I.S. EN 12322:1999
Current
The latest, up-to-date edition.
IN VITRO DIAGNOSTIC MEDICAL DEVICES - CULTURE MEDIA FOR MICROBIOLOGY - PERFORMANCE CRITERIA FOR CULTURE MEDIA
Hardcopy , PDF
English
01-01-1999
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.
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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.
| DocumentType |
Standard
|
| Pages |
22
|
| PublisherName |
National Standards Authority of Ireland
|
| 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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