EN ISO 18593:2018

Microbiology of the food chain - Horizontal methods for surface sampling (ISO 18593:2018)

This document specifies horizontal methods for sampling techniques using contact plates, stick swabs, sponges and cloths on surfaces in the food chain environment in order to detect and enumerate culturable microorganisms such as pathogenic or non-pathogenic bacteria or yeasts and moulds.
NOTE       The term "environment" means any item in contact with the food product or likely to represent a contamination or recontamination source; for example, material, premises or operators.
This document does not apply to the validation of cleaning and disinfection procedures.
This document does not apply to sampling techniques for primary production samples, which are covered by ISO 13307. Sampling techniques for carcasses are covered by ISO 17604. Sampling techniques for analysis of noroviruses and hepatitis A viruses are covered by ISO 15216-1.
This document does not give advice on sampling frequency, the number of sampling points, or the need to rotate sampling points, as these are chosen on a case-by-case basis.

Mikrobiologie der Lebensmittelkette - Horizontales Verfahren für Probenahmetechniken von Oberflächen (ISO 18593:2018)

Dieses Dokument legt horizontale Verfahren für Probenahmetechniken mittels Abklatschplatten, Stieltupfer, Schwämmen und Tüchern an Oberflächen in der Umgebung der Lebensmittelkette fest, um kultivierbare Mikroorganismen wie beispielsweise pathogene oder nicht pathogene Bakterien sowie Hefen und Schimmel¬pilze nachzuweisen und zu zählen.
ANMERKUNG   Der Begriff "Umgebung" schließt alle Gegenstände in Kontakt mit dem Lebensmittel oder die, die wahrscheinlich eine Kontaminations  oder Rekontaminationsquelle darstellen mit ein, z. B. Material, Einrichtungen oder Bearbeiter.
Dieses Dokument gilt nicht für die Validierung von Reinigungs  und Desinfektionsverfahren.
Dieses Dokument gilt nicht für Probenahmetechniken für primäre Produktionsproben, die von ISO 13307 abgedeckt werden. Probenahmetechniken für Schlachttierkörper werden von ISO 17604 abgedeckt. Probenahmetechniken für die Analyse von Noroviren und Hepatitis A Viren werden von ISO 15216-1 abgedeckt.
Dieses Dokument macht keine Angaben hinsichtlich der Probenahmehäufigkeit, Anzahl an Probenahmestellen oder der Notwendigkeit zur Rotation der Probenahmestelle, da diese je nach Fall ausgewählt werden.

Microbiologie de la chaîne alimentaire - Méthodes horizontales pour les prélèvements de surface (ISO 18593:2018)

Le présent document spécifie les méthodes horizontales pour les techniques de prélèvement d'échantillons au moyen de boîtes de contact, d'écouvillons, d'éponges et de chiffonnettes sur les surfaces de l'environnement de la chaîne alimentaire afin de rechercher et de dénombrer des micro-organismes cultivables tels que les bactéries pathogènes ou non pathogènes, les levures et les moisissures.
NOTE       Le terme «environnement» est compris comme tout élément entrant en contact avec le produit alimentaire ou étant susceptible de représenter une source de contamination ou de recontamination, par exemple matériel, locaux ou opérateurs.
Le présent document ne s'applique pas à la validation des protocoles de nettoyage et de désinfection.
Le présent document ne s'applique pas aux techniques de prélèvement de surfaces en production primaire, qui sont couvertes par l'ISO 13307. Les techniques de prélèvement sur les carcasses sont couvertes par l'ISO 17604. Les techniques de prélèvement en vue d'analyser les norovirus et les virus de l'hépatite A sont couvertes par l'ISO 15216‑1.
Le présent document ne dispense pas de conseils sur la fréquence des prélèvements, le nombre de points de prélèvement, ou la nécessité d'alterner les points de prélèvement car ces éléments sont déterminés au cas par cas.

