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)

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 ISO 1 61 40-1 : 2 01 6(E)

Contents Page
Foreword ........................................................................................................................................................................................................................................ iv
Introduction .................................................................................................................................................................................................................................. v

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

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

Bibliography ............................................................................................................................................................................................................................. 1 2

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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 o f 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 o f
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
di fferent types o f ISO documents should be noted. This document was dra fted 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 o f the elements o f this document may be the subject o f
patent rights. ISO shall not be held responsible for identi fying any or all such patent rights. Details o f
any patent rights identified during the development o f 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 in formation given for the convenience o f users and does not
constitute an endorsement.
For an explanation on the meaning o f ISO specific terms and expressions related to con formity
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 in formation
The committee responsible for this document is ISO/TC 34, Food products, Subcommittee SC 9,
Microbiology.
This first edition o f 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  con firmation 
and typing

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 ISO 1 61 40-1 : 2 01 6(E)

Introduction

The use of validated methods is an important requirement for obtaining reliable results with a
s p e ci fic me tho d . It also fac i l itate s the comp arabi l ity o f re s u lts ob tai ne d with the s ame me tho d i n

d i fferent lab oratorie s . Va l idation pro ce du re s covere d b y I S O 1614 0 (a l l p ar ts) i nvolve va riou s a s p e c ts

o f va l id ation, s uch as va l idation o f a lternative ( proprie ta r y) me tho d s , s i ngle l ab orator y va l idation,

va l idation o f (a lternative) me tho d s us i ng a l i m ite d nu mb er o f l ab oratorie s , a nd veri fic ation o f me tho d s

(demon s tration o f a l ab orator y to corre c tly apply a va l idate d me tho d) . I n add ition, there i s a clo s e l i n k

to ISO 17468 describing the procedure for the validation of the standard methods themselves.

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INTERNATIONAL STANDARD ISO 16140-1:2016(E)

Microbiology of the food chain — Method validation —

Part 1:
Vocabulary
1 Scope
This p ar t of ISO 1614 0 defi ne s genera l term s and defi n ition s relati ng to me tho d va l idation of

m ic robiolo g y i n the fo o d cha i n .

This p ar t of I S O 1614 0 is appl ic able to the va l idation o f me tho d s for the a na lys i s (de te c tion or

quanti fic ation) o f m ic ro organ i s m s i n

— products intended for human consumption,

— products intended for animal feeding,
— environmental samples in the area of food and feed production, handling, and
— s a mple s from the pri mar y pro duc tion s tage .

2 Terms and definitions

2.1
acceptability limit
AL
maximum positive or negative acceptable difference between the referen ce value (2.60) (or if not known,
the accepted reference value) of a (2.69 sample ) and an i nd ividua l re s u lt ob ta i ne d when applyi ng the

op erati ng pro ce du re o f an a na lytic a l me tho d

N o te 1 to entr y: B e c au s e accuracy (2.2 ) i s de fi ne d a s ‘the clo s ene s s o f agre ement b e twe en a me a s u re d qu a ntity

va lue a nd a n a s s igne d qu a ntity va lue o f a me a s u ra nd’, accep tab i l ity l i m its c a n b e i nter p re te d a s the m a xi mu m

me a s u re o f the l ack o f acc u rac y for quan titative m eth ods (2.57).
2.2
accuracy
me as u rement acc u rac y

clo s ene s s o f agre ement b e twe en a me a s u re d qua ntity va lue a nd an a s s igne d quantity va lue of a

measurand
N o te 1 to entr y: T he co ncep t ‘me a s u rement acc u rac y’ i s no t a qu a ntity a nd i s no t given a nu mer ic a l qu a ntity

value. A measurement is said to be more accurate when it offers a smaller measurement error.
N o te 2 to entr y: T he ter m ‘me a s u rement acc u rac y’ s ho u ld no t b e u s e d fo r me a s u rement truen ess (2.77) and the
term measurement precision (2.51 ) s hou ld no t b e u s e d for ‘me a s u rement acc u rac y’, wh ich , however, i s rel ate d to

both these concepts.

