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 ISO 11843-2. 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 ISO 11843 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 ISO 11843 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.