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: 19-Jul-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 - Microbiology of food and animal feeding stuffs - Protocol for the validation of alternative methods (ISO 16140:2003)
• Effective Date: 08-Jun-2022
• 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

Overview

EN ISO 16140-1:2016 - "Microbiology of the food chain - Method validation - Part 1: Vocabulary" is a CEN-endorsed ISO standard that defines general terms and definitions used for method validation of microbiological analyses in the food chain. It applies to methods for detection or quantification of microorganisms in:

• products intended for human consumption,
• products intended for animal feed,
• environmental samples from food and feed production and handling, and
• samples from primary production.

This part standardises the vocabulary needed to design, run and interpret validation studies, helping ensure consistent communication across laboratories, industry and regulators.

Key topics and technical terms

EN ISO 16140-1:2016 provides definitions and clarifications for core validation concepts, including:

• Alternative method and reference method - scope and relationship for validation comparisons
• Accuracy, bias, precision, and acceptability limit - statistical measures used to assess method performance
• Accuracy profile and β‑expectation tolerance interval (β‑ETI) - approaches to represent quantitative method capacity
• Detection level for qualitative methods (e.g., probability P = 0.95; theoretical reference of three viable cells in an inoculum)
• Blind replicates, collaborator, interlaboratory study, and exclusivity study - terms for study design and performance evaluation
• Measurement uncertainty concepts (combined standard deviation, coverage factor) and assigned value definitions
  The standard draws on related metrology guidance (JCGM sources) and cross-references microbiology-specific terminology (e.g., analyte as microorganism or toxin).

Applications

EN ISO 16140-1:2016 is practical for:

• Preparing and interpreting method validation studies for microbiological tests (detection or enumeration)
• Harmonising terminology in validation protocols, reports and regulatory submissions
• Supporting quality assurance, method development, and accreditation documentation
• Designing interlaboratory comparisons, single-laboratory validations, and verification exercises

By standardising vocabulary, it improves comparability of results between laboratories and supports robust decision-making in food safety testing and compliance.

Who uses this standard

• Food and feed microbiology laboratories (public and private)
• Method developers and manufacturers of proprietary test kits (alternative methods)
• Accreditation bodies and regulatory agencies
• QA/QC managers in food production and laboratory networks
• Researchers designing validation and interlaboratory studies

Related standards

• ISO 16140-2 (protocol for validation of alternative methods) - directly linked to Part 1 vocabulary
• ISO 17468 (validation of standard methods) and ISO 17511 - referenced for measurement concepts and metrological traceability

Using EN ISO 16140-1:2016 ensures consistent, searchable terminology across validation documents, aiding clarity in method validation, food safety testing, and regulatory compliance.

Standards Content (Sample)

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
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

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 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
2 © ISO 2016 – All rights reserved

ISO 16140-1:2016(E)
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.
ISO 16140-1:2016(E)
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
p
...