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From ISO 594 To ISO 80369

The new ISO 80369-7 standard introduces stricter dimensional and material requirements for Luer connectors that replace the previous ISO 594 standards. Manufacturers will need to update part drawings to meet new tolerances and conduct testing to ensure connectors prevent incorrect mating. Connectors must now be made of materials with over 700MPa modulus to pass performance tests including fluid leakage, stress cracking, and separation resistance according to updated test methods in ISO 80369-7. Compliance with legacy tests is not sufficient for the new standard.

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143 views2 pages

From ISO 594 To ISO 80369

The new ISO 80369-7 standard introduces stricter dimensional and material requirements for Luer connectors that replace the previous ISO 594 standards. Manufacturers will need to update part drawings to meet new tolerances and conduct testing to ensure connectors prevent incorrect mating. Connectors must now be made of materials with over 700MPa modulus to pass performance tests including fluid leakage, stress cracking, and separation resistance according to updated test methods in ISO 80369-7. Compliance with legacy tests is not sufficient for the new standard.

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TECHNICAL TIP

F R O M I S O 5 9 4 TO I S O 8 0 3 6 9 : M A K I N G S E N S E O F T H E L AT E S T
LUER REQUIREMENTS

With the release of a new ISO 80369-7 standard for Luer There are several additional characteristics that were not
connectors, many medical device manufacturers are now striving outlined in the old ISO 594 standards. As a result, injection
to achieve compliance with both new and legacy connectors. mold changes may be required to meet these new tolerances.

Bearing little resemblance to ISO 594-1/-2, the new ISO 80369-7 Next, a sample group of manufactured parts then should be
may be confusing and ambiguous with regard to exactly what measured to ensure they are within specification. Although
is needed to comply. Therefore, it is worth distilling the primary not an explicit requirement, it would be worthwhile to consider
areas of interest for those ready to test their product. dimensional stability of the part after sterilization and over time.
A post-aging dimensional study using sterilized parts is by far
the most common approach.

Our Test Services can support in the following areas:

• 2D/3D CAD model compliance reviews, drawing updates


and assessment reports

• Touch probe dimensional verification tests and reports


The following requirements from ISO 80369-7 are the most
important to adhere to for achieving compliance: • Part scanning, reverse engineering and 2D/3D CAD
modeling of legacy parts
• Dimensional and Non-Interconnectability Requirements

• Luer Connector Material Requirements

• Performance Testing

1. Dimensional and Non-Interconnectability Requirements

ISO 80369-7 has introduced the requirement that connectors


must have dimensional characteristics that prevent the incorrect
mating of the Luer connector with other liquid and gas medical
connectors. These dimensional requirements vary based on the
type of connector (i.e. male luer slip connector, female luer slip
connector, etc.).

The simplest and most cost-effective way to comply with


this requirement is to design and manufacture the connector
within the prescribed geometries and tolerances detailed in
the standard. The alternative is a lengthy and complex non-
interconnectability study involving multiple connector mating tests.

A manufacturer should begin by updating the part drawings to


reflect the ISO 80369-7 requirements.

F O R M O R E I N F O R M AT I O N
STERIS Applied Sterilization Technologies
Web: www.steris-ast.com // Email: ast_info@steris.com
(EMEAA) +44 (0) 8456 88 99 70
(Americas) 877.783.7479

TechTip #56 | Rev 1, 08/19


TECHNICAL TIP

F R O M I S O 5 9 4 TO I S O 8 0 3 6 9 : M A K I N G S E N S E O F T H E L AT E S T
LUER REQUIREMENTS

2. Luer Connector Material Requirements 2. Sub-Atmospheric Pressure Air Leakage. Compliance is


checked by applying the tests of ISO 80369-20:2015,
Connectors must now be manufactured from a material with a
Annex D
nominal modulus of elasticity (Young’s Modulus) either in flexure
or in tension greater than 700 MPa. 3. Stress Cracking. Compliance is checked by applying the
tests of ISO 80369-20:2015, Annex E followed by either
Fluid Leakage tests

4. Resistance to Separation from Axial Load. Compliance


is checked by applying the tests of ISO 80369-20:2015,
Annex F

5. Resistance to Separation from Unscrewing (Luer Lock


only). Compliance is checked by applying the tests of ISO
80369-20:2015, Annex G
Compliance must be verified by tests described in ASTM D638-
14 (tension) or ASTM D790-15e2 (flexure). The material vendor 6. Resistance to Overriding (Luer Lock only). Compliance is
should be able to provide material data sheets to confirm this. checked by applying the tests of ISO 80369-20:2015, Annex G

3. Performance Testing Summary

Connectors must now be manufactured from a material with a Despite the differences between ISO 80369-7 and its
nominal modulus of elasticity (Young’s Modulus) either in flexure predecessor, the new standard is poised to serve as the go-to
or in tension greater than 700 MPa. international standard for Luer testing and compliance. Our own
interpretation of some of the complex language has been built
As with ISO 594, connectors are required to undergo on many rounds of reading and testing, and we have therefore
performance testing. However, compliance with legacy test developed a familiarity with its step-by-step logic.
methods is not sufficient to comply with the new performance
test requirements outlined in ISO 80369-7. The good news about ISO 80369-7 is that it completely
supplants ISO 594-1/-2, and thus fulfills its requirements, which
There have been some updates to the test methods and a means device engineers need not worry about reverting to the
notable absence of the Gauging and the Ease of Assembly old standard in certain situations.
tests. An option is now available to perform Fluid Leakage by
employing a new, recommended Pressure Decay method. It would be important to also review and consider the annexes
of ISO 80369-7 in relation to usability, application-specific
A summary of the required tests are as follows: suggested attributes, and design verification and validation
1. Fluid Leakage (Leakage by Pressure Decay Method. activities.
Compliance is checked by applying the tests of ISO 80369-
20:2015, Annex B or Positive Pressure Liquid Leakage
Method. Compliance is checked by applying the tests of
ISO 80369-20:2015, Annex C)

F O R M O R E I N F O R M AT I O N
STERIS Applied Sterilization Technologies
Web: www.steris-ast.com // Email: ast_info@steris.com
(EMEAA) +44 (0) 8456 88 99 70
(Americas) 877.783.7479

TechTip #56 | Rev 1, 08/19

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