EN 13704:2002

Chemical disinfectants - Quantitative suspension test for the evaluation of sporicidal activity of chemical disinfectants used in food, industrial, domestic and institutional areas - Test method and requirements (phase 2, step 1)

This European Standard specifies a test method (phase 2/step 1) (see annex H) and the minimum requirements for sporicidal activity of chemical disinfectant products that form a homogeneous, physically stable preparation in hard water and that are used in food, industrial, domestic and institutional areas, excluding areas and situations where disinfection is medically indicated and excluding products used on living tissues except those for hand hygiene in the above considered areas.
This European Standard applies at least to the following :
a) processing, distribution and retailing of :
1) food of animal origin :
- milk and milk products ;
- meat and meat products ;
- fish, seafood, and related products ;
- eggs and egg products ;
- animal feeds ;
- etc. ;
2) food of vegetable origin :
- beverages ;
- fruits, vegetables and derivatives (including sugar, distillery, etc.) ;
- flour, milling and baking ;
- animal feeds ;
- etc. ;
b) institutional and domestic areas :
- catering establishments ;
- public areas ;
- public transports ;
- schools ;
- nurseries ;
- shops ;
- sports rooms ;
- waste containers (bins, etc.) ;
- hotels ;
- dwellings ;
- clinically non sensitive areas of hospitals ;
- offices ;
- etc. ;
c) other industrial areas :
- packaging material ;
- biotechnology (yeast, proteins, enzymes, etc.) ;
- pharmaceutical ;
- cosmetics and toiletries ;
- textiles ;
- space industry, computer industry ;
- etc.
Using this European Standard, it is not possible to determine the sporicidal activity of undiluted product as some dilution is always produced by adding the inoculum and interfering substance. Products can only be tested at a concentration of 80 % or less.
NOTE   The method described is intended to determine the activity of commercial formulations or active substances on spores in the conditions in which they are used.

Chemische Desinfektionsmittel - Quantitativer Suspensionsversuch zur Bestimmung der sporiziden Wirkung chemischer Desinfektionsmittel in den Bereichen Lebensmittel, Industrie, Haushalt und öffentliche Einrichtungen - Prüfverfahren und Anforderungen (Phase 2, Stufe 1)

Diese Europäische Norm legt ein Prüfverfahren (Phase 2, Stufe 1) (siehe Anhang H) und Anforderungen an die sporizide Mindestwirkung von chemischen Desinfektionsmitteln fest, die in hartem Wasser eine homogene, physikalisch stabile Lösung ergeben, und die im Lebensmittelbereich, in der Industrie, im Haushalt und in öffentlichen Einrichtungen benutzt werden, ausgenommen davon sind Bereiche und Situationen, in denen die Desinfektion medizinisch indiziert ist und Produkte, die auf lebenden Geweben benutzt werden, mit Ausnahme derjenigen für die Handhygiene in den oben angegebenen Bereichen.
Diese Europäische Norm gilt grundsätzlich für den folgenden Anwendungsbereich:
a) Verarbeitung, Vertrieb und Verkauf von:
1) Lebensmitteln tierischer Herkunft:
¾ Milch und Milchprodukte;
¾ Fleisch und Fleischprodukte;
¾ Fisch, Meerestiere und daraus hergestellte Zubereitungen;
¾ Eier und Eiprodukte;
¾ Tiernahrung
¾ usw.
2) Lebensmitteln pflanzlicher Herkunft:
¾ Getränke;
¾ Früchte, Gemüse und daraus hergestellte Zubereitungen (einschließlich Zucker, Destillationsprodukte usw.);
¾ Mehl, gemahlene und gebackene Produkte;
¾ Tiernahrung
¾ usw.
b) Öffentliche Einrichtungen und Haushaltsbereiche:
¾ Verpflegungseinrichtungen;
¾ Öffentliche Bereiche;
¾ Öffentliche Verkehrsmittel;
¾ Schulen;
¾ Kindergärten;
¾ Geschäfte;
¾ Sportstätten;
¾ Abfallbehälter (Mülltonnen usw.);
¾ Hotels;
¾ Wohngebäude;
¾ Klinisch nicht relevante Bereiche von Krankenhäusern;
¾ Büroräume
¾ usw.
c) Andere industrielle Bereiche:
¾ Verpackungsmaterial;
¾ Biotechnologie (Hefe, Proteine, Enzyme usw.);
¾ Hersteller von Pharmazeutika;
¾ Hersteller von Kosmetika und Toilettenartikeln;
¾ Hersteller von Textilien;
¾ Weltraumforschungsindustrie und Computerindustrie
¾ usw.

