SIST EN ISO 16140-2:2016

Microbiology of the food chain - Method validation - Part 2: Protocol for the validation of alternative (proprietary) methods against a reference method (ISO 16140-2:2016)

This part of ISO 16140 specifies the general principle and the technical protocol for the validation
of alternative, mostly proprietary, methods for microbiology in the food chain. Validation studies
according to this part of ISO 16140 are intended to be performed by organizations involved in method
validation.
This part of ISO 16140 is applicable to the validation of methods for the analysis (detection or
quantification) of microorganisms in
— products intended for human consumption,
— products intended for animal feeding,
— environmental samples in the area of food and feed production, handling, and
— samples from the primary production stage.
This part of ISO 16140 is in particular applicable to bacteria and fungi. Some clauses of this part of
ISO 16140 could be applicable to other (micro) organisms or their metabolites on a case-by-case-basis.
In the future, guidance for other organisms (e.g. viruses and parasites) will be included in either this
part or a separate part of ISO 16140.

Mikrobiologie der Lebensmittelkette - Verfahrensvalidierung - Teil 2: Arbeitsvorschrift für die Validierung von alternativen (urheberrechtlich geschützten) Verfahren anhand eines Referenzverfahrens (ISO 16140-2:2016)

Dieser Teil von ISO 16140 legt die allgemeinen Benennungen und Definitionen in Bezug auf die Verfahrensvalidierung auf dem Gebiet der Mikrobiologie der Lebensmittelkette fest.
Der vorliegende Teil von ISO 16140 ist anwendbar auf die Validierung von Verfahren zur Untersuchung (Nachweis oder quantitative Bestimmung) von Mikroorganismen in:
   Erzeugnissen, die für den menschlichen Verzehr und als Futtermittel vorgesehen sind;
   Umgebungsproben im Bereich der Herstellung und Handhabung von Lebensmitteln;
   Proben aus dem Bereich der Primärproduktion.

Microbiologie de la chaîne alimentaire - Validation des méthodes - Partie 2: Protocole pour la validation de méthodes alternatives (commerciales) par rapport à une méthode de référence (ISO 16140-2:2016)

L'ISO 16140-2 :2016 établit le principe général ainsi que le protocole technique de validation des méthodes alternatives, qui sont pour la plupart commerciales, dans le domaine de la microbiologie de la chaîne alimentaire. Les études de validation conformément à l'ISO 16140-2 :2016 sont destinées à être effectuées par des organismes impliqués dans la validation de méthode.
Elle est applicable à la validation de méthodes pour l'analyse (détection ou quantification) de micro-organismes présents dans:
-      les produits destinés à la consommation humaine,
-      les produits destinés à l'alimentation animale,
-      les échantillons environnementaux dans le domaine de la production et de la manutention de produits alimentaires, et
-      les échantillons au stade de la production primaire.
L'ISO 16140-2 :2016 est notamment applicable aux bactéries et aux champignons. Certains paragraphes de l'ISO 16140-2 :2016 peuvent être applicables à d'autres micro-organismes ou à leurs métabolites au cas par cas. À l'avenir, des préconisations concernant d'autres organismes (par exemple, virus et parasites) seront incluses dans l'ISO 16140 (toutes les parties).

Mikrobiologija v prehranski verigi - Validacija metode - 2. del: Protokol za validacijo alternativnih (lastniških) metod glede na referenčno metodo (ISO 16140-2:2016)

Ta del standarda ISO 16140 določa splošno načelo in tehnični protokol za validacijo
alternativnih, večinoma lastniških metod za mikrobiologijo v prehranski verigi. Študije validacije
v skladu s tem delom standarda ISO 16140 so namenjene organizacijam, ki se ukvarjajo z validacijo metod.
Ta del standarda ISO 16140 se uporablja za validacijo metod za analizo (odkrivanje ali kvantifikacijo) mikroorganizmov v:
– proizvodih, namenjenih za prehrano ljudi;
– proizvodih, namenjenih za živalsko krmo;
– okoljskih vzorcih na področju proizvodnje hrane in krme; ter
– vzorcih iz faze primarne proizvodnje.
Ta del standarda ISO 16140 se uporablja zlasti za bakterije in glive. Nekatere točke tega dela
standarda ISO 16140 se lahko uporabljajo za druge (mikro-) organizme ali njihove metabolite za vsak posamezen primer.
V prihodnosti bodo v ta del ali ločen del standarda ISO 16140 vključeni napotki za druge organizme (npr. viruse in parazite).

