Elitech FreezePoint 6000 Series User Manual page 134

Installation, Operation, and Performance Qualification
D. Verification of Instruments CAL2 (if used for 3-point calibration):
6. Verification Procedure - Check of Accuracy*
Purpose: Verification of Linearity of the Instrument.
Method: Prior to verification procedure, one measurement with distilled water is to be performed to
avoid risk of contamination with salt at the thermistor. We recommend this procedure if the osmolality
measured changes from high to low!
A. Choose a Standard Solution (e.g. ELITechGroup Calibration Standards or Reference Solutions)
B. Perform 5 measurements. Compute mean value and standard deviation. Compare the mean
* Both verification procedures presented here – testing for Precision and Accuracy are recommendations
from us as manufacturer. Each laboratory should use the materials and expected ranges provided in this
document as a guidance to develop a comprehensive Quality Control program exclusive to their laboratory.
It may be necessary to observe national or international Pharmacopoeias, Quality Control programs or
national Clinical Standards.
** Alternatively, the results can be compared with the total expected result range, which includes
contributions of uncertainties due to instrument's accuracy, repeatability and solutions' expected range
(bias).
COMMENTS
..........................................................................................................................................................................
..........................................................................................................................................................................
Date ............................
Completed by ..............................................
Date ............................
Verified by ..............................................
Compute either standard deviation (SD) or coefficient of variation (CV) depending if instrument
precision specifications ("Precision (within run repeatability)" on page 126) for the measuring
range of the CAL1 solution are based on SD or CV. Also compute the mean value.
Compare the SD (or CV) result with the instrument precision specifications for the measuring
range corresponding to the nominal value of the CAL1 solution, confirming that the results meet
the specified criterion. Also compare and confirm that the mean value does not differ from the
nominal value of CAL1 by more than the same criterion. The calibration needs to be repeated if
either comparison does not meet the specified criterion.
Perform 10 measurements with the previously used calibration solution for CAL2.
Compute either standard deviation (SD) or coefficient of variation (CV) depending if instrument
precision specifications ("Precision (within run repeatability)" on page 126) for the measuring
range of the CAL2 solution are based on SD or CV. Also compute the mean value.
Compare the SD (or CV) result with the instrument precision specifications for the measuring
range corresponding to the nominal value of the CAL2 solution, confirming that the results meet
the specified criterion. Also compare and confirm that the mean value does not differ from the
nominal value of CAL2 by more than the same criterion. The calibration needs to be repeated if
either comparison does not meet the specified criterion.
or a solution of known osmolality that lies within the calibrated range and close to the expected
value of your Sample Solution.
value with the specified accuracy of the device in the corresponding range. ("Accuracy
(Linearity)" on page 127)**. (Standard deviation is computed for reference purposes only.)
134