SIST EN 13727:2012+A2:2016
(Main)Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of bactericidal activity in the medical area - Test method and requirements (phase 2, step 1)
Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of bactericidal activity in the medical area - Test method and requirements (phase 2, step 1)
This European Standard specifies a test method and the minimum requirements for bactericidal activity of chemical disinfectant and antiseptic products that form a homogeneous, physically stable preparation when diluted with hard water, or - in the case of ready-to-use products - with water. Products can only be tested at a concentration of 80 % or less (97 % with a modified method for special cases) as some dilution is always produced by adding the test organisms and interfering substance.
This European Standard applies to products that are used in the medical area in the fields of hygienic handrub, hygienic handwash, surgical handrub, surgical handwash, instrument disinfection by immersion, and surface disinfection by wiping, spraying, flooding or other means.
This European Standard applies to areas and situations where disinfection or antisepsis is medically indicated. Such indications occur in patient care, for example:
- in hospitals, in community medical facilities and in dental institutions;
- in clinics of schools, of kindergartens and of nursing homes;
and may occur in the workplace and in the home. It may also include services such as laundries and kitchens supplying products directly for the patients.
NOTE 1 The method described is intended to determine the activity of commercial formulations or active substances under the conditions in which they are used.
NOTE 2 This method corresponds to a phase 2 step 1 test.
NOTE 3 This method cannot be used to evaluate the activity of products against Legionella in watersystems and against mycobacteria.
EN 14885 specifies in detail the relationship of the various tests to one another and to 'use recommendations'.
Chemische Desinfektionsmittel und Antiseptika - Quantitativer Suspensionsversuch zur Bestimmung der bakteriziden Wirkung im humanmedizinischen Bereich - Prüfverfahren und Anforderungen (Phase 2, Stufe 1)
Diese Europäische Norm legt ein Prüfverfahren für und die Mindestanforderungen an die bakterizide Wirkung von chemischen Desinfektionsmitteln und Antiseptika fest, die bei Verdünnung mit Wasser standardisierter Härte als homogene, physikalisch stabile Zubereitung vorliegen, bzw. bei gebrauchsfertigen Produkten bei der Verdünnung mit Wasser. Die Produkte können nur bei einer Konzentration von 80 % oder weniger (97 % bei einem modifizierten Verfahren für Sonderfälle) geprüft werden, da durch Zugabe der Prüfkeime und der Belastungssubstanz immer eine gewisse Verdünnung bewirkt wird.
Diese Europäische Norm gilt für Produkte, die im medizinischen Bereich auf den Gebieten der hygienischen Händedesinfektion, hygienischen Händewaschung, chirurgischen Händedesinfektion, chirurgischen Hände-waschung, Instrumentendesinfektion durch Eintauchen und Oberflächendesinfektion durch Abwischen, Besprühen, Überfluten oder auf sonstige Weise verwendet werden.
Diese Europäische Norm gilt für Bereiche und unter Bedingungen, wo eine Desinfektion oder Antiseptik aus medizinischen Gründen angezeigt ist. Indikationen dieser Art liegen z. B. bei der Patientenbetreuung in:
Krankenhäusern, kommunalen medizinischen Einrichtungen und im Dentalbereich;
medizinischen Einrichtungen in Schulen, Kindergärten und Heimen;
vor und können auch am Arbeitsplatz und im häuslichen Bereich gegeben sein. Eingeschlossen sein können auch Einrichtungen wie Wäschereien und Küchen, die der direkten Versorgung der Patienten dienen.
ANMERKUNG 1 Das beschriebene Verfahren dient zur Bestimmung der Wirkung handelsüblicher Zubereitungen oder Wirkstoffe unter den Bedingungen, unter denen sie angewendet werden.
ANMERKUNG 2 Dieses Verfahren entspricht einer Prüfung der Phase 2, Stufe 1.
ANMERKUNG 3 Dieses Verfahren kann nicht angewendet werden, um die Wirkung von Produkten gegen Legionella in wasserführenden Systemen, gegen Mykobakterien und bakterielle Sporen zu bewerten.
EN 14885 legt im Einzelnen die Beziehung der verschiedenen Prüfungen untereinander sowie zu den „Anwendungsempfehlungen“ fest.
Antiseptiques et désinfectants chimiques - Essai quantitatif de suspension pour l'évaluation de l'activité bactéricide en médecine - Méthode d'essai et prescriptions (Phase 2, Étape 1)
La présente Norme européenne spécifie une méthode d’essai et les prescriptions minimales relatives à l’activité bactéricide des produits antiseptiques et désinfectants chimiques qui forment une préparation homogène, physiquement stable, lorsqu’ils sont dilués dans de l'eau dure ou dans le cas de produits prêts à l’emploi dans l’eau. Les produits ne peuvent être soumis à l’essai qu’à la concentration de 80 % (97 % avec une méthode modifiée pour les cas particuliers) ou à des concentrations inférieures, car l’ajout des microorganismes d’essai et de la substance interférente s’accompagne forcément d’une dilution.
