EN ISO 22174:2024
(Main)Microbiology of the food chain - Polymerase chain reaction (PCR) for the detection and quantification of microorganisms - General requirements and definitions (ISO 22174:2024)
Microbiology of the food chain - Polymerase chain reaction (PCR) for the detection and quantification of microorganisms - General requirements and definitions (ISO 22174:2024)
This document specifies the general requirements for the in vitro amplification of nucleic acid sequences (DNA or RNA).
This document is applicable to the testing for microorganisms and viruses from the food chain using the polymerase chain reaction (PCR). This document, or parts of it, is applicable to other fields of PCR diagnostics based on a case-by-case evaluation.
The minimum requirements laid down in this document are intended to ensure that comparable and reproducible results are obtained in different laboratories.
This document has been established for microorganisms from the food chain and is applicable to:
— products intended for human consumption;
— products for feeding animals;
— environmental samples in the area of food and feed production and handling;
— samples from the primary production stage.
Mikrobiologie der Lebensmittelkette - Polymerase-Kettenreaktion (PCR) zum Nachweis von Mikroorganismen - Allgemeine Anforderungen und Definitionen (ISO 22174:2024)
Dieses Dokument legt die allgemeinen Anforderungen an die in-vitro-Amplifikation von Nukleinsäuresequenzen (DNA oder RNA) fest.
Dieses Dokument ist anwendbar für die Untersuchung auf Mikroorganismen und Viren aus der Lebensmittelkette unter Anwendung der Polymerase-Kettenreaktion (en: polymerase chain reaction, PCR). Dieses Dokument, oder Teile davon, sind auf der Grundlage einer Einzelfallbeurteilung auch für andere Bereiche der PCR-Diagnostik anwendbar.
Die in diesem Dokument festgelegten Mindestanforderungen dienen dazu, vergleichbare und reproduzierbare Ergebnisse in verschiedenen Laboren sicherzustellen.
Dieses Dokument wurde für Mikroorganismen aus der Lebensmittelkette erstellt und ist anwendbar für
- Produkte, die für den menschlichen Verzehr vorgesehen sind,
- Produkte, die Futtermittel sind,
- Umgebungsproben im Bereich der Herstellung und Handhabung von Lebensmitteln und Futtermitteln,
- Proben aus dem Bereich der Primärproduktion.
Microbiologie de la chaîne alimentaire - Réaction de polymérisation en chaîne (PCR) pour la recherche et la quantification de micro-organismes - Exigences générales et définitions (ISO 22174:2024)
Le présent document spécifie les exigences générales relatives à l’amplification in vitro des séquences d’acide nucléique (ADN ou ARN).
Le présent document s’applique aux essais pour la détection de micro‑organismes et de virus issus de la chaîne alimentaire en faisant appel à la réaction de polymérisation en chaîne (PCR). Le présent document, ou certaines de ses parties, s’applique(nt) à d’autres domaines de diagnostic par PCR sur la base d’une évaluation au cas par cas.
Les exigences minimales déclarées dans le présent document sont destinées à garantir l’obtention de résultats comparables et reproductibles dans des laboratoires différents.
Le présent document a été conçu pour les micro‑organismes issus de la chaîne alimentaire et s’applique aux:
— produits destinés à la consommation humaine;
— produits destinés à l’alimentation animale;
— échantillons environnementaux prélevés dans des zones de production et de manipulation de produits alimentaires et d’aliments pour animaux;
— échantillons de production primaire.
