NS EN 12322 : 1999 AMD 1 2002
Current
The latest, up-to-date edition.
IN VITRO DIAGNOSTIC MEDICAL DEVICES - CULTURE MEDIA FOR MICROBIOLOGY - PERFORMANCE CRITERIA FOR CULTURE MEDIA
12-01-2013
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
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 |
Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.