EN 12353:2006
(Main)Chemical disinfectants and antiseptics - Preservation of test organisms used for the determination of bactericidal, mycobactericidal, sporicidal and fungicidal activity
Chemical disinfectants and antiseptics - Preservation of test organisms used for the determination of bactericidal, mycobactericidal, sporicidal and fungicidal activity
This European Standard specifies methods for keeping test organisms used and defined in European Standards for the determination of bactericidal, mycobactericidal, sporicidal and fungicidal activity of chemical disinfectants and antiseptics drawn up by CEN/TC 216. These methods for keeping test organisms can only be carried out in connection with at least one of those standards where a reference to this standard is established.
NOTE Annex A (informative) contains a non-exhaustive list of test organisms for which this standard can be applied.
Chemische Desinfektionsmittel und Antiseptika - Aufbewahrung von Testorganismen für die Prüfung der bakteriziden, mykobakteriziden, sporiziden und fungiziden Wirkung
Diese Europäische Norm legt ein Verfahren zur Haltung von Prüfkeimen fest, wie sie in den Europäischen Normen des CEN/TC 216 zur Bestim¬mung der bakteriziden, mykobakteriziden, sporiziden und fungiziden Wirkung chemischer Desinfektionsmittel und Antiseptika verwendet und festgelegt werden. Dieses Verfahren zur Haltung von Prüfkeimen kann nur in Verbindung mit mindestens einer dieser Normen erfolgen, wenn dort auf diese Norm verwiesen wurde.
ANMERKUNG 1 Anhang A (informativ) enthält eine nicht abschließende Liste von Prüfkeimen für welche diese Norm angewendet werden kann.
ANMERKUNG 2 Europäische Normen (EN und prEN), die auf diese Europäischen Normen verweisen, sind im Anhang Literaturhinweise aufgelistet.
Antiseptiques et désinfectants chimiques - Conservation des microorganismes d'essai utilisés pour la détermination de l'activité bactéricide, mycobactéricide, sporicide et fongicide
La présente Norme européenne spécifie les méthodes de conservation des microorganismes d’essai utilisées et définies dans les Normes européennes relatives à la détermination de l’activité bactéricide, mycobactéricide, sporicide et fongicide des désinfectants et antiseptiques chimiques établies par le CEN/TC 216. Ces méthodes peuvent être mises en oeuvre uniquement en association avec au moins une des normes citant en référence la présente norme.
NOTE 1 L’Annexe A (informative) dresse une liste non exhaustive des microorganismes d’essai auxquels s’applique la présente norme.
NOTE 2 Les Normes européennes (EN et prEN) faisant référence à la présente Norme européenne sont indiquées dans la Bibliographie.
Kemična razkužila in antiseptiki – Shranjevanje preskusnih organizmov za določanje baktericidnega, sporocidnega in fungicidnega delovanja
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Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Chemische Desinfektionsmittel und Antiseptika - Aufbewahrung von Testorganismen für die Prüfung der bakteriziden, mykobakteriziden, sporiziden und fungiziden WirkungAntiseptiques et désinfectants chimiques - Conservation des microorganismes d'essai utilisés pour la détermination de l'activité bactéricide, mycobactéricide, sporicide et fongicideChemical disinfectants and antiseptics - Preservation of test organisms used for the determination of bactericidal, mycobactericidal, sporicidal and fungicidal activity71.100.35Kemikalije za dezinfekcijo v industriji in domaChemicals for industrial and domestic disinfection purposes07.100.99Drugi standardi v zvezi z mikrobiologijoOther standards related to microbiologyICS:Ta slovenski standard je istoveten z:EN 12353:2006SIST EN 12353:2006en,fr,de01-september-2006SIST EN 12353:2006SLOVENSKI
STANDARDSIST EN 12353:20011DGRPHãþD
EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN 12353June 2006ICS 07.100.99; 11.080.20; 71.100.35Supersedes EN 12353:1999
English VersionChemical disinfectants and antiseptics - Preservation of testorganisms used for the determination of bactericidal,mycobactericidal, sporicidal and fungicidal activityAntiseptiques et désinfectants chimiques - Conservationdes microorganismes d'essai utilisés pour la déterminationde l'activité bactéricide, mycobactéricide, sporicide etfongicideChemische Desinfektionsmittel und Antiseptika -Aufbewahrung von Testorganismen für die Prüfung derbakteriziden, mykobakteriziden, sporiziden und fungizidenWirkungThis European Standard was approved by CEN on 23 February 2006.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, Romania,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© 2006 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN 12353:2006: ESIST EN 12353:2006
Test organisms – Culture collection references and relation to CEN/TC 216 standards and prENs.15 Annex B (informative)
Graphical representations.18 Bibliography.22
This European Standard aims at describing methods for preservation of test organisms used for such purposes. SIST EN 12353:2006
5.1 Principle A freeze dried sample of the test organism is obtained from a culture collection. This sample is cultured, prepared for storage, filled into storage vessels and placed in the deep freeze.
