SIST EN ISO 7218:2024

Microbiology of the food chain - General requirements and guidance for microbiological examinations (ISO 7218:2024)

This document specifies general requirements and gives guidance on microbiological examinations.
It is applicable to:
—     the implementation of specific horizontal or vertical International Standards developed by ISO/TC 34/SC 9 or ISO/TC 34/SC 5 for detection or enumeration of microorganisms, named hereafter “specific standards”;
—     good laboratory practices for microbiology laboratories testing samples from the food chain;
—     guidance for microbiological laboratories testing samples from the food chain on the technical requirements for conforming to ISO/IEC 17025.
The requirements of this general standard supersede corresponding ones in existing specific standards.
Additional instructions for examinations using the polymerase chain reaction (PCR) are specified in ISO 22174.
This document is applicable to examinations for bacteria, yeasts and moulds and can be used, if supplemented with specific guidance, for parasites and viruses. It does not apply to examinations for toxins or other metabolites (e.g. amines) from microorganisms.
This document is applicable to microbiology of the food chain, from primary production stage to food and animal feed products, including the premises where the food or feed production and handling takes place. It is also applicable to the microbiological examination of water where water is used in food production or is regarded as a food in national legislation.

Mikrobiologie der Lebensmittelkette - Allgemeine Anforderungen und Leitlinien für mikrobiologische Untersuchungen (ISO 7218:2024)

Dieses Dokument legt allgemeine Anforderungen fest und gibt Leitlinien für mikrobiologische Untersuchungen.
Es ist anwendbar auf:
-   die Implementierung von durch ISO TC 34/SC 9 oder ISO TC 34/SC 5 entwickelten spezifischen horizontalen oder vertikalen Internationalen Normen für den Nachweis oder die Zählung von Mikroorganismen, im Folgenden „spezifische Normen“ genannt;
-   gute Laborpraxis für mikrobiologische Labore, die Proben aus der Lebensmittelkette untersuchen;
-   Leitlinien für mikrobiologische Labore, in denen Proben aus der Lebensmittelkette hinsichtlich der technischen Anforderungen für die Einhaltung von ISO/IEC 17025 untersucht werden.
Die Anforderungen dieser allgemeinen Norm ersetzen die entsprechenden Anforderungen in den bestehenden spezifischen Normen.
Zusätzliche Anweisungen für Untersuchungen unter Anwendung der Polymerase-Kettenreaktion (PCR) sind in ISO 22174 festgelegt.
Dieses Dokument ist anwendbar auf die Untersuchung von Bakterien, Hefen und Schimmelpilzen und kann bei entsprechender Ergänzung um spezifische Anleitungen auf Parasiten und Viren angewendet werden. Es ist nicht anwendbar auf die Untersuchung auf Toxine oder sonstige Stoffwechselprodukte (z. B. Amine) von Mikroorganismen.
Dieses Dokument ist anwendbar auf die Mikrobiologie der Lebensmittelkette, von der Primärproduktion bis hin zu Lebensmitteln und Futtermittelprodukten, einschließlich der Räumlichkeiten, in denen die Herstellung und Handhabung von Lebensmitteln oder Futtermitteln stattfindet. Es ist darüber hinaus anwendbar auf die mikrobiologische Untersuchung von Wasser, wenn Wasser in der Lebensmittelproduktion verwendet wird oder in nationalen Rechtsvorschriften als Lebensmittel gilt.

Microbiologie de la chaîne alimentaire - Exigences générales et recommandations pour les examens microbiologiques (ISO 7218:2024)

Le présent document spécifie des exigences générales et donne des recommandations relatives aux examens microbiologiques.
Il couvre:
—     l’application des normes internationales horizontales ou verticales spécifiques élaborées par l’ISO/TC 34/SC 9 ou l’ISO/TC 34/SC 5 pour la détection ou le dénombrement des micro-organismes, nommées ci-après «normes spécifiques»;
—     les bonnes pratiques de laboratoire pour les laboratoires de microbiologie soumettant à essai des échantillons issus de la chaîne alimentaire;
—     les recommandations destinées aux laboratoires de microbiologie soumettant à essai des échantillons issus de la chaîne alimentaire concernant les exigences techniques conformément à l’ISO/IEC 17025.
Les exigences de la présente norme générale prennent le pas sur les exigences correspondantes des normes spécifiques existantes.
Des instructions supplémentaires concernant les examens ayant recours à la réaction de polymérisation en chaîne (PCR) sont spécifiées dans l’ISO 22174.
Le présent document est applicable aux examens des bactéries, des levures et des moisissures et peut être utilisé s’il est complété par des recommandations spécifiques, pour les examens des parasites et des virus. Il ne s’applique pas aux examens des toxines ou autres métabolites (par exemple, les amines) provenant de micro-organismes.
Le présent document est applicable à la microbiologie de la chaîne alimentaire, du stade de la production primaire aux produits alimentaires pour la consommation humaine et pour les animaux, y compris les locaux de production et de manutention des aliments ou aliments pour animaux. Il 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.

