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  • EN 12322:1999/A1:2001

    Current The latest, up-to-date edition.

    IN VITRO DIAGNOSTIC MEDICAL DEVICES - CULTURE MEDIA FOR MICROBIOLOGY - PERFORMANCE CRITERIA FOR CULTURE MEDIA

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    Language(s): 

    Published date:  24-10-2001

    Publisher:  Comite Europeen de Normalisation

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    Table of Contents - (Show below) - (Hide below)

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Definitions
    4 Performance evaluation
      4.1 General quality criteria
      4.2 Control strains
      4.3 Microbiological quality criteria
      4.4 Performance evaluation and interpretation of
          results
    5 Information to be supplied by the manufacturer
    6 Documentation
    Annex A (informative) Guidance on preservation and
            maintenance of control strains
    Annex B (informative) Bibliography
    Annex ZA (informative) Clauses of this European Standard
             addressing essential requirements or other
             provisions of EU Directives

    Abstract - (Show below) - (Hide below)

    Gives the requirements for the performance of culture media. Concerns the comparability, traceability, reproducibility and suitability of culture media used in microbiological laboratories. These characteristics are achieved by applying the quality criteria given in this standard. Applies to non- commercial organizations that distribute media to satellite locations; 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); laboratories that prepare culture media for their own use. Does not cover cell culture media.

    General Product Information - (Show below) - (Hide below)

    Committee TC 140
    Document Type Standard
    Publisher Comite Europeen de Normalisation
    Status Current

    Standards Referenced By This Book - (Show below) - (Hide below)

    UNI CEN ISO/TS 11133-1 : 2009 MICROBIOLOGY OF FOOD AND ANIMAL FEEDING STUFFS - GUIDELINES ON PREPARATION AND PRODUCTION OF CULTURE MEDIA - PART 1: GENERAL GUIDELINES ON QUALITY ASSURANCE FOR THE PREPARATION OF CULTURE MEDIA IN THE LABORATORY
    CEN ISO/TS 11133-1:2009 Microbiology of food and animal feeding stuffs - Guidelines on preparation and production of culture media - Part 1: General guidelines on quality assurance for the preparation of culture media in the laboratory (ISO/TS 11133-1:2009)
    DD CEN ISO/TS 11133-1:2009 Microbiology of food and animal feeding stuffs. Guidelines on preparation and production of culture media General guidelines on quality assurance for the preparation of culture media in the laboratory
    DD ENV ISO 11133-1:2000 Microbiology of food and animal feeding stuffs. Guidelines on quality assurance and performance testing of culture media General guidelines on quality assurance of culture media in the laboratory
    S.R. CEN ISO TS 11133-1:2009 MICROBIOLOGY OF FOOD AND ANIMAL FEEDING STUFFS - GUIDELINES ON PREPARATION AND PRODUCTION OF CULTURE MEDIA - PART 1: GENERAL GUIDELINES ON QUALITY ASSURANCE FOR THE PREPARATION OF CULTURE MEDIA IN THE LABORATORY
    ISO/TS 11133-1:2009 Microbiology of food and animal feeding stuffs Guidelines on preparation and production of culture media Part 1: General guidelines on quality assurance for the preparation of culture media in the laboratory

    Standards Referencing This Book - (Show below) - (Hide below)

    DIN 58959-7 Beiblatt 1:1997-06 MEDICAL MICROBIOLOGY; QUALITY ASSURANCE IN MEDICAL MICROBIOLOGICAL LABORATORIES; SOURCES OF SUPPLY FOR BACTERIAL AND FUNGAL STRAINS SERVING AS REFERENCE RESP. CONTROL STRAINS
    EN 46001 : 1996 QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9001
    EN ISO 9002:1994/AC:1997 QUALITY SYSTEMS - SPECIFICATION FOR PRODUCTION AND INSTALLATION
    ISO 8402:1994 Quality management and quality assurance — Vocabulary
    ISO 9002:1994 Quality systems — Model for quality assurance in production, installation and servicing
    EN 1659:1996 In vitro diagnostic systems - Culture media for microbiology - Terms and definitions
    EN ISO 9001:2015 Quality management systems - Requirements (ISO 9001:2015)
    DIN 58959-6:1997-06 MEDICAL MICROBIOLOGY; QUALITY ASSURANCE IN MEDICAL MICROBIOLOGICAL LABORATORIES; REQUIREMENTS FOR BACTERIAL AND FUNGAL STRAINS WHICH SERVE AS CONTROL STRAINS
    ISO 9001:2015 Quality management systems — Requirements
    EN 46002 : 1996 QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9002
    EN ISO 8402 : 1995 QUALITY MANAGEMENT AND QUALITY ASSURANCE - VOCABULARY
    DIN 58959-7:1997-06 MEDICAL MICROBIOLOGY; QUALITY ASSURANCE IN MEDICAL MICROBIOLOGICAL LABORATORIES; GENERAL REQUIREMENTS FOR THE USE OF CONTROL STRAINS
    DIN 58959-6 Beiblatt 1:1997-06 MEDICAL MICROBIOLOGY; QUALITY ASSURANCE IN MEDICAL MICROBIOLOGICAL LABORATORIES; METHODS FOR PRODUCTION AND PRESERVATION OF MICROORGANISMS AS STOCK CULTURES (CONTROL STRAINS)
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