Microbiology of food and animal feeding stuffs - Protocol for the validation of alternative methods - Amendment 1 (ISO 16140:2003/AMD 1:2011)

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/AMD 1:2011)

Microbiologie des aliments - Protocole pour la validation des méthodes alternatives - Amendement 1: Étude interlaboratoire sur les méthodes quantitatives (ISO 16140:2003/AMD 1:2011)

Mikrobiologija živil in krme - Protokol za validacijo alternativnih metod - Dopolnilo 1: Medlaboratorijske raziskave o kvantitativnih metodah (ISO 16140:2003/AMD 1:2011)

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Withdrawn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
04-Dec-2011
Withdrawal Date
07-Sep-2016
Current Stage
9900 - Withdrawal (Adopted Project)
Start Date
07-Sep-2016
Due Date
30-Sep-2016
Completion Date
08-Sep-2016

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 16140:2003/A1:2012
01-januar-2012
Mikrobiologija živil in krme - Protokol za validacijo alternativnih metod - Dopolnilo
1: Medlaboratorijske raziskave o kvantitativnih metodah (ISO 16140:2003/AMD
1:2011)
Microbiology of food and animal feeding stuffs - Protocol for the validation of alternative
methods - Amendment 1 (ISO 16140:2003/AMD 1:2011)
Mikrobiologie von Lebensmitteln und Futtermitteln - Arbeitsvorschrift für die Validierung
alternativer Verfahren (ISO 16140:2003/AMD 1:2011)
Microbiologie des aliments - Protocole pour la validation des méthodes alternatives -
Amendement 1: Étude interlaboratoire sur les méthodes quantitatives (ISO
16140:2003/AMD 1:2011)
Ta slovenski standard je istoveten z: EN ISO 16140:2003/A1:2011
ICS:
07.100.30 Mikrobiologija živil Food microbiology
SIST EN ISO 16140:2003/A1:2012 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 16140:2003/A1:2012

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SIST EN ISO 16140:2003/A1:2012


EUROPEAN STANDARD
EN ISO 16140:2003/A1

NORME EUROPÉENNE

EUROPÄISCHE NORM
August 2011
ICS 07.100.30
English Version
Microbiology of food and animal feeding stuffs - Protocol for the
validation of alternative methods - Amendment 1 (ISO
16140:2003/AMD 1:2011)
Microbiologie des aliments - Protocole pour la validation Mikrobiologie von Lebensmitteln und Futtermitteln -
des méthodes alternatives - Amendement 1 (ISO Arbeitsvorschrift für die Validierung alternativer Verfahren -
16140:2003/AMD 1:2011) Änderung 1 (ISO 16140:2003/AMD 1:2011)
This amendment A1 modifies the European Standard EN ISO 16140:2003; it was approved by CEN on 29 July 2011.

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, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2011 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 16140:2003/A1:2011: E
worldwide for CEN national Members.

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SIST EN ISO 16140:2003/A1:2012
EN ISO 16140:2003/A1:2011 (E)
Contents Page
Foreword .3

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SIST EN ISO 16140:2003/A1:2012
EN ISO 16140:2003/A1:2011 (E)
Foreword
This document (EN ISO 16140:2003/A1:2011) 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 Amendment to the European Standard EN ISO 16140:2003 shall be given the status of a national
standard, either by publication of an identical text or by endorsement, at the latest by February 2012, and
conflicting national standards shall be withdrawn at the latest by February 2012.
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.
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, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 16140:2003/AMD 1:2011 has been approved by CEN as a EN ISO 16140:2003/A1:2011
without any modification.

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