ISO 7218:2024
(Main)Microbiology of the food chain — General requirements and guidance for microbiological examinations
Microbiology of the food chain — General requirements and guidance for microbiological examinations
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.
Microbiologie de la chaîne alimentaire — Exigences générales et recommandations pour les examens microbiologiques
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.
General Information
Relations
Buy Standard
Standards Content (Sample)
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 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
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Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
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
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 .
...
Norme
internationale
ISO 7218
Quatrième édition
Microbiologie de la chaîne
2024-06
alimentaire — Exigences générales
et recommandations pour les
examens microbiologiques
Microbiology of the food chain — General requirements and
guidance for microbiological examinations
Numéro de référence
DOCUMENT PROTÉGÉ PAR COPYRIGHT
© ISO 2024
Tous droits réservés. Sauf prescription différente ou nécessité dans le contexte de sa mise en œuvre, aucune partie de cette
publication ne peut être reproduite ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique,
y compris la photocopie, ou la diffusion sur l’internet ou sur un intranet, sans autorisation écrite préalable. Une autorisation peut
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CH-1214 Vernier, Genève
Tél.: +41 22 749 01 11
E-mail: copyright@iso.org
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Publié en Suisse
ii
Sommaire Page
Avant-propos .vii
Introduction .viii
1 Domaine d’application . 1
2 Références normatives . 1
3 Termes et définitions . 1
4 Locaux . 5
4.1 Généralités .5
4.2 Considérations de sécurité biologique .5
4.3 Conception du laboratoire .6
4.4 Locaux du laboratoire .6
4.4.1 Généralités .6
4.4.2 Locaux dédiés à la manipulation des échantillons et aux essais .6
4.4.3 Locaux généraux .7
4.5 Implantation et aménagement des locaux .7
4.5.1 Objectifs .7
4.5.2 Aménagement .7
4.5.3 Autres dispositions applicables aux locaux du laboratoire .8
4.5.4 Nettoyage et désinfection .9
5 Personnel . 9
5.1 Généralités .9
5.2 Compétence .9
5.3 Vérification de la compétence continue du personnel.10
5.4 Hygiène .10
6 Équipement et consommables . 10
6.1 Généralités .10
6.2 Matériel de stérilisation et autre matériel de chauffage .11
6.2.1 Généralités .11
6.2.2 Autoclave .11
6.2.3 Préparateur de milieux de culture . 13
6.2.4 Matériels produisant de la vapeur, y compris les bains d’eau bouillante . 13
6.2.5 Four à stériliser .14
6.2.6 Four à micro-ondes . 15
6.2.7 Plaques de cuisson à induction et chauffe-ballons .16
6.2.8 Brûleur à gaz ou incinérateur à fil .16
6.3 Matériel à régulation de température et dispositifs de surveillance de la température .16
6.3.1 Généralités .16
6.3.2 Étuve .17
6.3.3 Bain thermostaté .18
6.3.4 Blocs chauffants .19
6.3.5 Réfrigérateurs et chambres froides . 20
6.3.6 Congélateur et surgélateur/congélateur à ultra basse température .21
6.3.7 Dispositifs de surveillance de la température, y compris les enregistreurs
automatiques .21
6.3.8 Balances et diluteurs gravimétriques . 22
6.4 Matériel pour ensemencement d’un volume défini . 23
6.4.1 Pipettes et pipetteurs . 23
6.4.2 Distributeurs .24
6.4.3 Dispositifs d’ensemencement en spirale . 25
6.4.4 Diluteurs en série . 26
6.5 Hottes de sécurité (= Postes de sécurité microbiologique) .27
6.5.1 Description .27
6.5.2 Utilisation . 28
6.5.3 Nettoyage et désinfection . 28
iii
6.5.4 Entretien et contrôle . 28
6.6 Homogénéisateurs, mélangeurs, mixeurs et agitateurs par vibrations . 29
6.6.1 Homogénéisateurs et mélangeurs . . 29
6.6.2 Agitateurs de type vortex . 30
6.7 Distillateurs, déionisateurs et osmoseurs. 30
6.7.1 Description . 30
6.7.2 Utilisation . 30
6.7.3 Entretien . 30
6.7.4 Vérification .31
6.8 Matériel de séparation et de concentration .31
6.8.1 Séparateur immunomagnétique .31
6.8.2 Centrifugeuse .32
6.8.3 Systèmes de filtration .32
6.9 Matériel sous atmosphère modifiée .32
6.9.1 Description .32
6.9.2 Utilisation .32
6.9.3 Entretien . 33
6.9.4 Vérification . 33
6.10 Autres équipements .
...
