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Why Use A Connector Assembly Device

 

Why Use A Connector Assembly Device

 

 
Needed for Valid Test Results
A Connector Assembly Device is mandatory for valid testing of Small Bore Medical Connectors defined in ISO 80369 Part 20: Common Test Methods. Tests conducted without controlled connector assembly will be invalid. This issue has many parts which are addressed individually below.
 
ISO 594 Replaced by ISO 80369-7
The tests were originally identify and specified in ISO 594. ISO 80369-7:2016 cancels and replaces the first edition ISO 594-1:1986 and the second edition of ISO 594-2:1998, clauses, subclauses, tables, figures, and annexes of which have been consolidated and technically revised. Because of this, ISO 594 connections must be tested per ISO 80369-7 requirements. Read: Discussion on the change. The test definitions were moved from ISO 594 to ISO 80369-20 so that they could be shared among all of the ISO 80369 parts.
 
ISO 80369-20 Specifies Very Light Torque and Force Requirements.
When the ISO 80369-20 Test Parameters Luer Fitting Standard was designed, the test method was targeted to replicate the lightest assembly strength needed to make a leak proof Luer connection. The torque and force requirements were set at the low end of the scale so that even a child could assemble the Luer connection and the seal would hold fast. It is known that as more force or torque is applied the seal will improve. Testing the Luer seal at low values automatically validates higher torque or force values.
 
ISO 80369-20 Specifies Specific Values which are Verifiable.
When a test piece and reference fitting are assembled, the force and torque applied to the assembly should be recorded. Both force and torque are defined in ISO 80369-20 Common Test Methods and can be measured and shown to meet the required range. This is important because if the test is performed on an assembly that has been assembled outside of these ranges, the test is invalid. If assembled with too little force or torque the test will likely fail. If assembled with too much force or torque the probability that the assembly will pass the test is greatly improved, but the test will be invalid.
 
ISO 80369-20 Requires Simultaneous Application of Both Force and Torque.
ISO 80369-20 is cited below and in each of the citations the force and torque must be applied at the same time; simultaneously. Applied separately the force and torque have different results in the Luer Test Piece/Reference Fitting assembly and will exhibit different results under test conditions. To assure compliance with the ISO 80369-20 Common Test Methods, and repeatability of ISO 80369 designated test results, the force and torque must be applied in unison.
 
Variation in Test Results Create Test Disputes.
If there is a contest between two entities about test results; when the test results are reporting disparate test results; check for adherence to the ISO 80369-20 Common Test Methods requirements. Assure that torque and force are applied simultaneously. Assure that the torque and force values are verifiable. Check to see if one or both parties in the dispute are violating the ISO 80369-20 Common Test Methods requirements. I think that it is too common that many companies do not use a machine like the Medi-Luer Assembly Machine, or the Enersol Connector Assembly Device. This holds true for both manufacturers and testing laboratories. The problem with that fact is that the test results may be invalid. If invalid test results were submitted to FDA for approval, the whole approval process may be flawed. Any test result that exceeds the limits of the ISO 80369-20 Common Test Methods are flawed and worthy of being questioned.
 
How to Correctly Make the ISO Luer Test Piece/Reference Connector Assembly.
The best way to correctly make the ISO Luer Test Piece/Reference Fitting assembly is to use the Medi-Luer Assembly Machine, or the Enersol Connector Assembly Device. When used appropriately these devices will eliminate the test violations because they are designed specifically to make the ISO Luer Test to Reference Connector/Fitting assembly. What makes these machines special is that they apply the force and torque simultaneously. This is a little tricky to accomplish because most testing machines will apply either force or torque, not both simultaneously. These devices are designed to accomplish the simultaneous assembly.
 
Testing In-House or Out-Sourced?
If the requirement is only to have a few pieces tested, a limited testing requirement, we can make a referral to a laboratory which will make the ISO Luer Test Piece/Reference Fitting assembly in full accordance with the ISO 594 Luer standard.
 
Citations from ISO 80369-20: Common Test Methods:
The citations listed below all indicate simultaneous applacation of force and torque. These citations encompass all of the test methods listed in ISO 80369-20. ISO 80369-20 lists the test methods in separate Appendices.
 
ISO 80369-20 Annex B: Leakage By Pressure Decay Test Method
Paragraph B.4.b)
For a non-locking (slip) connector, assemble by applying an axial force of between 26,5 N and 27,5 N for 5 s to 6 s while rotating the connector under test to a torque of between 0,08 N·m and 0,10 N·m and a rotation not exceeding 90°.
Paragraph B.4.c)
For a locking connector with fixed threads, assemble by applying an axial force of between 26,5 N and 27,5 N for 5 s to 6 s while rotating the connector under test to a torque of between 0,08 N·m and 0,12 N·m.
Paragraph B.4.d)
For a connector with a floating or rotatable collar, assemble by introducing the mating features (i.e. connector taper) together with an axial force of between 26,5 N and 27,5 N for 5 s to 6 s while rotating the collar of the connector under test to a torque of between 0,08 N·m and 0,12 N·m.
 
ISO 80369-20 Annex C: Falling Drop Positive-Pressure Liquid Leakage Test Method
Paragraph C.4.b)
For a non-locking (slip) connector, assemble by applying an axial force of between 26,5 N and 27,5 N for 5 s to 6 s while rotating the connector under test to a torque of between 0,08 N·m and 0,10 N·m and a rotation not exceeding 90°.
Paragraph C.4.c)
For a locking connector with fixed threads, assemble by applying an axial force of between 26,5 N and 27,5 N for 5 s to 6 s while rotating the connector under test to a torque of between 0,08 N·m and 0,12 N·m.
Paragraph C.4.d)
For a connector with a floating or rotatable collar, assemble by introducing the mating features (i.e. connector taper) together with an axial force of between 26,5 N and 27,5 N for 5 s to 6 s while rotating the collar of the connector under test to a torque of between 0,08 N·m and 0,12 N·m.
 
