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SLOVENSKI STANDARD
01-september-2022
Mikrobiologija v prehranski verigi - Sekvenciranje celotnega genoma za tipizacijo
in genomsko karakterizacijo bakterij - Splošne zahteve in smernice (ISO
23418:2022)
Microbiology of the food chain - Whole genome sequencing for typing and genomic
characterization of bacteria - General requirements and guidance (ISO 23418:2022)
Mikrobiologie der Lebensmittelkette - Gesamtgenomsequenzierung zur Typisierung und
genomischen Charakterisierung von Bakterien - Allgemeine Anforderungen und
Leitfaden (ISO 23418:2022)
Microbiologie de la chaîne alimentaire - Séquençage de génome entier pour le typage et
la caractérisation génomique des bactéries - Exigences générales et recommandations
(ISO 23418:2022)
Ta slovenski standard je istoveten z: EN ISO 23418:2022
ICS:
07.100.30 Mikrobiologija živil Food microbiology
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 23418
EUROPEAN STANDARD
NORME EUROPÉENNE
June 2022
EUROPÄISCHE NORM
ICS 07.100.30
English Version
Microbiology of the food chain - Whole genome
sequencing for typing and genomic characterization of
bacteria - General requirements and guidance (ISO
23418:2022)
Microbiologie de la chaîne alimentaire - Séquençage de Mikrobiologie der Lebensmittelkette - Vollständige
génome entier pour le typage et la caractérisation Genomsequenzierung zur Typisierung und
génomique des bactéries - Exigences générales et genomischen Charakterisierung von Bakterien in
recommandations (ISO 23418:2022) Lebensmitteln - Allgemeine Anforderungen und
Leitfaden (ISO 23418:2022)
This European Standard was approved by CEN on 20 May 2022.
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
© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 23418:2022 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 23418:2022) 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 December 2022, and conflicting national standards
shall be withdrawn at the latest by December 2022.
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 has been prepared under a Standardization Request given to CEN by the European
Commission and the European Free Trade Association.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
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 23418:2022 has been approved by CEN as EN ISO 23418:2022 without any modification.
INTERNATIONAL ISO
STANDARD 23418
First edition
2022-06
Microbiology of the food chain —
Whole genome sequencing for typing
and genomic characterization of
bacteria — General requirements and
guidance
Microbiologie de la chaîne alimentaire — Séquençage de génome
entier pour le typage et la caractérisation génomique des bactéries —
Exigences générales et recommandations
Reference number
ISO 23418:2022(E)
ISO 23418:2022(E)
© ISO 2022
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 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
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CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: [email protected]
Website: www.iso.org
Published in Switzerland
ii
ISO 23418:2022(E)
Contents Page
Foreword .v
Introduction . vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Principle . 6
4.1 General . 6
4.2 Laboratory operation: sample preparation and sequencing . 6
4.3 Bioinformatics analysis . 7
4.3.1 General . 7
4.3.2 SNP analyses . 7
4.3.3 MLST analyses . 7
4.3.4 Kmer distance analysis . 7
4.4 Metadata formats and sequence repository deposition . 7
4.5 Validation and verification of WGS workflow . 8
5 General laboratory guidance . 8
5.1 Bacterial isolation and DNA extraction . 8
5.2 Laboratory environment . 8
5.3 Standard operating procedures and nonconforming work . 8
5.4 Laboratory information management system . 8
5.5 Laboratory competence. 8
6 Laboratory operations . .9
6.1 Sample preparation and storage . 9
6.2 Bacterial isolates . 9
6.3 DNA isolation . 9
6.4 Library preparation and sequencing . 9
6.4.1 Library preparation . 9
6.4.2 DNA sequencing . 10
6.4.3 Use of controls . 10
6.4.4 Assessing raw read data quality . 10
6.4.5 Sample and data storage and retention . 10
7 Bioinformatic data analysis .11
7.1 Requirements for software and bioinformatic pipelines used for data analysis . 11
7.2 Logging and documentation . 11
7.3 Quality assessments . 11
7.4 SNP analyses .12
7.5 MLST analyses (cgMLST and wgMLST) .12
7.6 Target gene detection .13
7.7 Phylogenetic tree or dendrogram generation. 13
7.8 Metrics and log files .13
7.9 Interpreting and reporting the results of bioinformatics analyses .13
7.9.1 Interpreting results from bioinformatics pipelines .13
7.9.2 Reporting genomic analysis results . 14
8 Metadata .
...