Mikrobiologija v prehranski verigi - Horizontalne metode za tehnike vzorčenja s površin (ISO 18593:2018)

Ta dokument določa metode za ugotavljanje meje tekočine in plastičnosti zemljine, ki zajemajo dve od Atterbergovih mejnih vrednosti za zemljine.
Meja tekočine je vsebnost vode, pri kateri se stanje zemljine spremeni iz tekočega v plastično. Ta dokument opisuje ugotavljanje meje tekočine vzorca naravne zemljine ali vzorca zemljine, iz katerega je odstranjen material večji od približno 0,4 mm. Ta dokument opisuje dve metodi: metodo s konusom in Casagrandejevo metodo.
OPOMBA: Metoda s konusom v tem dokumentu se ne sme zamenjevati z metodo iz standarda ISO 17892-6. Meja plastičnosti zemljine je vsebnost vode, pri kateri zemljina pri nadaljnjem sušenju preneha biti plastična. Ugotavljanje meje plastičnosti običajno poteka v povezavi z ugotavljanjem meje tekočine. Ugotovljeno je, da so rezultati preskusa odvisni od presoje upravljavca in da bo pri rezultatih prišlo do nekaterih razlik.

General Information

• Status: Published
• Publication Date: 17-Jul-2018
• Withdrawal Date: 30-Jan-2019
• ICS: 07.100.30 - Food microbiology
• Technical Committee: CEN/TC 463 - Microbiology of the food chain
• Drafting Committee: CEN/TC 463 - Microbiology of the food chain
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 18-Jul-2018
• Completion Date: 18-Jul-2018
• Directive: 874/2012 - Commission Delegated Regulation (EU) No 874/2012 of 12 July 2012 supplementing Directive 2010/30/EU of the European Parliament and of the Council with regard to energy labelling of electrical lamps and luminaires
• Directive: 882/2004 - Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 onofficial controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules
• Ref Project: SIST EN ISO 18593:2018 - Microbiology of the food chain - Horizontal methods for surface sampling (ISO 18593:2018)

Overview - EN ISO 18593:2018 (ISO 18593:2018)

EN ISO 18593:2018 - titled Microbiology of the food chain - Horizontal methods for surface sampling - defines standard, horizontal methods for sampling surfaces in the food chain environment to detect and enumerate culturable microorganisms (pathogenic and non‑pathogenic bacteria, yeasts and moulds). It covers sampling devices and procedures using contact plates, stick swabs, sponges and cloths, and gives guidance on sampling locations, areas and timing. This edition (2018) supersedes ISO 18593:2004 and adds recommendations on sampling procedure and examples of neutralizers.

Key topics and technical requirements

• Scope and exclusions
  • Applies to surface sampling in food chain environments (materials, premises, operators).
  • Does not cover validation of cleaning/disinfection procedures or sampling for primary production (ISO 13307), carcasses (ISO 17604), noroviruses/hepatitis A (ISO 15216‑1).
  • Does not prescribe sampling frequency or number/rotation of points (case‑by‑case decisions).
• Sampling methods
  • Contact plate method (agar plates directly applied to surfaces).
  • Stick swab method (sterile swabs for crevices or irregular surfaces).
  • Sponge/cloth method (larger surface areas or rough textures).
• Procedure elements
  • Recommendations on sampling location, sampling area, and time of sampling.
  • Guidance on equipment, consumables, culture media and reagents (use ISO 7218 and ISO 11133 for laboratory practice).
  • Use of neutralizers where residual disinfectants could affect recovery (Annex A).
• Sample handling and analysis
  • Storage and transport requirements for contact plates and swab/sponge samples.
  • Microbiological analysis workflows and result expression/calculation.
• Normative references
  • Key referenced standards: ISO 6887‑1, ISO 6887‑5, ISO 7218, ISO 11133, ISO 16140‑2.

Practical applications & who uses it

• Food safety and quality assurance teams implementing environmental monitoring programs.
• Microbiology laboratories performing surface contamination testing and enumeration.
• HACCP/food safety auditors and regulatory bodies assessing compliance and risk of contamination.
• Food manufacturers, processors and equipment suppliers designing cleaning validation strategies (note: ISO 18593 does not validate cleaning efficacy but informs sampling).
• Consultants and contract labs developing sampling protocols for production, packaging and handling areas.

Related standards

• ISO 13307 - primary production sampling
• ISO 17604 - carcass sampling methods
• ISO 15216‑1 - norovirus and hepatitis A sampling/analysis
• ISO 7218, ISO 6887 series, ISO 11133, ISO 16140‑2 - laboratory practice, media and validation

Keywords: EN ISO 18593:2018, ISO 18593:2018, surface sampling, food chain microbiology, contact plates, swabs, sponges, environmental monitoring, food safety standards.

