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ISO/TC 34/SC 005 - Izba Mleka

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<strong>ISO</strong>/DIS 16297<br />

in order to make sure that . Ssamples chosen to evaluate the relationship should beare representative to the<br />

normal routine samples regarding these properties.<br />

Factors influencing the relation can be bacteriological or non-bacteriological, for example.<br />

These influences can be type of bacteria, growth phase, storage condition, sample preservation, geographic<br />

differences, seasonal variations, species and breed of the animals from which the milk originates, method of<br />

milking, disinfection, feeding methods or individual supplier.<br />

6.2 Measurement protocol<br />

6.2.1 Design<br />

The evaluation of the alternative method as an estimate of the reference method requires a great amount of<br />

different samples (typically 100 per log step). A minimum number of samples can be calculated according to<br />

<strong>ISO</strong> 21187 | IDF 196:2004, Annex A.<br />

Samples should:<br />

a) be natural milk samples;<br />

b) uniformly cover the whole range of interest;<br />

c) be representative of the routine samples to be analysed especially taken into account the above<br />

mentioned factors.<br />

Samples are analysed in duplicate with the reference method as well as with the alternative method at the<br />

same time or close to it.<br />

6.3 Calculations<br />

6.3.1 Visual check of a scatter diagram<br />

Before any calculation is made a scatter diagram should be checked visually to obtain a first impression of the<br />

character of the relationship and determine whether the expected relationship between the methods is<br />

approximated.<br />

6.3.2 Regression<br />

To find a useful function to describe the relationship, several statistic approaches can be used which all have<br />

their particularities and limits, but by combining the results a sufficiently exact solution can be approximated.<br />

6.3.2.1 Regression models<br />

After suitable (usually logarithmic) data transformation, the relationship between the alternative method and<br />

the reference method is assumed to be linear within the range of interest. In that case the relationship can be<br />

calculated by means of a simple linear regression model (y = abx + ba).<br />

If the relationship is not linear, it is recommended to seek advice from a statistician. Methods to check for<br />

linearity are specified in <strong>ISO</strong> 8196-3 | IDF 128-3, or use a regression program which gives the probability of<br />

lack of fit or non-linearity.<br />

If the repeatability error on for one or both methods after data transformation is still dependent on the level,<br />

apply a weighted least-squares method in accordance with <strong>ISO</strong> 11095. In such cases, it is recommended to<br />

seek advice from a statistician.<br />

In the general case where regression is applied to calibration, the vertical y-axis (dependent variable) is used<br />

for the reference method and the horizontal x-axis (independent variable) is used for the alternative method<br />

8 © <strong>ISO</strong> 2010 – All rights reserved© <strong>ISO</strong> 2010 – All rights<br />

reserved© <strong>ISO</strong> 2010 – All rights reserved

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