SIST EN ISO 22174:2005
(Main)Microbiology of food and animal feeding stuffs - Polymerase chain reaction (PCR) for the detection of food-borne pathogens - General requirements and definitions (ISO 22174:2005)
Microbiology of food and animal feeding stuffs - Polymerase chain reaction (PCR) for the detection of food-borne pathogens - General requirements and definitions (ISO 22174:2005)
This Standard applies to the testing of foodstuffs and isolates obtained from them for microbial contamination using the polymerase chain reaction (PCR) and relates to the general requirements for the in vitro propagation of nucleic acid sequences (DNA or RNA) and for the detection of the specificity of the amplified nucleic acid sequence.
Mikrobiologie von Lebensmitteln und Futtermitteln - Polymerase- Kettenreaktion (PCR) zum Nachweis von pathogenen Mikroorganismen in Lebensmitteln - Allgemeine Anforderungen und Begriffe (ISO 22174:2005)
Diese Internationale Norm beschreibt allgemeine Anforderungen an die in-vitro-Vervielfältigung (Amplifikation) von Nukleinsäuresequenzen (DNS oder RNS). Sie gilt für die Untersuchung von Lebensmitteln und daraus gewonnenen Isolaten auf mikrobielle Kontamination unter Anwendung der Polymerase-Kettenreaktion (PCR).
Die in dieser Internationalen Norm festgelegten Mindestanforderungen dienen dazu, vergleichbare und reproduzierbare Ergebnisse in verschiedenen Laboren sicherzustellen.
Diese Internationale Norm wurde für den Nachweis von pathogenen Mikroorganismen in oder isoliert aus Lebensmittel- und Futtermittelmatrices erarbeitet. Sie kann jedoch auch auf andere Matrices, z. B. Umweltproben, und zum Nachweis nicht pathogener Mikroorganismen angewendet werden.
Microbiologie des aliments - Réaction de polymérisation en chaîne (PCR) pour la recherche de micro-organismes pathogenes dans les aliments - Exigences générales et définitions (ISO 22174:2005)
L'ISO 22174:2005 s'applique aux essais d'aliments et aux extraits obtenus à partir de ces aliments pour la détection de micro-organismes pathogènes en faisant appel à la réaction de polymérisation en chaîne (PCR) et stipule les exigences générales relatives à l'amplification in vitro des séquences d'acide nucléique (ADN ou ARN).
Les exigences minimales déclarées dans l'ISO 22174:2005 sont destinées à garantir l'obtention de résultats comparables et reproductibles dans des laboratoires différents.
L'ISO 22174:2005 a été conçue pour les micro-organismes pathogènes présents dans les aliments ou extraits d'aliments et de matrices d'aliments mais elle peut également s'appliquer à d'autres matrices, comme les échantillons environnementaux, ainsi que pour la détection de micro-organismes non pathogènes.
Mikrobiologija živil in krme - Prisotnost patogenih mikroorganizmov v živilih z metodo verižne reakcije s polimerazo (PCR) - Splošne zahteve in definicije (ISO 22174:2005)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 22174:2005
01-junij-2005
Mikrobiologija živil in krme - Prisotnost patogenih mikroorganizmov v živilih z
metodo verižne reakcije s polimerazo (PCR) - Splošne zahteve in definicije (ISO
22174:2005)
Microbiology of food and animal feeding stuffs - Polymerase chain reaction (PCR) for the
detection of food-borne pathogens - General requirements and definitions (ISO
22174:2005)
Mikrobiologie von Lebensmitteln und Futtermitteln - Polymerase- Kettenreaktion (PCR)
zum Nachweis von pathogenen Mikroorganismen in Lebensmitteln - Allgemeine
Anforderungen und Begriffe (ISO 22174:2005)
Microbiologie des aliments - Réaction de polymérisation en chaîne (PCR) pour la
recherche de micro-organismes pathogenes dans les aliments - Exigences générales et
définitions (ISO 22174:2005)
Ta slovenski standard je istoveten z: EN ISO 22174:2005
ICS:
07.100.30 Mikrobiologija živil Food microbiology
SIST EN ISO 22174:2005 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
SIST EN ISO 22174:2005
---------------------- Page: 2 ----------------------
SIST EN ISO 22174:2005
EUROPEAN STANDARD
EN ISO 22174
NORME EUROPÉENNE
EUROPÄISCHE NORM
February 2005
ICS 07.100.30
English version
Microbiology of food and animal feeding stuffs - Polymerase
chain reaction (PCR) for the detection of food-borne pathogens -
General requirements and definitions (ISO 22174:2005)
Microbiologie des aliments - Réaction de polymérisation en Mikrobiologie von Lebensmitteln und Futtermitteln -
chaîne (PCR) pour la recherche de micro-organismes Polymerase- Kettenreaktion (PCR) zum Nachweis von
pathogènes dans les aliments - Exigences générales et pathogenen Mikroorganismen in Lebensmitteln -
définitions (ISO 22174:2005) Allgemeine Anforderungen und Begriffe (ISO 22174:2005)
This European Standard was approved by CEN on 20 October 2004.
