ISO 22118-2011 PDF

Full title and description

Microbiology of food and animal feeding stuffs — Polymerase chain reaction (PCR) for the detection and quantification of food-borne pathogens — Performance characteristics. ISO 22118:2011 specifies minimum performance-characteristic requirements for molecular methods based on PCR used to detect and quantify nucleic acid sequences (DNA or RNA) of food‑borne pathogens in foodstuffs, related isolates, environmental samples and animal feeding stuffs.

Abstract

ISO 22118:2011 defines the minimum requirements for the performance characteristics of PCR-based molecular methods used to detect and quantify food‑borne pathogens. The standard applies to detection of target nucleic acid sequences (DNA or RNA after reverse transcription) and is intended to ensure comparable, reproducible and fit-for-purpose analytical results between laboratories and methods by specifying how key performance parameters should be evaluated and reported.

General information

• Status: Published (International Standard); last systematic review confirmed in 2022 and the standard has since been placed in the ISO review/revision lifecycle.
• Publication date: 8 July 2011 (Edition 1).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 07.100.30 (Food microbiology).
• Edition / version: Edition 1, 2011.
• Number of pages: 10 (ISO published version; national translations or adoptions may show differing page counts due to national forewords and translation).

Scope

Specifies minimum requirements for the performance characteristics of PCR-based molecular detection and quantification methods for food‑borne pathogens. Applicable to testing of foodstuffs, isolates from foods, relevant environmental samples and animal feeding stuffs. The document addresses how to evaluate method performance so results are comparable and reproducible across laboratories and method types (conventional PCR, qualitative/quantitative PCR approaches where applicable), and it complements more general PCR requirements and definitions found in related ISO documents.

Key topics and requirements

• Definition of the performance characteristics to be assessed for PCR methods (examples: analytical specificity — inclusivity/exclusivity, analytical sensitivity, limit of detection (LOD), limit of quantification (LOQ), linearity, range).
• Requirements and guidance for assessing precision (repeatability and reproducibility) and trueness/accuracy of PCR assays.
• Guidance on method validation and verification procedures appropriate for food microbiology PCR methods.
• Recommendations on use of appropriate controls (positive, negative, inhibition/internal controls) and reference materials.
• Considerations for reporting results, uncertainty, and interpretation for qualitative and quantitative PCR outputs.
• Notes on applicability to different sample matrices (food types, environmental samples, feeding stuffs) and on limitations where rapid technological change in molecular methods may require case‑by‑case assessment.

Typical use and users

Used by food microbiology laboratories, method developers and manufacturers of molecular test kits, accreditation bodies and competent authorities/regulatory laboratories, research institutions and quality departments within food producers. It is a reference for laboratories validating or verifying PCR assays for detection/quantification of food‑borne pathogens and for conformity assessment and method comparison activities.

Related standards

Standards and documents commonly referenced alongside ISO 22118:2011 include other ISO microbiology and PCR-related documents (general PCR requirements and definitions), documents on real-time PCR methods, and ISO documents on method validation and proficiency testing in food microbiology. ISO work to update or replace this document (ISO/WD 22118) and newer ISO publications addressing general PCR requirements (for example the more recent ISO publication covering general PCR requirements for the food chain) should be consulted together with ISO 22118 for a complete validation framework.

Keywords

PCR, polymerase chain reaction, food microbiology, food-borne pathogens, performance characteristics, validation, limit of detection, limit of quantification, specificity, sensitivity, repeatability, reproducibility, method verification, ISO 22118.

FAQ

Q: What is this standard?

A: ISO 22118:2011 is an International Standard that specifies minimum performance-characteristic requirements for PCR-based methods used to detect and quantify nucleic acid sequences of food‑borne pathogens in foods, related isolates, environmental samples and animal feeding stuffs.

Q: What does it cover?

A: It covers how to evaluate key performance characteristics for PCR methods (e.g., specificity, sensitivity/LOD, quantification parameters, precision, robustness), recommended validation/verification practices, and reporting elements to help ensure comparable and reproducible results across laboratories.

Q: Who typically uses it?

A: Food testing laboratories, method and kit developers, accreditation bodies, regulators, research laboratories and quality teams within food industry organizations use it as a validation and method‑performance reference.

Q: Is it current or superseded?

A: ISO 22118:2011 was published on 8 July 2011 and was last confirmed during systematic review activity in 2022. It has been placed in ISO’s review/revision lifecycle and a working draft to revise the document (ISO/WD 22118) has been prepared; users should check the latest ISO publications and any newer PCR‑related ISO documents for updates or replacement documents when implementing methods.

Q: Is it part of a series?

A: Yes. ISO 22118 sits within the ISO family of food‑chain/microbiology documents addressing PCR and molecular methods; it complements related standards dealing with general PCR requirements, real‑time PCR guidance and other microbiology validation and proficiency-testing standards.

Q: What are the key keywords?

A: PCR, food-borne pathogens, performance characteristics, validation, limit of detection (LOD), limit of quantification (LOQ), specificity, sensitivity, repeatability, reproducibility, ISO 22118.