SIST-TS CEN ISO/TS 20836:2005
(Main)Microbiology of food and animal feeding stuffs - Polymerase chain reaction (PCR) for the detection of food-borne pathogens - Performance testing for thermal cyclers (ISO/TS 20836:2005)
Microbiology of food and animal feeding stuffs - Polymerase chain reaction (PCR) for the detection of food-borne pathogens - Performance testing for thermal cyclers (ISO/TS 20836:2005)
This Technical Specification specifies basic requirements for thermal cycler performance and maintenance. Although thermal cyclers are robust technical equipment, they do require regular maintenance. Their cooling/heating elements, either Peltier or other technology, have a limited lifetime. Functionality of the cooling/heating element depends both on the quality of heating-
/cooling devices and a proper use and care. Furthermore, this standard comprises precautions which should be taken for maintenance during routine use. Suggestions are made how to determine the performance of thermal cyclers either biochemically or physically.
Mikrobiologie von Lebensmitteln und Futtermitteln - Polymerase Kettenreaktion (PCR) zum Nachweis von pathogenen Mikroorganismen in Lebensmitteln - Leistungsprüfung für PCR-Geräte (ISO/TS 20836:2005)
Diese Technische Spezifikation beschreibt die Grundlagen für die Installation, Nutzung und Überprüfung der PCR-Geräte. Obwohl PCR-Geräte robuste technische Geräte sind, benötigen sie eine regelmäßige Überprüfung ihrer Funktion. Die Kühl- und Heizelemente haben eine begrenzte Lebenszeit. Die akkurate Funktion der Kühl- und Heizelemente ist abhängig von der Qualität der Elemente und der richtigen Nutzung und Wartung.
Zusätzlich zu den Anforderungen an ein definiertes System zur Pflege und Wartung von PCR-Geräten werden in der Technischen Spezifikation Verfahren zur biochemischen oder technischen Überprüfung der akkurate Funktion eines PCR-Gerätes beschrieben (siehe Anhänge A und B).
Microbiologie des aliments - Réaction de polymérisation en chaîne (PCR) pour la recherche des micro-organismes pathogenes dans les aliments - Criteres de performance pour les thermal cyclers (ISO/TS 20836:2005)
L'ISO/TS 20836:2005 précise des exigences fondamentales concernant l'installation, la performance et la maintenance des thermocycleurs. Bien que ces équipements soient des dispositifs solides, ils nécessitent une maintenance régulière. Leurs éléments chauffants/refroidissants ont une durée de vie limitée. Le bon fonctionnement de l'élément chauffant/refroidissant dépend à la fois de la qualité des dispositifs de chauffage/refroidissement et d'une utilisation et de maintenances appropriées.
En plus de la définition des exigences pour un programme de maintenance défini, des modes opératoires pour la détermination de la performance des thermocycleurs par des méthodes biochimiques ou physiques sont donnés.
Mikrobiologija živil in krme - Polimerazna verižna reakcija (PCR) za ugotavljanje prisotnosti povzročiteljev zastrupitev s hrano - Preskus izvedbe preiskave s pomnoževalnikom (ISO/TS 20836:2005)
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
SIST-TS CEN ISO/TS 20836:2005
01-oktober-2005
0LNURELRORJLMDåLYLOLQNUPH3ROLPHUD]QDYHULåQDUHDNFLMD 3&5 ]DXJRWDYOMDQMH
SULVRWQRVWLSRY]URþLWHOMHY]DVWUXSLWHYVKUDQR3UHVNXVL]YHGEHSUHLVNDYHV
SRPQRåHYDOQLNRP ,6276
Microbiology of food and animal feeding stuffs - Polymerase chain reaction (PCR) for the
detection of food-borne pathogens - Performance testing for thermal cyclers (ISO/TS
20836:2005)
Mikrobiologie von Lebensmitteln und Futtermitteln - Polymerase Kettenreaktion (PCR)
zum Nachweis von pathogenen Mikroorganismen in Lebensmitteln - Leistungsprüfung
für PCR-Geräte (ISO/TS 20836:2005)
Microbiologie des aliments - Réaction de polymérisation en chaîne (PCR) pour la
recherche des micro-organismes pathogenes dans les aliments - Criteres de
performance pour les thermal cyclers (ISO/TS 20836:2005)
Ta slovenski standard je istoveten z: CEN ISO/TS 20836:2005
ICS:
07.100.30 Mikrobiologija živil Food microbiology
SIST-TS CEN ISO/TS 20836:2005 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST-TS CEN ISO/TS 20836:2005
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SIST-TS CEN ISO/TS 20836:2005
TECHNICAL SPECIFICATION
CEN ISO/TS 20836
SPÉCIFICATION TECHNIQUE
TECHNISCHE SPEZIFIKATION
August 2005
ICS 07.100.30
English Version
Microbiology of food and animal feeding stuffs - Polmerase
chain reaction (PCR) for the detection of food-borne pathogens -
Performance testing for thermal cyclers (ISO/TS 20836:2005)
Microbiologie des aliments - Réaction de polymérisation en Mikrobiologie von Lebensmitteln und Futtermitteln -
chaîne (PCR) pour la recherche des micro-organismes Polymerase Kettenreaktion (PCR) zum Nachweis von
pathogènes dans les aliments - Critères de performance pathogenen Mikroorganismen in Lebensmitteln -
pour les thermal cyclers (ISO/TS 20836:2005) Leistungsprüfung für PCR-Geräte (ISO/TS 20836:2005)
This Technical Specification (CEN/TS) was approved by CEN on 28 September 2004 for provisional application.
