Medical Design Briefs - January 2024 - 19

ISO 80369-7 TEST
Test
Piece Type
Male Locking
Luer
Male Slip Luer
Female
Locking Luer
Male Slip Luer
Female Slip
Luer
Male Slip Luer
X(*)
X
X(*,^)
X
X(*,^)
X
X(*)
X
Table 1. Test requirements for each possible configuration. The tests with a (*) are only required if the female locking Luer under test isn't specifically indicated for use
with a male Luer lock device. In addition, the tests with a (^) can be omitted through a worst-case analysis and justification. In our discussions with representatives from
the ISO Technical Committee responsible for ISO 80369-7, we were able to conclude that in certain circumstances, a rigorous examination of each test could lead to a
determination of a worst-case configuration.
Testing Against Slip and Lock Reference
Connectors - When Is it Required?
The separation of ISO 594-1 for slip Luers
and 594-2 for locking Luers created a
convenient distinction between their separate
requirements, but also a lack of clarity
about if and when both sets of tests needed
to be performed. ISO 80369-7 contains
both requirements within the same document
but is still not explicit about when
one should invoke the tests against both
slip and lock reference connectors.
This is an important consideration
when qualifying a female locking Luer,
as both male slip and locking Luers can
easily be connected. The simplest answer
is that if a device with a female locking
Luer is intended to connect with a specific
device that has a male locking Luer,
then the female locking Luer only needs
to be tested against the male locking reference
connector. If the device's use is
not as specific, or if it's uncertain, then
both sets of requirements are in play. Table
1 lists the test requirements for each
possible configuration.
Modifications to Assembly and Test
Procedures
One of the critical elements of ISO
594 was a standardization of the torque
and axial force used to assemble a test
sample to a reference connector. ISO
Medical Design Briefs, January 2024
ISO 80369-7
Lock Connectors
Table 2. Assembly parameters of ISO 594 and 80369.
26.5≤x≤27.5
0.8≤x≤0.12
80369-20, which is the standard that defines
how to conduct the test methods,
narrows the range of acceptable torque
and axial force, utilizes the same assembly
values for every test, and clarifies the
assembly procedure for products with
floating or rotatable collars. Table 2 outlines
the assembly parameters of ISO 594
and 80369. In addition to changes in the
assembly parameters, many of the tests
have changed substantially as well; titles
Test
Standard
ISO 594-1
Test
Method
Axial Force (N)
All
ISO 594-2
Leakage, Separation
Force, Unscrewing
Torque, Resistance
to Overriding
Ease of Assembly
Stress Cracking
Slip Connectors
27.5
≤27.5
≤20
≥27.5
26.5≤x≤27.5
Torque (N*m)
≤0.1
≤0.12
≤0.08
≥0.12
0.8≤x≤0.10
and test parameters have been modified,
new tests have been added, and the ease
of assembly test was eliminated because
of its subjectivity. Table 3 compares and
contrasts some of the most significant
changes to each test.
Addition of Guidance for Performance of
Variable Tests
Annex J in ISO 80369-20 contains specific
instructions and guidance on how
Assembly Parameters
Reference
Connector
Type
Female
Locking Luer
Female
Slip Luer
Male Locking
Luer
SubFluid
Leakage
X
X
X
Atmospheric
Pressure
Air
Leakage
X
X
X
Stress
Cracking
X
X
X
Resistance to
Separation
from
Axial Load
X
X
X
X
X
Resistance
to
Separation
from
Unscrewing
X
Resistance to
Overriding
X
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Medical Design Briefs - January 2024

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