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 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.

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

Overview

EN 12322:1999 is a CEN European Standard for in vitro diagnostic medical devices that sets performance criteria for culture media for microbiology. The standard defines quality criteria to ensure the traceability, comparability, reproducibility and suitability of culture media used in clinical and research microbiology laboratories. EN 12322 applies to commercial suppliers, non‑commercial distributors and laboratories that prepare media for their own use. Cell culture media are excluded from its scope.

Key Topics and Requirements

EN 12322 focuses on practical quality attributes rather than prescribing specific test methods. Key technical topics include:

• Performance criteria for culture media - requirements that media must meet to be suitable for microbiological use in diagnostics and laboratory testing.
• Traceability - documentation and records that link media materials and production batches to their sources and specifications.
• Comparability and reproducibility - criteria to ensure consistent results between lots, manufacturers and laboratory preparations.
• Suitability for intended use - evidence that a given medium supports the expected growth, recovery or inhibition characteristics required for its diagnostic purpose.
• Quality control and documentation - maintenance of records, specifications and performance data to demonstrate compliance with the standard.
• Applicability to different product formats: ready‑to‑use media, dehydrated media, and semi‑finished media (reference to EN 1659:1996 for semi‑finished media).

Note: Specific numerical thresholds or test procedures are not reproduced here; EN 12322 provides the quality framework and criteria that organizations use to demonstrate compliance.

Applications and Who Uses It

EN 12322 is intended for stakeholders involved in the manufacture, distribution and use of microbiological culture media:

• Commercial manufacturers and distributors producing ready‑to‑use, dehydrated or semi‑finished media for clinical and research laboratories.
• Non‑commercial organizations supplying media to satellite labs or decentralized testing sites.
• Clinical, public‑health and research laboratories that prepare culture media in‑house and need to demonstrate traceability and consistency.
• Quality assurance and regulatory teams ensuring in vitro diagnostic (IVD) products meet European expectations for laboratory reproducibility and documentation.

Practical uses include establishing media specifications, lot‑release criteria, internal quality control procedures, and evidence for audits or regulatory submissions.

Related Standards

• EN 1659:1996 - referenced for definitions and treatment of semi‑finished media.
• Other standards in the in vitro diagnostic medical devices domain may complement EN 12322 for broader IVD quality management and validation programs.

Keywords: EN 12322:1999, culture media, microbiology, performance criteria, in vitro diagnostic, traceability, reproducibility, comparability, CEN.

Standards Content (Sample)

SLOVENSKI STANDARD
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
...