EN 1040:2005

Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of basic bactericidal activity of chemical disinfectants and antiseptics - Test method and requirements (phase 1)

This European Standard specifies a test method and the minimum requirements for basic bactericidal activity of chemical disinfectant and antiseptic products that form a homogeneous, physically stable preparation when diluted with water. Products can only be tested at a concentration of 80 % or less as some dilution is always produced by adding the test organisms and water.
This European Standard applies to active substances (antibacterial biocides) and to formulations under development that are planned to be used in food, industrial, domestic and institutional, medical and veterinary areas. It applies also to the evaluation of bactericidal activity of chemical antiseptics and disinfectants when appropriate standards are not available.
NOTE 1   This European Standard does not evaluate the activity of a product for an intended use.
NOTE 2   This method corresponds to a phase 1 test (Annex F).

Chemische Desinfektionsmittel und Antiseptika - Quantitativer Suspensionsversuch zur Bestimmung der bakteriziden Wirkung (Basistest) chemischer Desinfektionsmittel und Antiseptika - Prüfverfahren und Anforderungen (Phase 1)

Diese Europäische Norm legt ein Prüfverfahren und die Mindestanforderungen für die bakterizide Wirkung
von chemischen Desinfektionsmitteln und antiseptischen Produkten fest, die in Wasser als homogene und
physikalisch stabile Zubereitung vorliegen. Produkte können nur bei einer Konzentration von 80 % oder
weniger geprüft werden, da eine bestimmte Verdünnung durch Zugabe der Prüfkeime und von Wasser immer
auftritt.
Diese Europäische Norm gilt für Wirksubstanzen (antibakterielle Biozide) und für in Entwicklung stehende
Zubereitungen, deren Verwendung im Lebensmittelbereich, im industriellen und häuslichen Bereich und in
öffentlichen Einrichtungen sowie in der Medizin und Veterinärmedizin geplant ist. Es gilt auch für die
Bestimmung der bakteriziden Wirkung chemischer Desinfektionsmittel und Antiseptika, wenn einschlägige
Normen nicht zur Verfügung stehen.
ANMERKUNG 1 Durch dieses Dokument wird nicht die Wirksamkeit eines Produkts für eine vorgesehene Verwendung
bestimmt.
ANMERKUNG 2 Dieses Prüfverfahren entspricht einem Phase-1-Versuch (Anhang F).

Désinfectants et antiseptiques chimiques - Essai quantitatif de suspension pour l'évaluation de l'activité de base bactéricide antiseptiques et des désinfectants chimiques - Méthode d'essai et prescriptions (phase 1)

Kemična razkužila in antiseptiki - Kvantitativni suspenzijski preskus za vrednotenje osnovnega baktericidnega delovanja kemičnih razkužil in antiseptikov - Preskusna metoda in zahteve (faza 1)

General Information

• Status: Published
• Publication Date: 06-Dec-2005
• Withdrawal Date: 29-Jun-2006
• ICS: 11.080.20 - Disinfectants and antiseptics
• 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 4 - Horizontal working group
• Current Stage: 9093 - Decision to confirm - Review Enquiry
• Completion Date: 14-Feb-2023
• Ref Project: SIST EN 1040:2006 - Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of basic bactericidal activity of chemical disinfectants and antiseptics - Test method and requirements (phase 1)

Relations

• Replaces: EN 1040:1997 - Chemical disinfectants and antiseptics - Basic bactericidal activity - Test method and requirements (phase 1)
• Effective Date: 22-Dec-2008

