EN ISO 20836:2021
(Main)Microbiology of the food chain - Polymerase chain reaction (PCR) for the detection of microorganisms - Thermal performance testing of thermal cyclers (ISO 20836:2021)
Microbiology of the food chain - Polymerase chain reaction (PCR) for the detection of microorganisms - Thermal performance testing of thermal cyclers (ISO 20836:2021)
This document specifies requirements for the installation, maintenance, temperature calibration and temperature performance testing of standard thermal cyclers and real-time thermal cyclers. It is applicable to the detection of microorganisms as well as any other applications in the food chain using polymerase chain reaction (PCR)-based methods.
This document has been established for food testing, but is also applicable to other domains using thermal cyclers (e.g. environmental, human health, animal health, forensic testing).
Mikrobiologie von Lebensmitteln und Futtermitteln - Polymerase-Kettenreaktion (PCR) zum Nachweis von Mikroorganismen - Temperaturleistungsprüfung für Thermocycler (ISO 20836:2021)
Dieses Dokument legt Anforderungen an die Installation, Instandhaltung, Temperaturkalibrierung und Temperaturleistungsprüfung von Standard-Thermocyclern und Real-Time-Thermocyclern fest. Es ist anwendbar für den Nachweis von Mikroorganismen sowie alle anderen Anwendungen in der Lebensmittelkette mithilfe von Verfahren, die auf einer Polymerase-Kettenreaktion (PCR) beruhen.
Dieses Dokument wurde für Lebensmittelprüfungen erstellt, ist aber auch in anderen Bereichen anwendbar, in denen Thermocycler benutzt werden (z. B. Umwelt, menschliche Gesundheit, Tiergesundheit, forensische Tests).
Microbiologie de la chaîne alimentaire - Réaction de polymérisation en chaîne (PCR) pour la recherche de micro-organismes - Essais de performance thermique des thermocycleurs (ISO 20836:2021)
Le présent document spécifie les exigences relatives à l’installation, à la maintenance, à l’étalonnage de la température et aux essais de performance thermique des thermocycleurs classiques et des thermocycleurs en temps réel. Il s’applique à la recherche de micro-organismes, ainsi qu’à toute autre application de la chaîne alimentaire utilisant des méthodes fondées sur la réaction de polymérisation en chaîne (PCR).
Le présent document a pour vocation de s’appliquer aux essais sur les aliments, mais est aussi applicable à d’autres domaines utilisant des thermocycleurs (par exemple, des essais relatifs à l’environnement, à la santé humaine, à la santé animale, à la médecine légale).
Mikrobiologija v prehranski verigi - Polimerazna verižna reakcija (PCR) za ugotavljanje prisotnosti mikroorganizmov - Preskus toplotnega delovanja cikličnih termostatov (ISO 20836:2021)
Ta dokument določa zahteve za namestitev, vzdrževanje, umerjanje temperature in preskušanje toplotnega delovanja standardnih cikličnih termostatov in cikličnih termostatov v realnem času. Uporablja se za ugotavljanje prisotnosti mikroorganizmov in druge namene v prehranjevalni verigi z uporabo
metod, ki temeljijo na verižni reakciji s polimerazo (PCR).
Ta dokument je bil pripravljen za preskušanje hrane, vendar je uporaben tudi za druga področja, ki uporabljajo ciklične termostate (npr. okolje, zdravje ljudi, zdravje živali, forenzično preskušanje).
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-februar-2022
Nadomešča:
SIST-TS CEN ISO/TS 20836:2005
Mikrobiologija živil in krme - Polimerazna verižna reakcija (PCR) za ugotavljanje
prisotnosti mikroorganizmov - Preskus toplotnega delovanja cikličnih termostatov
(ISO 20836:2021)
Microbiology of the food chain - Polymerase chain reaction (PCR) for the detection of
microorganisms - Thermal performance testing of thermal cyclers (ISO 20836:2021)
Mikrobiologie von Lebensmitteln und Futtermitteln - Polymerase-Kettenreaktion (PCR)
zum Nachweis von pathogenen Mikroorganismen in Lebensmitteln - Leistungsprüfung
für PCR-Geräte (ISO 20836:2021)
Microbiologie de la chaîne alimentaire - Réaction de polymérisation en chaîne (PCR)
pour la recherche de micro-organismes - Essais de performance thermique des
thermocycleurs (ISO 20836:2021)
Ta slovenski standard je istoveten z: EN ISO 20836:2021
ICS:
07.100.30 Mikrobiologija živil Food microbiology
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 20836
EUROPEAN STANDARD
NORME EUROPÉENNE
December 2021
EUROPÄISCHE NORM
ICS 07.100.30 Supersedes CEN ISO/TS 20836:2005
English Version
Microbiology of the food chain - Polymerase chain reaction
(PCR) for the detection of microorganisms - Thermal
performance testing of thermal cyclers (ISO 20836:2021)
Microbiologie de la chaîne alimentaire - Réaction de Mikrobiologie von Lebensmitteln und Futtermitteln -
polymérisation en chaîne (PCR) pour la recherche de Polymerase-Kettenreaktion (PCR) zum Nachweis von
micro-organismes - Essais de performance thermique pathogenen Mikroorganismen in Lebensmitteln -
des thermocycleurs (ISO 20836:2021) Leistungsprüfung für PCR-Geräte (ISO 20836:2021)
This European Standard was approved by CEN on 19 November 2021.
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, 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 20836:2021 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 20836:2021) 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 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 June 2022, and conflicting national standards shall be
withdrawn at the latest by June 2022.
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 CEN ISO/TS 20836:2005.
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, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 20836:2021 has been approved by CEN as EN ISO 20836:2021 without any modification.