N o te 3 to entr y: ‘M e a s u rement acc u rac y’ i s s ome ti me s u nders to o d a s clo s ene s s o f agre ement b e twe en me a s u re d

qu a ntity va lue s th at a re b ei ng attrib ute d to the me a s u ra nd .

[S OU RC E : JC GM , 2 01 2 , mo d i fie d]

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2.3

graphical representation o f the capacity o f measurement o f the quantitative m eth od (2.57 ), obtained by
a c c u r a c y p r o fi l e

combining acceptability intervals and β-expectation  tolerance  intervals (2.8), both reported to different
levels of the referen ce value (2.60)
Note 1 to entry: For a given measurement method, di fferent accuracy profiles can be drawn, depending on the
experimental design where data were collected: under repeatability con dition s (2.64) or reproducibility con dition s

(2.67), for different matrices, etc.

Note 2 to entry: Calculations o f accuracy profile elements depend on experimental design.
2 .4
alternative method
method submitted for validation
method o f analysis that detects or quantifies, for a given category o f products, the same an alyte (2.6) as
is detected or quantified using the corresponding referen ce m eth od (2.59)
Note 1 to entry: The method can be proprietary. The term ‘alternative’ is used to re fer 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 o f the qualitative or quantitative analysis for the altern ative m eth od (2.4)
2 .6
analyte
component represented in the name o f a measurable quantity
[SOURCE: ISO 17511:2003, 3.2]
Note 1 to entry: For food microbiology, this means a microorganism, group o f microorganisms, or its products
(e.g. toxins) quantified or detected by the method o f analysis.
Note 2 to entry: Possible targets o f the techniques that are used for detection or enumeration o f 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 - e x p e c t a t i o n t o l e r a n c e i n t e r v a l

range of values within which a stated proportion of the population is expected to lie
β - E T I

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 sam ple (2.69) size increases.
2 .9
bias
measurement bias
estimate o f a systematic measurement error, or the systematic di fference between the quantitative
assign ed value(2.7) and the average of measurement (2.65) results replicate

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2.10
blind replicates
set of (2.69) submitted to evaluate performance in which the presence and/or concentration of
samples

the (2.6) is unknown to the analyst

an alyte

Note 1 to entry: Within validation (2.81) studies, blin d replicates (2.10) are used within the in terlaboratory study
(2.33). The organ izin g laboratory (2.45) prepares sam ples (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 i f they contain the an alyte
(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
f
CRM
c e r t i fi e d r e e r e n c e m a t e r i a l

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

referen ce m aterial

properties, accompanied by a certificate that provides the value o f the specified property, its associated
uncertainty, and a statement o f 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 (2.69) or (2.75) samples test portion s

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
value (1 − α) o f the probability associated with a confidence interval or a statistical coverage interval
c o n fi d e n c e i n t e r v a l

EXAMPLE Confidence intervals can be obtained for arithmetic means, standard deviations, regression
coe fficients, etc.
Note 1 to entry: (1 − α) is often expressed as a percentage.
2.16
specific probability o f obtaining some result from a sam ple (2.69) if it did not exist in the population
c o n fi d e n c e l e ve l

as a whole
Note 1 to entry: The usual levels o f probability are 95 % or 99 %, but any level can be used.
2.17
procedure or test which is carried out to veri fy a presumptive result
c o n fi r m a t i o n p r o c e d u r e o r t e s t

Note 1 to entry: Not all methods have a confirmation procedure.

