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.
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EN 1659:1996 In vitro diagnostic systems - Culture media for microbiology - Terms and definitions
EN ISO 8402:1995 Quality management and quality assurance - Vocabulary (ISO 8402:1994)
EN 1659:1996 In vitro diagnostic systems - Culture media for microbiology - Terms and definitions
EN ISO 8402:1995 Quality management and quality assurance - Vocabulary (ISO 8402:1994)