Mikrobiologija v prehranski verigi - Splošne zahteve in smernice za mikrobiološke preiskave (ISO 7218:2024)

Ta dokument določa splošne zahteve in podaja smernice za mikrobiološke preiskave.
Uporablja se za:
–     izvajanje posebnih horizontalnih ali vertikalnih mednarodnih standardov, ki jih je pripravil tehnični odbor ISO/TC 34/SC 9 oziroma ISO/TC 34/SC 5 za odkrivanje ali štetje mikroorganizmov, v nadaljnjem besedilu »posebni standardi«;
–     dobro laboratorijsko prakso za mikrobiološke laboratorije, ki preskušajo vzorce v prehranski verigi;
–     smernice za mikrobiološke laboratorije, ki preskušajo vzorce v prehranski verigi, v zvezi s tehničnimi zahtevami za zagotavljanje skladnosti s standardom ISO/IEC 17025.
Zahteve tega splošnega standarda nadomeščajo ustrezne zahteve obstoječih posebnih standardov.
Dodatna navodila za preiskave s polimerazno verižno reakcijo (PCR) so podana v standardu ISO 22174.
Ta dokument se uporablja za preiskave bakterij, kvasovk in plesni, če je dopolnjen s posebnimi navodili, pa ga je mogoče uporabiti tudi za parazite in viruse. Ne uporablja se za preiskave toksinov ali drugih metabolitov (npr. aminov) iz mikroorganizmov.
Ta dokument se uporablja za mikrobiologijo prehranske verige, od faze primarne proizvodnje do živilskih proizvodov in živalske krme, vključno z območji, kjer se izvajata proizvodnja in ravnanje s hrano ali krmo. Uporablja se tudi za mikrobiološko preiskovanje vode v proizvodnji hrane oziroma se voda šteje za živilo v nacionalni zakonodaji.

General Information

• Status: Published
• Public Enquiry End Date: 30-Jul-2022
• Publication Date: 10-Jul-2024
• ICS: 07.100.30 - Food microbiology
• Technical Committee: KŽP - Agricultural food products
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 11-Jul-2024
• Due Date: 15-Sep-2024
• Completion Date: 11-Jul-2024
• Ref Project: EN ISO 7218:2024 - Microbiology of the food chain - General requirements and guidance for microbiological examinations (ISO 7218:2024)

Relations

• Revised: SIST EN ISO 7218:2007/A1:2013 - Microbiology of food and animal feeding stuffs - General requirements and guidance for microbiological examinations - Amendment 1 (ISO 7218:2007/Amd 1:2013)
• Effective Date: 21-Jan-2020
• Revised: SIST EN ISO 7218:2007 - Microbiology of food and animal feeding stuffs - General requirements and guidance for microbiological examinations (ISO 7218:2007)
• Effective Date: 21-Jan-2020

Standards Content (Sample)

SLOVENSKI STANDARD
01-september-2024
Mikrobiologija v prehranski verigi - Splošne zahteve in smernice za mikrobiološke
preiskave (ISO 7218:2024)
Microbiology of the food chain - General requirements and guidance for microbiological
examinations (ISO 7218:2024)
Mikrobiologie der Lebensmittelkette - Allgemeine Anforderungen und Leitlinien für
mikrobiologische Untersuchungen (ISO 7218:2024)
Microbiologie de la chaîne alimentaire - Exigences générales et recommandations pour
les examens microbiologiques (ISO 7218:2024)
Ta slovenski standard je istoveten z: EN ISO 7218:2024
ICS:
07.100.30 Mikrobiologija živil Food microbiology
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 7218
EUROPEAN STANDARD
NORME EUROPÉENNE
July 2024
EUROPÄISCHE NORM
ICS 07.100.30 Supersedes EN ISO 7218:2007, EN ISO
7218:2007/A1:2013
English Version
Microbiology of the food chain - General requirements and
guidance for microbiological examinations (ISO
7218:2024)
Microbiologie de la chaîne alimentaire - Exigences Mikrobiologie der Lebensmittelkette - Allgemeine
générales et recommandations pour les examens Anforderungen und Leitlinien für mikrobiologische
microbiologiques (ISO 7218:2024) Untersuchungen (ISO 7218:2024)
This European Standard was approved by CEN on 28 April 2024.