Standards Content (Sample)

SLOVENSKI STANDARD
01-november-2018
0LNURELRORJLMDYSUHKUDQVNLYHULJL+RUL]RQWDOQHPHWRGH]DWHKQLNHY]RUþHQMDV
SRYUãLQ,62
Microbiology of the food chain - Horizontal methods for surface sampling (ISO
18593:2018)
Mikrobiologie der Lebensmittelkette - Horizontales Verfahren für Probenahmetechniken
von Oberflächen (ISO 18593:2018)
Microbiologie de la chaîne alimentaire - Méthodes horizontales pour les prélèvements de
surface (ISO 18593:2018)
Ta slovenski standard je istoveten z: EN ISO 18593:2018
ICS:
07.100.30 Mikrobiologija živil Food microbiology
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 18593
EUROPEAN STANDARD
NORME EUROPÉENNE
July 2018
EUROPÄISCHE NORM
ICS 07.100.30
English Version
Microbiology of the food chain - Horizontal methods for
surface sampling (ISO 18593:2018)
Microbiologie de la chaîne alimentaire - Méthodes Mikrobiologie der Lebensmittelkette - Horizontales
horizontales pour les prélèvements de surface (ISO Verfahren für Probenahmetechniken von Oberflächen
18593:2018) mittels Abklatschplatten und Tupfer (ISO 18593:2018)
This European Standard was approved by CEN on 30 May 2018.

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
© 2018 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 18593:2018 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 18593:2018) 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 January 2019, and conflicting national standards shall
be withdrawn at the latest by January 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.
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 18593:2018 has been approved by CEN as EN ISO 18593:2018 without any modification.

INTERNATIONAL ISO
STANDARD 18593
Second edition
2018-06
Microbiology of the food chain —
Horizontal methods for surface
sampling
Microbiologie de la chaîne alimentaire — Méthodes horizontales pour
les prélèvements de surface
Reference number
ISO 18593:2018(E)
©
ISO 2018
ISO 18593:2018(E)
© ISO 2018
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]
Fax: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii © ISO 2018 – All rights reserved

ISO 18593:2018(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Principle . 2
5 Culture media and reagents . 2
6 Equipment and consumables . 3
7 Sampling procedure . 3
7.1 General . 3
7.2 Sampling location . 3
7.3 Sampling area . 4
7.4 Time of sampling and frequency . 4
7.5 Sampling techniques . 4
7.5.1 General. 4
7.5.2 Contact plate method . 5
7.5.3 Stick swab method . 5
7.5.4 Sponge/cloth method . 5
8 Storage and transport . 6
8.1 Contact plate . 6
8.2 Stick swab, sponge/cloth . 6
9 Microbiological analysis of samples . 6
9.1 Contact plate method . 6
9.2 Stick swab/cloth/sponge method . 6
10 Expression of results and calculation . 7
10.1 General . 7
10.2 Contact plate method . 7
10.3 Method using stick swab, cloth or sponge. 7
11 Test report . 7
Annex A (informative) Neutralizers . 9
Bibliography .11
ISO 18593:2018(E)
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).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on 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 the following
URL: www .iso .org/iso/foreword .html.
This document was prepared by Technical Committee ISO/TC 34, Food products, Subcommittee SC 9,
Microbiology.
This second edition cancels and replaces the first edition (ISO 18593:2004), which has been technically
revised. The main changes are as follows:
— recommendations on sampling procedure have been added, including information on sampling
location, area and sampling time;
— examples of neutralizers have been added as Annex A.
iv © ISO 2018 – All rights reserved