Désinfectants chimiques - Essai quantitatif de suspension pour l'évaluation de l'activité sporicide des désinfectants chimiques utilisés dans le domaine de l'agro-alimentaire, dans l'industrie, dans les domaines domestiques et en collectivité - Méthode d'essai et prescriptions (phase 2, étape 1)

La présente Norme européenne décrit une méthode d'essai (phase 2, étape 1) (voir annexe H) et les prescriptions minimales relatives à l'activité sporicide des désinfectants chimiques qui forment une préparation homogène physiquement stable dans l'eau dure et qui sont utilisés dans le domaine de l'agro-alimentaire, dans l'industrie, dans le domaine domestique et en collectivité, à l'exception des domaines et des situations où la désinfection est médicalement prescrite et à l'exclusion des produits utilisés sur des tissus vivants (excepté ceux destinés à l'hygiène des mains dans les domaines indiqués ci-dessus).
La présente Norme européenne s'applique au moins aux domaines suivants :
a) fabrication, distribution et vente au détail de :
1) produits alimentaires d'origine animale :
¾ lait et produits laitiers ;
¾ viande et produits dérivés de la viande ;
¾ poisson, fruits de mer et leurs produits dérivés ;
¾ ¿ufs et produits avicoles ;
¾ produits alimentaires pour animaux ;
¾ etc. ;
2) produits alimentaires d'origine végétale :
¾ boissons ;
¾ fruits, légumes et leurs dérivés (y compris le sucre, la distillerie, etc.) ;
¾ farine, minoterie et boulangerie ;
¾ produits alimentaires pour animaux  ;
¾ etc. ;
b) domaines domestiques et collectivité :
¾ établissements de restauration ;
¾ lieux publics ;
¾ transports publics ;
¾ écoles ;
¾ haltes-garderies ;
¾ magasins ;
¾ salles de sport ;
¾ conteneurs pour déchets (poubelles, etc.) ;
¾ hôtels ;
¾ lieux d'habitation ;
¾ zones cliniquement non sensibles  des hôpitaux ;
¾ bureaux ;
¾ etc. ;
c) autres zones industrielles :
¾ matériaux d'emballage ;
¾ biotechnologie (levure, protéines, enzymes, etc.) ;
¾ pharmaceutique ;
¾ cosmétique et produits d'hygiène corporelle ;
¾ textiles ;
¾ industrie spatiale, industrie informatique ;
¾ etc..

Kemična razkužila - Kvantitativni suspenzijski preskus za ocenjevanje sporocidnega delovanja kemičnih razkužil v živilski in drugih industrijah in javnih ustanovah - Preskusna metoda in zahteve (faza 2, stopnja 1)

General Information

• Status: Withdrawn
• Publication Date: 05-Feb-2002
• Withdrawal Date: 17-Jul-2018
• ICS: 71.100.35 - Chemicals for industrial and domestic disinfection purposes
• Technical Committee: CEN/TC 216 - Chemical disinfectants and antiseptics
• Drafting Committee: CEN/TC 216/WG 3 - Food hygiene and domestic and institutional use
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Completion Date: 18-Jul-2018
• Ref Project: SIST EN 13704:2002 - Chemical disinfectants - Quantitative suspension test for the evaluation of sporicidal activity of chemical disinfectants used in food, industrial, domestic and institutional areas - Test method and requirements (phase 2, step 1)

