ISO 15216-1-2017 PDF

Full title and description

ISO 15216-1:2017 — Microbiology of the food chain — Horizontal method for determination of hepatitis A virus and norovirus using real-time RT‑PCR — Part 1: Method for quantification. This international standard specifies a validated laboratory procedure to quantify hepatitis A virus (HAV) and norovirus genogroups I (GI) and II (GII) RNA in selected foodstuffs, bottled water and on food-contact surfaces using real‑time reverse transcription PCR (RT‑qPCR).

Abstract

ISO 15216-1:2017 defines sample preparation (liberation/concentration of virus from the matrix), viral RNA extraction (lysis with guanidine thiocyanate and adsorption on silica), and RT‑qPCR assays and quantification procedures for HAV and norovirus (GI, GII). The method is intended for specified matrices (soft fruit, leafy/stem/bulb vegetables, bivalve molluscan shellfish, bottled water) and for food surfaces; it is not validated for all food types or for viruses other than the stated targets.

General information

• Status: Published (International Standard).
• Publication date: March 2017 (ISO 15216-1:2017).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 07.100.30 (Food microbiology).
• Edition / version: Edition 1 (2017); amended by ISO 15216-1:2017/Amd 1:2021 (Amendment 1).
• Number of pages: 48 pages (main document).

Scope

Specifies a horizontal (matrix‑adapted) method for the quantification of HAV and norovirus GI/GII RNA in defined food matrices and on food surfaces. The standard covers sample processing to release and concentrate viruses from the test sample, nucleic acid extraction, internal and external controls, amplification by real‑time RT‑PCR and interpretation of quantitative results. It explicitly notes that the method is not validated for other foodstuffs (including multi‑component foods), matrices or for other viruses.

Key topics and requirements

• Target organisms: hepatitis A virus (HAV) and norovirus genogroups I (GI) and II (GII).
• Sample types / validated matrices: soft fruit, leaf/stem/bulb vegetables, bivalve molluscan shellfish (BMS), bottled water and food-contact surfaces.
• Core workflow: virus elution/concentration from matrix → RNA extraction (guanidine thiocyanate lysis and silica adsorption) → target amplification and detection by real‑time RT‑PCR → quantification using appropriate standards and controls.
• Quality controls: inclusion of process controls, extraction controls and RT‑PCR inhibition controls; requirements for calibration/standards for quantification.
• Performance characteristics: defined detection/quantification criteria, repeatability/reproducibility expectations and matrix‑specific performance notes (derived from method validation studies).
• Limitations: not validated for multi‑component foods or matrices outside those listed; not a general method for all foodborne viruses.
• Amendment: an official amendment (Amd 1:2021) updates or clarifies limited points of the 2017 text.

Typical use and users

Used by public health and food testing laboratories, reference laboratories, research institutes, regulatory agencies and food industry quality/control laboratories for surveillance, outbreak investigation and routine monitoring of the specified viruses in validated food matrices. Users typically require molecular virology experience, appropriate biosafety practices and validated laboratory instrumentation for RT‑qPCR.

Related standards

ISO 15216 is a multi‑part series. Part 2 (ISO 15216-2:2019) provides a detection (qualitative) method for the same virus targets and matrices; national or regional adoptions (EN/ISO, BS EN, DIN EN, NEN-EN) are available. The 2017 Part 1 revision replaces earlier technical specifications (ISO/TS 15216-1:2013).

Keywords

Hepatitis A virus, norovirus, RT‑qPCR, quantification, food virology, food microbiology, method validation, sample preparation, viral RNA extraction, ISO 15216.

FAQ

Q: What is this standard?

A: ISO 15216-1:2017 is an international standard that specifies a laboratory method for quantifying hepatitis A virus and norovirus (GI/GII) RNA in certain foods, bottled water and on surfaces using real‑time RT‑PCR.

Q: What does it cover?

A: It covers sample processing (liberation and concentration of viruses), RNA extraction (including guanidine thiocyanate lysis and silica adsorption), RT‑qPCR amplification and quantification procedures, required controls, performance and interpretation criteria for the validated matrices. It does not cover all food types or other viruses.

Q: Who typically uses it?

A: Public‑health and food testing laboratories, national reference labs, regulatory bodies, research groups and food industry QC units that perform virological testing on validated food matrices. Users should be trained in molecular virology and laboratory quality systems.

Q: Is it current or superseded?

A: The document ISO 15216-1:2017 is the current Part 1 edition published in March 2017 and has an official amendment (ISO 15216-1:2017/Amd 1:2021). The series (including Part 2:2019) is maintained and reviewed on ISO’s periodic review cycle. Users should confirm the latest status or national adoptions before use.

Q: Is it part of a series?

A: Yes — ISO 15216 is a multipart series. Part 1 (quantification) is ISO 15216-1:2017 and Part 2 (detection) is ISO 15216-2:2019; both are produced by ISO/TC 34/SC 9 (food microbiology).

Q: What are the key keywords?

A: Hepatitis A virus, norovirus GI/GII, RT‑qPCR, quantification, food virology, sample concentration, RNA extraction, method validation, ISO 15216.