EN ISO 15216-1:2017/A1:2021
(Amendment)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 - Amendment 1 (ISO 15216-1:2017/Amd 1:2021)
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 - Amendment 1 (ISO 15216-1:2017/Amd 1:2021)
Mikrobiologie der Lebensmittelkette - Horizontales Verfahren zur Bestimmung von Hepatitis-A-Virus und Norovirus mittels Real-time-RT-PCR - Teil 1: Verfahren zur Quantifizierung - Änderung 1 (ISO 15216-1:2017/Amd 1:2021)
Not available
Microbiologie de la chaîne alimentaire - Méthode horizontale pour la recherche des virus de l'hépatite A et norovirus par la technique RT-PCR en temps réel - Partie 1: Méthode de quantification - Amendement 1 (ISO 15216-1:2017/Amd 1:2021)
Mikrobiologija v prehranski verigi - Horizontalna metoda za ugotavljanje virusa hepatitisa A in norovirusov z RT-PCR v realnem času - 1. del: Metoda za kvantifikacijo - Dopolnilo A1 (ISO 15216-1:2017/Amd 1:2021)
General Information
- Status
- Published
- Publication Date
- 20-Apr-2021
- Withdrawal Date
- 30-Oct-2021
- Technical Committee
- CEN/TC 463 - Microbiology of the food chain
- Drafting Committee
- CEN/TC 463 - Microbiology of the food chain
- Current Stage
- 6060 - Definitive text made available (DAV) - Publishing
- Start Date
- 21-Apr-2021
- Completion Date
- 21-Apr-2021
Relations
- Effective Date
- 18-Dec-2019
Overview
EN ISO 15216-1:2017/A1:2021 is an important international standard titled 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 - Amendment 1. Published by the European Committee for Standardization (CEN), this amendment updates the original 2017 standard and provides detailed guidance on the quantification of hepatitis A virus and noroviruses in food products and related matrices.
This standard applies molecular detection techniques based on real-time reverse transcription polymerase chain reaction (real-time RT-PCR), establishing reliable and reproducible methods to quantify viral contamination with high specificity and sensitivity. It is essential for food safety laboratories, public health authorities, and food manufacturers concerned with viral contamination control along the food chain.
Key Topics
- Horizontal Methodology: Provides a standardized, horizontal approach applicable across a wide range of food matrices and environmental samples.
- Real-Time RT-PCR Technique: Specifies the use of real-time reverse transcription PCR for viral RNA quantification, enabling rapid and accurate detection of hepatitis A virus and norovirus.
- Sample Preparation and Extraction: Describes detailed protocols for sample processing, including viral RNA extraction using magnetic silica technology, with modifications introduced in the 2021 amendment.
- Reagents and Buffers: Updates on reagents such as EDTA disodium dihydrate, concentration specifics, and preparation instructions to ensure consistency and reliability.
- Quality Control and Validation: Sets performance criteria for assay efficiency, sensitivity, and specificity aligned with microbiological safety standards.
- Automated and Manual Procedures: Accommodates both manual and automated RNA extraction systems to facilitate laboratory workflows and scalability.
Applications
- Food Safety Testing: Critical for testing fresh produce, shellfish, bottled water, and ready-to-eat foods to detect viral pathogens that impact public health.
- Epidemiological Surveillance: Supports monitoring and outbreak investigations by reliably quantifying viral load in contaminated food and environmental samples.
- Regulatory Compliance: Helps laboratories meet national and international food safety regulations by adhering to a harmonized, validated molecular method.
- Research and Development: Facilitates viral contamination studies and the development of improved food processing interventions targeting viral elimination.
- Quality Assurance Programs: Integrates into routine monitoring schemes within food processing facilities and water quality assessments.
Related Standards
ISO 15216-2:2013 - Microbiology of the food chain - Horizontal method for determination of hepatitis A virus and norovirus using real-time RT-PCR - Part 2: Method for qualitative detection
Complements Part 1 by providing the qualitative detection protocol for the same viruses.ISO/TS 15216 series - Technical specifications dealing with procedure validation and performance characteristics of viral detection in food.
ISO/IEC 17025 - General requirements for the competence of testing and calibration laboratories, applicable for laboratories implementing these methods.
CEN/TC 463 Standards - Other European standards for microbiology of the food chain that align with viral detection and quantification methods.
