ILNAS-EN ISO 19036:2019 - Preview only Copy via ILNAS e-Shop

ILNAS-EN ISO 19036:2019

Microbiology of the food chain -

Estimation of measurement
uncertainty for quantitative
determinations (ISO 19036:2019)
Microbiologie de la chaîne alimentaire -
Estimation de l'incertitude de mesure
pour les déterminations quantitatives
(ISO 19036:2019)
Mikrobiologie der Lebensmittelkette -
Feststellung von Messunsicherheiten bei
quantitativen Bestimmungen (ISO
19036:2019)

11/2019
 ILNAS-EN ISO 19036:2019

National Foreword

This European Standard EN ISO 19036:2019 was adopted as Luxembourgish Standard

ILNAS-EN ISO 19036:2019.

Every interested party, which is member of an organization based in Luxembourg, can

participate for FREE in the development of Luxembourgish (ILNAS), European (CEN,
CENELEC) and International (ISO, IEC) standards:

- Participate in the design of standards

- Foresee future developments
- Participate in technical committee meetings
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THIS PUBLICATION IS COPYRIGHT PROTECTED

Nothing from this publication may be reproduced or utilized in
any form or by any mean - electronic, mechanical, photocopying
or any other data carries without prior permission!
 ILNAS-EN ISO 19036:2019
EUROPEAN STANDARD EN ISO 19036
NORME EUROPÉENNE
EUROPÄISCHE NORM November 2019

ICS 07.100.30

English Version

Microbiology of the food chain - Estimation of

measurement uncertainty for quantitative determinations
(ISO 19036:2019)
Microbiologie de la chaîne alimentaire - Estimation de Mikrobiologie der Lebensmittelkette - Feststellung von
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l'incertitude de mesure pour les déterminations Messunsicherheiten bei quantitativen Bestimmungen

quantitatives (ISO 19036:2019) (ISO 19036:2019)

This European Standard was approved by CEN on 21 September 2019.

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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, 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: Rue de la Science 23, B-1040 Brussels

© 2019 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 19036:2019 E
worldwide for CEN national Members.
 EN ISO 19036:2019 (E) ILNAS-EN ISO 19036:2019

Contents Page

European foreword....................................................................................................................................................... 3
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2
 ILNAS-EN ISO 19036:2019 EN ISO 19036:2019 (E)

European foreword

This document (EN ISO 19036:2019) has been prepared by Technical Committee ISO/TC 34 "Food
products" in collaboration with Technical Committee CEN/TC 463 “Microbiology of the food chain” the
secretariat of which is held by AFNOR.

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 May 2020, and conflicting national standards shall be
withdrawn at the latest by May 2020.

Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN 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
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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, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.

Endorsement notice

The text of ISO 19036:2019 has been approved by CEN as EN ISO 19036:2019 without any modification.

3
 INTERNATIONAL
ILNAS-EN ISO 19036:2019
ISO
STANDARD 19036

First edition
2019-10

Microbiology of the food chain —

Estimation of measurement
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uncertainty for quantitative

determinations
Microbiologie de la chaîne alimentaire — Estimation de l'incertitude
de mesure pour les déterminations quantitatives

Reference number
ISO 19036:2019(E)

© ISO 2019
 ISO 19036:2019(E) ILNAS-EN ISO 19036:2019

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COPYRIGHT PROTECTED DOCUMENT

© ISO 2019
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
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 ILNAS-EN ISO 19036:2019 ISO 19036:2019(E)


Contents Page

Foreword...........................................................................................................................................................................................................................................v
Introduction................................................................................................................................................................................................................................. vi
1 Scope.................................................................................................................................................................................................................................. 1
2 Normative references....................................................................................................................................................................................... 1
3 Terms, definitions and symbols............................................................................................................................................................. 1
3.1 Terms and definitions ....................................................................................................................................................................... 1
3.2 Symbols.......................................................................................................................................................................................................... 4
4 General considerations................................................................................................................................................................................... 5
5 Technical uncertainty....................................................................................................................................................................................... 6
5.1 Identification of main sources of uncertainty............................................................................................................... 6
5.1.1 General aspects.................................................................................................................................................................. 6
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5.1.2 Sampling uncertainty.................................................................................................................................................... 7

5.1.3 Bias............................................................................................................................................................................................... 7
5.1.4 Critical factors..................................................................................................................................................................... 7
5.2 Estimation of technical uncertainty....................................................................................................................................... 8
5.2.1 General aspects.................................................................................................................................................................. 8
5.2.2 Reproducibility standard deviation derived from intralaboratory
experiments, sIR ................................................................................................................................................................ 8
5.2.3 Reproducibility standard deviation derived from interlaboratory studies................ 13
6 Matrix uncertainty..........................................................................................................................................................................................14
6.1 General aspects..................................................................................................................................................................................... 14
6.2 Case of homogeneous laboratory (or test) sample................................................................................................ 15
6.3 Multiple test portions from laboratory samples...................................................................................................... 15
6.4 Known characteristic of the matrix..................................................................................................................................... 16
7 Distributional uncertainties..................................................................................................................................................................17
7.1 General aspects..................................................................................................................................................................................... 17
7.2 Colony-count technique — Poisson uncertainty..................................................................................................... 17
7.3 Colony-count technique — Confirmation uncertainty....................................................................................... 17
7.4 Most probable number uncertainty.................................................................................................................................... 18
8 Combined and expanded uncertainty..........................................................................................................................................19
8.1 Combined standard uncertainty............................................................................................................................................ 19
8.1.1 General considerations............................................................................................................................................. 19
8.1.2 Combined standard uncertainty based on separate technical, matrix, and
distributional standard uncertainties......................................................................................................... 19
8.1.3 Combined standard uncertainty based on reproducibility standard
deviation alone................................................................................................................................................................ 20
8.2 Expanded uncertainty.................................................................................................................................................................... 20
8.3 Worked examples............................................................................................................................................................................... 20
8.3.1 Example 1 — Technical, matrix and Poisson components of uncertainty................... 20
8.3.2 Example 2 — Poisson component negligible........................................................................................ 20
8.3.3 Example 3 — Poisson, matrix and confirmation components............................................... 21
8.3.4 Example 4 — Technical, matrix and most probable number components................. 21
9 Expression of measurement uncertainty in the test reports...............................................................................22
9.1 General aspects..................................................................................................................................................................................... 22
9.2 Results below the limit of quantification....................................................................................................................... 23
9.2.1 General aspects............................................................................................................................................................... 23
9.2.2 Example................................................................................................................................................................................. 23
Annex A (informative) Calculation of standard deviations with two or more than two
test portions (intralaboratory reproducibility standard deviation and matrix
uncertainty standard deviation).......................................................................................................................................................25

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