ISO 17468:2023 PDF

Microbiology of the food chain — Technical requirements and guidance on the establishment or revision of a standardized reference method

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Title (English):

ISO 17468:2023

Microbiology of the food chain — Technical requirements and guidance on the establishment or revision of a standardized reference method

Document status:: Active
Format:: Electronic (PDF)
Number of pages:: 13
Publication date:: November 13, 2023
Edition:: ISO IS 17468 edition 2 version 1
ICS:: 07.100.30

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Description (English):

This document gives technical requirements and guidance on the establishment or revision of standardized reference methods used for the analysis of microorganisms in: — products intended for human consumption; — products for feeding animals; — environmental samples in the area of food and feed production and handling; — samples from the primary production stage. This document specifies the technical stages of the establishment of a new standardized reference method and of the revision of an existing standardized reference method. It includes, in particular, requirements and guidance on the validation of the selected method. This document is intended to be implemented in particular by ISO/TC 34/SC 9 and its corresponding structure at CEN level, which is CEN/TC 463.

Technical details

Technical committee: ISO/TC 34/SC 9 - Microbiology
SKU: ISO 17468:2023

Abstract

Overview - ISO 17468:2023 (Microbiology of the food chain)

ISO 17468:2023 provides technical requirements and practical guidance for the establishment or revision of standardized reference methods used to detect, confirm, type or quantify microorganisms across the food chain. The scope covers:

Products intended for human consumption
Products for feeding animals (pet food, animal feed)
Environmental samples from food/feed production and handling
Samples from primary production stages

This second edition updates procedures for method development and revision, adds an optional method optimization step, and cross-references ISO 16140 series parts related to method validation.

Key technical topics and requirements

Six staged technical procedure for standardizing a new reference method:
1. Method(s) selection (mandatory)
2. Method(s) optimization (optional) - new in 2023
3. Method(s) evaluation study (recommended)
4. “Real life” study (recommended) - not applicable to confirmation/typing methods
5. Selection of one candidate reference method (mandatory)
6. Interlaboratory study (ILS) (mandatory)
Validation requirements include single-laboratory and interlaboratory performance assessment (repeatability, reproducibility), inclusivity/exclusivity, limit of detection (LOD) and, for quantitative methods, trueness and precision - following ISO 16140-2, -4 and -6 where appropriate.
Roles and terminology: ILS organizer, ILS participant, candidate reference method, and standardized reference method are defined to guide study organization and reporting.
Confidentiality during study phases is emphasized; final validation data should be made publicly available (e.g., ISO Standards Maintenance Portal).
Specific guidance for culture media preparation (ISO 11133) and statistical accuracy (ISO 5725-2) are referenced.

Practical applications and who uses ISO 17468

Intended users:
- National and international working groups (e.g., ISO/TC 34/SC 9, CEN/TC 463)
- Method developers and manufacturers of microbiological test kits
- Diagnostic and food microbiology laboratories conducting method validation
- Accreditation bodies, regulators and risk assessors evaluating method fitness-for-purpose
Practical uses:
- Developing new standardized reference methods for pathogen detection (e.g., Salmonella detection in large test portions)
- Revising existing reference methods while assessing nature of changes (minor/major)
- Planning and conducting interlaboratory validation studies and publishing validation reports
- Ensuring harmonized, traceable approaches across the food chain for reliable microbial testing

Related standards

ISO 16140 series (method validation): Parts 1, 2, 4, 6
ISO 5725-2 (accuracy: repeatability/reproducibility)
ISO 11133 (culture media preparation)

Keywords: ISO 17468:2023, standardized reference method, microbiology of the food chain, method validation, interlaboratory study, ISO/TC 34/SC 9, ISO 16140.

Related standards

Standards mentioned in the description

Abstract

Overview - ISO 17468:2023 (Microbiology of the food chain)

Products intended for human consumption
Products for feeding animals (pet food, animal feed)
Environmental samples from food/feed production and handling
Samples from primary production stages

This second edition updates procedures for method development and revision, adds an optional method optimization step, and cross-references ISO 16140 series parts related to method validation.

Key technical topics and requirements

Six staged technical procedure for standardizing a new reference method:
1. Method(s) selection (mandatory)
2. Method(s) optimization (optional) - new in 2023
3. Method(s) evaluation study (recommended)
4. “Real life” study (recommended) - not applicable to confirmation/typing methods
5. Selection of one candidate reference method (mandatory)
6. Interlaboratory study (ILS) (mandatory)
Validation requirements include single-laboratory and interlaboratory performance assessment (repeatability, reproducibility), inclusivity/exclusivity, limit of detection (LOD) and, for quantitative methods, trueness and precision - following ISO 16140-2, -4 and -6 where appropriate.
Roles and terminology: ILS organizer, ILS participant, candidate reference method, and standardized reference method are defined to guide study organization and reporting.
Confidentiality during study phases is emphasized; final validation data should be made publicly available (e.g., ISO Standards Maintenance Portal).
Specific guidance for culture media preparation (ISO 11133) and statistical accuracy (ISO 5725-2) are referenced.

Practical applications and who uses ISO 17468

Intended users:
- National and international working groups (e.g., ISO/TC 34/SC 9, CEN/TC 463)
- Method developers and manufacturers of microbiological test kits
- Diagnostic and food microbiology laboratories conducting method validation
- Accreditation bodies, regulators and risk assessors evaluating method fitness-for-purpose
Practical uses:
- Developing new standardized reference methods for pathogen detection (e.g., Salmonella detection in large test portions)
- Revising existing reference methods while assessing nature of changes (minor/major)
- Planning and conducting interlaboratory validation studies and publishing validation reports
- Ensuring harmonized, traceable approaches across the food chain for reliable microbial testing

Related standards

ISO 16140 series (method validation): Parts 1, 2, 4, 6
ISO 5725-2 (accuracy: repeatability/reproducibility)
ISO 11133 (culture media preparation)

Keywords: ISO 17468:2023, standardized reference method, microbiology of the food chain, method validation, interlaboratory study, ISO/TC 34/SC 9, ISO 16140.

ISO 17468:2023 PDF

Technical details

Abstract

Overview - ISO 17468:2023 (Microbiology of the food chain)

Key technical topics and requirements

Practical applications and who uses ISO 17468

Related standards

Related standards

Abstract

Overview - ISO 17468:2023 (Microbiology of the food chain)

Key technical topics and requirements

Practical applications and who uses ISO 17468

Related standards

Related standards

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