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ISO 1 61 40-1 : 2 01 6(E)

2 .18
count
observed number o f 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
<qualitative methods> minimum concentration of organisms that produce evidence of growth in
a liquid medium with a probability o f P = 0,95 when inoculated into a defined culture medium and
incubated under defined conditions
Note 1 to entry: The theoretical level that con forms to this definition is three viable cells in an inoculum volume.
Note 2 to entry: The term ‘sen sitivity ’ (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

study involving pure n on-target strain s (2.44), which can be potentially cross-reactive, but are not
e x c l u s i v i t y s t u d y

expected to be detected or enumerated by the altern ative m eth od (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
positive result by the tested method that is actually confirmed as a negative result
2 .25
feed
feedstuff
any material or product intended to be, or reasonably expected to be, used for animal consumption
2 .26
f
degree whether data produced by a measurement process enables a user to make technically and
fi t n e s s o r p u r p o s e

administratively correct decisions for a stated purpose

2 .27
food
foodstuff
any material or product intended to be, or reasonably expected to be, used for human consumption
2 .28
fractional recovery
validation (2.81) criterion that is satisfied when (2.65)
replicate (2.69) of either the
samples altern ative

m eth od (2.4) or (2.59) yield 50 % (range 25 % – 75 %) positive responses

referen ce m eth od

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2.29
homogeneity
condition o f being o f uni form structure or composition with respect to one or more specified properties
Note 1 to entry: A referen ce m aterial (2.58 ) is said to be homogeneous with respect to a specified property i f the
property value, as determined by tests on sam ples (2.69 ) o f specified size, is found to lie within the specified
uncertainty limits, the samples being taken either from di fferent supply units (bottles, packages, etc.) or from a
single supply unit.
[SOURCE: ISO Guide 30:1992, 2.6]
2.30
procedure or test yielding the identity o f the an alyte (2.6)
i d e n t i fi c a t i o n p r o c e d u r e o r t e s t

2.31
inclusivity study
study involving pure target strain s (2.74) to be detected or enumerated by the altern ative m eth od (2.4)
2.32
in-house reference material
IRM
non-certified material or substance, produced by one laboratory, one or more o f whose property values
are su fficiently homogeneous and well established to be used for validation (2.81)
2.33
interlaboratory study
study per formed by multiple laboratories testing identical (2.69) at the same time, the results samples

of which are used to estimate alternative-method performance parameters

Note 1 to entry: The aim o f an interlaboratory study is to determine the variability o f the results obtained in
different laboratories using identical samples.
2.34
item
single specified food (2.27), feed (2.25 ), environmental, or primary production matrix (2.38)
EXAMPLE Food category (2.11): heat-processed milk and dairy products; food type (2.78 ): pasteurized dairy
product; food item: milk-based desserts.
2.35
level of detection
LOD x
<qualitative methods> measured an alyte (2.6) concentration, obtained by a given measurement
procedure, for which the probability of detection (2.53) is x
EXAMPLE LOD 50 is the level o f detection for which 50 % o f tests give a positive result.
Note 1 to entry: The term ‘level o f detection’ is used for qualitative methods in microbiology based on replicate
(2.65 ) analyses with three di fferent inoculation levels of the target an alyte (2.6) in a tested matrix (2.38). The
replicates are analysed, and the number o f positive results is recorded (e.g. 20 %, 70 %, and 100 %) respectively
at each inoculation level. These data are then used to determine the number o f cells that would give 50 %
positive using a generalized linear model (see ISO 16140-2). This differs from the procedure used for chemical
and physical methods for which a ‘limit o f detection’ is defined as the lowest quantity o f an analyte that can be
distinguished from the absence o f that analyte with a stated con fidence  level (2.16).
2.36
f
LOQ
l i m i t o q u a n t i fi c a t i o n

limit of determination
<quantitative methods> lowest an alyte (2.6) concentration that can be quantified with an acceptable
level of (2.51) and
precision truen ess (2.77) under the conditions of the test
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2 .37
line of identity
two - d i men s iona l C a r te s i an co ord i nate s ys tem, where the identity l i ne i s the y  =   x line
2.38

all the components of the (2.69)

m a t r i x ( p r o d u c t)

sample

2 .39
method comparison study
s tudy, p er forme d b y the organizin g laboratory (2.45) to compare the altern ative m eth od (2.4) with the
reference m eth od (2.59)
2 .40
negative agreement
NA
agreement when the qualitative altern ative m eth od (2.4) and referen ce m eth od (2.59) both present a
(2.43)
n egative test result

