EN ISO 19036:2019
(Main)Microbiology of the food chain - Estimation of measurement uncertainty for quantitative determinations (ISO 19036:2019)
Microbiology of the food chain - Estimation of measurement uncertainty for quantitative determinations (ISO 19036:2019)
This document specifies requirements and gives guidance for the estimation and expression of measurement uncertainty (MU) associated with quantitative results in microbiology of the food chain.
It is applicable to the quantitative analysis of:
— products intended for human consumption or the feeding of animals;
— environmental samples in the area of food production and food handling;
— samples at the stage of primary production.
The quantitative analysis is typically carried out by enumeration of microorganisms using a colony-count technique. This document is also generally applicable to other quantitative analyses, including:
— most probable number (MPN) techniques;
— instrumental methods, such as impediometry, adenosine triphosphate (ATP) and flow cytometry;
— molecular methods, such as methods based on quantitative polymerase chain reaction (qPCR).
The uncertainty estimated by this document does not include systematic effects (bias).
Mikrobiologie der Lebensmittelkette - Feststellung von Messunsicherheiten bei quantitativen Bestimmungen (ISO 19036:2019)
Dieses Dokument legt Anforderungen fest und bietet eine Anleitung für die Abschätzung und Angabe der Messunsicherheit (MU), die mit quantitativen Ergebnissen in der Mikrobiologie der Lebensmittelkette verbunden ist.
Sie ist anwendbar für die quantitative Analyse von:
- Produkten, die für den menschlichen Verzehr oder als Futtermittel bestimmt sind;
- Umgebungsproben aus den Bereichen der Herstellung von Lebensmitteln und beim Umgang mit Lebensmitteln;
- Proben aus der Primärproduktion.
Die quantitative Analyse erfolgt in der Regel durch die Auszählung der Mikroorganismen anhand eines Koloniezählverfahrens. Dieses Dokument gilt allgemein auch für andere quantitative Analysen, einschließlich:
- Verfahren der wahrscheinlichsten Keimzahl (MPN);
- instrumentelle Verfahren, wie Impediometrie, Adenosintriphosphat (ATP) und Durchflusszytometrie;
- molekulare Verfahren, wie Verfahren, die auf der quantitativen Polymerase Kettenreaktion (en: quantitative polymerase chain reaction, qPCR) basieren.
Die Schätzung der Unsicherheit, die in diesem Dokument enthalten ist, schließt systematische Effekte (systematische Abweichung von Messungen) nicht ein.
Microbiologie de la chaîne alimentaire - Estimation de l'incertitude de mesure pour les déterminations quantitatives (ISO 19036:2019)
Le présent document spécifie des exigences et fournit des recommandations pour l'estimation et l'expression de l'incertitude de mesure (IM) associée à des résultats quantitatifs en microbiologie de la chaîne alimentaire.
Elle s'applique à l'analyse quantitative des:
— produits destinés à la consommation humaine ou à l'alimentation animale;
— échantillons environnementaux dans le domaine de la production et de la manutention de produits alimentaires;
— échantillons au stade de la production primaire.
L'analyse quantitative est généralement effectuée par le dénombrement de micro-organismes à l'aide d'une technique par comptage des colonies. Le présent document s'applique aussi en général à d'autres analyses quantitatives, telles que:
— les techniques du nombre le plus probable (NPP);
— les méthodes instrumentales, comme l'impédancemétrie, l'adénosine triphosphate (ATP) et la cytométrie en flux;
— les méthodes moléculaires, comme les méthodes fondées sur la réaction de polymérisation en chaîne quantitative (qPCR).
L'incertitude estimée par le présent document n'inclut pas les effets systématiques (biais).
Mikrobiologija v prehranski verigi - Ocena merilne negotovosti pri kvantitativnem določanju (ISO 19036:2019)
Ta mednarodni standard podaja zahteve in napotke za oceno in izražanje merilne negotovosti (MU), povezane s kvantitativnimi rezultati mikrobiologije prehranske verige. Uporablja se za kvantitativno analizo:
– izdelkov, namenjenih za prehrano ljudi ali krmo živali;
– okoljskih vzorcev na področju proizvodnje hrane in ravnanja s hrano; ter
– vzorcev v fazi primarne proizvodnje.
Kvantitativna analiza se običajno opravi s štetjem mikroorganizmov s tehniko štetja kolonij. Na splošno se uporablja tudi za druge kvantitativne analize, vključno s tehnikami najverjetnejšega števila (MPN) in instrumentalnimi metodami. Negotovost, ki jo ocenjuje ta mednarodni standard, ne vključuje sistematičnih učinkov (»resničnost« ali »pristranskost«).
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
01-januar-2020
Mikrobiologija v prehranski verigi - Ocena merilne negotovosti pri kvantitativnem
določanju (ISO 19036:2019)
Microbiology of the food chain - Estimation of measurement uncertainty for quantitative
determinations (ISO 19036:2019)
Mikrobiologie der Lebensmittelkette - Feststellung von Messunsicherheiten bei
quantitativen Bestimmungen (ISO 19036:2019)
Microbiologie de la chaîne alimentaire - Estimation de l'incertitude de mesure pour les
déterminations quantitatives (ISO 19036:2019)
Ta slovenski standard je istoveten z: EN ISO 19036:2019
ICS:
07.100.30 Mikrobiologija živil Food microbiology
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 19036
EUROPEAN STANDARD
NORME EUROPÉENNE
November 2019
EUROPÄISCHE NORM
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
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.
Contents Page
European foreword . 3
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
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.
INTERNATIONAL ISO
STANDARD 19036
First edition
2019-10
Microbiology of the food chain —
Estimation of measurement
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)
© ISO 2019
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ii © ISO 2019 – All rights reserved
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
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, s . 8
IR
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
ISO 19036:2019(E)
Annex B (informative) Matrix effect and matrix uncertainty .30
Annex C (informative) Intrinsic variability (standard uncertainty) of most probable
number estimates .
...
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