SIST EN ISO 16140-4:2020/kFprA1:2024
(Amendment)Microbiology of the food chain - Method validation - Part 4: Protocol for method validation in a single laboratory - Amendment 1: Validation of a larger test portion size for qualitative methods (ISO 16140 4:2020/FDAM 1:2024)
Microbiology of the food chain - Method validation - Part 4: Protocol for method validation in a single laboratory - Amendment 1: Validation of a larger test portion size for qualitative methods (ISO 16140 4:2020/FDAM 1:2024)
Mikrobiologie der Lebensmittelkette - Verfahrensvalidierung - Teil 4: Arbeitsvorschrift für Einzel-Labor-Verfahrensvalidierung - ÄNDERUNG 1: Validierung größerer Prüfmengen für qualitative Verfahren (ISO 16140 4:2020/FDAM 1:2024)
Microbiologie de la chaîne alimentaire - Validation des méthodes - Partie 4: Protocole pour la validation de méthodes dans un seul laboratoire - Amendement 1: Validation d’une taille de prise d’essai plus grande pour des méthodes qualitatives (ISO 16140 4:2020/FDAM 1:2024)
Mikrobiologija v prehranski verigi - Validacija metode - 4. del: Protokol za validacijo metode v posameznem laboratoriju (hišne metode)- Dopolnilo A1: Validacija testnega vzorca večje velikosti za kvalitativne metode (ISO 16140 4:2020/FDAM 1:2024)
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Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 16140-4:2020/oprA1:2023
01-oktober-2023
Mikrobiologija v prehranski verigi - Validacija metode - 4. del: Protokol za
validacijo metode v posameznem laboratoriju (hišne metode)- Dopolnilo A1:
Validacija testnega vzorca večje velikosti za kvalitativne metode (ISO 16140
4:2020/DAM 1:2023)
Microbiology of the food chain - Method validation - Part 4: Protocol for method validation
in a single laboratory - Amendment 1: Validation of a larger test portion size for
qualitative methods (ISO 16140 4:2020/DAM 1:2023)
Mikrobiologie der Lebensmittelkette - Verfahrensvalidierung - Teil 4: Arbeitsvorschrift für
Einzel-Labor-Verfahrensvalidierung - ÄNDERUNG 1: Validierung größerer Prüfmengen
für qualitative Verfahren (ISO 16140 4:2020/DAM 1:2023)
Microbiologie de la chaîne alimentaire - Validation des méthodes - Partie 4: Protocole
pour la validation de méthodes dans un seul laboratoire - Amendement 1: Validation
d’une taille de prise d’essai plus grande pour des méthodes qualitatives (ISO 16140
4:2020/DAM 1:2023)
Ta slovenski standard je istoveten z: EN ISO 16140-4:2020/prA1
ICS:
07.100.30 Mikrobiologija živil Food microbiology
SIST EN ISO 16140-4:2020/oprA1:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
SIST EN ISO 16140-4:2020/oprA1:2023
SIST EN ISO 16140-4:2020/oprA1:2023
DRAFT AMENDMENT
ISO 16140-4:2020/DAM 1
ISO/TC 34/SC 9 Secretariat: AFNOR
Voting begins on: Voting terminates on:
2023-07-19 2023-10-11
Microbiology of the food chain — Method validation —
Part 4:
Protocol for method validation in a single laboratory
AMENDMENT 1: Validation of a larger test portion size for
qualitative methods
ICS: 07.100.30
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
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ISO 16140-4:2020/DAM 1:2023(E)
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PROVIDE SUPPORTING DOCUMENTATION. © ISO 2023
SIST EN ISO 16140-4:2020/oprA1:2023
ISO 16140-4:2020/DAM 1:2023(E)
DRAFT AMENDMENT
ISO 16140-4:2020/DAM 1
ISO/TC 34/SC 9 Secretariat: AFNOR
Voting begins on: Voting terminates on:
Microbiology of the food chain — Method validation —
Part 4:
Protocol for method validation in a single laboratory
AMENDMENT 1: Validation of a larger test portion size for
qualitative methods
ICS: 07.100.30
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
© ISO 2023
ISO/CEN PARALLEL PROCESSING
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NATIONAL REGULATIONS.
Website: www.iso.org ISO 16140-4:2020/DAM 1:2023(E)
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ii
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2023
SIST EN ISO 16140-4:2020/oprA1:2023
ISO 16140-4:2020/DAM 1:2023(E)
Foreword
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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
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www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 34, Food products, Subcommittee SC
9, Microbiology, in collaboration with the European Committee for Standardization (CEN) Technical
Committee CEN/TC 463, Microbiology of the food chain, in accordance with the Agreement on technical
cooperation between ISO and CEN (Vienna Agreement).
A list of all parts in the ISO 16140 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body.
A complete listing of these bodies can be found at www.iso.org/members.html.
iii
SIST EN ISO 16140-4:2020/oprA1:2023
SIST EN ISO 16140-4:2020/oprA1:2023
ISO 16140-4:2020/DAM 1:2023(E)
Microbiology of the food chain — Method validation —
Part 4:
Protocol for method validation in a single laboratory
AMENDMENT 1: Validation of a larger test portion size for
qualitative methods
Clause 3
Add the following definition:
3.13
larger test portion size
measured (volume or mass) representative sample taken from the laboratory sample or test sample
for use in the preparation of the initial suspension that is larger than the test portion that has been
described in the original method and/or validation document
4.1
Add the following text after the second paragraph:
The protocol which shall be used to validate a larger test portion size for qualitative methods in a single
laboratory is described in Annex H.
Annex H
Add the following annex after Annex G, before the Bibliography.
SIST EN ISO 16140-4:2020/oprA1:2023
ISO 16140-4:2020/DAM 1:2023(E)
Annex H
(normative)
Validation of a larger test portion size for qualitative methods
H.1 General
This annex describes a protocol for the validation for qualitative methods when using a larger test
portion size. This protocol is intended to demonstrate the effect of analysing a test portion larger than
the test portion initially used to validate the method. Validation of the larger test portion size applies
only to the laboratory conducting the study and only to the specific (food) category used.
Reference methods which were validated using a larger test portion size in accordance with ISO 17468
and alternative (proprietary) methods which were validated using a larger test portion size in
accordance with ISO 16140-2 only need to be verified by a laboratory following ISO 16140-3.
The validated larger test portion size can be used in other laboratories once this has been validated
in an interlaboratory study in accordance with ISO 16140-2 or ISO 16140-5. See the flow diagram in
Figure 1. Once validated in an interlaboratory study, any laboratory can implement the larger test
portion size after verification following ISO 16140-3. If not validated in an interlaboratory study,
validation in acco
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