FINAL DRAFT
International
Standard
ISO/FDIS 7218
ISO/TC 34/SC 9
Microbiology of the food chain —
Secretariat: AFNOR
General requirements and guidance
Voting begins on:
for microbiological examinations
2024-01-31
Microbiologie de la chaîne alimentaire — Exigences générales et
Voting terminates on:
recommandations pour les examens microbiologiques
2024-03-27
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPOR TING DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO
ISO/CEN PARALLEL PROCESSING LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
Reference number
ISO/FDIS 7218:2024(en) © ISO 2024
FINAL DRAFT
ISO/FDIS 7218:2024(en)
International
Standard
ISO/FDIS 7218
ISO/TC 34/SC 9
Microbiology of the food chain —
Secretariat: AFNOR
General requirements and guidance
Voting begins on:
for microbiological examinations
Microbiologie de la chaîne alimentaire — Exigences générales et
Voting terminates on:
recommandations pour les examens microbiologiques
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPOR TING DOCUMENTATION.
© ISO 2024
IN ADDITION TO THEIR EVALUATION AS
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO
ISO/CEN PARALLEL PROCESSING
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
or ISO’s member body in the country of the requester.
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland Reference number
ISO/FDIS 7218:2024(en) © ISO 2024
ii
ISO/FDIS 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 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/FDIS 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 .
...
ISO/FDIS 7218:2023(E)
Date: 2023-09-28
ISO/TC 34/SC 9
Secretariat: AFNOR
Date: 2024-01-17
Microbiology of the food chain — General requirements and
guidance for microbiological examinations
Microbiologie de la chaîne alimentaire — Exigences générales et lignes directricesrecommandations pour
les examens microbiologiques
FDIS stage
Warning for WDs and CDs
This document is not an ISO International Standard. It is distributed for review and comment. It is subject to
change without notice and may not be referred to as an International Standard.
Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of
which they are aware and to provide supporting documentation.
ISO/FDIS 7218:2024(en)
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: + 41 22 749 01 11
EmailE-mail: copyright@iso.org
Website: www.iso.orgwww.iso.org
Published in Switzerland
ii
ISO/FDIS 7218:2024(en)
Contents
Foreword . viii
Introduction. ix
1 Scope .1
2 Normative references .1
3 Terms and definitions .1
4 Premises .5
4.1 General .5
4.2 Biosafety considerations .6
4.3 Laboratory design .6
4.4 Laboratory areas .6
4.4.1 General .6
4.4.2 Areas associated with samples and testing .6
4.4.3 General areas .7
4.5 Layout and fittings of the premises .7
4.5.1 Objectives .7
4.5.2 Fittings .7
4.5.3 Other arrangements for laboratory premises .8
4.5.4 Cleaning and disinfection .9
5 Personnel .9
5.1 General .9
5.2 Competence .9
5.3 Verification of ongoing staff competence .9
5.4 Hygiene .9
6 Equipment and consumables . 10
6.1 General . 10
6.2 Sterilization and other heating equipment . 11
6.2.1 General . 11
6.2.2 Autoclave . 11
6.2.3 Culture media preparator . 12
6.2.4 Steamers, including boiling-water baths . 13
6.2.5 Sterilizing oven . 13
6.2.6 Microwave oven . 14
6.2.7 Hotplate and heating mantle . 15
6.2.8 Gas burner or wire incinerator . 15
6.3 Temperature controlled equipment and monitoring devices . 15
6.3.1 General . 15
6.3.2 Incubator . 15
iii
ISO/FDIS 7218:2024(en)
6.3.3 Thermostatically controlled bath . 17
6.3.4 Heating blocks . 18
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 . 20
6.3.8 Balances and gravimetric diluters . 21
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 . 25
6.5.1 Description . 25
6.5.2 Use . 25
6.5.3 Cleaning and disinfection . 26
6.5.4 Maintenance and inspection . 26
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 Ve
...
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