Division 1.33

Ruggedness means the susceptibility of an analytical method to changes in experimental conditions which can be expressed as a list of the sample materials, analytes, storage conditions, environmental and/or sample preparation conditions under which the method can be applied as presented or with specified minor modifications. For all experimental conditions which could in practice be subject to fluctuation (e.g. stability of reagents, composition of the sample, pH, temperature) any variations which could affect the analytical result should be indicated.