SRPS EN 12322:2008

In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media

Scope

This European Standard specifies requirements for the performance of culture media. It is concerned with the traceability, comparability, reproducibility and suitability of culture media used in microbiological laboratories. These characteristics are achieved by applying the quality criteria outlined in this standard. This European Standard is applicable to : a) commercial organizations distributing media to microbiology laboratories in ready-to-use form, as dehydrated media or as semi-finished media (see 2.5 in EN 1659 : 1996) ; b) non commercial organizations that distribute media to satellite locations ; c) laboratories that prepare culture media for their own use. Cell culture media are not covered by this standard.

Related directives

NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.