The period of validity of this CEN/TS is limited initially to three years. After two years the members of CEN will be requested to submit their
comments, particularly on the question whether the CEN/TS can be converted into a European Standard.
CEN members are required to announce the existence of this CEN/TS in the same way as for an EN and to make the CEN/TS available
promptly at national level in an appropriate form. It is permissible to keep conflicting national standards in force (in parallel to the CEN/TS)
until the final decision about the possible conversion of the CEN/TS into an EN is reached.
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. CEN ISO/TS 20836:2005: E
worldwide for CEN national Members.
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SIST-TS CEN ISO/TS 20836:2005
CEN ISO/TS 20836:2005 (E)
Foreword
This document (CEN ISO/TS 20836:2005) 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".
According to the CEN/CENELEC Internal Regulations, the national standards organizations of
the following countries are bound to announce this CEN Technical Specification: 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
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SIST-TS CEN ISO/TS 20836:2005
TECHNICAL ISO/TS
SPECIFICATION 20836
First edition
2005-08-01
Microbiology of food and animal feeding
stuffs — Polymerase chain reaction
(PCR) for the detection of food-borne
pathogens — Performance testing for
thermal cyclers
Microbiologie des aliments — Réaction de polymérisation en chaîne
(PCR) pour la recherche des micro-organismes pathogènes dans les
aliments — Critères de performance pour les thermal cyclers
Reference number
ISO/TS 20836:2005(E)
©
ISO 2005
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SIST-TS CEN ISO/TS 20836:2005
ISO/TS 20836:2005(E)
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ii © ISO 2005 – All rights reserved
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SIST-TS CEN ISO/TS 20836:2005
ISO/TS 20836:2005(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions. 1
4 Installation of thermal cyclers . 2
5 Maintenance of thermal cyclers . 2
6 Performance tests. 2
6.1 General. 2
6.2 Biochemical performance test . 2
6.3 Physical performance test . 2
7 Test report and documentation of irregularities . 3
Annex A (informative) Biochemical performance test — PCR method for testing the temperature
accuracy . 4
Annex B (informative) Physical performance test . 11
Bibliography . 13
© ISO 2005 – All rights reserved iii
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SIST-TS CEN ISO/TS 20836:2005
ISO/TS 20836:2005(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.
In other circumstances, particularly when there is an urgent market requirement for such documents, a
technical committee may decide to publish other types of normative document:
⎯ an ISO Publicly Available Specification (ISO/PAS) represents an agreement between technical experts in
an ISO working group and is accepted for publication if it is approved by more than 50 % of the members
of the parent committee casting a vote;
⎯ an ISO Technical Specification (ISO/TS) represents an agreement between the members of a technical
committee and is accepted for publication if it is approved by 2/3 of the members of the committee casting
a vote.
An ISO/PAS or ISO/TS is reviewed after three years in order to decide whether it will be confirmed for a
further three years, revised to become an International Standard, or withdrawn. If the ISO/PAS or ISO/TS is
confirmed, it is reviewed again after a further three years, at which time it must either be transformed into an
International Standard or be withdrawn.
