What is BS EN 12322 - Performance criteria for culture media about?
BS EN 12322 is a European standard that discusses the culture media for microbiology. BS EN 12322 outlines the requirements for the performance of culture media to enhance the efficiency of culture media.
BS EN 12322 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 BS EN 12322.
BS EN 12322 applies to:
- Commercial organizations that distribute media to microbiology laboratories in ready-to-use form, as dehydrated media, or as semi-finished media (see 5 in EN 1659:1996)
- Non-commercial organizations that distribute media to satellite locations
- Laboratories that prepare culture media for their use
Note: Cell culture media are not covered by BS EN 12322.
Who is BS EN 12322 - Performance criteria for culture media for?
BS EN 12322 on performance criteria for culture media is useful for:
- Manufacturers of In vitro diagnostic medical devices
- Microbiological laboratories
- In vitro diagnostic centres
- Regulatory authorities
Why should you use BS EN 12322 - Performance criteria for culture media?
In the microbiology laboratory, many tests and procedures depend on culture media being consistent and providing reproducible results.
Several hundreds of formulae of dehydrated culture media are commercially available, and many more designed for specific growth responses or purposes are described in the literature. In addition, in clinical and industrial laboratories, the main objectives are growth and rapid and sensitive detection of micro-organisms. Performance criteria for culture media are necessary for obtaining comparable products of the same medium type, regardless of source.
Performance criteria under BS EN 12322 assist all microbiology laboratories in the evaluation of nutritive and selective properties of (new) culture media.
BS EN 12322 guideline provides you with performance evaluation, general quality criteria, control strains, microbiological quality criteria, performance evaluation, interpretation of results, and information to be supplied by the manufacturer to maintain acceptable performance criteria for culture media.
Uniform performance criteria for culture media assists in the manufacture of “standardized” products and limit the amount of testing of commercial culture media in microbiology laboratories.