scope:

This European Standard provides guidelines for a quality control procedure of a diagnostic kit to assure that the assay results will fulfil the intended purpose of the test by both manufacturers and users. This European Standard applies to diagnostic kits used in agriculture, plant and animal pest and disease control monitoring of feed and environmental contamination due to microorganisms. This standard does not apply to diagnostic kits used either in food industry or for human health monitoring, or control of non biological contaminants.