ISO/TS 20836 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
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SIST-TS CEN ISO/TS 20836:2005
ISO/TS 20836:2005(E)
Introduction
This Technical Specification is part of a series of International Standards 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);
⎯ Requirements for sample preparation for qualitative detection (ISO 20837);
⎯ Performance testing for thermal cyclers (ISO/TS 20836);
⎯ Requirements for amplification and detection for qualitative methods (ISO 20838).
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
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.
© ISO 2005 – All rights reserved v
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SIST-TS CEN ISO/TS 20836:2005
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SIST-TS CEN ISO/TS 20836:2005
TECHNICAL SPECIFICATION ISO/TS 20836:2005(E)
Microbiology of food and animal feeding stuffs — Polymerase
chain reaction (PCR) for the detection of food-borne
pathogens — Performance testing of thermal cyclers
WARNING — The use of this Technical Specification may involve hazardous materials, operations and
equipment. This Technical Specification does not purport to address all of the safety problems
associated with its use. It is the responsibility of the user of this Technical Specification to establish
appropriate safety and health practices and to determine the applicability of regulatory limitations
prior to use.
1 Scope
This Technical Specification provides basic requirements for the installation, performance and maintenance of
thermal cyclers. Although thermal cyclers are robust technical equipment, they do require regular
maintenance. Their cooling/heating elements, either Peltier or other technology, have a limited lifetime. Proper
functioning of the cooling/heating element depends both on the quality of the cooling/heating devices and
proper use and care.
In addition to outlining the requirement for a defined maintenance programme, procedures are described for
the determination of thermal cycler performance by biochemical or physical methods (see Annexes A and B).
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 22174, Microbiology of food and animal feeding stuffs — Polymerase chain reaction (PCR) for the
detection of food-borne pathogens — General requirements and definitions
ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 22174 and the following apply.
3.1
heated lid
optional feature of a thermal cycler used to prevent evaporation from the reaction tube
3.2
temperature uniformity
homogeneity of the temperature within the thermally controlled unit (e.g. heating block)
3.3
biochemical performance test
test procedure which determines the performance of a thermal cycler by biochemical means (e.g. a
temperature-sensitive PCR)
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SIST-TS CEN ISO/TS 20836:2005
ISO/TS 20836:2005(E)
3.4
physical performance test
test procedure which determines the performance of a thermal cycler by physical means
3.5
non-robust PCR system
PCR system in which minor deviations from the prescribed PCR chemistry or PCR temperature protocol result
in a less efficient amplification
3.6
critical position
position or area where a deviation of the sample temperature from the displayed temperature is more likely to
occur than in other areas of the thermal cycler sample holder
4 Installation of thermal cyclers
The manufacturer’s instructions should be followed.
The following should be taken into consideration:
a) thermal cyclers should be installed and run at an appropriate temperature and humidity;
b) thermal cyclers should be located
⎯ so they can be inspected visually,
⎯ in such a way as to allow a steady exchange of heat with the environment and free circulation of air,
and
⎯ in a constant environment.
5 Maintenance of thermal cyclers
The laboratory should establish and employ a defined maintenance programme for each thermal cycler
machine, based on the documented hours of use or number of runs.
6 Performance tests
6.1 General
The performance testing of each thermal cycler should be carried out and documented, either indirectly using
a biochemical performance test or directly using a physical performance test.
6.2 Biochemical performance test
A biochemical procedure for thermal cycler performance testing should be carried out, which may be a
temperature-sensitive non-robust PCR method.
An example of a suitable method is described in Annex A. Any other PCR methods that can be shown to fulfil
the requirements may also be used.
The performance test frequency should be based on the documented hours of use or the number of runs of
each thermal cycler machine.
6.3 Physical performance test
A physical test procedure should be carried out to measure the actual sample temperature within each well
during the temperature cycle, and to compare it to the displayed temperature.
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SIST-TS CEN ISO/TS 20836:2005
ISO/TS 20836:2005(E)
An example of a suitable method is described in Annex B. A physical performance test should be undertaken
if a biochemical performance test is not performed, or if the biochemical performance test indicates inefficient
amplification.
The performance test frequency should be based on the documented hours of use or the number of runs of
each thermal cycler machine.
7 Test report and documentation of irregularities
The test report shall conform to ISO/IEC 17
...
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