SIST EN ISO 16140:2003

Microbiology of food and animal feeding stuffs - Protocol for the validation of alternative methods (ISO 16140:2003)

This EN ISO 16140 defines the general principle and the technical protocol for the validation of alternative methods in the field of microbiological analysis of food, animal feeding stuff and environmental and veterinary samples (see 5.1.1.2.1) for:
- the validation of alternative methods which can be used in particular in the framework of the official control;
- the international acceptance of the results obtained by the alternative method.
It also gives the general principles of certification of these alternative methods, based on the validation protocol defined in this EN ISO 16140 (see 4.2).
Where an alternative method is used on a routine basis for internal laboratory use without the requirement to meet (higher) external criteria of quality assurance, a less stringent comparative validation of the alternative method than that set in this standard may be appropriate.

Mikrobiologie von Lebensmitteln und Futtermitteln - Arbeitsvorschrift für die Validierung alternativer Verfahren (ISO 16140:2003)

Diese Norm EN ISO 16140 legt das allgemeine Prinzip und die technische Arbeitsvorschrift für die Validierung alternativer Verfahren auf dem Gebiet der mikrobiologischen Untersuchung von Lebensmitteln und Futtermitteln sowie von Umwelt- und veterinärmedizinischen Proben (siehe 5.1.1.2.1) für folgende Punkte fest:
- Validierung von alternativen Verfahren, die besonders im Rahmen der amtlichen Lebensmittelüberwachung angewendet werden können;
- internationale Anerkennung der durch das alternative Verfahren ermittelten Ergebnisse.
Sie enthält auch die allgemeinen Prinzipien für die Zertifizierung dieser alternativen Verfahren, die auf der in der vorliegenden Norm EN ISO 16140 festgelegten Arbeitsvorschrift für die Validierung (siehe 4.2) beruhen.
Wenn ein alternatives Verfahren als Routineuntersuchung für die hausinterne Verwendung ohne die Anforderung, die (höheren) externen Kriterien der Qualitätssicherung zu erfüllen, angewendet wird, kann eine weniger strenge vergleichende Validierung des alternativen Verfahrens zweckmäßig sein als die, die in dieser Norm festgelegt ist.

Microbiologie des aliments - Protocole pour la validation des méthodes alternatives (ISO 16140:2003)

Le présent document définit le principe général ainsi que le protocole technique de validation des méthodes alternatives dans le domaine de l'analyse microbiologique des aliments, des produits alimentaires pour animaux, et des échantillons environnementaux et vétérinaires (5.1.1.2.1) en vue de :
- la validation des méthodes alternatives pouvant etre utilisées en particulier dans le cadre du contrôle officiel ;
- l'acceptation internationale des résultats obtenus avec la méthode alternative.
Il indique également les principes généraux régissant la certification de ces méthodes alternatives, sur la base du protocole de validation défini dans le présent document (voir 4.2).
Lorsqu'une méthode alternative est utilisée de façon routiniere en laboratoire sans qu'il soit nécessaire de répondre a des criteres extérieurs (plus exigeants) en matiere d'assurance de qualité, une validation comparative de la méthode alternative moins restrictive que ce que prévoit la présente norme peut convenir.

Mikrobiologija živil in krme - Protokol za validacijo alternativnih metod (ISO 16140:2003)

Ta EN ISO 16140 določa splošni princip in tehnični protokol za validacijo alternativnih metod na področju mikrobiološke analize živil, krme ter okoljskih in veterinarskih vzorcev (glej 5.1.1.2.1) za:
- validacijo alternativnih metod, ki se lahko uporablja predvsem v okviru uradnih kontrol;
- mednarodno sprejemljivost rezultatov, pridobljenih z alternativno metodo.
Prav tako podaja splošna načela certifikacije teh alternativnih metod, zasnovanih na validacijskem protokolu, določenem v tem EN ISO 16140 (glej 4.2).
Kjer se na ustaljen način za interno uporabo v laboratoriju uporablja alternativna metoda brez zahtev za izpolnitev (višjih) zunanjih meril zagotavljanja kakovosti, je lahko primerna manj strožja primerljiva validacija alternativne metode, kot je tista, podana v tem standardu.

General Information

• Status: Withdrawn
• Publication Date: 31-Oct-2003
• Withdrawal Date: 07-Sep-2016
• ICS: 07.100.30 - Food microbiology
• Technical Committee: KŽP - Agricultural food products
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 07-Sep-2016
• Due Date: 30-Sep-2016
• Completion Date: 08-Sep-2016
• Ref Project: EN ISO 16140:2003 - Microbiology of food and animal feeding stuffs - Protocol for the validation of alternative methods (ISO 16140:2003)

Relations

• Replaced By: 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)
• Effective Date: 08-Jun-2022
• Replaced By: SIST EN ISO 16140-1:2016 - Microbiology of the food chain - Method validation - Part 1: Vocabulary (ISO 16140-1:2016)
• Effective Date: 08-Jun-2022
• Replaced By: SIST EN ISO 16140-1:2016 - Microbiology of the food chain - Method validation - Part 1: Vocabulary (ISO 16140-1:2016)
• Effective Date: 01-Oct-2016
• Replaced By: 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)
• Effective Date: 01-Oct-2016
• Amended By: 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: 08-Jun-2022
• Amended By: 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-Jan-2012

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 16140:2003
01-november-2003
Mikrobiologija živil in krme - Protokol za validacijo alternativnih metod (ISO
16140:2003)
Microbiology of food and animal feeding stuffs - Protocol for the validation of alternative
methods (ISO 16140:2003)
Mikrobiologie von Lebensmitteln und Futtermitteln - Arbeitsvorschrift für die Validierung
alternativer Verfahren (ISO 16140:2003)
Microbiologie des aliments - Protocole pour la validation des méthodes alternatives (ISO
16140:2003)
Ta slovenski standard je istoveten z: EN ISO 16140:2003
ICS:
07.100.30 Mikrobiologija živil Food microbiology
SIST EN ISO 16140:2003 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 16140:2003

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SIST EN ISO 16140:2003
EUROPEAN STANDARD
EN ISO 16140
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2003
ICS 07.100.30
English version
Microbiology of food and animal feeding stuffs - Protocol for the
validation of alternative methods (ISO 16140:2003)
Microbiologie des aliments - Protocole pour la validation Mikrobiologie von Lebensmitteln und Futtermitteln -
des méthodes alternatives (ISO 16140:2003) Arbeitsvorschrift für die Validierung alternativer Verfahren
(ISO 16140:2003)
This European Standard was approved by CEN on 6 July 2002.
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 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 Management Centre has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and United
Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2003 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 16140:2003 E
worldwide for CEN national Members.

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SIST EN ISO 16140:2003
EN ISO 16140:2003 (E)
Contents
page
Foreword. 3
Introduction . 4
1 Scope. 5
2 Normative references . 5
3 Terms and definitions. 6
4 General principles for the validation and the certification of alternative methods. 7
5 Qualitative methods - Technical protocol for their validation.8
6 Quantitative methods -Technical protocol for their validation . 18
Annex A (normative)  Specific rules for the acceptance of external results already obtained in a prior
validation scheme . 33
Annex B (informative)  Classification of sample types for validation studies . 35
Annex C (normative)  Use of naturally contaminated samples and preparation of artificially
contaminated samples in validation studies. 38
Annex D (normative)  Duplication of samples for the determination of relative accuracy and of relative
detection level for qualitative methods . 40
Annex E (normative)  Calculation of the confidence intervals associated with the number of samples
tested.
...