2 .41
negative control
sample(2.69) in which the target an alyte (2.6) is either absent or below the detection level (2.20) of the
method used
2 .42
negative deviation
ND
negative result of the altern ative m eth od (2.4) when the corresponding referen ce m eth od (2.59) result is
positive
2 .43
negative tes t result
(2.76) indicating the
test result an alyte (2.6) was not detected in a given test portion (2.75 ) a s defi ne d b y

the procedure of the qualitative m eth od (2.56)

2 .4 4
non-target s train
s tra i n, defi ne d accord i ng to the s cop e o f the reference m eth od (2.59 ) th at wou ld no t re a s onably b e

exp e c te d to b e de te c te d or enumerate d b y the altern ative m eth od (2.4)

2 .45
organizing laboratory
exp er t lab orator y

i ndep endent lab orator y

lab orator y with re s p on s ibi l ity for ma nagi ng a l l o f the te ch n ic a l and s tati s tic a l ac tivitie s i nvolve d i n the

validation (2.81 ) s tudy, i . e . m eth od com parison study (2.39) and the interlaboratory study (2.33)
N o te 1 to entr y: T he o rga n i z i n g l ab orator y i s no t i nvol ve d i n de velop ment a nd/or m a rke ti ng o f a proprietary

m eth od (2.55 ) th at the y wi l l b e va l id ati n g.

2 .46
outlier
member of a set of values which is inconsistent with other members of that set
[S O U RC E : I S O 57 2 5 -1 : 19 9 4, 3 . 2 1 , mo d i fie d]

N o te 1 to entr y: T h i s e x treme va lue no rm a l l y ap p e a rs ra ndo m l y i n le s s th a n 1 % o f rep e titive te s ts , b ut more

fre quentl y i f ab no r m a l s itu ation s o cc u r. S tati s tic a l te s t pro ce du re s c a n b e u s e d to qu a nti fy th i s p rob ab i l ity.

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 ISO 1 61 40-1 : 2 01 6(E)

2 .47
paired s tudy
paired/matched data
s tudy when the qua l itative referen ce m eth od (2.59) and altern ative m eth od (2.4 ) have a com mon fi rs t

enrichment step
N o te 1 to entr y: (2.75) of a (2.69) is used to obtain a result with
I n th i s c a s e , o n l y one test portion sam ple

the (2.59) and the

referen ce m eth od (2.4). The incubated broth is then used in the second
altern ative m eth od

procedure step of both the reference method and the alternative method. The results from both methods are
s tron gl y dep endent up o n e ach o ther.

2 .48
positive agreement
PA
qualitative altern ative m eth od (2.4) and referen ce m eth od (2.59 ) b o th pre s ent a con fi rme d positive test

result(2.50 ) (con fi rme d p o s itive re s u lts)

2 .49
positive deviation
PD
(con fi rme d) p o s itive re s u lt o f the altern ative m eth od (2.4) when the corresponding reference m eth od

(2.59) result is negative

2 .50
positive tes t result
(2.76) indicating the presence of the
test result an alyte (2.6) in a given test portion (2.75 ) as defi ne d b y

the procedure of the method

N o te 1 to entr y: W hen the referen ce m eth od (2.59) or altern ative m eth od (2.4 ) p rovide s a p rel i m i n a r y p o s iti ve

te s t re s u lt re qu i ri n g fu r ther te s ti n g to con fi r m th i s re s u lt, th i s te s t re s u lt c a n b e con s idere d a s a p re s u mp tive

p o s itive te s t re s u lt. I f the fu r ther te s ti ng s p e c i fie d b y the me tho d’s pro ce du re co n fi r m s th at the te s t re s u l t c a n

i nde e d b e co n s idere d a s b ei n g p o s itive , the te s t re s u lt c a n b e con s idere d a s a co n fi r me d p o s iti ve te s t re s u lt.

