What changes with the application of ISO 80369-20?
Can the Enersol S15 Force/Torque Assembly Machine be used under ISO 80369-20 Requirements?
Let’s start with the Root Logic:
The Luer connection is designed so that a medical professional can achieve a leak-free seal between male and female connectors using no tools; only hand power, by applying simultaneous axial force (push) and torque (twist). The greater the human powered push and twist, the more secure is the leak-proof connection. Conversely; there will be no seal if no axial force or no torque is applied to an assembly.
Prior to ISO 80369-20:
Maximum Test Parameters:
Prior to ISO 80369-20; all medical Luer connector specifications were based on ISO 594. ISO 594 identified only maximum values for Axial Force and Torque. The maximum value was established to simulate a child making the assembly; postulating that this would be the worst case scenario for any connection. If an assembly passes a test in that condition, any connection made by a person with more muscle mass would surely be an acceptable leak-free connection. If a weight-lifter were to make the assembly it would be more secure and less likely to leak. The S15 Enersol Force/Torque Fitting Assembly Machine, or a similar machine, was needed to assure that the maximum values were not exceeded.
Minimum Test Parameters:
Prior to ISO 80369-20 no specifications, including ISO 594, identified any minimum values for Axial Force and Torque. Any push and twist up to the maximum specified values was allowed for the test. Because of the intrinsic design ability of the Luer conical connection; if only half the maximum specified axial force and torque were applied and the connection passed the test, the connection will certainly pass the test if the maximum specified axial force and torque were applied. Logically thinking; anyone making these tests desires the test part to pass the test. Knowing that the part is more likely to pass the test if more push and twist is applied; a logical person will make an effort to apply the maximum specified axial force and torque when assembling the reference connector to the test piece. If a leak occurs in the test, rest assured that the person conducting the test will double check the assembly axial force and torque and test again.
With the 2015 codification of ISO 80369-20:
Because the codification process of ISO specifications is conducted by large international committee, the concept of having only a maximum value was difficult to be accepted. I think this is because "standard testing" requires that all parameters be controlled by minimum and maximum boundaries. Thus ISO 80369-20 added an unnecessary minimum axial force and minimum torque. ISO 80369-20 also added minimum and maximum dwell time.
Will the S15 Enersol Force/Torque Fitting Assembly Machine be able to be used for tests conducted under ISO 80369-20?
The answer is YES and NO.
You may be required to provide validation that the axial force, and torque were applied between the minimum and maximum values by a customer or third party observer. In this situation the S15 Enersol Force/Torque Fitting Assembly Machine will not provide that data. You may be allowed to use the S15 Enersol Force/Torque Fitting Assembly Machine as an exception, but my experience says that it will be nearly an impossible task to gain such an exception.
When you are providing testing for your own company’s products where logic and functionality can be accepted, then the S15 Enersol Force/Torque Fitting Assembly Machine will easily meet the requirements. Remembering the logic as stated above; the Luer connection by design becomes more leak-free as more axial force and torque is applied, you only need to assure that you have not applied more than the maximum allowed values. It is obvious that applying less is counterproductive. The additional requirement of dwell time, with the focus on not exceeding the maximum value, can be achieved with a stopwatch or some similar timer while making the connection.
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 document: ISO80369-20:2015; which is a copyrighted document. To purchase a copy visit
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Original Posting: 1/11/2016
Last Revision: 2/15/2016
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