General Information

• Status: Published
• Public Enquiry End Date: 14-Apr-2013
• Publication Date: 13-Sep-2016
• ICS: 07.100.30 - Food microbiology
• Technical Committee: KŽP - Agricultural food products
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 28-Jul-2016
• Due Date: 02-Oct-2016
• Completion Date: 14-Sep-2016
• Ref Project: EN ISO 16140-2:2016 - Microbiology of the food chain - Method validation - Part 2: Protocol for the validation of alternative (proprietary) methods against a reference method (ISO 16140-2:2016)

Relations

• Replaces: SIST EN ISO 16140:2003 - Microbiology of food and animal feeding stuffs - Protocol for the validation of alternative methods (ISO 16140:2003)
• Effective Date: 08-Jun-2022
• Replaces: SIST EN ISO 16140:2003/A1:2012 - Microbiology of food and animal feeding stuffs - Protocol for the validation of alternative methods - Amendment 1 (ISO 16140:2003/AMD 1:2011)
• Effective Date: 01-Oct-2016
• Replaces: SIST EN ISO 16140:2003 - Microbiology of food and animal feeding stuffs - Protocol for the validation of alternative methods (ISO 16140:2003)
• Effective Date: 01-Oct-2016
• Amended By: SIST EN ISO 16140-2:2016/kFprA1:2024 - Microbiology of the food chain - Method validation - Part 2: Protocol for the validation of alternative (proprietary) methods against a reference method - Amendment 1: Revision of qualitative method comparison study data evaluation, relative level of detection calculations in the interlaboratory study, calculation and interpretation of the relative trueness study, and inclusion of a commercial sterility testing protocol for specific products (ISO 16140-2:2016/FDAM 1:2024)
• Effective Date: 23-Jun-2021

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 16140-2:2016
01-oktober-2016
1DGRPHãþD
SIST EN ISO 16140:2003
SIST EN ISO 16140:2003/A1:2012
0LNURELRORJLMDYSUHKUDQVNLYHULJL9DOLGDFLMDPHWRGHGHO3URWRNRO]D
YDOLGDFLMRDOWHUQDWLYQLKODVWQLãNLKPHWRGJOHGHQDUHIHUHQþQRPHWRGR,62

Microbiology of the food chain - Method validation - Part 2: Protocol for the validation of
alternative (proprietary) methods against a reference method (ISO 16140-2:2016)
Mikrobiologie der Lebensmittelkette - Verfahrensvalidierung - Teil 2: Arbeitsvorschrift für
die Validierung von alternativen (urheberrechtlich geschützten) Verfahren anhand eines
Referenzverfahrens (ISO 16140-2:2016)
Microbiologie de la chaîne alimentaire - Validation des méthodes - Partie 2: Protocole
pour la validation de méthodes alternatives (commerciales) par rapport à une méthode
de référence (ISO 16140-2:2016)
Ta slovenski standard je istoveten z: EN ISO 16140-2:2016
ICS:
07.100.30 Mikrobiologija živil Food microbiology
SIST EN ISO 16140-2:2016 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 16140-2:2016

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SIST EN ISO 16140-2:2016


EN ISO 16140-2
EUROPEAN STANDARD

NORME EUROPÉENNE

July 2016
EUROPÄISCHE NORM
ICS 07.100.30 Supersedes EN ISO 16140:2003
English Version

Microbiology of the food chain - Method validation - Part 2:
Protocol for the validation of alternative (proprietary)
methods against a reference method (ISO 16140-2:2016)
Microbiologie de la chaîne alimentaire - Validation des Mikrobiologie der Lebensmittelkette -
méthodes - Partie 2: Protocole pour la validation de Verfahrensvalidierung - Teil 2: Arbeitsvorschrift für die
méthodes alternatives (commerciales) par rapport à Validierung von alternativen (urheberrechtlich
une méthode de référence (ISO 16140-2:2016) geschützten) Verfahren anhand eines
Referenzverfahrens (ISO 16140-2:2016)
This European Standard was approved by CEN on 12 May 2016.

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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, 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: Avenue Marnix 17, B-1000 Brussels
© 2016 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 16140-2:2016 E
worldwide for CEN national Members.

