Determining Calibration Tolerance for new Leak and Occlusion Equipment

H

hfmm_87

#1
Hi all,

This is my first post in here, I work in a medical company at Tijuana, Mexico, we are introducing a leak and occlusion tester developed by an external supplier with out requirements, this will perform an occlusion test and right away the occlusion is done it will perform a leak test, all this with a pressure transducer that converts the PSI with a formula depending on the volume, pressure decay, of the IV set that is going to be tested on the equipment for the leak.
For the occlusion test the equipment works on a table, we have severeal leak masters from 0 to 7 LPMs and we are creating a table with pressure decay, according to the pressure decay it will relate to the LPMs that fo thrue the IV set and relate to the proper number of LPMs created on the table.

Our current specs for leak is 1.0 sccm or 0.5 sccm, for occlusion goes between 0.1 LPMs and 5.0 LPMs.

For the calibration of equipment we are able to calibrate the pression with a Pressure Calibrator (Druck) and verify the leak and occlusion with leak masters. Here is the real question, the supplier did not give us tolerance for this equipment neither on pressure/leak/occlusion, as we are working together with the supplier this has been one of the thigs that has stoped us on the develope process, we are using 5% tolerance for each leak master on leak and occlusion, but this is just because thats the tolerance that the leak master is given us.

How can we deterime the calibration tolerances of the equipment for the several test?
 
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#3
Another quick "Bump". My Thanks in advance to anyone who can help with this one.

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