ISO 17468:2023

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.