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SIST EN ISO 16140-2:2016
EN ISO 16140-2:2016 (E)
Contents Page
European foreword . 3
2

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SIST EN ISO 16140-2:2016
EN ISO 16140-2:2016 (E)
European foreword
This document (EN ISO 16140-2:2016) has been prepared by Technical Committee ISO/TC 34 "Food
products" in collaboration with Technical Committee CEN/TC 275 “Food analysis - Horizontal methods”
the secretariat of which is held by DIN.
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 January 2017, and conflicting national standards shall
be withdrawn at the latest by January 2017.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent
rights.
This document supersedes EN ISO 16140:2003.
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, Former Yugoslav Republic
...

SLOVENSKI STANDARD
oSIST prEN ISO 16140-2:2013
01-marec-2013
0LNURELRORJLMDåLYLOLQNUPH0HWRGDYDOLGDFLMHGHO3URWRNRO]DYDOLGDFLMR
PHWRGDOWHUQDWLYQLKUHIHUHQþQLPHWRGL,62',6
Microbiology of food and animal feed - Method validation - Part 2: Protocol for the
validation of alternative (proprietary) methods against a reference method (ISO/DIS
16140-2:2013)
Mikrobiologie von Lebensmitteln und Futtermitteln - Verfahrensvalidierung - Teil 2:
Arbeitsvorschrift für die Validierung von alternativen (urheberrechtlich geschützten)
Verfahren anhand eines Referenzverfahrens (ISO/DIS 16140-2:2013)
Microbiologie des aliments - Validation des méthodes - Partie 2: Protocole pour la
validation de méthodes alternatives (brevetées) par rapport à une méthode de référence
(ISO/DIS 16140-2:2013)
Ta slovenski standard je istoveten z: prEN ISO 16140-2 rev
ICS:
07.100.30 Mikrobiologija živil Food microbiology
oSIST prEN ISO 16140-2:2013 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN ISO 16140-2:2013

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oSIST prEN ISO 16140-2:2013


EUROPEAN STANDARD
DRAFT
prEN ISO 16140-2 rev
NORME EUROPÉENNE

EUROPÄISCHE NORM

January 2013
ICS 07.100.30 Will supersede EN ISO 16140:2003
English Version
Microbiology of food and animal feed - Method validation - Part
2: Protocol for the validation of alternative (proprietary) methods
against a reference method (ISO/DIS 16140-2:2013)
Microbiologie des aliments - Validation des méthodes - Mikrobiologie von Lebensmitteln und Futtermitteln -
Partie 2: Protocole pour la validation de méthodes Verfahrensvalidierung - Teil 2: Arbeitsvorschrift für die
alternatives (brevetées) par rapport à une méthode de Validierung von alternativen (urheberrechtlich geschützten)
référence (ISO/DIS 16140-2:2013) Verfahren anhand eines Referenzverfahrens (ISO/DIS
16140-2:2013)
This draft European Standard is submitted to CEN members for parallel enquiry. It has been drawn up by the Technical Committee
CEN/TC 275.

If this draft becomes a European Standard, 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.

This draft European Standard was established by CEN 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.

Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are aware and to
provide supporting documentation.

Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and
shall not be referred to as a European Standard.


EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2013 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN ISO 16140-2 rev:2013: E
worldwide for CEN national Members.

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oSIST prEN ISO 16140-2:2013
prEN ISO 16140-2:2013 (E)
Contents Page
Foreword .3
2

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oSIST prEN ISO 16140-2:2013
prEN ISO 16140-2:2013 (E)
Foreword
This document (prEN ISO 16140-2:2013) has been prepared by Technical Committee ISO/TC 34 "Food
products" in collaboration with Technical Committee CEN/TC 275 “Food analysis - Horizontal methods” the
secretariat of which is held by DIN.
This document is currently submitted to the parallel Enquiry.
This document will supersede EN ISO 16140:2003.
Endorsement notice
The text of ISO/DIS 16140-2:2013 has been approved by CEN as a prEN ISO 16140-2:2013 without any
modification.
3

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oSIST prEN ISO 16140-2:2013

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oSIST prEN ISO 16140-2:2013

DRAFT INTERNATIONAL STANDARD ISO/DIS 16140-2
ISO/TC 34/SC 9 Secretariat
...