
connector geometries.
ISO 80369-1
General Requirements
• This standard is already published
• The second edition is currently in ballot
• Comments from this DIS ballot were reviewed partially in
March, 2015
• Discussions were held to remove the definition of Small
Bore from the standard to prevent it from limiting the
connector size
• The committee agreed to remove the number references
• The committee also discussed the following:
• Allowing softer materials in sealing surfaces
• Allowing proprietary connectors to claim compliance
to 80369-1
• The standard is expected to be updated to a second
edition later in 2016
ISO 80369-2
Respiratory (Breathing Systems)
• The task group now comprises of many global players
from the industry
• DIS draft is complete, and the ballot is open
• R1 and R2 designs are changing to address
misconnections and dead space
• The standard is expected to release by the end of 2016
ISO 80369-3
Enteral Feeding
• DIS with the proposed connector designs has passed
with many favorable votes in the recent ballot
• FDA issued a notification to manufacturers of medical
devices with connectors recognizing AAMI’s US
Provisional Standard for Enteral until the final 80369-3 is
published: www.fda.gov
• Efforts to delay the implementation of CA Mandate Bill AB
1847 has passed through multiple steps and is awaiting
the Governor’s signature. A successful resolution will push
the deadline to July, 2016.
• The standard is expected to be released by the end of 2015
ISO 80369-4
Urinary and Urethral
• No updates at this time
ISO 80369 STANDARDS & UPDATES
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80369
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