BS EN 12322:1999:2001 Edition
$86.31
In vitro diagnostic medical devices. Culture media for microbiology. Performance criteria for culture media
| Published By | Publication Date | Number of Pages |
| BSI | 2001 | 14 |
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.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | BRITISH STANDARD |
| 2 | National foreword |
| 4 | Foreword Foreword to amendment A1 Contents |
| 5 | Introduction 1 Scope 2 Normative references 3 Definitions 3.1 batch of culture media; lot of culture media 3.2 control strain |
| 6 | 3.3 reference strain 3.4 reference stock 3.5 stock culture 3.6 working culture 4 Performance evaluation 4.1 General quality criteria 4.2 Control strains |
| 7 | 4.3 Microbiological quality criteria |
| 8 | 4.4 Performance evaluation and interpretation of results 5 Information to be supplied by the manufacturer 6 Documentation |
| 9 | Annex A (informative) Guidance on preservation and maintenance of control strains A.1 General A.2 Reference strains from commercial sources A.3 In house prepared control strains (stock cultures) A.3.1 Maintenance A.3.2 Storage of control cultures A.4 Working cultures |
| 10 | Annex B (informative) Bibliography |
| 12 | Annex ZA (informative) Clauses of this European Standard addressing essential requirements or other provis… Table ZA.1 – Correspondence between this European Standard and Directive 98/79/EC |