INTERNATIONAL ISO
STANDARD 20836
First edition
2021-11
Microbiology of the food chain —
Polymerase chain reaction (PCR)
for the detection of microorganisms
— Thermal performance testing of
thermal cyclers
Microbiologie de la chaîne alimentaire — Réaction de polymérisation
en chaîne (PCR) pour la recherche de micro-organismes — Essais de
performance thermique des thermocycleurs
Reference number
ISO 20836:2021(E)
ISO 20836:2021(E)
© ISO 2021
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
ISO 20836:2021(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
3.1 Polymerase chain reaction . 1
3.2 Thermal cycler . 2
3.3 Temperature characteristics . 2
3.4 Temperature measurement . 5
4 Installation of thermal cyclers . .6
5 Maintenance of thermal cyclers .6
6 Performance testing of thermal cyclers . 6
6.1 General . 6
6.2 Performance testing programme . 7
6.3 Metrological traceability . 7
6.4 Temperature performance testing method . 8
6.4.1 General . 8
6.4.2 Principle . 8
6.4.3 Equipment . 8
6.4.4 Environmental conditions . 9
6.4.5 Procedure . 9
6.4.6 Performance test results . 10
6.4.7 Performance test report . 10
6.4.8 Compliancy testing . 11
6.5 Optical performance testing method . 11
Annex A (informative) Sensor locations .13
Annex B (informative) Universal temperature protocol .18
Annex C (informative) Compliancy testing .19
Annex D (informative) Example of a thermal cycler temperature profile .22
Annex E (informative) Example of performance test and compliancy test .23
Bibliography .27
iii
ISO 20836:2021(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.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to
the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see
www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee TC 34, Food products, Subcommittee SC 9,
Microbiology, in collaboration with the European Co
...
SLOVENSKI STANDARD
01-februar-2022
Nadomešča:
SIST-TS CEN ISO/TS 20836:2005
Mikrobiologija v prehranski verigi - Polimerazna verižna reakcija (PCR) za
ugotavljanje prisotnosti mikroorganizmov - Preskus toplotnega delovanja cikličnih
termostatov (ISO 20836:2021)
Microbiology of the food chain - Polymerase chain reaction (PCR) for the detection of
microorganisms - Thermal performance testing of thermal cyclers (ISO 20836:2021)
Mikrobiologie von Lebensmitteln und Futtermitteln - Polymerase-Kettenreaktion (PCR)
zum Nachweis von pathogenen Mikroorganismen in Lebensmitteln - Leistungsprüfung
für PCR-Geräte (ISO 20836:2021)
Microbiologie de la chaîne alimentaire - Réaction de polymérisation en chaîne (PCR)
pour la recherche de micro-organismes - Essais de performance thermique des
thermocycleurs (ISO 20836:2021)
Ta slovenski standard je istoveten z: EN ISO 20836:2021
ICS:
07.100.30 Mikrobiologija živil Food microbiology
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 20836
EUROPEAN STANDARD
NORME EUROPÉENNE
December 2021
EUROPÄISCHE NORM
ICS 07.100.30 Supersedes CEN ISO/TS 20836:2005
English Version
Microbiology of the food chain - Polymerase chain reaction
(PCR) for the detection of microorganisms - Thermal
performance testing of thermal cyclers (ISO 20836:2021)
Microbiologie de la chaîne alimentaire - Réaction de Mikrobiologie von Lebensmitteln und Futtermitteln -
polymérisation en chaîne (PCR) pour la recherche de Polymerase-Kettenreaktion (PCR) zum Nachweis von
micro-organismes - Essais de performance thermique pathogenen Mikroorganismen in Lebensmitteln -
des thermocycleurs (ISO 20836:2021) Leistungsprüfung für PCR-Geräte (ISO 20836:2021)
This European Standard was approved by CEN on 19 November 2021.
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, 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 20836:2021 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 20836:2021) 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 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 June 2022, and conflicting national standards shall be
withdrawn at the latest by June 2022.
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 CEN ISO/TS 20836:2005.
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, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 20836:2021 has been approved by CEN as EN ISO 20836:2021 without any modification.
INTERNATIONAL ISO
STANDARD 20836
First edition
2021-11
Microbiology of the food chain —
Polymerase chain reaction (PCR)
for the detection of microorganisms
— Thermal performance testing of
thermal cyclers
Microbiologie de la chaîne alimentaire — Réaction de polymérisation
en chaîne (PCR) pour la recherche de micro-organismes — Essais de
performance thermique des thermocycleurs
Reference number
ISO 20836:2021(E)
ISO 20836:2021(E)
© ISO 2021
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
ISO 20836:2021(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
3.1 Polymerase chain reaction . 1
3.2 Thermal cycler . 2
3.3 Temperature characteristics . 2
3.4 Temperature measurement . 5
4 Installation of thermal cyclers . .6
5 Maintenance of thermal cyclers .6
6 Performance testing of thermal cyclers . 6
6.1 General . 6
6.2 Performance testing programme . 7
6.3 Metrological traceability . 7
6.4 Temperature performance testing method . 8
6.4.1 General . 8
6.4.2 Principle . 8
6.4.3 Equipment . 8
6.4.4 Environmental conditions . 9
6.4.5 Procedure . 9
6.4.6 Performance test results . 10
6.4.7 Performance test report . 10
6.4.8 Compliancy testing . 11
6.5 Optical performance testing method . 11
Annex A (informative) Sensor locations .13
Annex B (informative) Universal temperature protocol .18
Annex C (informative) Compliancy testing .19
Annex D (informative) Example of a thermal cycler temperature profile .22
Annex E (informative) Example of performance test and compliancy test .23
Bibliography .27
iii
ISO 20836:2021(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.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to
the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see
www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee TC 34, Food products, Subcommittee SC 9,
Microbiology, in collaboration with the Europ
...
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