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, Türkiye 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
© 2024 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 7218:2024 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 7218:2024) 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 January 2025, and conflicting national standards shall
be withdrawn at the latest by January 2025.
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 EN ISO 7218:2007.
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, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 7218:2024 has been approved by CEN as EN ISO 7218:2024 without any modification.

International
Standard
ISO 7218
Fourth edition
Microbiology of the food chain —
2024-06
General requirements and guidance
for microbiological examinations
Microbiologie de la chaîne alimentaire — Exigences générales et
recommandations pour les examens microbiologiques
Reference number
ISO 7218:2024(en) © ISO 2024
ISO 7218:2024(en)
© ISO 2024
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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii
ISO 7218:2024(en)
Contents Page
Foreword .vii
Introduction .viii
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Premises . 5
4.1 General .5
4.2 Biosafety considerations .5
4.3 Laboratory design .5
4.4 Laboratory areas .5
4.4.1 General .5
4.4.2 Areas associated with samples and testing .6
4.4.3 General areas .6
4.5 Layout and fittings of the premises .6
4.5.1 Objectives .6
4.5.2 Fittings .7
4.5.3 Other arrangements for laboratory premises .7
4.5.4 Cleaning and disinfection .8
5 Personnel . 8
5.1 General .8
5.2 Competence .8
5.3 Verification of ongoing staff competence .9
5.4 Hygiene .9
6 Equipment and consumables . 9
6.1 General .9
6.2 Sterilization and other heating equipment .10
6.2.1 General .10
6.2.2 Autoclave .10
6.2.3 Culture media preparator .11
6.2.4 Steamers, including boiling-water baths . 12
6.2.5 Sterilizing oven . 12
6.2.6 Microwave oven . 13
6.2.7 Hotplate, induction cooker and heating mantle .14
6.2.8 Gas burner or wire incinerator .14
6.3 Temperature controlled equipment and monitoring devices . 15
6.3.1 General . 15
6.3.2 Incubator . 15
6.3.3 Thermostatically controlled bath .16
6.3.4 Heating blocks .17
6.3.5 Refrigerators and cold-storage rooms .18
6.3.6 Freezer and deep freezer/ultra-low temperature freezer .19
6.3.7 Temperature-monitoring devices, including automatic recorders .19
6.3.8 Balances and gravimetric diluters . 20
6.4 Defined volume inoculation equipment .21
6.4.1 Pipettes and pipettors .21
6.4.2 Dispensers . 22
6.4.3 Spiral platers . 23
6.4.4 Serial diluters .24
6.5 Protective cabinets .24
6.5.1 Description .24
6.5.2 Use . 25
6.5.3 Cleaning and disinfection . 25
6.5.4 Maintenance and inspection . 26

iii
ISO 7218:2024(en)
6.6 Homogenizers, blenders, mixers and shakers . 26
6.6.1 Homogenizers and blenders . 26
6.6.2 Vortex mixers .27
6.7 Stills, deionizers and reverse-osmosis units . 28
6.7.1 Description . 28
6.7.2 Use . 28
6.7.3 Maintenance . 28
6.7.4 Verification . 28
6.8 Separation and concentration equipment . 28
6.8.1 Immunomagnetic separator (IMS) . 28
6.8.2 Centrifuge . 29
6.8.3 Filtration systems . 29
6.9 Modified atmosphere equipment . 29
6.9.1 Description . 29
6.9.2 Use . 29
6.9.3 Maintenance . 30
6.9.4 Verification . 30
6.10 Other equipment . 30
6.10.1 pH meter . 30
6.10.2 Colony-counting device .31
6.10.3 Timers and timing devices .31
6.10.4 Optical microscope .32
6.10.5 Glass washers, glassware and other laboratory ware .32
6.10.6 Disposable equipment and consumables . 33
6.10.7 Other equipment and software . 34
7 Sterilization/decontamination and disposal of laboratory materials .34
7.1 Sterilization . 34
7.1.1 General . 34
7.1.2 Sterilization by dry heat . 34
7.1.3 Sterilization by moist heat (steam) . 34
7.2 Decontamination and disinfection . 34
7.2.1 Decontamination of glassware and materials before use . 34
7.2.2 Decontamination of glassware and materials after use . 34
7.3 Waste management . 35
7.4 Washing . 35
8 Preparation and use of culture media and reagents .35
9 Laboratory samples .36
9.1 Sampling techniques and sampling plans . 36
9.1.1 General . 36
9.1.2 Sampling . 36
9.2 Sample transport . 36
9.3 Sample receipt .37
9.4 Sample handling .37
9.4.1 General .37
9.4.2 Storage before examination . 38
9.4.3 Test portions . 38
9.4.4 Storage of laboratory samples after examination . 38
9.5 Pre-testing of samples . 38
10 Examination .39
10.1 Hygienic precautions during sample preparation and examination . 39
10.1.1 General . 39
10.1.2 Basic precautions . 39
10.1.3 Sample handling . 39
10.1.4 Sample handling tools and implements . 40
10.1.5 Spillages. 40
10.1.6 Process controls . 40
10.1.7 Aerosols . 40

