This part of ISO11843 gives a method of estimating the critical value of the response variable from the mean and standard deviation of repeated measurements of the reference state in certain situations (see 5.1) in which the value of the net state variable is zero, for all reasonable and foreseeable purposes. Hence, it can be decided whether values of the response variable in an actual state (or test sample) are above the range of values attributable to the reference state.
General procedures for determination of critical values of the response variable and the net state variable and of the minimum detectable value have been given in ISO11843-2. Those procedures are applicable in situations in which there is relevant straight-line calibration and the residual standard deviation of the measured responses is either constant or is a linear function of the net state variable. The procedure given in this part of ISO11843 for the determination of the critical value of the response variable only is recommended for situations in which no calibration data are used. The distribution of data is assumed to be normal or near-normal.
The procedure given in this part of ISO11843 is recommended for situations in which it is difficult to obtain a large amount of the actual states although a large amount of the basic state can be prepared.