ISO 18465-2017 PDF

Full title and description

ISO 18465:2017 — Microbiology of the food chain — Quantitative determination of emetic toxin (cereulide) using LC‑MS/MS. This international standard specifies a laboratory method for the quantitative analysis of the emetic toxin cereulide by high-performance or ultra-performance liquid chromatography coupled to tandem mass spectrometry (LC‑MS/MS), intended for application to foods and other products for human consumption.

Abstract

ISO 18465:2017 describes an LC‑MS/MS‑based analytical procedure to extract, separate and quantify cereulide (the emetic toxin produced by some strains of Bacillus cereus) in foods. The method covers instrumental measurement (HPLC/UHPLC coupled to tandem mass spectrometry), calibration/quantification approaches and reporting requirements so that laboratories can produce traceable, quantitative results for cereulide in matrices intended for human consumption. The published version of the standard was reviewed and confirmed in 2022 and remains the current edition.

General information

• Status: Published (International Standard, confirmed).
• Publication date: January 2017 (published edition 1, 2017-01).
• Publisher: International Organization for Standardization (ISO); also published/adopted as EN/ national adoptions in some regions.
• ICS / categories: 07.100.30 — Food microbiology.
• Edition / version: Edition 1 (2017).
• Number of pages: 14 (ISO publication page count; some national/adopted versions show slight pagination differences).

Scope

The standard applies to the quantitative determination of cereulide in products intended for human consumption. It specifies sample preparation (extraction and cleanup), chromatographic separation and tandem mass spectrometric detection, calibration and quantification procedures and the information to be reported with results. It is intended for use by testing and reference laboratories performing routine and confirmatory analyses for food safety, outbreak investigation and research.

Key topics and requirements

• Analytical principle: HPLC/UHPLC separation coupled to tandem mass spectrometric detection (LC‑MS/MS).
• Sample preparation: extraction and cleanup procedures appropriate for food matrices to isolate cereulide prior to instrumental analysis.
• Calibration and quantification: use of appropriate calibration standards and internal standards to achieve traceable quantitative results.
• Performance and validation: requirements for method performance verification, quality controls, and documentation to ensure reliable, comparable results.
• Reporting: required elements in the analytical report (result units, method description, limits of detection/quantification where applicable, uncertainties and any deviations).
• Applicability: designed specifically for products intended for human consumption and for laboratories competent in LC‑MS/MS analysis of trace toxins.

Typical use and users

Used by food testing laboratories, public health and clinical reference laboratories, food manufacturers, regulatory bodies and research institutions for: (1) routine and confirmatory testing for cereulide in food safety monitoring; (2) outbreak investigations where emetic food poisoning is suspected; (3) method development/validation and proficiency testing; and (4) regulatory compliance and product safety assessments.

Related standards

ISO 18465 is part of the ISO/TC 34 series on microbiology of the food chain and sits alongside other laboratory and quality standards commonly used in food/toxin analysis, for example standards and guidance on method validation and laboratory competence (e.g. ISO 16140 series for method validation and ISO/IEC 17025 for laboratory accreditation), and other ISO methods covering microbiological and chemical analyses of food. National and regional adoptions exist (EN ISO and national editions) with equivalent technical content but possible pagination/format differences.

Keywords

cereulide, emetic toxin, Bacillus cereus, LC‑MS/MS, HPLC, UHPLC, food microbiology, quantitative analysis, method validation, food safety

FAQ

Q: What is this standard?

A: ISO 18465:2017 is an international standard that specifies a quantitative LC‑MS/MS method for measuring cereulide (the emetic toxin produced by some Bacillus cereus strains) in food and food‑related products.

Q: What does it cover?

A: It covers sample extraction and cleanup, chromatographic separation (HPLC/UHPLC), tandem mass spectrometric detection, calibration/quantification practices, quality control and reporting elements needed to produce traceable quantitative results for cereulide in products intended for human consumption.

Q: Who typically uses it?

A: Food testing and reference laboratories, public health agencies, regulatory authorities, food manufacturers and research groups involved in food safety, toxin monitoring and outbreak investigations.

Q: Is it current or superseded?

A: The 2017 edition (Edition 1) is published and was reviewed and confirmed in 2022; it is the current edition at the time of confirmation. Users should monitor ISO or their national standards body for any future revisions.

Q: Is it part of a series?

A: It belongs to the body of ISO standards produced under ISO/TC 34/SC 9 (Microbiology of the food chain). It is used alongside other ISO standards for method validation and laboratory competence (for example ISO 16140 and ISO/IEC 17025) when implementing routine analytical services for food safety.

Q: What are the key keywords?

A: Cereulide, emetic toxin, LC‑MS/MS, UHPLC, HPLC, food microbiology, quantitative determination, Bacillus cereus, method validation, food safety.