Overview
EN ISO 17468:2023 (Microbiology of the food chain) provides technical requirements and practical guidance for establishing or revising standardized reference methods used to detect, confirm or type microorganisms in:
- products intended for human consumption,
- animal feed,
- environmental samples from food/feed production and handling areas,
- samples from primary production.
Published by CEN/ISO, this second edition updates the 2016 version and is intended for implementation by ISO/TC 34/SC 9 and CEN/TC 463. It defines the staged technical procedure and validation expectations needed before a method becomes a recognized reference method in food microbiology.
Key Topics and Requirements
- Pre-standardization workflow: Six technical stages for method standardization:
- Method selection (mandatory)
- Method optimization (optional)
- Method evaluation study (recommended)
- “Real life” study using routine laboratory samples (recommended; not for confirmation/typing methods)
- Selection of a candidate reference method (mandatory)
- Interlaboratory study (ILS) to estimate repeatability/reproducibility (mandatory)
- Validation focus: Guidance on validating performance characteristics (accuracy, precision, robustness) and statistical assessment, in line with established validation protocols.
- Interlaboratory studies: Roles and responsibilities for the ILS organizer and ILS participants; ILS is required to demonstrate method reproducibility across labs.
- Method types covered: Detection, confirmation and typing procedures are explicitly included; procedural differences (e.g., for confirmation/typing) are acknowledged.
- Documentation & stages: Includes flow charts and annexes (e.g., guidance on optimization studies) to support reproducible standardization practice.
- Normative references: Cross-references to ISO 16140 series (method validation), ISO 5725-2 (precision), and ISO 11133 (culture media).
Applications and Who Uses It
EN ISO 17468:2023 is essential for:
- National standards bodies and CEN/ISO technical committees setting reference methods
- Diagnostic and accredited microbiology laboratories validating and adopting reference methods
- Method developers (industry and academia) preparing methods for standardization
- Regulatory authorities, food producers, and third-party auditors requiring harmonized, validated microbiological methods for food safety and feed safety monitoring
Practical benefits include improved comparability of microbiological results, clearer validation pathways for new or revised methods, and a consistent basis for method adoption in the food and feed sectors.
Related Standards
Relevant documents referenced in EN ISO 17468:2023:
Keywords: EN ISO 17468:2023, Microbiology of the food chain, standardized reference method, method validation, interlaboratory study, food microbiology, method optimization.