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Chemische Desinfektionsmittel und Antiseptika - Quantitativer Suspensionsversuch zur Bestimmung der bakteriziden Wirkung (Basistest) chemischer Desinfektionsmittel und Antiseptika - Prüfverfahren und Anforderungen (Phase 1)Désinfectants et antiseptiques chimiques - Essai quantitatif de suspension pour l'évaluation de l'activité de base bactéricide antiseptiques et des désinfectants chimiques - Méthode d'essai et prescriptions (phase 1)Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of basic bactericidal activity of chemical disinfectants and antiseptics - Test method and requirements (phase 1)71.100.35Kemikalije za dezinfekcijo v industriji in domaChemicals for industrial and domestic disinfection purposes11.080.20Dezinfektanti in antiseptikiDisinfectants and antisepticsICS:Ta slovenski standard je istoveten z:EN 1040:2005SIST EN 1040:2006en01-junij-2006SIST EN 1040:2006SLOVENSKI
STANDARDSIST EN 1040:20011DGRPHãþD

EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN 1040December 2005ICS 11.080.20; 71.100.35Supersedes EN 1040:1997
English VersionChemical disinfectants and antiseptics - Quantitative suspensiontest for the evaluation of basic bactericidal activity of chemicaldisinfectants and antiseptics - Test method and requirements(phase 1)Antiseptiques et désinfectants chimiques
- Essai quantitatifde suspension pour l'évaluation de l'activité bactéricide debase des antiseptiques et des désinfectants chimiques
-Méthode d'essai et prescriptions (phase 1)Chemische Desinfektionsmittel und Antiseptika -Quantitativer Suspensionsversuch zur Bestimmung derbakteriziden Wirkung (Basistest) chemischerDesinfektionsmittel und Antiseptika - Prüfverfahren undAnforderungen (Phase 1)This European Standard was approved by CEN on 28 July 2005.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the Central Secretariat or to any CEN member.This European Standard exists in three official versions (English, French, German). A version in any other language made by translationunder the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the officialversions.CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre: rue de Stassart, 36
B-1050 Brussels© 2005 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN 1040:2005: ESIST EN 1040:2006

REFERENCED STRAINS IN NATIONAL COLLECTIONS.24 ANNEX B (INFORMATIVE)
SUITABLE NEUTRALIZERS AND RINSING LIQUIDS.25 ANNEX C (INFORMATIVE)
GRAPHICAL REPRESENTATION OF TEST PROCEDURES.27 ANNEX D (INFORMATIVE)
EXAMPLE OF A TYPICAL TEST REPORT.31 ANNEX E (INFORMATIVE)
PRECISION OF THE TEST RESULT.34 ANNEX F (INFORMATIVE)
INFORMATION ON THE APPLICATION AND INTERPRETATION OF EUROPEAN STANDARD ON CHEMICAL DISINFECTANTS AND ANTISEPTICS.38 BIBLIOGRAPHY.40 SIST EN 1040:2006

(obligatory test conditions). 5.1.3 Additional and optional contact times and temperatures are specified. Additional test organisms can be used. 5.2 Materials and reagents 5.2.1 Test organisms The bactericidal activity shall be evaluated using the following strains as test organisms:1)  Pseudomonas aeruginosa ATCC 15442;  Staphylococcus aureus ATCC 6538. NOTE See Annex A for strain references in some other culture collections.
1) The ATCC numbers are the collection numbers of strains supplied by the American Type Culture Collection (ATCC). This information is given for the convenience of users of this European Standard and does not constitute an endorsement by CEN of the product named.
NOTE 2 For each culture medium and reagent, a limitation for use should be fixed. 5.2.2.2 Water The water shall be freshly glass-distilled water and not demineralized water. Sterilize in the autoclave [5.3.2.1a)]. NOTE 1 Sterilization is not necessary if the water is used e.g. for preparation of culture media and subsequently sterilized. NOTE 2 If distilled water of adequate quality is not available, water for injections (see bibliographic reference [1]) can be used. 5.2.2.3 Tryptone Soya Agar (TSA) Tryptone soya agar, consisting of: Tryptone, pancreatic digest of casein
15,0 gSoya peptone, papaic digest of Soybean meal
5,0 gSodium chloride (NaCl)
5,0 gAgar
15,0 gWater (5.2.2.2) to 1 000,0 mlSterilize in the autoclave [5.3.2.1a)]. After sterilization the pH of the
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