Effect of Fixtures on Test Method Validation

D

deepuasok

#1
Hi all :),

Our company is currently validating the test methods for a particular medical product. We have mostly tension/compression tests measuring the attachment/removal forces between the various mated components of the medical devices. But we found many test methods which could be leveraged for this validations study from other product families which were pretty much the same methods,range,crosshead speed etc. except for the test fixtures. Would this be a significant factor. As the test fixture serves the purpose of holding the component,without actually being a part of the measurement system, should'nt we be able to leverage those methods even though the fixtures are different. Basically the method of attaching/removing the cap,adaptor etc are the same,but the fixture used to hold them are different.What is your opinion on this?

-Deepu :bigwave:
 
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Bev D

Heretical Statistician
Staff member
Super Moderator
#2
no opinion, just experience. in my experience the fixture can have a substantial effect on the measuements, they actually are considered to be part of the measuring system.

I once went through 3 different fixtures before I found one that would be (mostly) neutral in a measurement of hte pull force required to separate two mating parts. If you draw the free body force diagrams you can see how any holding fixture can change the forces that are applied to the object vs those that are wasted in the system. (I do work in the medical device industry)
 
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