ISO 16140-2:2016 PDF

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

Open preview (PDF)

Title (English):

ISO 16140-2:2016

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

Document status:: Active
Format:: Electronic (PDF)
Number of pages:: 66
Publication date:: June 17, 2016
Edition:: ISO IS 16140 edition 1 version 1
ICS:: 07.100.30

Delivery type:

Full version25 €Read online 24h10 €Read online 72h15 €

Document language:

enru

Delivery time:Immediate download

Price:25 €

Description (English):

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).

Technical details

Technical committee: ISO/TC 34/SC 9 - Microbiology
SKU: ISO 16140-2:2016

Abstract

Overview - ISO 16140-2:2016 (Method validation for microbiology of the food chain)

ISO 16140-2:2016 establishes a harmonized protocol for the validation of alternative (mostly proprietary) microbiological methods against a reference method. It is part of the ISO 16140 series (Microbiology of the food chain - Method validation) and is intended for organizations conducting validation studies. The standard covers both qualitative (detection) and quantitative (enumeration) methods used for microorganisms in foods, feeds, environmental samples in production/processing, and primary production samples. It is especially applicable to bacteria and fungi, with some clauses applicable to other organisms (viruses, parasites) on a case-by-case basis.

Key technical topics and requirements

Two-phase validation approach
- Method comparison study (performed in the organizing laboratory)
- Interlaboratory study (multi-lab evaluation)
Protocols for qualitative and quantitative methods
- Qualitative: sensitivity study, Relative Level of Detection (RLOD), inclusivity/exclusivity testing
- Quantitative: relative trueness, accuracy profile, limit of quantification (LOQ), inclusivity/exclusivity
Paired vs unpaired study designs
- Guidance when methods share the same initial test portion (paired) or require separate portions (unpaired)
Statistical and interpretative tools
- Use of Acceptability Limits (AL), RLOD models, accuracy profile methodology and interlaboratory variance assessment
Annexes and supporting guidance
- Classification of sample types, contamination protocols, strain selection criteria, RLOD calculation models, and worked examples of accuracy profile application

Practical applications - who uses ISO 16140-2:2016

Method developers validating proprietary rapid tests or novel assays for market adoption
Independent validation bodies and accredited laboratories conducting method validation studies
Food and feed industry laboratories assessing alternative methods for routine monitoring and quality control
Regulators and certification bodies evaluating method performance data for acceptance or recognition
Researchers and contract testing labs designing comparative studies and interlaboratory trials

Using ISO 16140-2 helps produce reproducible, auditable validation data for adoption of faster or easier alternatives to reference methods, supporting risk-based testing and regulatory acceptance.

Related standards

ISO 16140-1 - Vocabulary for method validation (normative reference)
Other parts of ISO 16140 (in preparation): verification, single-lab validation, factorial interlaboratory validation, and validation for confirmation/typing

Keywords: ISO 16140-2:2016, method validation, microbiology of the food chain, alternative methods, proprietary methods, method comparison study, interlaboratory study, RLOD, accuracy profile, inclusivity exclusivity.

Related standards

Standards mentioned in the description

Abstract

Overview - ISO 16140-2:2016 (Method validation for microbiology of the food chain)

Key technical topics and requirements

Two-phase validation approach
- Method comparison study (performed in the organizing laboratory)
- Interlaboratory study (multi-lab evaluation)
Protocols for qualitative and quantitative methods
- Qualitative: sensitivity study, Relative Level of Detection (RLOD), inclusivity/exclusivity testing
- Quantitative: relative trueness, accuracy profile, limit of quantification (LOQ), inclusivity/exclusivity
Paired vs unpaired study designs
- Guidance when methods share the same initial test portion (paired) or require separate portions (unpaired)
Statistical and interpretative tools
- Use of Acceptability Limits (AL), RLOD models, accuracy profile methodology and interlaboratory variance assessment
Annexes and supporting guidance
- Classification of sample types, contamination protocols, strain selection criteria, RLOD calculation models, and worked examples of accuracy profile application

Practical applications - who uses ISO 16140-2:2016

Method developers validating proprietary rapid tests or novel assays for market adoption
Independent validation bodies and accredited laboratories conducting method validation studies
Food and feed industry laboratories assessing alternative methods for routine monitoring and quality control
Regulators and certification bodies evaluating method performance data for acceptance or recognition
Researchers and contract testing labs designing comparative studies and interlaboratory trials

Using ISO 16140-2 helps produce reproducible, auditable validation data for adoption of faster or easier alternatives to reference methods, supporting risk-based testing and regulatory acceptance.

Related standards

ISO 16140-1 - Vocabulary for method validation (normative reference)
Other parts of ISO 16140 (in preparation): verification, single-lab validation, factorial interlaboratory validation, and validation for confirmation/typing

ISO 16140-2:2016 PDF

Technical details

Abstract

Overview - ISO 16140-2:2016 (Method validation for microbiology of the food chain)

Key technical topics and requirements

Practical applications - who uses ISO 16140-2:2016

Related standards

Related standards

Abstract

Overview - ISO 16140-2:2016 (Method validation for microbiology of the food chain)

Key technical topics and requirements

Practical applications - who uses ISO 16140-2:2016

Related standards

Related standards

Microbiology of the food chain - Method validation - Part 3: Protocol for the verification of reference metho…

Microbiology of the food chain - Method validation - Part 2: Protocol for the validation of alternative (prop…

Microbiology of the food chain - Method validation - Part 1: Vocabulary (ISO 16140-1:2016)