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ISO 16140-2:2016

Current
Current

The latest, up-to-date edition.

Microbiology of the food chain Method validation Part 2: Protocol for the validation of alternative (proprietary) methods against a reference method
Available format(s)

Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users

Language(s)

French, English

Published date

06-17-2016

ISO 16140-2:2016 specifies the general principle and the technical protocol for the validation of alternative, mostly proprietary, methods for microbiology in the food chain. Validation studies according to ISO 16140-2:2016 are intended to be performed by organizations involved in method validation.

It is applicable to the validation of methods for the analysis (detection or quantification) of microorganisms in

- products intended for human consumption,

- products intended for animal feeding,

- environmental samples in the area of food and feed production, handling, and

- samples from the primary production stage.

It is in particular applicable to bacteria and fungi. Some clauses of ISO 16140-2:2016 could be applicable to other (micro) organisms or their metabolites on a case-by-case-basis. In the future, guidance for other organisms (e.g. viruses and parasites) will be included in ISO 16140:2016 (all parts).

DevelopmentNote
Supersedes ISO/DIS 16140-2. Together with ISO 16140-1, it supersedes ISO 16140. (06/2016)
DocumentType
Standard
Pages
69
ProductNote
THIS STANDFARD ALSO REFERS TO 79/373/EEC
PublisherName
International Organization for Standardization
Status
Current
Supersedes

DIN EN ISO 16297 E : 2014 MILK - BACTERIAL COUNT - PROTOCOL FOR THE EVALUATION OF ALTERNATIVE METHODS (ISO 16297:2013)
BS EN ISO 17468:2016 Microbiology of the food chain. Technical requirements and guidance on establishment or revision of a standardized reference method
S.R. CEN ISO/TS 13136:2012 MICROBIOLOGY OF FOOD AND ANIMAL FEED - REAL-TIME POLYMERASE CHAIN REACTION (PCR)-BASED METHOD FOR THE DETECTION OF FOOD-BORNE PATHOGENS - HORIZONTAL METHOD FOR THE DETECTION OF SHIGA TOXIN-PRODUCING ESCHERICHIA COLI (STEC) AND THE DETERMINATION OF O157, O111, O26, O103 AND O145 SEROGROUPS (ISO/TS 13136:2012)
BS EN ISO 6887-1:2017 Microbiology of the food chain. Preparation of test samples, initial suspension and decimal dilutions for microbiological examination General rules for the preparation of the initial suspension and decimal dilutions
ISO 17468:2016 Microbiology of the food chain — Technical requirements and guidance on establishment or revision of a standardized reference method
I.S. EN ISO 6887-1:2017 MICROBIOLOGY OF THE FOOD CHAIN - 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 6887-1:2017)
PD CEN ISO/TS 13136:2012 Microbiology of food and animal feed. Real-time polymerase chain reaction (PCR)-based method for the detection of food-borne pathogens. Horizontal method for the detection of Shiga toxin-producing Escherichia coli (STEC) and the determination of O157, O111, O26, O103 and O145 serogroups
DIN EN ISO 6579-1 : 2017 MICROBIOLOGY OF THE FOOD CHAIN - HORIZONTAL METHOD FOR THE DETECTION, ENUMERATION AND SEROTYPING OF SALMONELLA - PART 1: DETECTION OF SALMONELLA SPP. (ISO 6579-1:2017)
I.S. EN ISO 6579-1:2017 MICROBIOLOGY OF THE FOOD CHAIN - HORIZONTAL METHOD FOR THE DETECTION, ENUMERATION AND SEROTYPING OF SALMONELLA - PART 1: DETECTION OF SALMONELLA SPP. (ISO 6579-1:2017)
I.S. EN ISO 17468:2016 MICROBIOLOGY OF THE FOOD CHAIN - TECHNICAL REQUIREMENTS AND GUIDANCE ON ESTABLISHMENT OR REVISION OF A STANDARDIZED REFERENCE METHOD (ISO 17468:2016)
DIN EN ISO 6887-1:2014-01 (Draft) MICROBIOLOGY OF THE FOOD CHAIN - 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 6887-1:2017)
DIN EN ISO 6579-1 E : 2017 MICROBIOLOGY OF THE FOOD CHAIN - HORIZONTAL METHOD FOR THE DETECTION, ENUMERATION AND SEROTYPING OF SALMONELLA - PART 1: DETECTION OF SALMONELLA SPP. (ISO 6579-1:2017)
UNE-EN ISO 17468:2017 Microbiology of the food chain - Technical requirements and guidance on establishment or revision of a standardized reference method (ISO 17468:2016)
UNE-EN ISO 6887-1:2017 Microbiology of the food chain - 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 6887-1:2017)
UNE-EN ISO 6579-1:2017 Microbiology of the food chain - Horizontal method for the detection, enumeration and serotyping of Salmonella - Part 1: Detection of Salmonella spp. (ISO 6579-1:2017)
ISO 6887-1:2017 Microbiology of the food chain — 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/TS 13136:2012 Microbiology of food and animal feed — Real-time polymerase chain reaction (PCR)-based method for the detection of food-borne pathogens — Horizontal method for the detection of Shiga toxin-producing Escherichia coli (STEC) and the determination of O157, O111, O26, O103 and O145 serogroups
EN ISO 6887-1:2017 Microbiology of the food chain - 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 6887-1:2017)
EN ISO 17468:2016 Microbiology of the food chain - Technical requirements and guidance on establishment or revision of a standardized reference method (ISO 17468:2016)
BS EN ISO 6579-1:2017 Microbiology of the food chain. Horizontal method for the detection, enumeration and serotyping of Salmonella Detection of Salmonella spp.
DIN EN ISO 16297:2014-09 MILK - BACTERIAL COUNT - PROTOCOL FOR THE EVALUATION OF ALTERNATIVE METHODS (ISO 16297:2013)
CEN ISO/TS 13136:2012 Microbiology of food and animal feed - Real-time polymerase chain reaction (PCR)-based method for the detection of food-borne pathogens - Horizontal method for the detection of Shiga toxin-producing Escherichia coli (STEC) and the determination of O157, O111, O26, O103 and O145 serogroups (ISO/TS 13136:2012)

AS 5013.24.1:2020 Food microbiology Microbiology of the food chain - Horizontal method for the detection and enumeration of Listeria monocytogenes and of Listeria spp. - Detection method (ISO 11290-1:2017, MOD)
ISO 16140-1:2016 Microbiology of the food chain Method validation Part 1: Vocabulary
ISO/TS 22117:2010 Microbiology of food and animal feeding stuffs Specific requirements and guidance for proficiency testing by interlaboratory comparison
ISO 11133:2014 Microbiology of food, animal feed and water — Preparation, production, storage and performance testing of culture media
ISO 5725-2:1994 Accuracy (trueness and precision) of measurement methods and results Part 2: Basic method for the determination of repeatability and reproducibility of a standard measurement method

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