• I.S. EN 12322:1999

    Current The latest, up-to-date edition.

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

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  01-01-1999

    Publisher:  National Standards Authority of Ireland

    For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
    Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

    Dates of withdrawal of national standards are available from NSAI.

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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.

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    Document Type Standard
    Publisher National Standards Authority of Ireland
    Status Current
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