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 Central Secretariat 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 Central Secretariat has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,
Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels
© 2005 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 22174:2005: E
worldwide for CEN national Members.
---------------------- Page: 3 ----------------------
SIST EN ISO 22174:2005
EN ISO 22174:2005 (E)
Foreword
This document (EN ISO 22174:2005) has been prepared by Technical Committee CEN/TC 275 "Food
analysis - Horizontal methods", the secretariat of which is held by DIN, in collaboration with Technical
Committee ISO/TC 34 "Agricultural food products".
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 August 2005, and conflicting national standards shall be withdrawn
at the latest by August 2005.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Cyprus, Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland
and United Kingdom.
2
---------------------- Page: 4 ----------------------
SIST EN ISO 22174:2005
INTERNATIONAL ISO
STANDARD 22174
First edition
2005-02-15
Microbiology of food and animal feeding
stuffs — Polymerase chain reaction
(PCR) for the detection of food-borne
pathogens — General requirements and
definitions
Microbiologie des aliments — Réaction de polymérisation en chaîne
(PCR) pour la recherche de micro-organismes pathogènes dans les
aliments — Exigences générales et définitions
Reference number
ISO 22174:2005(E)
©
ISO 2005
---------------------- Page: 5 ----------------------
SIST EN ISO 22174:2005
ISO 22174:2005(E)
PDF disclaimer
This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but
shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In
downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat
accepts no liability in this area.
Adobe is a trademark of Adobe Systems Incorporated.
Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation
parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In
the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.
© ISO 2005
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or
ISO's member body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2005 – All rights reserved
---------------------- Page: 6 ----------------------
SIST EN ISO 22174:2005
ISO 22174:2005(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope. 1
2 Normative references. 1
3 Terms and definitions. 1
4 Principle. 6
4.1 General. 6
4.2 Preliminary microbial enrichment . 6
4.3 Nucleic acid preparation . 6
4.4 PCR amplification. 6
4.5 Detection and confirmation of PCR products. 7
5 Test material. 7
6 General laboratory requirements. 7
6.1 General. 7
6.2 Personnel. 7
6.3 Laboratory setup. 7
6.4 Waste management. 8
7 Reagents. 8
8 Apparatus and equipment. 8
8.1 General. 8
8.2 Special considerations. 8
9 Procedure. 8
9.1 Sample preparation. 8
9.2 Amplification. 9
9.3 Control reaction. 9
9.4 Confirmation of PCR results. 9
10 Evaluation. 10
11 Test report. 10
Bibliography . 11
© ISO 2005 – All rights reserved iii
---------------------- Page: 7 ----------------------
SIST EN ISO 22174:2005
ISO 22174:2005(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
ISO 22174 was prepared by the European Committee for Standardization (CEN) Technical Committee
CEN/TC 275, Food analysis — Horizontal methods, in collaboration with Technical Committee ISO/TC 34,
Food products, Subcommittee SC 9, Microbiology, in accordance with the Agreement on technical
cooperation between ISO and CEN (Vienna Agreement).
iv © ISO 2005 – All rights reserved
---------------------- Page: 8 ----------------------
SIST EN ISO 22174:2005
ISO 22174:2005(E)
Introduction
The polymerase chain reaction (PCR) is a fast, sensitive and specific method for the detection of food-borne
pathogens. Although a relatively young technology, the application of PCR-based methods in food analysis is
increasing.