Relations

• Replaced By: EN 13704:2018 - Chemical disinfectants - Quantitative suspension test for the evaluation of sporicidal activity of chemical disinfectants used in food, industrial, domestic and institutional areas - Test method and requirements (phase 2, step 1)
• Effective Date: 24-Dec-2014

Standards Content (Sample)

SLOVENSKI STANDARD
01-september-2002
.HPLþQDUD]NXåLOD.YDQWLWDWLYQLVXVSHQ]LMVNLSUHVNXV]DRFHQMHYDQMH
VSRURFLGQHJDGHORYDQMDNHPLþQLKUD]NXåLOYåLYLOVNLLQGUXJLKLQGXVWULMDKLQMDYQLK
XVWDQRYDK3UHVNXVQDPHWRGDLQ]DKWHYHID]DVWRSQMD
Chemical disinfectants - Quantitative suspension test for the evaluation of sporicidal
activity of chemical disinfectants used in food, industrial, domestic and institutional areas
- Test method and requirements (phase 2, step 1)
Chemische Desinfektionsmittel - Quantitativer Suspensionsversuch zur Bestimmung der
sporiziden Wirkung chemischer Desinfektionsmittel in den Bereichen Lebensmittel,
Industrie, Haushalt und öffentliche Einrichtungen - Prüfverfahren und Anforderungen
(Phase 2, Stufe 1)
Désinfectants chimiques - Essai quantitatif de suspension pour l'évaluation de l'activité
sporicide des désinfectants chimiques utilisés dans le domaine de l'agro-alimentaire,
dans l'industrie, dans les domaines domestiques et en collectivité - Méthode d'essai et
prescriptions (phase 2, étape 1)
Ta slovenski standard je istoveten z: EN 13704:2002
ICS:
71.100.35 Kemikalije za dezinfekcijo v Chemicals for industrial and
industriji in doma domestic disinfection
purposes
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN 13704
NORME EUROPÉENNE
EUROPÄISCHE NORM
February 2002
ICS 71.100.35
English version
Chemical disinfectants - Quantitative suspension test for the
evaluation of sporicidal activity of chemical disinfectants used in
food, industrial, domestic and institutional areas - Test method
and requirements (phase 2, step 1)
Désinfectants chimiques - Essai quantitatif de suspension Chemische Desinfektionsmittel - Quantitativer
pour l'évaluation de l'activité sporicide des désinfectants Suspensionsversuch zur Bestimmung der sporiziden
chimiques utilisés dans le domaine de l'agro-alimentaire, Wirkung chemischer Desinfektionsmittel in den Bereichen
dans l'industrie, dans les domaines domestiques et en Lebensmittel, Industrie, Haushalt und öffentliche
collectivité - Méthode d'essai et prescriptions (phase 2, Einrichtungen - Prüfverfahren und Anforderungen (Phase 2,
étape 1) Stufe 1)
This European Standard was approved by CEN on 11 November 2001.
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 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 Management Centre has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,
Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2002 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 13704:2002 E
worldwide for CEN national Members.

