EN ISO 16140-1:2016

SLOVENSKI STANDARD
01-oktober-2016
1DGRPHãþD
SIST EN ISO 16140:2003
SIST EN ISO 16140:2003/A1:2012
Mikrobiologija v prehranski verigi - Validacija metode - 1. del: Slovar (ISO 16140-
1:2016)
Microbiology of the food chain - Method validation - Part 1: Vocabulary (ISO 16140-
1:2016)
Mikrobiologie der Lebensmittelkette - Verfahrensvalidierung - Teil 1: Terminologie (ISO
16140-1:2016)
Microbiologie de la chaîne alimentaire - Validation des méthodes - Partie 1: Vocabulaire
(ISO 16140-1:2016)
Ta slovenski standard je istoveten z: EN ISO 16140-1:2016
ICS:
01.040.07 Naravoslovne in uporabne Natural and applied sciences
vede (Slovarji) (Vocabularies)
07.100.30 Mikrobiologija živil Food microbiology
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 16140-1
EUROPEAN STANDARD
NORME EUROPÉENNE
July 2016
EUROPÄISCHE NORM
ICS 07.100.30 Supersedes EN ISO 16140:2003
English Version
Microbiology of the food chain - Method validation - Part 1:
Vocabulary (ISO 16140-1:2016)
Microbiologie de la chaîne alimentaire - Validation des Mikrobiologie der Lebensmittelkette -
méthodes - Partie 1: Vocabulaire (ISO 16140-1:2016) Verfahrensvalidierung - Teil 1: Terminologie (ISO
16140-1:2016)
This European Standard was approved by CEN on 12 May 2016.

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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, 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: Avenue Marnix 17, B-1000 Brussels
© 2016 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 16140-1:2016 E
worldwide for CEN national Members.

Contents Page
European foreword . 3
European foreword
This document (EN ISO 16140-1:2016) 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 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 January 2017, and conflicting national standards shall
be withdrawn at the latest by January 2017.
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.
This document supersedes EN ISO 16140:2003.
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, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 16140-1:2016 has been approved by CEN as EN ISO 16140-1:2016 without any
modification.
INTERNATIONAL ISO
STANDARD 16140-1
First edition
2016-06-15
Microbiology of the food chain —
Method validation —
Part 1:
Vocabulary
Microbiologie de la chaîne alimentaire — Validation des méthodes —
Partie 1: Vocabulaire
Reference number
ISO 16140-1:2016(E)
©
ISO 2016
ISO 16140-1:2016(E)
© ISO 2016, Published in Switzerland
All rights reserved. Unless otherwise specified, 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
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ii © ISO 2016 – All rights reserved

ISO 16140-1:2016(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Terms and definitions . 1
Bibliography .12
ISO 16140-1:2016(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.
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
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
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. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical
Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information
The committee responsible for this document is ISO/TC 34, Food products, Subcommittee SC 9,
Microbiology.
This first edition of ISO 16140-1, together with ISO 16140-2, cancels and replaces ISO 16140:2003, which
has been technically revised. It also incorporates the Amendment ISO 16140:2003:Amd.1:2011.
ISO 16140 consists of the following parts, under the general title Microbiology of the food chain —
Method validation:
— Part 1: Vocabulary
— Part 2: Protocol for the validation of alternative (proprietary) methods against a reference method
The following parts are under preparation:
— Part 3: Protocol for the verification of reference and validated alternative methods implemented in a
single laboratory
— Part 4: Protocol for single-laboratory (in-house) method validation
— Part 5: Protocol for factorial interlaboratory validation of non-proprietary methods
— Part 6: Protocol for the validation of alternative (proprietary) methods for microbiological confirmation
and typing
iv © ISO 2016 – All rights reserved

ISO 16140-1:2016(E)
Introduction
The use of validated methods is an important requirement for obtaining reliable results with a
specific method. It also facilitates the comparability of results obtained with the same method in
different laboratories. Validation procedures covered by ISO 16140 (all parts) involve various aspects
of validation, such as validation of alternative (proprietary) methods, single laboratory validation,
validation of (alternative) methods using a limited number of laboratories, and verification of methods
(demonstration of a laboratory to correctly apply a validated method). In addition, there is a close link
to ISO 17468 describing the procedure for the validation of the standard methods themselves.
INTERNATIONAL STANDARD ISO 16140-1:2016(E)
Microbiology of the food chain — Method validation —
Part 1:
Vocabulary
1 Scope
This part of ISO 16140 defines general terms and definitions relating to method validation of
microbiology in the food chain.
This part of ISO 16140 is applicable to the validation of methods 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, and
— samples from the primary production stage.
2 Terms and definitions
2.1
acceptability limit
AL
maximum positive or negative acceptable difference between the reference value (2.60) (or if not known,
the accepted reference value) of a sample (2.69) and an individual result obtained when applying the
operating procedure of an analytical method
Note 1 to entry: Because accuracy (2.2) is defined as ‘the closeness of agreement between a measured quantity
value and an assigned quantity value of a measurand’, acceptability limits can be interpreted as the maximum
measure of the lack of accuracy for quantitative methods (2.57).
2.2
accuracy
measurement accuracy
closeness of agreement between a measured quantity value and an assigned quantity value of a
measurand
Note 1 to entry: The concept ‘measurement accuracy’ is not a quantity and is not given a numerical quantity
value. A measurement is said to be more accurate when it offers a smaller measurement error.
Note 2 to entry: The term ‘measurement accuracy’ should not be used for measurement trueness (2.77) and the
term measurement precision (2.51) should not be used for ‘measurement accuracy’, which, however, is related to
both these concepts.
Note 3 to entry: ‘Measurement accuracy’ is sometimes understood as closeness of agreement between measured
quantity values that are being attributed to the measurand.
[SOURCE: JCGM, 2012, modified]
ISO 16140-1:2016(E)
2.3
accuracy profile
graphical representation of the capacity of measurement of the quantitative method (2.57), obtained by
combining acceptability intervals and β-expectation tolerance intervals (2.8), both reported to different
levels of the reference value (2.60)
Note 1 to entry: For a given measurement method, different accuracy profiles can be drawn, depending on the
experimental design where data were collected: under repeatability conditions (2.64) or reproducibility conditions
(2.67), for different matrices, etc.
Note 2 to entry: Calculations of accuracy profile elements depend on experimental design.
2.4
alternative method
method submitted for validation
method of analysis that detects or quantifies, for a given category of products, the same analyte (2.6) as
is detected or quantified using the corresponding reference method (2.59)
Note 1 to entry: The method can be proprietary. The term ‘alternative’ is used to refer to the entire ‘test
procedure and reaction system’. This term includes all ingredients, whether material or otherwise, required for
implementing the method.
2.5
alternative method result
final result of the qualitative or quantitative analysis for the alternative method (2.4)
2.6
analyte
component represented in the name of a measurable quantity
[SOURCE: ISO 17511:2003, 3.2]
Note 1 to entry: For food microbiology, this means a microorganism, group of microorganisms, or its products
(e.g. toxins) quantified or detected by the method of analysis.
Note 2 to entry: Possible targets of the techniques that ar
...