2 . 51
precision
measurement precision
clo s ene s s o f agre ement b e twe en i nd ic ation s or me as u re d quantity va lue s ob ta i ne d b y replicate (2.65)
me as u rements on the s ame or s i m i la r obj e c ts u nder s p e ci fie d cond ition s

N o te 1 to entr y: M e a s u rement pre c i s io n i s u s u a l l y e xp re s s e d nu mer ic a l l y b y me a s u re s o f i mpre c i s io n , s uch a s

s ta nd a rd devi ation , va r i a nce , o r co e ffic ient o f va r i ation u nder the s p e c i fie d cond itio n s o f me a s u rement.

N o te 2 to entr y: T he ‘s p e c i fie d cond ition s ’ c a n b e , for e xa mp le , repeatability con dition s (2.64) of measurement,
intermediate precision conditions of measurement, or reproducibility con dition s (2.67) of measurement (see
ISO 5725-3).
N o te 3 to entr y: M e a s u rement pre c i s ion i s u s e d to de fi ne me a s u rement rep e atab i l ity, i nter me d iate me a s u rement

precision, and measurement reproducibility (2.66).

N o te 4 to entr y: S o me ti me s , ‘me a s u rement pre c i s io n’ i s er ro ne ou s l y u s e d to me a n me a s u rement acc u rac y.

2 . 52
primary production sample
sam ple (2.69) of animal faeces, or from the environment of animals or non-faecal samples from
bre e d i ng flo cks

2 . 53
probability of detection
POD
prop or tion o f p o s itive a na lytic a l outcome s for a qualitative m eth od (2.56) for a given matrix (2.38) at a
given an alyte (2.6) level or concentration

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ISO 16140-1:2016(E)

2.54
processing
any action that substantially alters the initial product, including heating, smoking, curing, maturing,
drying, marinating, extraction, extrusion, or a combination o f those processes
Note 1 to entry: Processed products may contain ingredients that are necessary for their manu facture or to give
them specific characteristics.
2.55
proprietary method
method with a trademark/brand name, which is owned and generally marketed by a commercial company
EXAMPLE Enzyme-linked immunosorbent assay (ELISA) or polymerase chain reaction (PCR) methods.
Note 1 to entry: Generally, some o f the components o f the method are undisclosed.
2.56
qualitative method
method o f analysis whose response is that the an alyte (2.6) is either detected or not detected, either
directly or indirectly in a specified test portion (2.75)
2.57
quantitative method
method o f analysis whose response is the amount [count (2.18 ) or mass] o f the an alyte (2.6) measured
either directly (e.g. enumeration in a mass or a volume), or indirectly (e.g. colour absorbance, impedance,
etc.) in a specified test portion (2.75)
2.58
reference material
RM
material or substance whose property values are su fficiently homogeneous and well established to be
used for the calibration of an apparatus, the assessment of a measurement method, or for assigning
values to materials
[SOURCE: ISO Guide 30:1992, 2.1, modified]
2.59
reference method
internationally recognized and widely accepted method
Note 1 to entry: For the purpose o f this part o f ISO 16140, these are ISO standards and standards jointly published
by ISO and CEN or other regional/national standards o f equivalent standing.
2.60
reference value
quantity value used as a basis for comparison with values o f quantities o f the same kind
[SOURCE: JCGM, 2012, modified]
2.61
relative level of detection
RLOD
level of detection(2.35) at 0,50 (LOD50) of the (proprietary)
P = altern ative m eth od (2.4) divided by the
level of detection at 0,50 (LOD50) of the
P= (2.59)
referen ce m eth od

Note 1 to entry: For the purposes o f alternative-method acceptance, the derived RLOD is checked with the
acceptability lim it (2.1 ) for con formity.

