SIST EN ISO 16140-4:2020/A2:2025

SLOVENSKI STANDARD
01-november-2025
Mikrobiologija v prehranski verigi - Validacija metode - 4. del: Protokol za
validacijo metode v posameznem laboratoriju - Dopolnilo A2: Protokol za
validacijo metod identifikacije mikroorganizmov v posameznem laboratoriju (ISO
16140-4:2020/Amd 2:2025)
Microbiology of the food chain - Method validation - Part 4: Protocol for method validation
in a single laboratory - Amendment 2: Protocol for single-laboratory validation of
identification methods of microorganisms (ISO 16140-4:2020/Amd 2:2025)
Mikrobiologie der Lebensmittelkette - Verfahrensvalidierung - Teil 4: Arbeitsvorschrift für
Einzel-Labor-Verfahrensvalidierung - Änderung 2: Arbeitsvorschrift für Einzel-Labor-
Verfahrensvalidierung von Identifizierungsverfahren von Mikroorganismen (ISO 16140-
4:2020/Amd 2:2025)
Microbiologie de la chaîne alimentaire - Validation des méthodes - Partie 4: Protocole
pour la validation de méthodes dans un seul laboratoire - Amendement 2 (ISO 16140-
4:2020/Amd 2:2025)
Ta slovenski standard je istoveten z: EN ISO 16140-4:2020/A2:2025
ICS:
07.100.30 Mikrobiologija živil Food microbiology
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 16140-4:2020/A2
EUROPEAN STANDARD
NORME EUROPÉENNE
August 2025
EUROPÄISCHE NORM
ICS 07.100.30
English Version
Microbiology of the food chain - Method validation - Part 4:
Protocol for method validation in a single laboratory -
Amendment 2: Protocol for single-laboratory validation of
identification methods of microorganisms (ISO 16140-
4:2020/Amd 2:2025)
Microbiologie de la chaîne alimentaire - Validation des Mikrobiologie der Lebensmittelkette -
méthodes - Partie 4: Protocole pour la validation de Verfahrensvalidierung - Teil 4: Arbeitsvorschrift für die
méthodes dans un seul laboratoire - Amendement 2: Einzellabor-Verfahrensvalidierung - Änderung 2:
Protocole pour la validation dans un seul laboratoire Arbeitsvorschrift für die Einzellabor-
de méthodes d'identification des microorganismes (ISO Verfahrensvalidierung von Identifizierungsverfahren
16140-4:2020/Amd 2:2025) von Mikroorganismen (ISO 16140-4:2020/Amd
2:2025)
This amendment A2 modifies the European Standard EN ISO 16140-4:2020; it was approved by CEN on 25 August 2025.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of
this amendment into the relevant 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 amendment 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
© 2025 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 16140-4:2020/A2:2025 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 16140-4:2020/A2:2025) 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 Amendment to the European Standard EN ISO 16140-4:2020 shall be given the status of a national
standard, either by publication of an identical text or by endorsement, at the latest by February 2026,
and conflicting national standards shall be withdrawn at the latest by February 2026.
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.
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 16140-4:2020/Amd 2:2025 has been approved by CEN as EN ISO 16140-
4:2020/A2:2025 without any modification.

International
Standard
ISO 16140-4
First edition
Microbiology of the food chain —
2020-07
Method validation —
AMENDMENT 2
Part 4:
2025-08
Protocol for method validation in a
single laboratory
AMENDMENT 2: Protocol for single-
laboratory validation of identification
methods of microorganisms
Microbiologie de la chaîne alimentaire — Validation des
méthodes —
Partie 4: Protocole pour la validation de méthodes dans un seul
laboratoire
AMENDEMENT 2: Protocole pour la validation dans un seul
laboratoire de méthodes d’identification des microorganismes
Reference number
ISO 16140-4:2020/Amd.2:2025(en) © ISO 2025

ISO 16140-4:2020/Amd.2:2025(en)
© ISO 2025
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 16140-4:2020/Amd.2:2025(en)
Foreword
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