# Commission Decision of 12 August 2002 implementing Council Directive 96/23/EC concerning the performance of analytical methods and the interpretation of results (notified under document number C(2002) 3044) (Text with EEA relevance) (2002/657/EC), Division 3.1.2.7: Ruggedness (major changes)

Extent: E+W+S+N.I.

The analytical method should be tested under different experimental conditions, which include for example, different species, different matrices or different sampling conditions. The changes introduced should be major. The importance of these changes can be evaluated, for instance, using the Youden approach (15)(16). Each performance characteristic should be determined for all major changes that have been shown to have a significant effect on the performance of the assay.

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Source: https://www.legislation.gov.uk/eudn/2002/657/annex/chapter/3.1/division/3.1.2.7 (the official version)
Page: https://openlegislation.uk/eu-decision-2002-657/annex/chapter-3.1/division-3.1.2.7
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.