La présente Norme européenne s'applique aux produits utilisés en médecine dans la friction hygiénique des mains, le lavage hygiénique des mains, la friction chirurgicale des mains, le lavage chirurgical des mains, la désinfection des instruments par immersion, ainsi que la désinfection des surfaces par essuyage, pulvérisation, inondation ou d'autres moyens.
La présente Norme européenne s'applique aux zones et aux situations où la désinfection ou l'antisepsie est médicalement indiquée. Ces indications se rencontrent lors de soins apportés aux patients, par exemple :
- dans des hôpitaux, centres de soins médicaux et cabinets dentaires ;
- dans des infirmeries d’écoles, de jardins d’enfants et de maisons de retraite ;
et peuvent aussi se rencontrer sur les lieux de travail ou à domicile. Elles peuvent également concerner des services tels que des blanchisseries et des cuisines qui fournissent des produits directement aux patients.
NOTE 1 La méthode décrite vise à déterminer l’activité des formulations commerciales ou des substances actives dans les conditions dans lesquelles elles sont utilisées.
NOTE 2 Cette méthode correspond à un essai de phase 2, étape 1.
NOTE 3 Cette méthode ne peut pas être utilisée pour évaluer l'activité des produits vis-à-vis de Legionella dans les réseaux d'eau, des mycobactéries et des spores de bactéries.
L'EN 14885 spécifie en détail la relation entre les différents essais et les «recommandations d'emploi».
Kemična razkužila in antiseptiki - Kvantitativni suspenzijski preskus za vrednotenje baktericidnega delovanja kemičnih razkužil in antiseptikov v humani medicini - Preskusna metoda in zahteve (faza 2, stopnja 1)
Ta evropski standard določa preskusno metodo in minimalne zahteve za baktericidno delovanje kemičnih razkužil in antiseptikov, ki tvorijo homogen, fizikalno stabilen pripravek, če so razredčeni s trdo vodo ali, pri proizvodih, ki so pripravljeni za uporabo, z vodo. Proizvode je mogoče preskušati samo pri 80-odstotni ali nižji koncentraciji (s prilagojeno metodo v posebnih primerih 97-odstotni), ker dodajanje preskusnih organizmov in moteče snovi vedno povzroči razredčenje.
Ta evropski standard velja za proizvode, ki se uporabljajo na področju zdravstva pri higienskem drgnjenju rok, higienskem umivanju rok, kirurškem drgnjenju rok, kirurškem umivanju rok, dezinfekciji instrumentov s potapljanjem in površinski dezinfekciji z brisanjem, pršenjem, zalivanjem ali na druge načine.
Ta evropski standard se uporablja za področja in primere, ko obstajajo zdravniške indikacije za dezinfekcijo ali antisepso. Te indikacije se pojavljajo pri negi bolnikov, na primer:
– v bolnišnicah, javnih zdravstvenih in zobozdravstvenih ustanovah;
v klinikah šol, vrtcev in domov za starejše;
in lahko nastanejo na delovnem mestu ali doma. Vključujejo lahko tudi storitve, kot so pralnice in kuhinje, ki proizvode dostavljajo neposredno bolnikom.
OPOMBA 1: Opisana metoda je namenjena določevanju dejavnosti komercialnih oblik ali aktivnih snovi pod pogoji, v katerih se uporabljajo.
OPOMBA 2 Ta metoda ustreza preskusu stopnje 1 faze 2.
OPOMBA 3 Te metode ni mogoče uporabiti za vrednotenje delovanja izdelkov proti legioneli v vodnih sistemih in proti mikobakterijam.
Standard EN 14885 podrobno določa razmerje med različnimi preizkusi in priporočili za uporabo.
