EN ISO 16140-1:2016

Microbiology of the food chain - Method validation - Part 1: Vocabulary (ISO 16140-1:2016)

ISO 16140-1:2016 defines general terms and definitions relating to method validation of microbiology in the food chain.
It 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.

Mikrobiologie der Lebensmittelkette - Verfahrensvalidierung - Teil 1: Terminologie (ISO 16140-1:2016)

Dieser Teil von ISO 16140 legt die allgemeinen Benennungen und Definitionen in Bezug auf die Verfahrensvalidierung auf dem Gebiet der Mikrobiologie der Lebensmittelkette fest.
Der vorliegende Teil von ISO 16140 ist anwendbar auf die Validierung von Verfahren zur Untersuchung (Nachweis oder quantitative Bestimmung) von Mikroorganismen in:
   Erzeugnissen, die für den menschlichen Verzehr und als Futtermittel vorgesehen sind;
   Umgebungsproben im Bereich der Herstellung und Handhabung von Lebensmitteln;
   Proben aus dem Bereich der Primärproduktion.

Microbiologie de la chaîne alimentaire - Validation des méthodes - Partie 1: Vocabulaire (ISO 16140-1:2016)

L'ISO 16140-1 :2016 spécifie les termes généraux associés à la validation d'une méthode de microbiologie de la chaîne alimentaire et donne leurs définitions.
Elle est applicable à la validation de méthodes 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 le domaine de la production et de la manutention de produits alimentaires, et
-      les échantillons au stade de la production primaire.

Mikrobiologija v prehranski verigi - Validacija metode - 1. del: Slovar (ISO 16140-1:2016)

Ta del standarda ISO 16140 določa splošne pogoje in določila v zvezi z validacijo metode
mikrobiologije v prehranski verigi.
Ta del standarda ISO 16140 se uporablja za validacijo metod za analizo (odkrivanje ali
kvantifikacijo) mikroorganizmov v:
– proizvodih, namenjenih za prehrano ljudi;
– proizvodih, namenjenih za živalsko krmo;
– okoljskih vzorcih na področju proizvodnje hrane in krme; ter
– vzorcih iz faze primarne proizvodnje.

General Information

• Status: Published
• Publication Date: 30-Oct-2016
• ICS: 01.040.07 - Natural and applied sciences (Vocabularies)
• ICS: 07.100.30 - Food microbiology
• Technical Committee: CEN/TC 463 - Microbiology of the food chain
• Drafting Committee: CEN/TC 463 - Microbiology of the food chain
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 20-Jul-2016
• Completion Date: 20-Jul-2016
• Ref Project: SIST EN ISO 16140-1:2016 - Microbiology of the food chain - Method validation - Part 1: Vocabulary (ISO 16140-1:2016)

Relations

• Replaces: EN ISO 16140:2003/A1:2011 - Microbiology of food and animal feeding stuffs - Protocol for the validation of alternative methods - Amendment 1 (ISO 16140:2003/AMD 1:2011)
• Effective Date: 27-Jul-2016
• Replaces: EN ISO 16140:2003 - Microbiology of food and animal feeding stuffs - Protocol for the validation of alternative methods (ISO 16140:2003)
• Effective Date: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 16140-1:2016
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
SIST EN ISO 16140-1:2016 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 16140-1:2016
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SIST EN ISO 16140-1:2016
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.
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EN ISO 16140-1:2016 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

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SIST EN ISO 16140-1:2016
EN ISO 16140-1:2016 (E)
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.
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SIST EN ISO 16140-1:2016
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SIST EN ISO 16140-1:2016
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
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SIST EN ISO 16140-1:2016
ISO 16140-1:2016(E)
COPYRIGHT PROTECTED DOCUMENT
© 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

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
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. [phone]
Fax [phone]
[e-mail]
www.iso.org
ii © ISO 2016 – All rights reserved
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SIST EN ISO 16140-1:2016
ISO 16140-1:2016(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................iv

Introduction ..................................................................................................................................................................................................................................v

1 Scope ................................................................................................................................................................................................................................. 1

2 Terms and definitions ..................................................................................................................................................................................... 1

Bibliography .............................................................................................................................................................................................................................12

© ISO 2016 – All rights reserved iii
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SIST EN ISO 16140-1:2016
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
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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.

