EN 12353:2013
(Main)Chemical disinfectants and antiseptics - Preservation of test organisms used for the determination of bactericidal (including Legionella), mycobactericidal, sporicidal, fungicidal and virucidal (including bacteriophages) activity
Chemical disinfectants and antiseptics - Preservation of test organisms used for the determination of bactericidal (including Legionella), mycobactericidal, sporicidal, fungicidal and virucidal (including bacteriophages) activity
This European Standard specifies methods for keeping test organisms used and defined in European Standards for the determination of bactericidal (incl. Legionella pneumophila), mycobactericidal, sporicidal, fungicidal and virucidal (incl. bacteriophages) 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 European Standard is established.
NOTE 1 Annex A (informative) contains a non-exhaustive list of test organisms for which this standard can be applied.
NOTE 2 European Standards (EN and prEN) where this European Standard is referenced are listed in the Bibliography.
NOTE 3 A specific part on the preservation of bacterial spores may be added once the results of the ongoing ring trials are available.
Chemische Desinfektionsmittel und Antiseptika - Aufbewahrung von Testorganismen für die Prüfung der bakteriziden (einschließlich Legionella), mykobakteriziden, sporiziden, fungiziden und viruziden (einschlißlich Bakteriophagen) Wirkung
Diese Europäische Norm legt Verfahren zur Haltung von Prüfkeimen fest, wie sie in den Europäischen Normen des CEN/TC 216 zur Bestimmung der bakteriziden (einschließlich Legionella pneumophila), mykobakteriziden, sporiziden, fungiziden und viruziden (einschließlich Bakteriophagen) Wirkung chemischer Desinfektionsmittel und Antiseptika verwendet und festgelegt werden. Diese Verfahren zur Haltung von Prüfkeimen können nur in Verbindung mit mindestens einer der Normen erfolgen, in denen auf diese Norm verwiesen wird.
ANMERKUNG 1 Anhang A (informativ) enthält eine nicht abschließende Liste von Prüfkeimen, auf die diese Norm angewendet werden kann.
ANMERKUNG 2 Europäische Normen (EN und prEN), die auf diese Europäischen Normen verweisen, sind in den Literaturhinweisen aufgelistet.
ANMERKUNG 3 Ein spezifischer Teil über die Aufbewahrung von bakteriellen Sporen kann hinzugefügt werden, sobald die Ergebnisse der laufenden Ringversuche vorliegen.
Antiseptiques et désinfectants chimiques - Conservation des microorganismes d'essai utilisés pour la détermination de l’activité bactéricide (Legionella incluses), mycobactéricide, sporicide, fongicide et virucide (bactériophages inclus)
La présente Norme européenne spécifie les méthodes de conservation des micro-organismes d’essai utilisées et définies dans les Normes européennes relatives à la détermination de l’activité bactéricide (Legionella pneumophila incluse), mycobactéricide, sporicide, fongicide et virucide (bactériophages inclus) des désinfectants et antiseptiques chimiques établies par le CEN/TC 216. Ces méthodes peuvent être mises en œuvre uniquement en association avec au moins une des normes citant en référence la présente Norme Européenne.
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.
NOTE 3 Une partie spécifique sur la conservation des spores bactériennes pourra être ajoutée dès que les résultats des essais interlaboratoires en cours seront disponibles.
Kemična razkužila in antiseptiki - Shranjevanje preskusnih organizmov za določanje baktericidnega (vključno Legionella), mikobaktericidnega, sporocidnega, fungicidnega in virucidnega (vključno bakteriofagi) delovanja
Ta tehnična specifikacija določa metodo za zagotavljanje informacij o storitvah in omrežjih v storitvi TPEG. Aplikacija TPEG-SNI je zasnovana za omogočanje učinkovite in jezikovno neodvisne dostave informacij o razpoložljivosti enake storitve na drugem nosilnem kanalu ali podobnih podatkov o storitvah drugega ponudnika storitev, in sicer neposredno od ponudnika storitev do končnih uporabnikov. Izraz »aplikacija« se v specifikacijah TPEG uporablja za opis posebnih aplikacij, ki so na najvišji plasti sklada protokolov ISO/OSI (ISO/IEC 7498-1). Vsaki aplikaciji TPEG (npr. TPEG-RTM) se dodeli enolična številka, tj. identifikacija aplikacije (AID). AID se opredeli ob razvoju nove aplikacije. AID se v aplikaciji TPEG za informacije o storitvah in omrežjih (ta dokument) uporablja za določanje načina obdelave vsebine TPEG in omogoča usmerjanje podatkov v ustrezen aplikacijski odkodirnik. AID = 0000 se dodeli aplikaciji TPEG-SNI, opisani v tej tehnični specifikaciji. Opisanih je več preglednic z informacijami, ki zagotavljajo izčrpne možnosti za opis storitev, njihovega časovnega razporeda, vsebine, geografske pokritosti itn. V vseh tokovih TPEG je obvezna dostava do t. i. GST. Poleg tega je možno signaliziranje povezav vsebine med različnimi nosilci in storitvami.
