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EN 12322:1999

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

Edition date: 2025-02-20
In Force
Summary: 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.

La présente norme européenne spécifie les exigences relatives à la performance des milieux de culture. Elle traite de la traçabilité, de la comparabilité, de la reproductibilité et de la pertinence des milieux de culture utilisés dans les laboratoires. Ces caractéristiques sont obtenues en appliquant les critères de qualité présentés dans la présente norme.

Diese Europäische Norm legt Leistungsanforderungen an Kulturmedien fest. Sie bezieht sich auf die Rückverfolgbarkeit, Vergleichbarkeit, Reproduzierbarkeit und Eignung von Kulturmedien, die in mikrobiologischen Laboratorien eingesetzt werden. Diese Merkmale werden durch Einhaltung der in dieser Norm beschriebenen Qualitätskriterien erreicht.
ICS: 07.100.10-Medical microbiology
CTN: CEN/TC 140 - 6122

Modificaciones Normas

Es modificada por EN 12322:1999/A1:2001

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