EN ISO 16140:2003/A1:2011
(Amendment)Microbiology of food and animal feeding stuffs - Protocol for the validation of alternative methods - Amendment 1 (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)
2011-01-07 EMA: // final draft provided to ISO/CS according to notification received in dataservice on 2010-12-22.
Mikrobiologie von Lebensmittel und Futtermitteln - Arbeitsvorschrift für die Validierung alternativer Verfahren - Änderung 1 (ISO 16140:2003/AMD 1:2011)
Microbiologie des aliments - Protocole pour la validation des méthodes alternatives - Amendement 1 (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.
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Standards Content (Sample)
SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
Contents Page
Foreword .3
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.
INTERNATIONAL ISO
STANDARD 16140
First edition
2003-05-01
AMENDMENT 1
2011-08-15
Microbiology of food and animal feeding
stuffs — Protocol for the validation of
alternative methods
AMENDMENT 1
Microbiologie des aliments — Protocole pour la validation des
méthodes alternatives
AMENDEMENT 1
Reference number
ISO 16140:2003/Amd.1:2011(E)
©
ISO 2011
ISO 16140:2003/Amd.1:2011(E)
© ISO 2011
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or
ISO's member body in the country of the requester.
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ii © ISO 2011 – All rights reserved
ISO 16140:2003/Amd.1:2011(E)
Contents Page
Foreword . iv
6.3 Interlaboratory study . 2
6.3.1 General . 2
6.3.2 Terms and definitions . 2
6.3.3 Measurement protocol and samples . 4
6.3.4 Determination of the trueness and precision characteristics . 5
6.3.5 Scrutiny of the measurement results for consistency . 7
6.3.6 Comparison of the trueness and precision characteristics of the reference method and
the alternative method . 8
Annex Q (normative) Calculation of Rousseeuw's scale estimator Q . 9
n
Annex V (informative) Indicators for Mandel's robust h- and k-statistics . 11
Annex W (informative) Example: Determination of E. coli . 12
Bibliography additions . 18
ISO 16140:2003/Amd.1:2011(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
Amendment 1 to ISO 16140:2003 was prepared by Technical Committee ISO/TC 34, Food products,
Subcommittee SC 9, Microbiology.
iv © ISO 2011 – All rights reserved
ISO 16140:2003/Amd.1:2011(E)
Microbiology of food and animal feeding stuffs — Protocol for
the validation of alternative methods
AMENDMENT 1
Page 22, 6.3
Replace the existing text with that commencing on p. 2.
Page 61, Annex Q
Replace the existing text with that commencing on p. 9.
Page 74, Bibliography
Insert Annexes V and W commencing on p. 11 before the bibliography.
Additions to the bibliography are given on p. 18.
ISO 16140:2003/Amd.1:2011(E)
6.3 Interlaboratory study
6.3.1 General
An interlaboratory study aims to determine the comparative performance characteristics (trueness and
precision characteristics) of the alternative method against the reference method.
Guidelines and requirements for organizing, dispatching and conducting the interlaboratory study are given in
Annex H and in ISO 5725-2.
At least eight laboratories shall participate in an interlaboratory study.
The organizing laboratory is responsible for the preparation of the test protocol and a data sheet (see below)
to be used by each laboratory for recording all measurement results and critical experimental conditions
(see H.3).
The analyst in each collaborating laboratory shall demonstrate competence in the use of the alternative
method and of the reference method prior to participating in the study.
In microbiology, the data {y} of repeated measurements do not always show a normal (Gaussian) distribution.
Therefore, the distribution of these data should be checked for normality if more than 30 values are available
at the same level. In order to get a more symmetric distribution, take logarithms of the counts.
The data obtained from interlaboratory studies often contain outliers, i.e. measurement values that deviate so
much from comparable measurements that they are considered inconsistent. If they are retained in the data
set, the trueness and precision characteristics (averages, standard deviations, etc.) obtained with classical
methods of statistical analysis are unreliable. Therefore, ISO 5725-2 includes outlier tests (Cochran, Grubbs)
in order to detect and eventually discard outliers and to obtain reliable trueness and precision characteristics.
Often this causes disputes as to which of the outliers should be discarded from or retained in the statistical
analysis. In order to avoid such disputes, robust estimates of the trueness and precision characteristics are
used in this International Standard. Since they are insensitive to any extreme values, they always use the
complete data set obtained from the interlaboratory study.
However, each extreme value should be checked for a clerical error in transcribing the measurement result,
an error in computation, a slip in performing the measurement or an analysis of the wrong sample. If possible,
such values should be replaced by the correct values. Other extreme measurement results or laboratories
reporting extreme values are not excluded from the statistical analysis unless exclusion is based on
sound microbiological reasons.
6.3.2 Terms and definitions
For the purpose of this document, the following terms and definitions apply.
6.3.2.1
accuracy
closeness of agreement between a test result or measurement result and the true value
NOTE 1 In practice, the accepted reference value is substituted for the true value.
[13]
[ISO 3534-2:2006 , 3.3.1]
NOTE 2 Accuracy refers to a combination of trueness and precision.
2 © ISO 2011 – All rights reserved
ISO 16140:2003/Amd.1:2011(E)
6.3.2.2
trueness
closeness of agreement between the expectation of a test result or a measurement result and the true value
NOTE 1 The measure of trueness is usually expressed in terms of bias.
NOTE 2 In practice, the accepted reference value is substituted for the true value.
[13]
[ISO 3534-2:2006 , 3.3.3]
6.3.2.3
precision
closeness of agreement between independent test/measurement results obtained under stipulated conditions
NOTE Quantitative measures of precision depend critically on the stipulated conditions. Repeatability conditions and
reproducibility conditions are particular sets of extreme stipulated conditions.
[13]
[ISO 3534-2:2006 , 3.3.4]
6.3.2.4
repeatability
precision under repeatability conditions
[13]
[ISO 3534-2:2006 , 3.3.5]
6.3.2.5
repeatability conditions
observation conditions where independent test/measurement results are obtained with the same method on
identical test/measurement items in the same test or measuring facility by the same operator using the same
equipment within short intervals of time
[13]
[ISO 3534-2:2006 , 3.3.6]
6.3.2.6
repeatability standard deviation
standard deviation of test result or measurement results obtained under repeatability conditions
[13]
[ISO 3534-2:2006 , 3.3.7]
6.3.2.7
repeatability limit
r
value less than or equal to which the absolute difference b
...
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