ISO 18593:2018(E)
Introduction
It can be important to determine the presence of, or the number of microbes on, the surfaces of utensils,
work surfaces and other equipment in the food chain environment in order to estimate the level of
contamination in the food chain environment.
This document describes horizontal methods for surface sampling.
INTERNATIONAL STANDARD ISO 18593:2018(E)
Microbiology of the food chain — Horizontal methods for
surface sampling
1 Scope
This document specifies horizontal methods for sampling techniques using contact plates, stick
swabs, sponges and cloths on surfaces in the food chain environment in order to detect and enumerate
culturable microorganisms such as pathogenic or non-pathogenic bacteria or yeasts and moulds.
NOTE The term “environment” means any item in contact with the food product or likely to represent a
contamination or recontamination source; for example, material, premises or operators.
This document does not apply to the validation of cleaning and disinfection procedures.
This document does not apply to sampling techniques for primary production samples, which are
covered by ISO 13307. Sampling techniques for carcasses are covered by ISO 17604. Sampling techniques
for analysis of noroviruses and hepatitis A viruses are covered by ISO 15216-1.
This document does not give advice on sampling frequency, the number of sampling points, or the need
to rotate sampling points, as these are chosen on a case-by-case basis.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 6887-1, Microbiology of the food chain — Preparation of test samples, initial suspension and decimal
dilutions for microbiological examination — Part 1: General rules for the preparation of the initial
suspension and decimal dilutions
ISO 6887-5, Microbiology of food and animal feeding stuffs — Preparation of test samples, initial suspension
and decimal dilutions for microbiological examination — Part 5: Specific rules for the preparation of milk
and milk products
ISO 7218, Microbiology of food and animal feeding stuffs — General requirements and guidance for
microbiological examinations
ISO 11133, Microbiology of food, animal feed and water — Preparation, production, storage and
performance testing of culture media
ISO 16140-2, Microbiology of the food chain — Method validation — Part 2: Protocol for the validation of
alternative (proprietary) methods against a reference method
3 Terms and definitions
No terms and definitions are listed in this document.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https: //www .iso .org/obp
— IEC Electropedia: available at http: //www .electropedia .org/
ISO 18593:2018(E)
4 Principle
Sampling schemes aim to evaluate microbial contamination levels of surfaces from the food chain
environment in order to implement corrective actions to avoid food contamination by microorganisms.
Ineffective sampling programmes or techniques may result in the non-detection of microorganisms
when they are present.
This document describes surface sampling methods to detect or enumerate microorganisms from
surfaces in the food chain environment. Different sampling techniques are described, including contact
plates, stick swabs, cloths and sponges.
This document also gives recommendations on the locations and areas to be sampled and the most
appropriate sampling time.
According to the device and the microorganism to be detected or enumerated, determination of the
microbial contamination of the surface can be performed by
— sampling of the surface, and
— analysis according to specific standards.
5 Culture media and reagents
Follow current laboratory practice as specified in ISO 7218. Follow performance testing of culture
media as specified in ISO 11133.
5.1 Diluent.
In general, the diluent is sterile buffered peptone water, peptone salt as specified in ISO 6887-1, peptone
solution at 1 g/l or quarter-strength Ringer’s solution as specified in ISO 6887-5, with neutralizer(s)
(5.3) added if necessary.
NOTE To extend transport time, an appropriate transport diluent can be added, if properly validated.
5.2 Medium for contact plate.
Plates (6.1) may vary in diameter or area, according to the type of surface to be sampled. The medium
is chosen according to the ISO method for the microorganism(s) of concern, with neutralizer(s) (5.3)
added if necessary. The medium shall form a convex meniscus with the contact plate.
Alternative media formulations shall be supported by a validation study as specified in ISO 16140-2.
5.3 Neutralizer.
In cases where residues of disinfectants are expected, appropriate neutralizer(s) should be added to the
diluent (5.1) or media (5.2) before sampling, to prevent any inhibitory effect of the disinfectants on the
growth of microorganisms.
[9]
Do not add neutralizer to the diluent when no residual disinfectant is expected . A neutralizer used to
quench residual disinfectant can have a slight deleterious impact on bacterial cells and it is likely that
such an impact would be greater when cells are stressed.
[9]
An appropriate neutralizer for all situations (a “universal neutralizer”) cannot be prescribed . A
number of neutralizers are recommended in EN 1276, EN 1650, EN 13697 and EN 13704.
See Annex A for examples of neutralizers.
2 © ISO 2018 – All rights reserved

ISO 18593:2018(E)
6 Equipment and consumables
Disposable apparatus is an acceptable alternative to reusable glassware if it has similar specifications.
Usual microbiological laboratory equipment in accorda
...