EN 14347:2005

Chemical disinfectants and antiseptics - Basic sporicidal activity - Test method and requirements (phase 1)

This document specifies a test method (phase 1) and the minimum requirements for sporicidal activity of chemical disinfectant or 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.
This document applies to products that are used in in agricultural (but not crop protection), domestic service, food hygiene and other industrial fields, institutional, medical and veterinary applications.
NOTE 1   This method cannot be applied for testing sporicidal activity of a product against spores of Clostridium spec.
NOTE 2   This document does not evaluate the activity of a product for an intended use. More specific test methods described in European Standards (see introduction) are used for further assessement of the efficacy of chemical disinfectants and antiseptics for a defined purpose.
NOTE 3   This method corresponds to a phase 1 test (see Annex E).

Chemische Desinfektionsmittel und Antiseptika - Sporizide Wirkung (Basistest) - Prüfverfahren und Anforderungen (Phase 1)

Dieses Dokument legt ein Prüfverfahren (Phase 1) und die Mindestanforderungen an die sporizide Wirkung
von chemischen Desinfektionsmitteln oder Antiseptika fest, die bei Verdünnung mit Wasser eine homogene,
physikalisch stabile Zubereitung bilden. Die Produkte können nur bei einer Konzentration von 80 % oder
weniger geprüft werden, weil durch Zugabe der Prüfkeime immer eine gewisse Verdünnung erfolgt.
Dieses Dokument gilt für Produkte, die in der Landwirtschaft (außer beim Schutz von Erntegut), in der
Hauswirtschaft, in der Lebensmittelhygiene und auf anderen industriellen Gebieten sowie in der
medizinischen und veterinärmedizinischen Praxis und in öffentlichen Einrichtungen verwendet werden.
ANMERKUNG 1 Diese Europäische Norm kann nicht auf die Prüfung der sporiziden Wirkung eines Produkts gegen
Sporen von Clostridium sp. angewendet werden.
ANMERKUNG 2 Diese Europäische Norm dient nicht zur Bewertung der Wirksamkeit des Produkts für eine
vorgesehene Verwendung. In Europäischen Normen beschriebene spezifischere Prüfverfahren (siehe Einleitung) werden
zur weiterführenden Bewertung der Wirksamkeit chemischer Desinfektionsmittel und Antiseptika für eine festgelegte
Anwendungsart angewendet.
ANMERKUNG 3 Dieses Verfahren entspricht einem Prüfverfahren der Phase 1 (siehe Anhang E).

Désinfectants et antiseptiques chimiques - Activité sporicide de base - Méthode d'essai et prescriptions (phase 1)

La présente norme spécifie une méthode d'essai (phase 1) et les prescriptions minimales relatives à l'activité sporicide des antiseptiques ou désinfectants chimiques qui forment une préparation homogène physiquement stable lorsqu'elle est diluée dans de l'eau. Les produits peuvent uniquement être soumis à essai à une concentration de 80 % ou moins car une dilution est toujours produite en ajoutant les organismes d'essai.
La présente norme s'applique aux produits utilisés dans l'agriculture (mais pas pour la protection des cultures), dans le secteur domestique, dans le secteur de l'hygiène alimentaire et dans d'autres domaines industriels, et pour des applications dans les collectivités, en médecine humaine et vétérinaire.
NOTE 1   Cette méthode ne peut être appliquée pour soumettre à essai l'activité sporicide d'un produit vis-à-vis des spores de Clostridium sp.
NOTE 2   La présente norme n'évalue pas l'activité d'un produit pour une utilisation prévue. Des méthodes d'essais plus spécifiques décrites dans des normes européennes (voir Introduction) sont utilisées pour une évaluation additionnelle de l'efficacité des antiseptiques et des désinfectants chimiques employés pour une utilisation précise.
NOTE 3   Cette méthode correspond à un essai de phase 1 (Annexe E).

