kSIST FprEN ISO 7218:2024
(Main)Microbiology of the food chain - General requirements and guidance for microbiological examinations (ISO/FDIS 7218:2024)
Microbiology of the food chain - General requirements and guidance for microbiological examinations (ISO/FDIS 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/FDIS 7218:2024)
In diesem Dokument werden allgemeine Anforderungen festgelegt und Leitlinien für mikrobiologische Untersuchungen bereitgestellt.
Es ist anwendbar auf:
die praktische Anwendung 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;
die 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 zur Einhaltung der ISO/IEC 17025 untersucht werden.
Die Anforderungen in 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 die spezifischen Anleitungen auf Parasiten und Viren angewendet werden. Es ist nicht anwendbar auf die Untersuchung von Toxinen oder sonstigen Stoffwechselprodukten (z. B. Amine) von Mikroorganismen.
Dieses Dokument ist anwendbar auf die Mikrobiologie der Lebensmittelkette, von der Primärproduktion bis hin zu Lebens- 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/FDIS 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/FDIS 7218:2024)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
oSIST prEN ISO 7218:2022
01-julij-2022
Mikrobiologija v prehranski verigi - Splošne zahteve in smernice za mikrobiološke
preiskave (ISO/DIS 7218:2022)
Microbiology of the food chain - General requirements and guidance for microbiological
examinations (ISO/DIS 7218:2022)
Mikrobiologie der Lebensmittelkette – Allgemeine Anforderungen und Leitlinien für
mikrobiologische Untersuchungen (ISO/DIS 7218:2022)
Microbiologie de la chaîne alimentaire - Exigences générales et lignes directrices pour
les examens microbiologiques (ISO/DIS 7218:2022)
Ta slovenski standard je istoveten z: prEN ISO 7218
ICS:
07.100.30 Mikrobiologija živil Food microbiology
oSIST prEN ISO 7218:2022 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
oSIST prEN ISO 7218:2022
oSIST prEN ISO 7218:2022
DRAFT INTERNATIONAL STANDARD
ISO/DIS 7218
ISO/TC 34/SC 9 Secretariat: AFNOR
Voting begins on: Voting terminates on:
2022-05-09 2022-08-01
Microbiology of the food chain — General requirements
and guidance for microbiological examinations
Microbiologie de la chaîne alimentaire — Exigences générales et lignes directrices pour les examens
microbiologiques
ICS: 07.100.30
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
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STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 7218:2022(E)
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 2022
oSIST prEN ISO 7218:2022
ISO TC 34/SC 9
Date: 11 February 2022
ISO/DIS 7218:2022(E)
ISO/DIS 7218(E)
ISO TC 34/SC 9 WG7
Microbiology of the food chain — General requirements and guidance for
microbiological examinations
Microbiologie de la chaîne alimentaire — Exigences générales et lignes directrices pour les examens
microbiologiques
DIS stage
© ISO 2022
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Published in Switzerland
ii
oSIST prEN ISO 7218:2022
ISO/DIS 7218 (E)
Contents Page
Foreword . v
Introduction . vi
1 Scope .7
2 Normative references .7
3 Terms and definitions .7
4 Premises . 10
4.1 General . 10
4.2 Biosafety considerations . 10
4.3 Laboratory design . 10
4.4 Laboratory areas . 10
4.5 Layout and fittings of the premises . 11
4.6 Cleaning and disinfection . 13
5 Personnel . 14
5.1 General . 14
5.2 Competence . 14
5.3 Verification of ongoing staff competence . 14
5.4 Hygiene . 14
6 Equipment and consumables . 15
6.1 General . 15
6.2 Sterilization and other heating equipment . 16
6.3 Temperature controlled equipment and monitoring devices . 21
6.4 Balances and gravimetric diluters . 27
6.5 Defined volume inoculation equipment . 28
6.6 Protective cabinets . 32
6.7 Homogenizers, blenders, mixers and shakers . 34
6.8 Stills, deionizers and reverse-osmosis units . 36
6.9 Separation and concentration equipment . 37
6.10 Modified atmosphere equipment . 38
6.11 Other equipment . 39
7 Sterilization/decontamination and disposal of laboratory materials . 43
7.1 Sterilization . 43
7.2 Decontamination and disinfection . 44
7.3 Waste management. 44
7.4 Washing . 45
8 Preparation and use of culture media . 45
9 Laboratory samples . 45
9.1 Sampling techniques and sampling plans . 45
9.2 Sample transport . 46
9.3 Sample receipt . 47
9.4 Sample handling . 47
9.5 Pre-testing of samples. 48
10 Examination . 49
oSIST prEN ISO 7218:2022
ISO/DIS 7218(E)
10.1 Hygienic precautions during sample preparation and examination . 49
10.2 Preparation of initial suspension and dilutions . 51
11 Enumeration (quantitative) methods . 52
11.1 General . 52
11.2 Enumeration using a solid medium . 53
11.3 Enumeration using liquid media . 65
11.4 Estimates of uncertainty of test results . 69
12 Detection (qualitative) methods . 69
12.1 General . 69
12.2 Principle . 70
13 Confirmation and identification methods . 70
13.1 General . 70
13.2 Preparation of a pure culture . 71
13.3 Confirmation methods . 71
13.4 Identification methods . 72
14 Selection and characterisation of control microorganisms . 74
14.1 General . 74
14.2 Characterisation of microorganisms . 74
14.3 Selection of control microorganisms . 74
15 Test report . 76
16 Laboratory quality control in microbiology . 77
16.1 General . 77
16.2 Internal Quality Control (IQC) . 78
16.3 External Quality Assessment (EQA) . 79
17 Validation and verification of microbiological methods . 80
17.1 General . 80
17.2 Performance characteristics . 80
17.3 Validation . 80
17.4 Verification . 81
Annex A (informative) Properties of disinfectants . 82
Annex B (informative) Confidence intervals for colony count technique. 84
Annex C (normative) General confirmation tests .
...
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