• NEN EN 12322 : 1999 AMD 1 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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    Published date:  12-01-2013

    Publisher:  Netherlands Standards

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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.

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    Document Type Standard
    Publisher Netherlands Standards
    Status Current
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