Kemična razkužila in antiseptiki - Osnovno sporocidno delovanje - Preskusna metoda in zahteve (faza 1, stopnja 1)

General Information

• Status: Published
• Publication Date: 15-Mar-2005
• Withdrawal Date: 29-Sep-2005
• 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: 11-Apr-2022
• Ref Project: SIST EN 14347:2005 - Chemical disinfectants and antiseptics - Basic sporicidal activity - Test method and requirements (phase 1)

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Chemische Desinfektionsmittel und Antiseptika - Sporizide Wirkung (Basistest) - Prüfverfahren und Anforderungen (Phase 1)Désinfectants et antiseptiques chimiques - Activité sporicide de base - Méthode d'essai et prescriptions (phase 1)Chemical disinfectants and antiseptics - Basic sporicidal activity - Test method and requirements (phase 1)71.100.35Kemikalije za dezinfekcijo v industriji in domaChemicals for industrial and domestic disinfection purposesICS:Ta slovenski standard je istoveten z:EN 14347:2005SIST EN 14347:2005en,fr,de01-junij-2005SIST EN 14347:2005SLOVENSKI
STANDARD
EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN 14347March 2005ICS 11.080.20; 71.100.35English versionChemical disinfectants and antiseptics - Basic sporicidal activity- Test method and requirements (phase 1, step 1)Désinfectants chimiques - Activité sporicide de base -Méthode d'essai et exigencesChemische Desinfektionsmittel und Antiseptika - SporizideWirkung (Basistest) - Prüfverfahren und Anforderungen(Phase 1, Stufe 1)This European Standard was approved by CEN on 8 December 2004.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 14347:2005: ESIST EN 14347:2005

Referenced strains in national collections.25 Annex B (informative)
.............................................................................................................................................26 Annex C (informative)
Graphical representation of test procedures.28 Annex D (informative)
Test report.30 Annex E (informative)
Information on the application and interpretation of European Standards on chemical disinfectants and antiseptics.35 Annex F (normative)
Precision of the Test Result.37 Bibliography.39
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 document and does not constitute an endorsement by CEN of the product named. SIST EN 14347:2005

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 [5.3.2.1 a)]. NOTE 1 Sterilization is not necessary if the water is used - e.g. for preparation of culture media - and subsequently sterilized. NOTE 2 If water of adequate quality is not available, water for injections (see bibliographic reference [2]) can be used. 5.2.2.3 Tryptone Soya Agar (TSA) Tryptone, pancreatic digest of casein 15,0 g Soya peptone, papaic digest of Soybean meal 5,0 g Sodium chloride (NaCl) 5,0 g Agar 15,0 g Water (5.2.2.2) to 1 000,0 ml Sterilize in the autoclave [5.3.2.1 a)]. After sterilization the pH of the medium shall be equivalent to 7,2 ± 0,2 when measured at 20 °C. NOTE In special circumstances (problems with neutralization - see 5.5.1.2 and 5.5.1.3) it may be necessary to add neutralizer to TSA (Annex B.3). SIST EN 14347:2005

Protease peptone 15,0 g Liver digest 2,5 g Yeast extract 5,0 g Sodium chloride (NaCl) 5,0 g Agar 12,0 g Water (5.2.2.2) to 1 000,0 ml Defibrinated sterile sheep blood 70 ml to 100 ml Sterilize in the autoclave excluding the sheep blood [5.3.2.1 a)]. After sterilization cool down to
45 °C to 50 °C and add the sterile defibrinated sheep blood and mix thoroughly. Fill into Petri dishes. 5.2.2.5 Neutralizer The neutralizer shall be validated for the product being tested in accordance with 5.5.2.4. The neutralizer shall be sterile. NOTE 1 Information on neutralizers that have been found to be suitable for some categories of products is given in Annex B. NOTE 2 The neutralizer has to form a homogenous, clear, not cloudy preparation when added to TSB [5.2.2.6 b)]. 5.2.2.6 Tryptone Soya Broth (TSB) a) Composition of Tryptone Soya Broth (TSB) Tryptone, pancreatic digest of casein 17,0 g Soya peptone, papaic digest of Soybean meal 3,0 g Sodium chloride (NaCl) 5,0 g Dipotassiumhydrogenphosphat (K2HPO4) 2,5 g Water (5.2.2.2) to 1 000,0 ml Sterilize in the autoclave [5.3.2.1 a)]. After sterilization the pH of the medium shall be equivalent to 7,3 ± 0,2 when measured at 20 °C. b) Trypone Soya Broth (TSB) with neutralizer. TSB [5.2.2.6 a)]. An adequate neutralizer shall be added according to its chemical properties be
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