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BS EN 12322:1999

Current

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

24-12-2001

€140.23
Excluding VAT

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.

Committee
CH/212
DevelopmentNote
Supersedes 96/560834 DC. (08/2005)
DocumentType
Standard
Pages
14
PublisherName
British Standards Institution
Status
Current
Supersedes

This European Standard specifies requirements for the performance of culture media. It is concerned with the traceability, comparability, reproducibility and suitability of culture media used in microbiological laboratories. These characteristics are achieved by applying the quality criteria outlined in this standard. This European Standard is applicable to : a) 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) ; b) non commercial organizations that distribute media to satellite locations ; c) laboratories that prepare culture media for their own use. Cell culture media are not covered by this standard.

DIN 58959-9:1997-06 Quality management in medical microbiology - Part 9: Requirements for the use of control strains for testing culture media
EN 46001 : 1996 QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9001
EN ISO 9002:1994/AC:1997 QUALITY SYSTEMS - SPECIFICATION FOR PRODUCTION AND INSTALLATION
ISO 8402:1994 Quality management and quality assurance — Vocabulary
ISO 9002:1994 Quality systems — Model for quality assurance in production, installation and servicing
EN 1659:1996 In vitro diagnostic systems - Culture media for microbiology - Terms and definitions
EN ISO 9001:2015 Quality management systems - Requirements (ISO 9001:2015)
DIN 58959-6:1997-06 MEDICAL MICROBIOLOGY; QUALITY ASSURANCE IN MEDICAL MICROBIOLOGICAL LABORATORIES; REQUIREMENTS FOR BACTERIAL AND FUNGAL STRAINS WHICH SERVE AS CONTROL STRAINS
ISO 9001:2015 Quality management systems — Requirements
EN 46002 : 1996 QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9002
EN ISO 8402 : 1995 QUALITY MANAGEMENT AND QUALITY ASSURANCE - VOCABULARY
DIN 58959-7:1997-06 MEDICAL MICROBIOLOGY; QUALITY ASSURANCE IN MEDICAL MICROBIOLOGICAL LABORATORIES; GENERAL REQUIREMENTS FOR THE USE OF CONTROL STRAINS
DIN 58959-6 Beiblatt 1:1997-06 MEDICAL MICROBIOLOGY; QUALITY ASSURANCE IN MEDICAL MICROBIOLOGICAL LABORATORIES; METHODS FOR PRODUCTION AND PRESERVATION OF MICROORGANISMS AS STOCK CULTURES (CONTROL STRAINS)
DIN 58959-9 Beiblatt 1:1997-06 MEDICAL MICROBIOLOGY; QUALITY ASSURANCE IN MEDICAL MICROBIOLOGICAL LABORATORIES; RECOMMENDED CONTROL STRAINS FOR COMMONLY USED CULTURE MEDIA

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