SIST EN 12322:2000

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

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.

In-vitro-Diagnostika - Kulturmedien für die Mikrobiologie - Leistungskriterien für Kulturmedien

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.

Dispositifs médicaux de diagnostic in vitro - Milieux de culture de microbiologie - Criteres de performance des milieux de culture

La présente norme européenne spécifie les exigences relatives a 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 criteres de qualité présentés dans la présente norme.

Diagnostični medicinski pripomočki in vitro – Gojišča za mikrobiologijo – Merila za kakovost gojišč

General Information

• Status: Published
• Publication Date: 31-Dec-1999
• ICS: 07.100.10 - Medical microbiology
• ICS: 11.100.10 - In vitro diagnostic test systems
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 01-Jan-2000
• Due Date: 01-Jan-2000
• Completion Date: 01-Jan-2000
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Directive: 98/79/EC - Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices
• Mandate: M/252 - Standardization Mandate to CEN/CENELEC concerning the development of European standards relating to in vitro diagnostic medical devices
• Ref Project: EN 12322:1999 - In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media

Relations

• Amended By: SIST EN 12322:2000/A1:2002 - In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media
• Effective Date: 22-Dec-2008

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 12322:2000
01-januar-2000
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In vitro diagnostic medical devices - Culture media for microbiology - Performance
criteria for culture media
In-vitro-Diagnostika - Kulturmedien für die Mikrobiologie - Leistungskriterien für
Kulturmedien
Dispositifs médicaux de diagnostic in vitro - Milieux de culture de microbiol
...