SFS-EN ISO 11133:en

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ISO 11133:2014 defines terms related to quality assurance of culture media and specifies the requirements for the preparation of culture media intended for the microbiological analysis of food, animal feed, and samples from the food or feed production environment as well as all kinds of water intended for consumption or used in food production. These requirements are applicable to all categories of culture media prepared for use in laboratories performing microbiological analyses.
ISO 11133:2014 also sets criteria and describes methods for the performance testing of culture media. It applies to producers such as:

commercial bodies producing and/or distributing ready-to-use or semi-finished reconstituted or dehydrated media;
non-commercial bodies supplying media to third parties;
microbiological laboratories preparing culture media for their own use.

Tämän julkaisun valmistelusta Suomessa vastaa SFS Suomen Standardit, puh. 09 149 9331.

Sisällysluettelo

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions

3.1 General terms and definitions
3.2 Terminology of performance testing
3.3 Terminology of culture media
3.4 Terminology for test microorganisms

4 Quality assurance management

4.1 Documentation
4.2 Storage
4.3 Laboratory preparation of media
4.4 Storage and shelf-life of prepared media
4.5 Preparation for use
4.6 Incubation of solid media in Petri dishes
4.7 Disposal of media

5 Test organisms for performance testing

5.1 General
5.2 Selection of test organisms
5.3 Preservation and maintenance of test organisms
5.4 Microorganisms for performance testing

6 Quality control and performance testing of culture media

6.1 General requirements
6.2 Physical and chemical quality control
6.3 Microbiological quality control
6.4 General requirements for microbiological performance testing
6.5 Performance evaluation and interpretation of results
6.6 Confirmation media and reagents

7 Methods for performance testing of solid culture media

7.1 General
7.2 Methods for quantitative tests
7.3 Testing of culture media used for membrane filtration
7.4 Methods for qualitative tests

8 Methods for performance testing of liquid culture media

8.1 General
8.2 Quantitative tube method for performance testing of liquid enrichment media (dilution to extinction method)
8.3 Qualitative tube method for performance testing of selective liquid media
8.4 Qualitative single tube method (turbidity) for performance testing of liquid media

9 Methods for performance testing of diluents and transport media

9.1 General
9.2 Method for testing diluents
9.3 Method for testing transport media

10 Documentation of test results

10.1 Information provided by the manufacturer
10.2 Traceability

Annex A Designation of the components of culture media in International Standards on microbiological analysis of food, animal feed and water (informative)
Annex B Preparation of reference stock and working culture (normative)
Annex C Flow charts of methods for performance testing (normative)
Annex D Example of card for recording test results of culture media (informative)
Annex E Test microorganisms and performance criteria for culture media commonly used in food microbiology (normative)
Annex F Test microorganisms and performance criteria for culture media commonly used in water microbiology (normative)
Annex G Use of control charts to monitor quantitative testing of solid culture media (normative)
Annex H Quality assurance of culture media — Troubleshooting (informative)
Annex I Quantitative testing of liquid media (informative)
Annex J Definition of microbiological performance tests for standardized culture media (normative)

Bibliography

Näytä kaikki

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions

3.1 General terms and definitions
3.2 Terminology of performance testing
3.3 Terminology of culture media
3.4 Terminology for test microorganisms

4 Quality assurance management

4.1 Documentation
4.2 Storage
4.3 Laboratory preparation of media
4.4 Storage and shelf-life of prepared media
4.5 Preparation for use
4.6 Incubation of solid media in Petri dishes
4.7 Disposal of media

5 Test organisms for performance testing

5.1 General
5.2 Selection of test organisms
5.3 Preservation and maintenance of test organisms
5.4 Microorganisms for performance testing

6 Quality control and performance testing of culture media

6.1 General requirements
6.2 Physical and chemical quality control
6.3 Microbiological quality control
6.4 General requirements for microbiological performance testing
6.5 Performance evaluation and interpretation of results
6.6 Confirmation media and reagents

7 Methods for performance testing of solid culture media

7.1 General
7.2 Methods for quantitative tests
7.3 Testing of culture media used for membrane filtration
7.4 Methods for qualitative tests

