EN ISO 22117:2019
(Main)Microbiology of the food chain - Specific requirements and guidance for proficiency testing by interlaboratory comparison (ISO 22117:2019)
Microbiology of the food chain - Specific requirements and guidance for proficiency testing by interlaboratory comparison (ISO 22117:2019)
This document specifies requirements and gives guidelines for the organization of proficiency testing (PT) schemes for microbiological examinations of
a) foods and beverages,
b) feeding animals,
c) environmental samples from food and feed production and handling, and
d) primary production stages.
This document is also applicable to the microbiological examination of water where water is either used in food production or is regarded as a food in national legislation.
This document relates to the technical organization and implementation of PT schemes, as well as the statistical treatment of results of microbiological examinations.
This document is designed for use with ISO/IEC 17043 and ISO 13528, and deals only with areas where specific or additional details are necessary for PT schemes dealing with microbiological examinations for the areas specified in the first paragraph.
Mikrobiologie der Lebensmittelkette - Spezielle Anforderungen und Anleitungen an die Eignungsprüfung durch Ringversuche (ISO 22117:2019)
Dieses Dokument legt Anforderungen fest und enthält eine Anleitung für die Organisation von Eignungsprüfungsprogrammen (Eignungsprüfung, en: proficieny testing, abgekürzt mit PT) für die mikrobiologische Untersuchung von:
a) Lebensmitteln und Getränken;
b) Futtermitteln;
c) Umgebungsproben aus der Lebensmittel- und Futtermittelherstellung und -handhabung, und
d) Primärproduktionsstufen.
Dieses Dokument ist auch für die mikrobiologischen Untersuchungen von Wasser anwendbar, wenn Wasser entweder in der Lebensmittelproduktion verwendet oder in der nationalen Gesetzgebung als Lebensmittel angesehen wird.
Dieses Dokument bezieht sich auf die technische Organisation und die Umsetzung von Eignungsprüfungs-programmen sowie auf die statistische Behandlung von Ergebnissen mikrobiologischer Untersuchungen.
Dieses Dokument ist für die Anwendung in Verbindung mit ISO/IEC 17043 und ISO 13528 vorgesehen und behandelt nur die Gebiete, in denen spezifische oder zusätzliche Einzelheiten für Eignungsprüfungs¬pro-gramme, die sich mit mikrobiologischen Untersuchungen in den im ersten Absatz aufgeführten Bereichen befassen, notwendig sind.
Microbiologie de la chaîne alimentaire - Exigences spécifiques et recommandations relatives aux essais d'aptitude par comparaison interlaboratoires (ISO 22117:2019)
Le présent document spécifie des exigences et fournit des lignes directrices relatives à l'organisation de programmes d'essai d'aptitude pour les examens microbiologiques concernant:
a) les aliments et les boissons;
b) l'alimentation animale;
c) les échantillons environnementaux prélevés dans les secteurs de la production et de la manutention des aliments;
d) les étapes de production primaire.
Le présent document peut également s'appliquer à l'examen microbiologique de l'eau si celle-ci est utilisée dans la production alimentaire ou si la législation nationale la considère comme un aliment.
Le présent document concerne l'organisation technique et la mise en œuvre de programmes d'essai d'aptitude et également le traitement statistique des résultats des examens microbiologiques.
Le présent document est destiné à être utilisé avec l'ISO/IEC 17043 et l'ISO 13528 et ne traite que des domaines où des détails spécifiques ou supplémentaires sont nécessaires pour les programmes d'essai d'aptitude traitant des examens microbiologiques pour les domaines spécifiés dans le premier alinéa.
Mikrobiologija v prehranski verigi - Posebne zahteve in napotki za preskušanje strokovnosti z medlaboratorijsko primerjavo (ISO 22117:2019)
Ta dokument določa zahteve in podaja smernice za urejanje shem preskušanja strokovnosti (PT) za mikrobiološke preiskave
a) hrane in pijače,
b) krmljenja živali,
c) okoljskih vzorcev hrane ter proizvodnje in ravnanja s hrano; in
d) primarnih stopenj proizvodnje.
Ta dokument se uporablja tudi za mikrobiološko preiskovanje vode, ki se uporablja v proizvodnji hrane oziroma se v nacionalni zakonodaji obravnava kot živilo.
Ta dokument se nanaša na tehnično organizacijo in izvajanje shem preskušanja strokovnosti ter statistično obdelavo rezultatov mikrobioloških preiskav.