iv
ISO 7218:2024(en)
10.1.8 Molecular methods .41
10.2 Preparation of initial suspension and dilutions .41
10.2.1 General .41
10.2.2 Concentration .41
11 Enumeration (quantitative) methods . 41
11.1 General .41
11.2 Enumeration using a solid medium .42
11.2.1 General .42
11.2.2 Pour plate technique .42
11.2.3 Surface plating techniques .43
11.2.4 Enumeration of yeasts and moulds. 44
11.2.5 Incubation.45
11.2.6 Calculation and expression of results obtained with solid culture media .45
11.2.7 Calculations for enumeration methods .47
11.3 Enumeration using liquid media . 54
11.3.1 Principle . 54
11.3.2 General MPN procedure . 54
11.3.3 Limitations of MPN . 54
11.3.4 Inoculation procedure . 55
11.3.5 Choice of MPN configuration . 55
11.3.6 Incubation. 56
11.3.7 Interpretation and expression of results . 56
11.3.8 Determination of MPN values using MPN calculators . 56
11.3.9 Rarity categories .57
11.4 Estimates of uncertainty of test results.57
12 Detection (qualitative) methods .58
12.1 General . 58
12.2 Principle . 58
13 Confirmation and identification methods .58
13.1 General . 58
13.2 Preparation of a pure culture .59
13.3 Confirmation methods .59
13.3.1 Latex agglutination test .59
13.3.2 Nucleic acid hybridization or molecular amplification methods .59
13.3.3 Slide agglutination tests . 60
13.4 Identification methods . 60
13.4.1 Biochemical galleries . 60
13.4.2 DNA sequencing . 60
13.4.3 Mass spectrometry .61
14 Selection and characterization of control microorganisms . 61
14.1 General .61
14.2 Characterization of microorganisms.62
14.2.1 General .62
14.2.2 Phenotypic characterization .62
14.2.3 Molecular characterization .62
14.3 Selection of control microorganisms.62
15 Test report .63
16 Laboratory quality control in microbiology .64
16.1 General . 64
16.2 Internal quality control . 65
16.2.1 General . 65
16.2.2 Process controls . 65
16.2.3 Replicate testing . 66
16.2.4 Spiked samples . 66
16.2.5 IQC assessment using control charts . 66
16.3 External quality assessment . 66

v
ISO 7218:2024(en)
17 Validation and verification of microbiological methods . 67
17.1 General .67
17.2 Performance characteristics .67
17.3 Validation .67
17.4 Verification . . 68
Annex A (informative) Properties of disinfectants .69
Annex B (informative) Confidence intervals for colony count technique .70
Annex C (normative) General confirmation tests .73
Bibliography .78

vi
ISO 7218:2024(en)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of 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 of 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 different types
of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the
ISO/IEC Directives, Part 2 (see www.iso.org/directives).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions
related to conformity assessment, as well as information about ISO’s adherence to the World Trade
Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 34, Food products, Subcommittee SC 9,
Microbiology, in collaboration with the European Committee for Standardization (CEN) Technical Committee
CEN/TC 463, Microbiology of the food chain, in accordance with the Agreement on technical cooperation
between ISO and CEN (Vienna Agreement).
This fourth edition cancels and replaces the third edition (ISO 7218:2007), which has been technically
revised. It also incorporates the Amendment ISO 7218:2007/Amd 1:2013.
The main changes are as follows:
— the calculations section has been simplified and two further calculators have been added;
— the equipment section has been reorganized into groups with similar purposes and requirements;
— cross-references have been added to other general microbiology standards such as those for media,
validation and verification, and uncertainty to reduce repetition;
— information on laboratory quality control and characterization of control microorganisms has been added.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.

vii
ISO 7218:2024(en)
Introduction
When conducting microbiological examinations, it is especially important that:
— only those microorganisms present in the samples are detected and/or enumerated;
— these microorganisms do not contaminate the environment.
To achieve this, good laboratory practices are essential, including personal hygiene and aseptic working
techniques which exclude extraneous contamination as far as possible.
Only limited information on the precautions to be taken during microbiological examinations is given in
this document, so a thorough knowledge of the microbiological techniques and microorganisms involved
is essential. It is important that examinations are conduc
...