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

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

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1   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:
  1. 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);
  2. b) non-commercial organizations that distribute media to satellite locations;
  3. c) laboratories that prepare culture media for their own use.
Cell culture media are not covered by this standard.