SIST EN 12322:2000/A1:2002

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

Migrated from Progress Sheet (TC Comment) (2000-07-10): UAP of 4 months (TC Res 5/1999) (CC/990525)

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

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

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

General Information

• Status: Published
• Publication Date: 30-Apr-2002
• 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-May-2002
• Due Date: 01-May-2002
• Completion Date: 01-May-2002
• 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/A1:2001 - In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media

Relations

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

Overview

SIST EN 12322:2000/A1:2002 is a European standard published by the European Committee for Standardization (CEN) that defines the performance criteria for culture media used in microbiology, specifically for in vitro diagnostic medical devices. This amendment to the original EN 12322:1999 standard was approved in 2001 and sets essential requirements to ensure the quality and reliability of culture media for microbiological testing.

The standard is integral for manufacturers and laboratories that prepare or use culture media to support accurate microbiological diagnostics in clinical, pharmaceutical, or research settings. It aligns with the provisions of EU Directive 98/79/EC on in vitro diagnostic medical devices, supporting regulatory compliance within the European Union and other CEN member countries.

Key Topics

• Scope of Culture Media
  SIST EN 12322:2000/A1:2002 covers various types of culture media intended for microbiology, focusing on media performance rather than formulation. It ensures that media used for microbial growth meet stringent criteria to support diagnostic accuracy.

• Performance Criteria
  The standard specifies test methods and acceptance criteria to evaluate culture media, including:

  • Microbial growth support
  • Selectivity and differentiation of microorganisms
  • Sterility and stability
  • Reproducibility of results across production batches

• Compliance with EU Directive 98/79/EC
  The standard supports manufacturers in meeting essential regulatory requirements, facilitating market access and ensuring patient safety through validated performance metrics.

• Amendment Details
  The amendment A1 introduces updates to enhance clarity, testing protocols, and alignment with regulatory directives, ensuring up-to-date compliance and industry best practices.

Applications

• Clinical Microbiology Laboratories
  Ensures that diagnostic laboratories use culture media that reliably support the identification and analysis of pathogens, contributing to accurate patient diagnosis and treatment.

• Medical Device Manufacturers
  Assists producers of in vitro diagnostic devices in developing and validating culture media that conform to European regulatory standards, streamlining product approval processes.

• Pharmaceutical Quality Control
  Supports pharmaceutical companies in maintaining microbiological quality in drug manufacturing environments, where culture media are critical for contamination testing.

• Research and Development
  Provides a framework for researchers designing and testing new culture media formulations for microbiological studies.

Related Standards

• EN ISO 11133 - Microbiology of food, animal feed, and water - Preparation, production, storage, and performance testing of culture media
• Directive 98/79/EC - In vitro diagnostic medical devices directive governing product safety and performance
• ISO 13485 - Quality management systems for medical devices, including in vitro diagnostics
• EN ISO 15189 - Medical laboratories - Requirements for quality and competence

Practical Value

Adopting SIST EN 12322:2000/A1:2002 ensures that culture media used in microbiological diagnostics deliver consistent and validated performance, critical for patient safety and regulatory compliance. It helps reduce variability in diagnostic testing results and supports harmonization of practices across European healthcare and research institutions.

By implementing this standard, stakeholders can:

• Enhance trust in diagnostic outcomes
• Facilitate cross-border regulatory acceptance of medical devices
• Maintain high standards of laboratory quality management
• Ensure media stability and sterility for safer laboratory workflows

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Keywords: SIST EN 12322:2000/A1:2002, culture media performance criteria, microbiology culture media, in vitro diagnostic medical devices, European standard, microbiological diagnostics, EU Directive 98/79/EC compliance, medical device regulation, microbiological test media, CEN standard for culture media.

Standards Content (Sample)

SLOVENSKI STANDARD
01-maj-2002
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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 microbiologie - Criteres
de performance des milieux de culture
Ta slovenski standard je istoveten z: EN 12322:1999/A1:2001
ICS:
07.100.10 Medicinska mikrobiologija Medical microbiology
11.100.10 'LDJQRVWLþQLSUHVNXVQL In vitro diagnostic test
VLVWHPLLQYLWUR systems
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN 12322:1999/A1
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2001
ICS 07.100.10
English version
In vitro diagnostic medical devices - Culture media for
microbiology - Performance criteria for culture media
Dispositifs médicaux de diagnostic in vitro - Milieux de In-vitro-Diagnostika - Kulturmedien für die Mikrobiologie -
culture de microbiologie - Critères de performance des Leistungskriterien für Kulturmedien
milieux de culture
This amendment A1 modifies the European Standard EN 12322:1999; it was approved by CEN on 30 September 2001.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of this
amendment into the relevant national standard without any alteration. Up-to-date lists and bibliographical references concerning such
national standards may be obtained on application to the Management Centre or to any CEN member.
This amendment exists in three official versions (English, French, German). A version in any other language made by translation under the
responsibility of a CEN member into its own language and notified to the Management Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,
Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2001 CEN A
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