8 Methods for performance testing of liquid culture media

8.1 General
8.2 Quantitative tube method for performance testing of liquid enrichment media (dilution to extinction method)
8.3 Qualitative tube method for performance testing of selective liquid media
8.4 Qualitative single tube method (turbidity) for performance testing of liquid media

9 Methods for performance testing of diluents and transport media

9.1 General
9.2 Method for testing diluents
9.3 Method for testing transport media

10 Documentation of test results

10.1 Information provided by the manufacturer
10.2 Traceability

Annex A Designation of the components of culture media in International Standards on microbiological analysis of food, animal feed and water (informative)
Annex B Preparation of reference stock and working culture (normative)
Annex C Flow charts of methods for performance testing (normative)
Annex D Example of card for recording test results of culture media (informative)
Annex E Test microorganisms and performance criteria for culture media commonly used in food microbiology (normative)
Annex F Test microorganisms and performance criteria for culture media commonly used in water microbiology (normative)
Annex G Use of control charts to monitor quantitative testing of solid culture media (normative)
Annex H Quality assurance of culture media — Troubleshooting (informative)
Annex I Quantitative testing of liquid media (informative)
Annex J Definition of microbiological performance tests for standardized culture media (normative)

Bibliography

Tuoteryhmä(t)

07.100.20 Vesimikrobiologia »
07.100.30 Elintarvikemikrobiologia »

Sidokset

Velvoittavat viittaukset

ISO 6887-1:1999 Microbiology of food and animal feeding stuffs -- Preparation of test samples, initial suspension and decimal dilutions for microbiological examination -- Part 1: General rules for the preparation of the initial suspension and decimal dilutions
ISO 6887-2:2003 Microbiology of food and animal feeding stuffs -- Preparation of test samples, initial suspension and decimal dilutions for microbiological examination -- Part 2: Specific rules for the preparation of meat and meat products
ISO 6887-3:2003 Microbiology of food and animal feeding stuffs -- Preparation of test samples, initial suspension and decimal dilutions for microbiological examination -- Part 3: Specific rules for the preparation of fish and fishery products

ISO 6887-1:1999 Microbiology of food and animal feeding stuffs -- Preparation of test samples, initial suspension and decimal dilutions for microbiological examination -- Part 1: General rules for the preparation of the initial suspension and decimal dilutions
ISO 6887-2:2003 Microbiology of food and animal feeding stuffs -- Preparation of test samples, initial suspension and decimal dilutions for microbiological examination -- Part 2: Specific rules for the preparation of meat and meat products
ISO 6887-3:2003 Microbiology of food and animal feeding stuffs -- Preparation of test samples, initial suspension and decimal dilutions for microbiological examination -- Part 3: Specific rules for the preparation of fish and fishery products
ISO 6887-4:2003 Microbiology of food and animal feeding stuffs -- Preparation of test samples, initial suspension and decimal dilutions for microbiological examination -- Part 4: Specific rules for the preparation of products other than milk and milk products, meat and meat products, and fish and fishery products
ISO 6887-5:2010 Microbiology of food and animal feeding stuffs -- Preparation of test samples, initial suspension and decimal dilutions for microbiological examination -- Part 5: Specific rules for the preparation of milk and milk products
ISO 6887-6:2013 Microbiology of food and animal feed -- Preparation of test samples, initial suspension and decimal dilutions for microbiological examination -- Part 6: Specific rules for the preparation of samples taken at the primary production stage
ISO 7218:2007 Microbiology of food and animal feeding stuffs -- General requirements and guidance for microbiological examinations
ISO 7704:1985 Water quality -- Evaluation of membrane filters used for microbiological analyses
ISO 8199:2005 Water quality -- General guidance on the enumeration of micro-organisms by culture

Tekninen komitea

CEN/TC 463 Microbiology of the food chain »

Vahvistuspäivä

16.06.2014

Julkaisupäivä

04.07.2014

Painos

1

Sivumäärä

98

Julkaisun kieli

englanti