Reference details

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Reference
EN 12322:1999/A1:2001
Title
In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media
Organisation
CEN
Publisher status in source
PublishedThis is the status recorded in the source, not a statement that this is the latest edition.
Source access
19 October 2026

Research and application

Begin with the official scope and the product configuration. The title identifies a subject; it does not establish every product, use condition or legal requirement covered by the publication.

Product research routes

  • Medical devices

    Intended medical purpose, device classification and the evidence associated with design, performance and lifecycle controls.

  • In vitro diagnostic products

    Specimens, intended purpose and analytical and clinical performance for diagnostic devices and systems.

Questions for the evidence file

  • Intended purpose
  • Classification rationale
  • Risk management
  • Verification and performance evidence
  • Clinical evidence scope
  • Assay configuration

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