Mikrobiologija v prehranski verigi - Polimerazna verižna reakcija (PCR) za ugotavljanje prisotnosti in kvantifikacijo mikroorganizmov - Splošne zahteve in definicije (ISO 22174:2024)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-november-2024
Nadomešča:
SIST EN ISO 22174:2005
Mikrobiologija v prehranski verigi - Polimerazna verižna reakcija (PCR) za
ugotavljanje prisotnosti in kvantifikacijo mikroorganizmov - Splošne zahteve in
definicije (ISO 22174:2024)
Microbiology of the food chain - Polymerase chain reaction (PCR) for the detection and
quantification of microorganisms - General requirements and definitions (ISO
22174:2024)
Mikrobiologie der Lebensmittelkette - Polymerase-Kettenreaktion (PCR) zum Nachweis
von Mikroorganismen - Allgemeine Anforderungen und Definitionen (ISO 22174:2024)
Microbiologie de la chaîne alimentaire - Réaction de polymérisation en chaîne (PCR)
pour la recherche et la quantification de micro-organismes - Exigences générales et
définitions (ISO 22174:2024)
Ta slovenski standard je istoveten z: EN ISO 22174:2024
ICS:
07.100.30 Mikrobiologija živil Food microbiology
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 22174
EUROPEAN STANDARD
NORME EUROPÉENNE
September 2024
EUROPÄISCHE NORM
ICS 07.100.30 Supersedes EN ISO 22174:2005
English Version
Microbiology of the food chain - Polymerase chain reaction
(PCR) for the detection and quantification of
microorganisms - General requirements and definitions
(ISO 22174:2024)
Microbiologie de la chaîne alimentaire - Réaction de Mikrobiologie der Lebensmittelkette - Polymerase-
polymérisation en chaîne (PCR) pour la recherche et la Kettenreaktion (PCR) zum Nachweis von
quantification de micro-organismes - Exigences Mikroorganismen - Allgemeine Anforderungen und
générales et définitions (ISO 22174:2024) Definitionen (ISO 22174:2024)
This European Standard was approved by CEN on 21 July 2024.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a 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 European Standard 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, Türkiye 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
© 2024 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 22174:2024 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 22174:2024) 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 European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by March 2025, and conflicting national standards shall
be withdrawn at the latest by March 2025.
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.
This document supersedes EN ISO 22174:2005.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
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, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 22174:2024 has been approved by CEN as EN ISO 22174:2024 without any modification.
International
Standard
ISO 22174
Second edition
Microbiology of the food chain —
2024-08
Polymerase chain reaction (PCR)
for the detection and quantification
of microorganisms — General
requirements and definitions
Microbiologie de la chaîne alimentaire — Réaction de
polymérisation en chaîne (PCR) pour la recherche et la
quantification de micro-organismes — Exigences générales et
définitions
Reference number
ISO 22174:2024(en) © ISO 2024
ISO 22174:2024(en)
© ISO 2024
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
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Published in Switzerland
ii
ISO 22174:2024(en)
Contents Page
Foreword .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
3.1 General terms .2
3.2 Terms related to the extraction and purification of DNA/RNA .3
3.3 Terms related to reverse transcription of RNA to DNA .4
3.4 Terms related to DNA amplification by PCR/RT-PCR .4
3.5 Terms related to controls .5
3.6 Terms related to qPCR .6
3.7 Terms related to dPCR .7
4 Principle . 8
4.1 General .8
4.2 Laboratory sample .9
4.3 Sampling, transport and storage.9
4.4 Preparation of test sample .9
5 Microbial enrichment and virus concentration . 9
5.1 Microbial enrichment .9
5.2 Virus concentration .9
6 Nucleic acid preparation . 10
6.1 General .10
6.2 Prevention of amplification of DNA from dead cells .10
6.3 Nucleic acid extraction, release and purification .10
6.4 Nucleic acid quality and quantity .10
7 PCR amplification . .11
8 Detection and confirmation of amplicons .11
9 General environmental laboratory requirements .12
9.1 General . 12
9.2 Laboratory setup . 12
9.2.1 General . 12
9.2.2 Control of flows . 13
9.2.3 Cleaning of laboratory .14
9.2.4 Environmental monitoring for nucleic acid contamination .14
10 Reagents and consumables . 14
11 Equipment . 14
12 Procedure .15
12.1 Enrichment and sample treatment . 15
12.2 Amplification .16
12.2.1 General .16
12.2.2 Control reaction .
...
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