NEN EN 12322 : 1999 AMD 1 2001
Current
The latest, up-to-date edition.
IN VITRO DIAGNOSTIC MEDICAL DEVICES - CULTURE MEDIA FOR MICROBIOLOGY - PERFORMANCE CRITERIA FOR CULTURE MEDIA
01-12-2013
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
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