ISO 80369-20 Annex D: Subatmospheric-Pressure Air Leakage Test Method
Paragraph D.4.b)
For a non-locking (slip) connector, assemble by applying an axial force of between 26,5 N and 27,5 N for 5 s to 6 s while rotating the connector under test to a torque of between 0,08 N·m and 0,10 N·m and a rotation not exceeding 90°.
Paragraph D.4.c)
For a locking connector with fixed threads, assemble by applying an axial force of between 26,5 N and 27,5 N for 5 s to 6 s while rotating the connector under test to a torque of between 0,08 N·m and 0,12 N·m.
Paragraph D.4.d)
For a connector with a floating or rotatable collar, assemble by introducing the mating features (i.e. connector taper) together with an axial force of between 26,5 N and 27,5 N for 5 s to 6 s while rotating the collar of the connector under test to a torque of between 0,08 N·m and 0,12 N·m.
 
ISO 80369-20 Annex E: Stress Cracking Test Method
Paragraph E.4.b)
For a non-locking (slip) connector, assemble by applying an axial force of between 26,5 N and 27,5 N for 5 s to 6 s while rotating the connector under test to a torque of between 0,08 N·m and 0,10 N·m and a rotation not exceeding 90°.
Paragraph E.4.c)
For a locking connector with fixed threads, assemble by applying an axial force of between 26,5 N and 27,5 N for 5 s to 6 s while rotating the connector under test to a torque of between 0,08 N·m and 0,12 N·m.
Paragraph E.4.d)
For a connector with a floating or rotatable collar, assemble by introducing the mating features (i.e. connector taper) together with an axial force of between 26,5 N and 27,5 N for 5 s to 6 s while rotating the collar of the connector under test to a torque of between 0,08 N·m and 0,12 N·m.
 
ISO 80369-20 Annex F: Resistance To Separation From Axial Load Test Method
Paragraph F.4.b)
For a non-locking (slip) connector, assemble by applying an axial force of between 26,5 N and 27,5 N for 5 s to 6 s while rotating the connector under test to a torque of between 0,08 N·m and 0,10 N·m and a rotation not exceeding 90°.
Paragraph F.4.c)
For a locking connector with fixed threads, assemble by applying an axial force of between 26,5 N and 27,5 N for 5 s to 6 s while rotating the connector under test to a torque of between 0,08 N·m and 0,12 N·m.
Paragraph F.4.d)
For a connector with a floating or rotatable collar, assemble by introducing the mating features (i.e. connector taper) together with an axial force of between 26,5 N and 27,5 N for 5 s to 6 s while rotating the collar of the connector under test to a torque of between 0,08 N·m and 0,12 N·m.
 
ISO 80369-20 Annex G: Resistance To Separation From Axial Load Test Method
Paragraph G.4.b)
For a locking connector with fixed threads, assemble by applying an axial force of between 26,5 N and 27,5 N for 5 s to 6 s while rotating the connector under test to a torque of between 0,08 N·m and 0,12 N·m.
Paragraph G.4.c)
For a connector with a floating or rotatable collar, assemble by introducing the mating features (i.e. connector taper) together with an axial force of between 26,5 N and 27,5 N for 5 s to 6 s while rotating the collar of the connector under test to a torque of between 0,08 N·m and 0,12 N·m.
 
ISO 80369-20 Annex H: Resistance To Overriding Test Method
Paragraph H.4.b)
For a locking connector with fixed threads, assemble by applying an axial force of between 26,5 N and 27,5 N for 5 s to 6 s while rotating the connector under test to a torque of between 0,08 N·m and 0,12 N·m.
Paragraph H.4.c)
For a connector with a floating or rotatable collar, assemble by introducing the mating features (i.e. connector taper) together with an axial force of between 26,5 N and 27,5 N for 5 s to 6 s while rotating the collar of the connector under test to a torque of between 0,08 N·m and 0,12 N·m.
 
ISO 80369-20 Annex I: Disconnection By Unscrewing Test Method
Paragraph I.4.b)
For a non-locking (slip) connector, assemble by applying an axial force of between 26,5 N and 27,5 N for 5 s to 6 s while rotating the connector under test to a torque of between 0,08 N·m and 0,10 N·m and a rotation not exceeding 90°.
Paragraph I.4.c)
For a locking connector with fixed threads, assemble by applying an axial force of between 26,5 N and 27,5 N for 5 s to 6 s while rotating the connector under test to a torque of between 0,08 N·m and 0,12 N·m.
Paragraph I.4.d)
For a connector with a floating or rotatable collar, assemble by introducing the mating features (i.e. connector taper) together with an axial force of between 26,5 N and 27,5 N for 5 s to 6 s while rotating the collar of the connector under test to a torque of between 0,08 N·m and 0,12 N·m.
 

Disclaimer:
This data is provided for general information only. The intention is to provide accurate information; regardless; errors may exist in the supplied information. If accuracy is critical, base your final decisions on the data provided in the root documents: ISO594/1:1986; ISO 594/2:1998; ISO 80369-7; and ISO80369-20 which are copyrighted documents.
To purchase copies visit an Authorized Reseller.

Comments:
Original Posting: May 6, 2009
Last Revision: 1/16/2017
Error corrections in, or comments about, the above data can be sent to: gageguy@gagecrib.com

 
 
 

 

 

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