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2 .62
relative trueness
RT
degree o f correspondence between the response obtained by the reference m eth od (2.59) and the
response obtained by the altern ative m eth od (2.4) on identical samples (2.69)
2 . 63
repeatability
measurement repeatability
r

measurement precision under a set of repeatability con dition s (2.64) of measurement

[SOURCE: JCGM, 2012, modified]
2 .6 4
repeatability conditions
repeatability condition o f measurement
condition of measurement, out of a set of conditions that includes the same measurement procedure,
same operators, same measuring system, same operating conditions and same location, and replicate
measurements on the same or similar objects over a short period o f time
[SOURCE: JCGM, 2012, modified]
Note 1 to entry: A condition o f measurement is a repeatability condition only with respect to a specified set o f
repeatability conditions.
Note 2 to entry: In chemistry, the term ‘intra-serial precision condition o f measurement’ is sometimes used to
designate this concept.
2 .65
replicate
repeating the analysis from di fferent portions o f the same sample (2.69) to obtain an independent
measurement
2 .66
reproducibility
measurement reproducibility
R

measurement precision under reproducibility con dition s (2.67) of measurement

[SOURCE: JCGM, 2012, modified]
Note 1 to entry: Relevant statistical terms are given in ISO 5725-1 and ISO 5725-2.
2 .67
reproducibility conditions
reproducibility condition o f measurement
condition of measurement, out of a set of conditions that includes different locations, operators,
measuring systems, and (2.65 ) measurements on the same or similar objects
replicate

Note 1 to entry: The di fferent measuring systems may use di fferent measurement procedures.
Note 2 to entry: A specification should give the conditions changed and unchanged (to a practical extent).
[SOURCE: JCGM, 2012, modified]
2 .6 8
reproducibility s tandard deviation
standard deviation of test results (2.76) obtained under reproducibility con dition s (2.67)
[SOURCE: ISO 5725-1:1994, 3.19]

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ISO 1 61 40-1 : 2 01 6(E)

2 .69
sample
food (2.27), feed(2.25 ), environmental, or primary production specified item (2.34) to be included in
the validation (2.81) as per the intended use of the method
EXAMPLE Food category (2.11): heat processed milk and dairy products; food type (2.78 ): pasteurized dairy
product; food item (2.34): milk-based desserts; sample: vanilla ice cream.
2 .70
scope of validation
an alytes (2.6), matrices, and concentrations for which a validated method of analysis can be used
satis factorily
2 .71
sensitivity
SE
ability o f the referen ce m eth od (2.59) or altern ative m eth od (2.4) to detect the an alyte (2.6)
2 .72
specificity
SP
ability o f the reference m eth od (2.59) or altern ative m eth od (2.4) not to detect the an alyte (2.6)
2 .73
s ystematic error
systematic measurement error
component of measurement error that, in replicate (2.65) measurements, remains constant or varies in
a predictable manner
Note 1 to entry: An assigned quantity value for a systematic measurement error is a quantity value, or a measured
quantity value o f a measurement standard o f negligible measurement uncertainty, or a conventional quantity value.
2 .74
target s train
strain, defined according to the scope o f the referen ce m eth od (2.59) that is expected to be detected or
enumerated by the altern ative m eth od (2.4)
2 .75
tes t portion
specified quantity o f the sample (2.69) that is taken for analysis, e.g. 10 g, 25 g, 375 g o f samples, or
sponges for environm ental samples (2.21), or boot socks for prim ary production sam ples (2.52)
2 .76
tes t result
outcome o f an analytical procedure or method
2 .77
trueness
measurement trueness
closeness o f agreement between the average o f an infinite number o f replicate (2.65 ) measured quantity
values and a re ference quantity value
Note 1 to entry: Measurement trueness is not a quantity and thus cannot be expressed numerically, but measures
for closeness of agreement are given in ISO 5725 (all parts).
Note 2 to entry: Measurement trueness is inversely related to systematic measurement error, but is not related to
random measurement error.
Note 3 to entry: Measurement accuracy should not be used for ‘measurement trueness’ and vice versa.
[SOURCE: JCGM, 2012, modified]

