EN ISO 16140-5:2020

Microbiology of the food chain - Method validation - Part 5: Protocol for factorial interlaboratory validation for non-proprietary methods (ISO 16140-5:2020)

This document specifies the general principles and the technical protocols (based on orthogonal, factorial studies) for the validation of non-proprietary methods for microbiology of the food chain.
This document is applicable to the validation of methods used 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;
—     samples from the primary production stage.
This document is, in particular, applicable to bacteria and fungi. Some clauses can be applicable to other (micro)organisms or their metabolites, to be determined on a case-by-case basis.
This document specifies protocols for the validation against a reference method for both quantitative and qualitative methods. This document also provides a protocol for the validation of quantitative methods without a reference method. Qualitative methods cannot be validated without a reference method in accordance with this document.
NOTE    ISO 16140-2 specifies the general principle and the technical protocol for the validation of alternative, mostly proprietary, methods against a reference method.
This document is only applicable to the validation of methods that are fully specified with regard to all relevant parameters (including tolerances on temperatures and specifications on culture media) and that have already been optimized.
Methods that have been validated in accordance with this document can be used by the laboratories of the specified population of laboratories.

Mikrobiologie der Lebensmittelkette - Verfahrensvalidierung - Teil 5: Arbeitsvorschrift für eine faktorielle Ringversuch-Verfahrensvalidierung nicht urheberrechtlich geschützter Verfahren (ISO 16140-5:2020)

Dieses Dokument legt (auf der Grundlage von orthogonalen, faktoriellen Untersuchungen) die allgemeinen Grundsätze und technischen Arbeitsvorschriften für die Validierung nicht urheberrechtlich geschützter Verfahren in der Mikrobiologie der Lebensmittelkette fest.
Dieses Dokument ist anwendbar auf die Validierung von Verfahren zur Analyse (Nachweis oder Quantifizierung) von Mikroorganismen in:
- Erzeugnissen, die für den menschlichen Verzehr vorgesehen sind;
- Erzeugnissen, die als Futtermittel vorgesehen sind;
- Umgebungsproben im Bereich der Herstellung und Handhabung von Lebensmitteln und Futtermitteln;
- Proben aus dem Bereich der Primärproduktion.
Dieses Dokument ist insbesondere auf Bakterien und Pilze anwendbar. Einige Abschnitte können auf andere (Mikro )Organismen oder deren Metabolite angewendet werden. Die Bestimmung muss im Einzelfall erfolgen.
Dieses Dokument legt Arbeitsvorschriften für die Validierung mit Bezug auf ein Referenzverfahren sowohl für quantitative als auch qualitative Verfahren fest. Darüber hinaus stellt dieses Dokument eine Arbeitsvorschrift für die Validierung von quantitativen Verfahren ohne Bezug auf ein Referenzverfahren bereit. Qualitative Verfahren können nach diesem Dokument ohne Bezug auf ein Referenzverfahren nicht validiert werden.
ANMERKUNG ISO 16140 2 legt das allgemeine Prinzip und die technische Arbeitsvorschrift für die Validierung alternativer, zum Großteil urheberrechtlich geschützter Verfahren mit Bezug auf ein Referenzverfahren fest.
Dieses Dokument ist nur für die Validierung solcher Verfahren anwendbar, bei denen alle relevanten Parameter vollständig angegeben sind (einschließlich der Toleranzen zu Temperaturen und der Festlegungen zu Nährmedien) und die bereits optimiert wurden.
Verfahren, die nach diesem Dokument validiert wurden, können von den Laboren verwendet werden, die zu der festgelegten Grundgesamtheit der Labore gehören.

Microbiologie de la chaîne alimentaire - Validation des méthodes - Partie 5: Protocole pour la validation interlaboratoires de méthodes non commerciales par plan factoriel (ISO 16140-5:2020)

Le présent document établit les principes généraux ainsi que les protocoles techniques (fondé sur des études factorielles orthogonales) de validation de méthodes non commerciales, dans le domaine de la microbiologie de la chaîne alimentaire.
Le présent document est applicable à la validation de méthodes utilisées 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 les domaines de la production et de la manutention de produits alimentaires;
—          les échantillons au stade de la production primaire.
Le présent document est notamment applicable aux bactéries et aux champignons. Certains articles peuvent être applicables à d'autres (micro-)organismes ou à leurs métabolites, qui doivent être déterminés au cas par cas.
Le présent document spécifie des protocoles pour la validation de méthodes quantitatives et qualitatives par rapport à une méthode de référence. Il établit également un protocole pour la validation de méthodes quantitatives sans méthode de référence. Les méthodes qualitatives ne peuvent pas être validées sans méthode de référence conformément au présent document.
NOTE       L'ISO 16140‑2 spécifie le principe général et le protocole technique pour la validation de méthodes alternatives, majoritairement commerciales, par rapport à une méthode de référence.
Le présent document est uniquement applicable à la validation de méthodes dont les paramètres pertinents sont intégralement spécifiés (notamment les tolérances sur les températures et les spécifications sur les milieux de culture) et qui ont déjà été optimisées.
Les méthodes qui ont été validées conformément au présent document peuvent être utilisées par les laboratoires de la population de laboratoires spécifiée.

