Overview
EN ISO 16140-2:2016/A1:2024 is Amendment 1 to ISO 16140-2 and defines the protocol for validating alternative (proprietary) microbiological methods against an established reference method in the food chain. Published as a CEN-endorsed amendment in 2024, it updates data evaluation and calculation procedures used in validation studies and adds a commercial sterility testing protocol for specific products. This standard sits within the ISO 16140 series for method validation in food microbiology.
Key topics and technical requirements
- Scope: Validation protocol for alternative (proprietary) methods compared to a reference (internationally recognized) method.
- Amendment highlights:
- Revised evaluation of qualitative method comparison study data.
- Updated calculations for relative level of detection in interlaboratory studies.
- Clarified calculation and interpretation of relative trueness.
- Inclusion of a commercial sterility testing protocol for specified products.
- Validation stages: Two-stage approach - single-laboratory validation followed by an interlaboratory study for full validation; verification (ISO 16140-3) follows validated methods.
- Method types: Distinguishes reference methods (ISO/CEN standards) and alternative methods (including proprietary commercial tests, full test systems).
- Special cases: Allows validating a qualitative alternative method against a quantitative reference method (useful when reference criteria are expressed quantitatively), with guidance on test portion sizes and data handling.
- Data and study design: Emphasis on rigorous interlaboratory protocols, statistical evaluation (relative trueness, level of detection), and clear reporting for regulatory and accreditation purposes.
Applications
- Validation of rapid commercial assays (e.g., immunoassays, molecular/PCR kits) intended to replace or complement culture-based reference methods.
- Demonstrating performance claims of proprietary test kits for food safety testing, sterility testing of specific products, and laboratory quality assurance.
- Supporting method acceptance by accreditation bodies and regulatory authorities for routine testing of pathogens, hygiene indicators, and sterility.
Who should use this standard
- Food microbiology laboratories and QA/QC teams
- Test kit and diagnostic manufacturers developing proprietary methods
- Accreditation bodies and regulatory agencies assessing method acceptance
- Standards committees and method validation specialists
Related standards
Keywords: ISO 16140-2, method validation, microbiology of the food chain, alternative methods, proprietary methods, reference method, interlaboratory study, relative trueness, level of detection, sterility testing.