In brief, existing protocols can be divided in two main groups, depending on the type of nucleic acid used as
target for amplification:
RNA-based amplification (RT-PCR);
DNA-based amplification (PCR).
Numerous variations of both methods have been established and can be characterized by their degree of
complexity and automation. The level of specificity of the methods varies from screening assays which detect
nucleic acid sequences common to a microbiological genus, to specific assays which identify nucleic acid
sequences unique to an individual strain- or type-specific nucleic acid sequence.
This International Standard presents a comprehensive list of requirements for PCR-based methods used for
the detection of microorganisms in food samples. It contains terms and definitions used in reference to PCR
and RT-PCR.
ISO 22174 is part of a series of International Standards and a Technical Specification under the general title
Microbiology of food and animal feeding stuffs — Polymerase chain reaction (PCR) for the detection of food-
borne pathogens:
General requirements and definitions (ISO 22174);
1)
Requirements for sample preparation for qualitative detection (ISO 20837) ;
1)
Requirements for amplification and detection for qualitative methods (ISO 20838) ;
1)
Performance testing for thermal cyclers (ISO/TS 20836) .
The International Organization for Standardization (ISO) draws attention to the fact that it is claimed that
compliance with this document may involve the use of one or more patents concerning the PCR technology.
ISO takes no position concerning the evidence, validity and scope of these patent rights.
ISO has been informed that Applied Biosystems, Roche Molecular Systems, Inc. and F. Hoffman-La Roche
Ltd. hold patent rights concerning the PCR technology. The companies have assured the ISO that they are
willing to negotiate licences under reasonable and non-discriminatory terms and conditions with applicants
throughout the world. In this respect, the statements of the holders of these patent rights are registered with
ISO. Information may be obtained from:
Licensing Department
Applied Biosystems
850 Lincoln Centre Drive
Foster City, CA 94404
USA
1) To be published.
© ISO 2005 – All rights reserved v
---------------------- Page: 9 ----------------------
SIST EN ISO 22174:2005
ISO 22174:2005(E)
and
Roche Molecular Systems, Inc.
Licensing Department
1145 Atlantic Avenue
Alameda, CA 94501
USA
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights other than those identified above. ISO shall not be held responsible for identifying any or all such patent
rights.
vi © ISO 2005 – All rights reserved
---------------------- Page: 10 ----------------------
SIST EN ISO 22174:2005
INTERNATIONAL STANDARD ISO 22174:2005(E)
Microbiology of food and animal feeding stuffs — Polymerase
chain reaction (PCR) for the detection of food-borne
pathogens — General requirements and definitions
WARNING — The use of this standard may involve hazardous materials, operations and equipment.
This standard does not purport to address all of the safety problems associated with its use. It is the
responsibility of the user of this standard to establish appropriate safety and health practices and
determines the applicability of regulatory limitations prior to use.
1 Scope
This International Standard gives the general requirements for the in vitro amplification of nucleic acid
sequences (DNA or RNA). It is applicable to the testing of foodstuffs and isolates obtained from foodstuffs for
food-borne pathogens using the polymerase chain reaction (PCR).
The minimum requirements laid down in this International Standard are intended to ensure that comparable
and reproducible results are obtained in different laboratories.
This International Standard has been established for food-borne pathogens in or isolated from food and feed
matrices, but is also applicable to other matrices (e.g. environmental samples) and for the detection of non-
pathogenic microorganisms.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
ISO 3534-1, Statistics — Vocabulary and symbols — Part 1: Probability and general statistical terms
ISO 5725-1, Accuracy (trueness and precision) of measurement methods and results — Part 1: General
principles and definitions
ISO 20837, Microbiology of food and animal feeding stuffs — Polymerase chain reaction (PCR) for the
detection of food-borne pa
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.