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.
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 |
| EN 12322:1999 | Equivalent |
| BS EN 12322:1999 | Identical |
| NEN EN 12322 : 1999 AMD 1 2001 | Identical |
| BS EN 12322:1999 | Equivalent |
| NF EN 12322 : 99 AMD 1 2002 | Identical |
| NBN EN 12322 : 1999 AMD 1 2001 | Identical |
| DIN EN 12322:1999-06 | Identical |
| NS EN 12322 : 1999 AMD 1 2002 | Identical |
| BS EN 12322:1999 | Equivalent |
| UNE-EN 12322:1999 | Identical |
| DIN 58959-7 Beiblatt 1:1997-06 | MEDICAL MICROBIOLOGY; QUALITY ASSURANCE IN MEDICAL MICROBIOLOGICAL LABORATORIES; SOURCES OF SUPPLY FOR BACTERIAL AND FUNGAL STRAINS SERVING AS REFERENCE RESP. CONTROL STRAINS |
| 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) |
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