Mikrobiologija v prehranski verigi - Validacija metode - 5. del: Protokol za medlaboratorijsko validacijo nelastniških metod (ISO 16140-5:2020)

General Information

• Status: Published
• Publication Date: 25-Aug-2020
• Withdrawal Date: 27-Feb-2021
• ICS: 07.100.30 - Food microbiology
• Technical Committee: CEN/TC 463 - Microbiology of the food chain
• Drafting Committee: CEN/TC 275/WG 6 - Microbiological contamination
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 26-Aug-2020
• Due Date: 15-Jun-2017
• Completion Date: 26-Aug-2020
• Directive: 882/2004 - Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 onofficial controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules
• Ref Project: SIST EN ISO 16140-5:2020 - Microbiology of the food chain - Method validation - Part 5: Protocol for factorial interlaboratory validation for non-proprietary methods (ISO 16140-5:2020)

Standards Content (Sample)

SLOVENSKI STANDARD
01-november-2020
Mikrobiologija v prehranski verigi - Validacija metode - 5. del: Protokol za
medlaboratorijsko validacijo nelastniških metod (ISO 16140-5:2020)
Microbiology of the food chain - Method validation - Part 5: Protocol for factorial
interlaboratory validation for non-proprietary methods (ISO 16140-5:2020)
Mikrobiologie der Lebensmittelkette - Verfahrensvalidierung - Teil 5: Arbeitsvorschrift für
eine faktorielle Ringversuch-Verfahrensvalidierung (ISO 16140-5:2020)
Microbiologie de la chaîne alimentaire - Validation des méthodes - Partie 5: Protocole
pour la validation interlaboratoires de méthodes non commerciales par plan factoriel
(ISO 16140-5:2020)
Ta slovenski standard je istoveten z: EN ISO 16140-5:2020
ICS:
07.100.30 Mikrobiologija živil Food microbiology
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 16140-5
EUROPEAN STANDARD
NORME EUROPÉENNE
August 2020
EUROPÄISCHE NORM
ICS 07.100.30
English Version
Microbiology of the food chain - Method validation - Part 5:
Protocol for factorial interlaboratory validation for non-
proprietary methods (ISO 16140-5:2020)
Microbiologie de la chaîne alimentaire - Validation des Mikrobiologie der Lebensmittelkette -
méthodes - Partie 5: Protocole pour la validation Verfahrensvalidierung - Teil 5: Arbeitsvorschrift für
interlaboratoires de méthodes non commerciales par eine faktorielle Ringversuch-Verfahrensvalidierung
plan factoriel (ISO 16140-5:2020) (ISO 16140-5:2020)
This European Standard was approved by CEN on 25 May 2020.

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
© 2020 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 16140-5:2020 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 16140-5:2020) 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 February 2021, and conflicting national standards
shall be withdrawn at the latest by February 2021.
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.
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 16140-5:2020 has been approved by CEN as EN ISO 16140-5:2020 without any
modification.
INTERNATIONAL ISO
STANDARD 16140-5
First edition
2020-07
Microbiology of the food chain —
Method validation —
Part 5:
Protocol for factorial interlaboratory
validation for non-proprietary
methods
Microbiologie de la chaîne alimentaire — Validation des méthodes —
Partie 5: Protocole pour la validation interlaboratoires de méthodes
non commerciales par plan factoriel
Reference number
ISO 16140-5:2020(E)
©
ISO 2020
ISO 16140-5:2020(E)
© ISO 2020
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
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Phone: [phone]
Email: [e-mail]
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Published in Switzerland
ii © ISO 2020 – All rights reserved

ISO 16140-5:2020(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 General principles for the factorial interlaboratory validation of non-proprietary
methods . 3
4.1 General . 3
4.2 Validation against a reference method . 3
4.3 Validation without a reference method . 3
5 Qualitative methods — Technical protocol for factorial interlaboratory validation .3
5.1 In-house validation study . 3
5.2 Interlaboratory validation study against a reference method . 4
5.2.1 General considerations . 4
5.2.2 Measurement protocol . 4
5.2.3 Selection of the factors to be studied . 5
5.2.4 Experimental design . 6
5.3 Calculations and summary of data . 6
5.4 Interpretation of data . 8
5.4.1 Paired study . 8
5.4.2 Unpaired study . 9
5.4.3 Analysis of factorial effects with respect to RLOD . 9
6 Quantitative methods — Technical protocol for factorial interlaboratory validation .10
6.1 In-house validation study .10
6.2 Interlaboratory validation study against a reference method .10
6.2.1 General considerations .10
6.2.2 Measurement protocol .10
6.2.3 Experimental design .11
6.3 Calculations, summary, and interpretation of data .12
6.3.1 Summary of test results .12
6.3.2 Precision data .13
6.3.3 Accuracy profile .14
6.4 Interlaboratory validation study without a reference method .14
Annex A (informative) List of factors and factor levels for factorial validation.15
Annex B (informative) Example of a factorial interlaboratory study for a quantitative method .17
Annex C (informative) Example of a factorial interlaboratory study for a qualitative method .28
Bibliography .34
ISO 16140-5:2020(E)
Foreword
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This document was prepared by Technical Committee ISO/TC 34, Food products, Subcommitt
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