10 © ISO 2016 – All rights reserved

 ISO 1 61 40-1 : 2 01 6(E)

2 .78
type
for a given category (2.11), a group of item s (2.34) processed in a similar way, with similar intrinsic
characteristics and a similar microbial ecology
EXAMPLE Food category (2.11): heat-processed milk and dairy products; food type: pasteurized dairy
product.
2 .79
unpaired study
unpaired/unmatched data
study when the qualitative referen ce m eth od (2.59) and altern ative m eth od (2.4) have no common first
enrichment step
Note 1 to entry: In this case, both the re ference and alternative method use their own test portion (2.75) from a
sam ple (2.69). These test portion s (2.75) originate from the same sample. The resulting data are called unpaired
but are matched at the level o f the sample. The results are still dependent upon each other as they originate from
the same sample but due to the normal variation between test portions at a very low level o f contamination, one
test portion can be contaminated (and thus leads to a positive result) and the other test portion might not be
contaminated (and thus does not lead to a positive result). The expected variation between results is, therefore,
larger than for a (2.47).
paired study

2 . 80
unprocessed products
food(2.27) and (2.25) that have not undergone
feedstuffs processin g (2.54), and include products that
have been divided, parted, severed, sliced, boned, etc.
EXAMPLE Unprocessed meat means meat that has not undergone any preserving process.
2 . 81
validation
establishment o f the per formance characteristics o f a method and provision o f objective evidence that
the per formance requirements for a specified intended use are fulfilled
2 . 82
validation sample
homogeneous naturally or artificially contaminated material with a known assign ed value (2.7) used
for a validation (2.81) study
Note 1 to entry: A validation sample can also be a known blank sam ple (2.69).
2 . 83
verification
demonstration that a validated method functions in the user’s hands according to the method’s
specifications determined in the (2.81) study and is fit for its purpose
validation

Note 1 to entry: Verification can also be applied to non-validated standardized referen ce m eth ods (2.59).

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Bibliography

[1] ISO 3534-1:2006, Statistics — Vocabulary and symbols — Part 1: General statistical terms and
terms used in probability
[2] ISO 3534-2:2006, Statistics — Vocabulary and symbols — Part 2: Applied statistics
[3] ISO 5725 (all parts), Accuracy (trueness and precision) of measurement methods and results
[4] ISO 7218:2007, Microbiology of food and animal feeding stuffs — General requirements and
guidance  for  microbiological  examinations

[5] ISO 16140:2003, Microbiology of food and animal feeding stuffs — Protocol for the validation of
alternative methods
[6] ISO 17468, Microbiology ofthe food chain — Technical requirements and guidance on establishment
or revision of standard methods
[7] ISO 17511:2003, In vitro diagnostic medical devices — Measurement of quantities in biological
samples — Metrological traceability of values assigned to calibrators and control materials
[8] ISO Guide 30:1992, Terms  and  definitions  used  in  connection  with  reference  materials
[9] ISO Guide 35:2006, Reference  materials  —  General  and  statistical  principles  for  certification
[10] Codex Alimentarius Commission, International Food Standard 2013, 21th Procedural Manual
[11] Codex document: Guidelines on analytical terminology, CAC/GL 72-2009
[12] J oint C ommittee f or Guides in M etrology (JCGM). International vocabulary of metrology —
Basic and general concepts and associated terms (VIM), 3rd edition (2008 version with minor
corrections), 2012

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ICS  07.1 00.3 0

Price group A
© ISO 2016 – All rights reserved