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NS EN 12322 : 1999 AMD 1 2002

Current

Current

The latest, up-to-date edition.

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

Published date

12-01-2013

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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. 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.

DocumentType
Standard
PublisherName
Norwegian Standards (Norges Standardiseringsforbund)
Status
Current

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

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