Contents
page
Foreword.3
Introduction .4
1 Scope .5
2 Normative references .6
3 Terms and definitions.6
4 Requirements .7
5 Test method.7
5.1 Principle.7
5.2 Materials and reagents .8
5.3 Apparatus and glassware .10
5.4 Preparation of spore test suspension and test solutions .11
5.5 Procedure .12
5.6 Calculation and expression of results.15
5.7 Conclusion.17
5.8 Test report .18
Annex A (normative) Preparation of Bacillus spore stock suspensions .20
A.1 Material and reagents .20
A.2 Preparation of Bacillus spore stock suspensions .20
Annex B (normative) Validation of dilution-neutralization and membrane filtration methods .21
B.1 Principle.21
B.2 Preparation of spore suspension.21
B.3 Preparation of product test solution.21
B.4 Test for validation .21
B.5 Validation.24
Annex C (informative) Preparation of Clostridium sporogenes spore stock suspension.25
C.1 Culture media and reagents.25
C.2 Apparatus and glassware .26
C.3 Preparation of regenerated media and incubation conditions .26
C.4 Preparation of Clostridium spore stock suspension .26
Annex D (informative) Neutralizers.27
Annex E (informative) Rinsing liquids.28
Annex F (informative) Example of a typical test report .29
Annex G (informative) Referenced strains in national collections.32
G.1 Bacillus subtilis.32
G.2 Bacillus cereus.32
G.3 Clostridium sporogenes.32
Annex H (informative) Information on the application and interpretation of European standards on
chemical disinfectants and antiseptics .33
H.1 General guidelines for the application and interpretation of test methods in accordance with
European Standards for chemical disinfectants and antiseptics.33
H.2 Guide to interpretation of tests for chemical disinfectants and antiseptics .34
Foreword
This European Standard has been prepared by Technical Committee CEN/TC 216 "Chemical disinfectants and
antiseptics", 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 August 2002, and conflicting national standards shall be withdrawn at the latest by
August 2002.
In this standard the annexes A and B are normative. The annexes C, D, E, F, G and H are informative.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland,
France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Spain,
Sweden, Switzerland and the United Kingdom.
Introduction
This European Standard describes a suspension test method for establishing whether a chemical disinfectant has
or does not have a sporicidal activity in the fields described in clause 1.
The laboratory test closely simulates practical conditions of application. Chosen conditions (contact time,
temperature, in suspension, etc.) reflect parameters which are found in practical situations including conditions
which can influence the action of disinfectants. Each utilization concentration found from this test corresponds to
defined experimental conditions.
The conditions are intended to cover general purposes and to allow reference between laboratories and product
types.
However for some applications the recommendations of use of a product can differ and therefore additional test
conditions need to be used.
1 Scope
This European Standard specifies a test method (phase 2/step 1) (see annex H) and the minimum requirements for
sporicidal activity of chemical disinfectant products that form a homogeneous, physically stable preparation in hard
water and that are used in food, industrial, domestic and institutional areas, excluding areas and situations where
disinfection is medically indicated and excluding products used on living tissues except those for hand hygiene in
the above considered areas.
This European Standard applies at least to the following :
a) processing, distribution and retailing of :
1) food of animal origin :

milk and milk products ;

meat and meat products ;

fish, seafood, and related products ;

eggs and egg products ;

animal feeds ;

etc. ;
2) food of vegetable origin :

beverages ;

fruits, vegetables and derivatives (including sugar, distillery, etc.) ;

flour, milling and baking ;

animal feeds ;

etc. ;
b) institutional and domestic areas :

catering establishments ;

public areas ;

public transports ;

schools ;

nurseries ;

shops ;

sports rooms ;

waste containers (bins, etc.) ;

hotels ;

dwellings ;

clinically non sensitive areas of hospitals ;

offices ;

etc. ;
c) other industrial areas :

packaging material ;

biotechnology (yeast, proteins, enzymes, etc.) ;

pharmaceutical ;

cosmetics and toiletries ;

textiles ;

space industry, computer industry ;

etc.
Using this European Standard, it is not possible to determine the sporicidal activity of undiluted product as some
dilution is always produced by adding the inoculum and interfering substance. Products can only be tested at a
concentration of 80 % or less.
NOTE The method described is intended to determine the activity of commercial formulations or active substances on
spores in the conditions in which they are used.
2 Normative references
This European Standard incorporates by dated or undated reference, provisions from other publications. These
normative references are cited at the appropriate places in the text, and the publications are listed hereafter. For
dated references, subsequent amendments to or revisions of any of these publications apply to this European
Standard only when incorporated in it by amendment or revision. For undated references the latest edition of the
publication referred to applies (including amendments).
EN 1040, Chemical disinfectants and antiseptics – Basic bactericidal activity – Test method and requirements
(phase 1).
3 Terms and definitions
For the purposes of this European Standard, the following terms and definitions apply.
3.1
product (for chemical disinfection and/or antisepsis)
chemical agent or formulation used as a chemical disinfectant or antiseptic [EN 1040]
3.2
sporicide (in this standard)
product which kills spores of the genus Bacillus
NOTE The adjective derived from « sporicide » is « sporicidal ».
...