Ta dokument je zasnovan za uporabo s standardoma ISO/IEC 17043 in ISO 13528 ter obravnava samo področja, kjer so potrebne posebne ali dodatne podrobnosti za sheme preskušanja strokovnosti, ki zajemajo mikrobiološke preiskave za področja, opredeljena v prvem odstavku.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-maj-2019
1DGRPHãþD
SIST-TS CEN ISO/TS 22117:2011
Mikrobiologija v prehranski verigi - Posebne zahteve in napotki za preskušanje
strokovnosti z medlaboratorijsko primerjavo (ISO 22117:2019)
Microbiology of the food chain - Specific requirements and guidance for proficiency
testing by interlaboratory comparison (ISO 22117:2019)
Mikrobiologie der Lebensmittelkette - Spezielle Anforderungen und Anleitungen an die
Eignungsprüfung durch Ringversuche (ISO 22117:2019)
Microbiologie de la chaîne alimentaire - Exigences spécifiques et recommandations
relatives aux essais d'aptitude par comparaison interlaboratoires (ISO 22117:2019)
Ta slovenski standard je istoveten z: EN ISO 22117:2019
ICS:
07.100.30 Mikrobiologija živil Food microbiology
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 22117
EUROPEAN STANDARD
NORME EUROPÉENNE
March 2019
EUROPÄISCHE NORM
ICS 07.100.30 Supersedes CEN ISO/TS 22117:2010
English Version
Microbiology of the food chain - Specific requirements and
guidance for proficiency testing by interlaboratory
comparison (ISO 22117:2019)
Microbiologie de la chaîne alimentaire - Exigences Mikrobiologie der Lebensmittelkette - Spezielle
spécifiques et recommandations relatives aux essais Anforderungen und Anleitungen an die
d'aptitude par comparaison interlaboratoires (ISO Eignungsprüfung durch Ringversuche (ISO
22117:2019) 22117:2019)
This European Standard was approved by CEN on 19 February 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, 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 22117:2019 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 22117:2019) 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 September 2019, and conflicting national standards
shall be withdrawn at the latest by September 2019.
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.
This document supersedes CEN ISO/TS 22117:2010.
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, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 22117:2019 has been approved by CEN as EN ISO 22117:2019 without any modification.
INTERNATIONAL ISO
STANDARD 22117
First edition
2019-02
Microbiology of the food chain —
Specific requirements and
guidance for proficiency testing by
interlaboratory comparison
Microbiologie de la chaîne alimentaire — Exigences spécifiques et
recommandations relatives aux essais d'aptitude par comparaison
interlaboratoires
Reference number
ISO 22117:2019(E)
©
ISO 2019
ISO 22117:2019(E)
© ISO 2019
All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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
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below or ISO’s member body in the country of the requester.
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Published in Switzerland
ii © ISO 2019 – All rights reserved
ISO 22117:2019(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Scheme design and purpose . 2
4.1 General . 2
4.2 Scheme objectives . 2
4.3 Laboratory requirements for schemes . 3
4.4 Choice of test matrices . 3
4.5 Information on test methods used by the PT provider . 3
4.6 Statistical design . 3
5 Technical requirements and guidance for sample design and content .4
5.1 Sources, characterization and traceability of organisms . 4
5.2 Target organisms level . 4
5.3 Non-target organisms and interferences . 5
5.4 Matrix selection and effects . 5
6 Sample verification by the provider . 6
6.1 General . 6
6.2 Sample homogeneity testing — General considerations . 6
6.3 Homogeneity testing for quantitative (enumeration) samples . 6
6.4 Homogeneity testing for qualitative methods . 7
6.5 Stability testing by the provider . 8
6.5.1 General. 8
6.5.2 Stability during storage conditions . . 8
6.5.3 Stability during transport conditions . 8
7 Sample handling . 9
7.1 General . 9
7.2 Instructions to participants . 9
8 Performance evaluations . 9
8.1 General . 9
8.2 Preliminary considerations . 9
8.3 Assessment of quantitati ve methods .10
8.3.1 General.10
8.3.2 Distribution of data .11
8.3.3 Determining the assigned value .12
8.3.4 Uncertainty of the assigned value .12
8.3.5 Methods of assessing performance .12
8.3.6 Using z-scores .12
8.3.7 Other methods of performance evaluation .14
8.3.8 Long-term performance assessment .16
8.4 Assessment of qualitati ve methods.17
8.4.1 General.17
8.4.2 Performance of individual laboratories .17
8.4.3 Scheme comparisons of laboratory performance .19
Annex A (informative) Example of details to be included in a PT scheme plan .21
Annex B (informative) Preparation of fungal spore suspensions .23
Annex C (informative) Methods of testing
...
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