EN 12353:2021
(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 document 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 document is established.
NOTE 1 Annex A (informative) contains a non-exhaustive list of test organisms for which this document can be applied.
NOTE 2 European Standards (EN) where this document is referenced are listed in the Bibliography.
NOTE 3 A specific description on the preservation of bacterial spores could be added once the results of the ongoing ring trials are available.
Chemische Desinfektionsmittel und Antiseptika - Aufbewahrung von Prüforganismen für die Prüfung der bakteriziden (einschließlich Legionella), mykobakteriziden, sporiziden, fungiziden und viruziden (einschließlich Bakteriophagen) Wirkung
Dieses Dokument legt Verfahren zur Haltung von Prüforganismen fest, wie sie in den Europäischen Normen des CEN/TC 216 zur Bestimmung der bakteriziden (einschließlich Legionella pneumophila), myko-bakteriziden, sporiziden, fungiziden und viruziden (einschließlich Bakteriophagen) Wirkung chemischer Desinfektionsmittel und Antiseptika verwendet und festgelegt werden. Diese Verfahren zur Haltung von Prüforganismen können nur in Verbindung mit mindestens einer der Normen erfolgen, in denen auf dieses Dokument verwiesen wird.
ANMERKUNG 1 Anhang A (informativ) enthält eine nicht abschließende Liste von Prüforganismen, auf die dieses Dokument angewendet werden kann.
ANMERKUNG 2 Europäische Normen (EN), die auf dieses Dokument verweisen, sind in den Literaturhinweisen aufgelistet.
ANMERKUNG 3 Eine spezifische Beschreibung über die Aufbewahrung von bakteriellen Sporen könnten hinzugefügt werden, sobald die Ergebnisse der laufenden Ringversuche vorliegen.
Antiseptiques et désinfectants chimiques - Conservation des micro-organismes d'essai utilisés pour la détermination de l'activité bactéricide (Legionella incluses), mycobactéricide, sporicide, fongicide et virucide (bactériophages inclus)
Le présent document 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 de conservation des micro-organismes d’essai peuvent être mises en oeuvre uniquement en association avec au moins une des normes citant en référence le présent document.
NOTE 1 L’Annexe A (informative) dresse une liste non exhaustive des micro-organismes d’essai auxquels s’applique le présent document.
NOTE 2 Les Normes européennes (EN) faisant référence au présent document sont indiquées dans la bibliographie.
NOTE 3 Une description spécifique sur la conservation des spores bactériennes peut 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 dokument določa metode za shranjevanje preskusnih organizmov, ki se uporabljajo v evropskih standardih in so tam opredeljene za določanje baktericidnega (vkl. Legionella pneumophila), mikobaktericidnega, sporocidnega, fungicidnega in virucidnega (vkl. bakteriofagi) delovanja kemičnih razkužil in antiseptikov, ki jih je pripravil tehnični odbor CEN/TC 216. Te metode za shranjevanje preskusnih organizmov je mogoče izvesti samo v povezavi z vsaj enim od standardov, ki se sklicujejo na ta dokument.
OPOMBA 1: Dodatek A (informativni) vsebuje nepopoln seznam preskusnih organizmov, za katere je mogoče uporabiti ta dokument.
OPOMBA 2: Evropski standardi (EN in prEN), ki se sklicujejo na ta dokument, so navedeni v bibliografiji.
OPOMBA 3: Ko bodo na voljo rezultati primerjalnih preskusov v teku, se lahko doda poseben del o shranjevanju bakterijskih spor.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-januar-2022
Nadomešča:
SIST EN 12353:2013
Kemična razkužila in antiseptiki - Shranjevanje preskusnih organizmov za
določanje baktericidnega (vključno Legionella), mikobaktericidnega,
sporocidnega, fungicidnega in virucidnega (vključno bakteriofagi) delovanja
Chemical disinfectants and antiseptics - Preservation of test organisms used for the
determination of bactericidal (including Legionella), mycobactericidal, sporicidal,
fungicidal and virucidal (including bacteriophages) activity
Chemische Desinfektionsmittel und Antiseptika - Aufbewahrung von Prüforganismen für
die Prüfung der bakteriziden (einschließlich Legionella), mykobakteriziden, sporiziden,
fungiziden und viruziden (einschließlich Bakteriophagen) Wirkung
Antiseptiques et désinfectants chimiques - Conservation des micro-organismes d'essai
utilisés pour la détermination de l'activité bactéricide (Legionella incluses),
mycobactéricide, sporicide, fongicide et virucide (bactériophages inclus))
Ta slovenski standard je istoveten z: EN 12353:2021
ICS:
07.100.99 Drugi standardi v zvezi z Other standards related to
mikrobiologijo microbiology
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.
