ISO 16140-2:2016

ISO 16140-2:2016

June 2016
International standard Current

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

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).

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Main informations

Collections

International ISO standards

Publication date

June 2016

Number of pages

66 p.

Reference

ISO 16140-2:2016

ICS Codes

07.100.30   Food microbiology

Print number

1
Sumary
Microbiology of the food chain - Method validation - Part 2 : Protocol for the validation of alternative (proprietary) methods against a reference method

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).

Replaced standards (2)
ISO 16140:2003
May 2003
International standard Cancelled
Microbiology of food and animal feeding stuffs - Protocol for the validation of alternative methods

<p>ISO 16140:2003 defines the general principle and the technical protocol for the validation of alternative methods in the field of microbiological analysis of food, animal feeding stuffs and environmental and veterinary samples for the validation of alternative methods which can be used in particular in the framework of the official control, and the international acceptance of the results obtained by the alternative method.</p> <p>It also establishes the general principles of certification of these alternative methods, based on the validation protocol defined in ISO 16140:2003.</p> <p>Where an alternative method is used on a routine basis for internal laboratory use without the requirement to meet (higher) external criteria of quality assurance, a less stringent comparative validation of the alternative method than that set in ISO 16140:2003 may be appropriate.</p>

ISO 16140/A1:2011
August 2011
International standard Cancelled
Amendment 1 to standard ISO 16140:2003

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