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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

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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.

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

Gives the requirements for the performance of culture media. Concerns the comparability, traceability, reproducibility and suitability of culture media used in microbiological laboratories.

DocumentType	Standard
Pages	22
PublisherName	National Standards Authority of Ireland
Status	Current

Standards	Relationship
EN 12322:1999/A1:2001	Identical
UNI EN 12322 : 2003	Identical
DIN EN 12322:1999-06	Identical
BS EN 12322:1999	Identical
UNE-EN 12322:1999	Identical