025
a
6
What is ISO80369
Hospitals andother healthcare facilitiesdependonavariety
of catheters, tubingand syringes todelivermedications and
other substances topatients throughvascular, enteral, respi-
ratory, epidural and intrathecal delivery systems. Thesedeliv-
ery systems frequentlyemployfittings called luer connectors
to linkvarious system components. Unfortunately, because
luer connectors areubiquitous, easy-to-useand compatible
betweendifferent delivery systems, clinicians can inadver-
tently connectwrong systems together, causingmedication
or other fluids tobedelivered through thewrong route. Such
errors can cause seriouspatient injuries anddeaths. To further
reduce theoccurrenceof thesemisconnections, theFDA is
activelyparticipating inan international effort todevelopand
implement standards for noninterchangeable connectors for
small boremedical connectors. A jointworkinggroupestab-
lishedby the International Organization for Standardization
(ISO) and the International Electrotechnical Commission (IEC)
leads this effort todevelopa seriesof standards for incom-
patible connectors. ISO80369-1 is thefirst in the seriesof
standards andestablishes theapplications specifiedbelow
thatwill have their ownunique connector geometries.
ISO80369-2:
BreathingSystems andDrivingGases
ISO80369-3:
Enteral andGastric
ISO80369-4:
Urethral andUrinary
ISO80369-5:
LimbCuff Inflation
ISO80369-6:
Neuraxial
ISO80369-7:
Intravascular (IV)
Whenwill it come intoeffect?
Each sectionof the ISO80369 standard isbeingdefined
separately. Currently, ISO80369-2and ISO80369-7are the
farthest along indevelopment, yet it isdifficult to saywhen
theentire standardwill be complete.
Howdoes it impactme?
Compliancewith the ISO80369 standardmay requiremajor
changeson thepart ofmedical devicemanufacturers. In
thenext fewyears, if these standards areapproved it could
meannewdesigns, newparts, newmoldings andupdating
or replacingmillionsof components.Whileyoumay choose
tomanufactureyour own customfittings, youmust consider
the significant costs associatedwith suchanendeavor. There
is also thepossibility that these customfittingsmay inadver-
tently connectwithother applications’ fittings that arenot yet
defined.
It is important tonote that if this standardpasses, it does
notmean that luers canno longer beused in the referenced
markets. Until connectors aredefinedandapproved for each
market, nodefinitiveaction canbe taken.
How can I prepare?
While the standardshavenot yet been completelyestab-
lished, themainprecaution thatmedical devicemanufacturers
can take tohelpprevent any futureproblems is to stayup-to-
dateon ISO80369news. Value Plastics isoneof onlya few
connector companiesworldwideactivelyparticipatingon ISO
80369 committees. Tokeep themedical device community
apprisedof newdevelopments,wehave chosen toprovide
information inoneweb location. ValuePlasticshas set upan
online resource tohelpmedical deviceOEMs stay informedof
the changes andupdates to this standard.
To read the latest updates, subscribe toalerts, andview
related resources, go toValuePlastics’ online resourceat
ISO80369STANDARDS&UPDATES
ISO
80369
i8.valueplastics.com