From the deep freeze samples a stock culture is prepared and subsequently used to prepare working cultures for the test procedure. In some cases the working cultures are directly prepared from the deep freeze samples. 5.2 Materials and reagents 5.2.1 Test organisms See Annex A for examples of test organisms.
The origin (culture collection), taxonomic name and reference number, date of receipt and batch number of the freeze dried test organisms shall be recorded (5.9.2). 5.2.2 Culture media and reagents 5.2.2.1 General All weights of chemical substances given in this European Standard refer to the anhydrous salts. Hydrated forms may be used as an alternative, but the weights required shall be adjusted to allow for consequent molecular weight differences. The reagents shall be of analytical grade and/or appropriate for microbiological purposes. They shall be free from substances that are toxic or inhibitory to the test organisms. SIST EN 12353:2006
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 for e.g. 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 Broth (TSB) for bacteria Tryptone soya broth, consisting of: Tryptone, pancreatic digest of casein
17,0 g Soya peptone, papaic digest of Soybean meal
3,0 g Sodium chloride (NaCl)
5,0 g Water (5.2.2.2)
800,0 ml Dipotassium phosphate (K2HPO4)
2,5 g Glucose
2,5 g Water (5.2.2.2)
to 1 000,0 ml Sterilize in the autoclave [5.3.2.1a)]. After sterilization the pH of the medium shall be equivalent to 7,2 ± 0,2 when measured at 20 °C ± 1 °C. 5.2.2.4 Malt Extract Broth (MEB) for fungi Malt extract broth, consisting of: Malt extract
20,0 g Water (5.2.2.2)
to 1 000,0 ml Sterilize in the autoclave [5.3.2.1a)]. After sterilization the pH of the medium shall be equivalent to 6,9 ± 0,2 when measured at 20 °C ± 1 °C
5.2.2.5 Cryoprotectant solution for bacteria, spore-forming bacteria, fungi Cryoprotectant solution, consisting of: Beef extract
3,0 g Tryptone, pancreatic digest of casein
5,0 g SIST EN 12353:2006
150,0 g Water (5.2.2.2)
to 1 000,0 ml Dissolve the constituents in boiling water. Sterilize in the autoclave [5.3.2.1a)]. After sterilization the pH of the solution shall be equivalent to 6,9 ± 0,2 when measured at 20 °C ± 1 °C. NOTE 1 Any commercially available cryoprotectant containing glycerol for preservation of test organisms equivalent to the solution described above may be used. NOTE 2 If justified, any other equivalent cryoprotectant solution may be used. 5.2.2.6 Middlebrook 7 H 9 broth with 10 % ADC enrichment and glycerol as reconstituent and cryoprotectant solution for mycobacteria (MADC) Middlebrook 7 H 9 broth, consisting of: Middlebrook 7 H 9 broth powder
4,7 g Glycerol (C3H8O3) [2]
100,0 ml Water (5.2.2.2)
750,0 ml Treat in the autoclave [5.3.2.1a)] for a holding time of only 10 min and cool to 45 °C. Add under aseptic conditions 100 ml Middlebrook ADC enrichment and then sterilized water (5.2.2.2) to 1 000,0 ml. The pH of the medium shall be equivalent to 6,6 ± 0,2 when measured at 20 °C ± 1 °C.
5.2.2.7 Polysorbate 80 solution Polysorbate 80 solution, consisting of: Polysorbate 80
0,5 g Water (5.2.2.2)
to 1 000,0 ml Sterilize in the autoclave [5.3.2.1a)]. 5.3 Apparatus and glassware 5.3.1 General Steriliz
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