EN 12353
EUROPEAN STANDARD
NORME EUROPÉENNE
September 2021
EUROPÄISCHE NORM
ICS 11.080.20; 71.100.35 Supersedes EN 12353:2013
English 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 - Chemische Desinfektionsmittel und Antiseptika -
Conservation des micro-organismes d'essai utilisés Aufbewahrung von Prüforganismen für die Prüfung
pour la détermination de l'activité bactéricide der bakteriziden (einschließlich Legionella),
(Legionella incluses), mycobactéricide, sporicide, mykobakteriziden, sporiziden, fungiziden und
fongicide et virucide (bactériophages inclus) viruziden (einschließlich Bakteriophagen) Wirkung
This European Standard was approved by CEN on 1 February 2021.
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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 12353:2021 E
worldwide for CEN national Members.
Contents Page
European foreword . 4
Introduction . 5
1 Scope . 6
2 Normative references . 6
3 Terms and definitions . 6
4 Requirements . 6
5 Methods . 7
5.1 Principle . 7
5.2 Test organisms, culture media and reagents . 7
5.2.1 Test organisms . 7
5.2.2 Culture media and reagents . 7
5.2.3 Cell cultures . 14
5.2.4 Host strains for dairy bacteriophages (Lactococcus lactis) . 15
5.3 Apparatus and glassware . 16
5.3.1 General . 16
5.3.2 Usual microbiological laboratory equipment . 16
5.4 Procedure for preservation of test organisms – General . 17
5.4.1 Handling of freeze-dried / frozen test organisms from culture collections . 17
5.4.2 Choice of incubation procedure, agar medium, cell culture/cell line . 17
5.5 Procedure for preservation of bacteria (incl. Legionella, aerobic spore-forming
bacteria, excl. mycobacteria and bacterial spores) and yeasts . 18
5.5.1 Reconstitution of the freeze-dried test organisms . 18
5.5.2 Preparation for storage . 18
5.5.3 Preparation of stock culture / working cultures . 19
5.6 Procedure for preservation of mycobacteria . 19
5.6.1 Reconstitution of the freeze-dried test organisms . 19
5.6.2 Preparation for storage . 19
5.6.3 Preparation of working cultures . 20
5.7 Procedure for preservation of moulds (e.g. Aspergillus brasiliensis) . 20
5.7.1 Reconstitution of the freeze-dried test organism . 20
5.7.2 Preparation for storage . 20
5.7.3 Preparation of stock culture / working cultures . 21
5.8 Procedure for preservation of viruses (except dairy bacteriophages) . 21
5.8.1 Reconstitution of frozen virus . 21
5.8.2 Preparation for storage of stock virus suspension . 21
5.8.3 Preparation of test virus suspension . 21
5.9 Procedure for preservation of bacteriophages . 22
5.9.1 Reconstitution of frozen bacteriophages . 22
5.9.2 Preparation for storage . 22
5.9.3 Preparation of bacteriophages working suspensions . 22
5.10 Verification of the purity and identity of test organisms . 22
5.10.1 General . 22
5.10.2 Information on source of strains . 23
5.10.3 Purity . 23
5.10.4 Identity . 23
5.11 Documentation . 23
5.11.1 General . 23
5.11.2 Freeze-dried test organism / frozen viruses . 23
5.11.3 Cryovials of frozen test organism . 23
5.11.4 Stock culture . 24
5.11.5 Verification of purity and identity . 24
5.11.6 Storage of documentation . 24
Annex A (informative) Test organisms – Culture collection references and relation to
CEN/TC 216 standards . 25
Annex B (informative) Graphical representations . 29
Bibliography . 34
European foreword
This document (EN 12353:2021) 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 March 2022, and conflicting national standards shall
be withdrawn at the latest by March 2022.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN 12353:2013.
The document was revised to adapt it to the latest state of science, to correct errors and ambiguities.
The following are the significant technical changes since the last edition:
— the methods of preservation of viruses are described more detailed (5.8);
— MEM is not the only suitable cell culture medium, therefore it was replaced by the general term
“cell culture medium” (5.2.2.17 and in the whole text);
— the description of BCYE Agar for Legionella was added (5.2.2.24);
— the information on source of strains was added (5.10.2);
— the information of the storage of documentation was added (5.11.6);
— Clostrioides difficile (A.3.3) was added;
— the CIP numbers for fungi were deleted (replaced by UMIP numbers) (see A.4);
— the used virus strains are re-drafted (see A.5).
The changes mentioned above have no impact on the test results obtained with reference to the
previous version. Those results are still valid.
Any feedback and questions on this document should be directed to the users’ national standards body.
A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organisations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Introduction
Standa
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.