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SIST EN ISO 16140-1:2016
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

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]
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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 are used for detection or enumeration of the analyte can

be DNA/RNA, proteins, lipopolysaccharides, or others.
2.7
assigned value
value that serves as an agreed-upon reference for comparison
Note 1 to entry: It is normally derived from or based on experimental work.
2.8
β-expectation tolerance interval
β-ETI

range of values within which a stated proportion of the population is expected to lie

Note 1 to entry: The stated proportion represents the probability that a value falls between an upper and lower

bound of a distribution.

Note 2 to entry: Tolerance intervals tend towards a fixed value as the sample (2.69) size increases.

2.9
bias
measurement bias

estimate of a systematic measurement error, or the systematic difference between the quantitative

assigned value (2.7) and the average of measurement replicate (2.65) results
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2.10
blind replicates

set of samples (2.69) submitted to evaluate performance in which the presence and/or concentration of

the analyte (2.6) is unknown to the analyst

Note 1 to entry: Within validation (2.81) studies, blind replicates (2.10) are used within the interlaboratory study

(2.33). The organizing laboratory (2.45) prepares samples (2.69) and sends them to the collaborators (2.13). These

samples are labelled (marked) in such a way that the collaborator (2.13) does not know if they contain the analyte

(2.6), or not.
2.11
category
group of sample (2.69) types (2.78) of the same origin
EXAMPLE Heat-processed milk and dairy products.
2.12
certified reference material
CRM

reference material (2.58) characterized by a metrologically valid procedure for one or more specified

properties, accompanied by a certificate that provides the value of the specified property, its associated

uncertainty, and a statement of metrological traceability
Note 1 to entry: Adapted from ISO Guide 30 and ISO Guide 35.
2.13
collaborator

individual laboratory technician, who works completely independently from other collaborators, using

different sets of blind samples (2.69) or test portions (2.75)
2.14
combined standard deviation
combined standard uncertainty

standard measurement uncertainty that is obtained using the individual standard uncertainties

associated with the input quantities in a measurement model
[SOURCE: JCGM, 2012, modified]
2.15
confidence interval

value (1 − α) of the probability associated with a confidence interval or a statistical coverage interval

EXAMPLE Confidence intervals can be obtained for arithmetic means, standard deviations, regression

coefficients, etc.
Note 1 to entry: (1 − α) is often expressed as a percentage.
2.16
confidence level

specific probability of obtaining some result from a sample (2.69) if it did not exist in the population

as a whole

Note 1 to entry: The usual levels of probability are 95 % or 99 %, but any level can be used.

2.17
confirmation procedure or test
procedure or test which is carried out to verify a presumptive result
Note 1 to entry: Not all methods have a confirmation procedure.
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2.18
count
observed number of objects
EXAMPLE Colonies or plaques.
2.19
coverage factor

number larger than one by which a combined standard measurement uncertainty is multiplied to

obtain an expanded measurement uncertainty
[SOURCE: JCGM, 2012, modified]
2.20
detection level

minimum concentration of organisms that produce evidence of growth in

a liquid medium with a probability of P = 0,95 when inoculated into a defined culture medium and

incubated under defined conditions

Note 1 to entry: The theoretical level that conforms to this definition is three viable cells in an inoculum volume.

Note 2 to entry: The term ‘sensitivity’ (2.71) is discouraged for detection level.

2.21
environmental sample

sample (2.69) from a surface of equipment or from the production environment, or from water used in

the manufacturing process
2.22
exclusivity study

study involving pure non-target strains (2.44), which can be potentially cross-reactive, but are not

expected to be detected or enumerated by the alternative method (2.4)
2.23
false-negative test result

negative result by the tested method that is actually confirmed as a positive result

2.24
false-positive test result
...