EN ISO 15216-1:2017/A1:2021 represents a critical evolution in the standardization of viral detection within the food microbiology sector. Its focus on the quantitative real-time RT-PCR method provides practical benefits in enhancing food safety surveillance, outbreak response, and regulatory adherence. Adoption of this amendment ensures robust, consistent testing practices in food virology, safeguarding public health across the global food supply chain.
Frequently Asked Questions
EN ISO 15216-1:2017/A1:2021 is a amendment published by the European Committee for Standardization (CEN). Its full title is "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 - Amendment 1 (ISO 15216-1:2017/Amd 1:2021)". This standard covers: Not available
Not available
EN ISO 15216-1:2017/A1:2021 is classified under the following ICS (International Classification for Standards) categories: 07.100.30 - Food microbiology. The ICS classification helps identify the subject area and facilitates finding related standards.
EN ISO 15216-1:2017/A1:2021 has the following relationships with other standards: It is inter standard links to EN ISO 15216-1:2017. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
You can purchase EN ISO 15216-1:2017/A1:2021 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of CEN standards.
Standards Content (Sample)
SLOVENSKI STANDARD
01-julij-2021
Mikrobiologija v prehranski verigi - Horizontalna metoda za ugotavljanje virusa
hepatitisa A in norovirusov z RT-PCR v realnem času - 1. del: Metoda za
kvantifikacijo - Dopolnilo A1 (ISO 15216-1:2017/Amd 1:2021)
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 - Amendment 1
(ISO 15216-1:2017/Amd 1:2021)
Mikrobiologie der Lebensmittelkette - Horizontales Verfahren zur Bestimmung von
Hepatitis-A-Virus und Norovirus mittels Real-time-RT-PCR - Teil 1: Verfahren zur
Quantifizierung - Änderung 1 (ISO 15216-1:2017/Amd 1:2021)
Microbiologie de la chaîne alimentaire - Méthode horizontale pour la recherche des virus
de l'hépatite A et norovirus par la technique RT-PCR en temps réel - Partie 1: Méthode
de quantification - Amendement 1 (ISO 15216-1:2017/Amd 1:2021)
Ta slovenski standard je istoveten z: EN ISO 15216-1:2017/A1:2021
ICS:
07.100.30 Mikrobiologija živil Food microbiology
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 15216-1:2017/A1
EUROPEAN STANDARD
NORME EUROPÉENNE
April 2021
EUROPÄISCHE NORM
ICS 07.100.30
English Version
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 -
Amendment 1 (ISO 15216-1:2017/Amd 1:2021)
Microbiologie de la chaîne alimentaire - Méthode Mikrobiologie der Lebensmittelkette - Horizontales
horizontale pour la recherche des virus de l'hépatite A Verfahren zur Bestimmung von Hepatitis-A-Virus und
et norovirus par la technique RT-PCR en temps réel - Norovirus mittels Real-time-RT-PCR - Teil 1: Verfahren
Partie 1: Méthode de quantification - Amendement 1 zur Quantifizierung - Änderung 1 (ISO 15216-
(ISO 15216-1:2017/Amd 1:2021) 1:2017/Amd 1:2021)
This amendment A1 modifies the European Standard EN ISO 15216-1:2017; it was approved by CEN on 15 January 2021.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of
this amendment into the relevant national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This amendment exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the
same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 15216-1:2017/A1:2021 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 15216-1:2017/A1:2021) has been prepared by Technical Committee ISO/TC 34
"Food products" in collaboration with Technical Committee CEN/TC 463 “Microbiology of the food
chain” the secretariat of which is held by AFNOR.
This Amendment to the European Standard EN ISO 15216-1:2017 shall be given the status of a national
standard, either by publication of an identical text or by endorsement, at the latest by October 2021,
and conflicting national standards shall be withdrawn at the latest by October 2021.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 15216-1:2017/Amd 1:2021 has been approved by CEN as EN ISO 15216-
1:2017/A1:2021 without any modification.
INTERNATIONAL ISO
STANDARD 15216-1
First edition
2017-03
AMENDMENT 1
2021-03
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
AMENDMENT 1
Microbiologie de la chaîne alimentaire — Méthode horizontale pour
la recherche des virus de l'hépatite A et norovirus par la technique
RT-PCR en temps réel —
Partie 1: Méthode de quantification
AMENDEMENT 1
Reference number
ISO 15216-1:2017/Amd.1:2021(E)
©
ISO 2021
ISO 15216-1:2017/Amd.1:2021(E)
© ISO 2021
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