General Information
Relations
Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.DChemische Desinfektionsmittel und Antiseptika - Aufbewahrung von Testorganismen für die Prüfung der bakteriziden (einschließlich Legionella), mykobakteriziden, sporiziden, fungiziden und viruziden (einschlißlich Bakteriophagen) WirkungAntiseptiques et désinfectants chimiques - Conservation des organismes test utilisés pour la détermination de l’activité bactéricide (Legionella inclus), mycobactéricide, sporicide, fongicide et virucide (bacteriophages inclus)Chemical disinfectants and antiseptics - Preservation of test organisms used for the determination of bactericidal (including Legionella), mycobactericidal, sporicidal, fungicidal and virucidal (including bacteriophages) 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 12353:2013SIST EN 12353:2013en,fr,de01-julij-2013SIST EN 12353:2013SLOVENSKI
STANDARDSIST EN 12353:20061DGRPHãþD
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 12353
February 2013 ICS 11.080.20; 71.100.35 Supersedes EN 12353:2006English Version
Chemical disinfectants and antiseptics - Preservation of test organisms used for the determination of bactericidal (including Legionella), mycobactericidal, sporicidal, fungicidal and virucidal (including bacteriophages) activity
Antiseptiques et désinfectants chimiques - Conservation des organismes test utilisés pour la détermination de l'activité bactéricide (Legionella inclus), mycobactéricide, sporicide, fongicide et virucide (bacteriophages inclus)
Chemische Desinfektionsmittel und Antiseptika - Aufbewahrung von Testorganismen für die Prüfung der bakteriziden (einschließlich Legionella), mykobakteriziden, sporiziden, fungiziden und viruziden (einschlißlich Bakteriophagen) Wirkung This European Standard was approved by CEN on 14 December 2012.
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, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre:
Avenue Marnix 17,
B-1000 Brussels © 2013 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 12353:2013: ESIST EN 12353:2013
Test organisms – Culture collection references and relation to
CEN/TC 216 standards and prENs . 23 A.1 Bacteria (except mycobacteria and spore-forming bacteria) . 23 A.2 Mycobacteria . 24 A.3 Spore-forming bacteria . 24 A.4 Fungi (moulds and yeasts) . 25 A.5 Viruses . 25 A.6 Bacteriophages . 26 Annex B (informative)
Graphical representations . 27 Bibliography . 32
Introduction Standardized tests for the determination of bactericidal (incl. Legionella pneumophila), mycobactericidal, sporicidal, fungicidal and virucidal (incl. bacteriophages) activity of chemical disinfectants and antiseptics necessitate the use of test organisms whose purity and identity have been verified and whose biological behaviour remains stable. Therefore it is essential to specify the storage requirements.
This European Standard aims at describing methods for preservation of test organisms used for such purposes. SIST EN 12353:2013
1 Scope This European Standard specifies methods for keeping test organisms used and defined in European Standards for the determination of bactericidal (incl. Legionella pneumophila), mycobactericidal, sporicidal, fungicidal and virucidal (incl. bacteriophages) 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 European Standard is established. NOTE 1 Annex A (informative) contains a non-exhaustive list of test organisms for which this standard can be applied. NOTE 2 European Standards (EN and prEN) where this European Standard is referenced are listed in the Bibliography. NOTE 3 A specific part on the preservation of bacterial spores may be added once the results of the ongoing ring trials are available. 2 Normative references The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. EN 14885, Chemical disinfectants and antiseptics — Application of European Standards for chemical disinfectants and antiseptics 3 Terms and definitions For the purposes of this document, the terms and definitions given in EN 14885 apply. 4 Requirements Each test organism specified in a CEN/TC 216 European Standard and referred to in this European Standard shall be handled as described in this European Standard. The purity and identity of the preserved test organism shall be verified during the preparation and regularly during the storage, except for viruses where only the identity is checked before the stock virus suspension is stored. The preserved test organism – except viruses - should be checked at regular intervals (at least in the case of longer storage than 14 months) to ensure that its susceptibility to products has not changed. As long as CEN/TC 216 has not developed specific tests for this purpose any suitable method can be used e.g. EN 1040 for bacteria, EN 1275 for fungi, EN 14348 for mycobacteria, EN 13623 for Legionella pneumophila, EN 14476 for viruses or EN 13610 for dairy bacteriophages. 5 Methods 5.1 Principle A sample of the test organism – in general in freeze dried form - is obtained from a culture collection. This sample is cultured, prepared for storage, filled into storage vessels and placed in the deep freeze.
The origin (culture collection), taxonomic name and reference number, date of receipt and batch number of the freeze dried test organisms shall be recorded (5.11.2). 5.2.2 Culture media and reagents 5.2.2.1 General The formulas of all media and reagents are given in case commercial ready-to-use material is not used. It is to be checked that each commercial supplier has established an appropriate quality control system.
All weights of chemical substances given in this European Standard refer to the anhydrous salts unless otherwise stated. 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. To improve reproducibility, it is recommended that whenever possible, commercially available dehydrated material is used for the preparation of culture media. The manufacturer's instructions relating to the preparation of these products should be rigorously followed.
All specified pH values are measured at (20 ± 1) °C. For each culture medium, cell culture 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. If distilled water of adequate quality is not available, water for injections (see bibliographic reference [1]) can be used. Sterilize in the autoclave (5.3.2.1a)). Sterilization is not necessary if the water is used for e.g. preparation of culture media and subsequently sterilized. 5.2.2.3 Tryptone Soya Broth (TSB) for bacteria, except Legionella 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.
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