General Information
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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 - Quantitativer Suspensionsversuch zur Bestimmung der bakteriziden Wirkung im humanmedizinischen Bereich - Prüfverfahren und Anforderungen (Phase 2, Stufe 1)Antiseptiques et désinfectants chimiques - Essai quantitatif de suspension pour l'évaluation de l'activité bactéricide en médecine - Méthode d'essai et prescriptions (Phase 2, Étape 1)Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of bactericidal activity in the medical area - Test method and requirements (phase 2, step 1)11.080.20Dezinfektanti in antiseptikiDisinfectants and antisepticsICS:Ta slovenski standard je istoveten z:EN 13727:2012+A2:2015SIST EN 13727:2012+A2:2016en,fr,de01-februar-2016SIST EN 13727:2012+A2:2016SLOVENSKI
STANDARD
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 13727:2012+A2
October
t r s w ICS
s sä r z rä t r Supersedes EN
s u y t yã t r s t ªA sã t r s uEnglish Version
Chemical disinfectants and antiseptics æ Quantitative suspension test for the evaluation of bactericidal activity in Antiseptiques et désinfectants chimiques æ Essai quantitatif de suspension pour l 5évaluation de l 5activité bactéricide en médecine æ Méthode d 5essai et
Chemische Desinfektionsmittel und Antiseptika æ Quantitativer Suspensionsversuch zur Bestimmung der bakteriziden Wirkung im humanmedizinischen Bereich This European Standard was approved by CEN on
s v October
t r s u and includes Amendment
t approved by CEN on
u August
t r s wä
egulations which stipulate the conditions for giving this European Standard the status of a national standard without any alterationä Upætoædate lists and bibliographical references concerning such national standards may be obtained on application to the CENæCENELEC Management Centre or to any CEN memberä
translation under the responsibility of a CEN member into its own language and notified to the CENæCENELEC Management Centre has the same status as the official versionsä
CEN members are the national standards bodies of Austriaá Belgiumá Bulgariaá Croatiaá Cyprusá Czech Republicá Denmarká Estoniaá Finlandá Former Yugoslav Republic of Macedoniaá Franceá Germanyá Greeceá Hungaryá Icelandá Irelandá Italyá Latviaá Lithuaniaá Luxembourgá Maltaá Netherlandsá Norwayá Polandá Portugalá Romaniaá Slovakiaá Sloveniaá Spainá Swedená Switzerlandá Turkey and United Kingdomä
EUROPEAN COMMITTEE FOR STANDARDIZATION COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre:
Avenue Marnix 17,
B-1000 Brussels
t r s w CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Membersä Refä Noä EN
s u y t yã t r s t ªA tã t r s w ESIST EN 13727:2012+A2:2016
Referenced strains in national collections . 33 Annex B (informative)
Neutralizers and rinsing liquids . 34 SIST EN 13727:2012+A2:2016
Graphical representation of test procedures . 36 Annex D (informative)
Example of a typical test report . 44 Annex E (informative)
Precision of the test result. 48 Annex ZA (informative)
Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC . 51 Bibliography . 52
P. aeruginosa, S. aureus, E. hirae, E. coli K12 P. aeruginosa, S. aureus, E. hirae, E. coli K12 P. aeruginosa, S. aureus, E. hirae, when temperature is
40 °C or higher: only
E. faecium P. aeruginosa, S. aureus, E. hirae
additional Any relevant test organism Test temperature according to the manufacturer’s recommendation, but between
20 °C and 20 °C 20 °C and 20 °C 20 °C and 70 °C 4°C and 30 °C Contact time according to the manufacturer’s recommendation
but between but no longer than
30 s and 60 s 1 min and 5 min 60 min 5 min or
60 min a Interfering substance
clean conditions
0,3 g/l bovine albumin solution (hygienic handrub) b 0,3 g/l bovine albumin solution (surgical handrub) b 0,3 g/l bovine albumin solution and/or 0,3 g/l bovine albumin solution and/or dirty conditions 3,0 g/l bovine albumin solution plus 3,0 ml/l erythrocytes (hygienic handwash) c 3,0 g/l bovine albumin solution plus 3,0 ml/l erythrocytes (surgical handwash) c 3,0 g/l bovine albumin solution plus 3,0 ml/l erythrocytes 3,0 g/l bovine albumin solution plus 3,0 ml/l erythrocytes additional clean or dirty;
any relevant substance clean or dirty; any relevant substance any relevant substance any relevant substance NOTE For the additional conditions, the concentration defined as a result can be lower than the one obtained under the minimum test conditions. a The contact times for surface disinfectants stated in this table are chosen on the basis of the practical conditions of the product. The recommended contact time for the use of the product is within the responsibility of the manufacturer. Products intended to disinfect surfaces that are likely to come into contact with the patient and / or the medical staff and surfaces, which are frequently touched by different people, leading to the transmission of microorganisms to the patient, shall be tested with a contact time of maximum 5 min. The same applies where the contact time of the product shall be limited for practical reasons. Products for other surfaces than stated above may be tested with a contact time of maximum 60 min. b hygienic and surgical handrub shall be tested as a minimum under clean conditions. c hygienic and surgical handwash shall be tested as a minimum under dirty conditions. SIST EN 13727:2012+A2:2016
b) Pseudomonas aeruginosa, ATCC 15442
c) Staphylococcus aureus, ATCC 6538
d) Enterococcus hirae, ATCC 10541
e) Enterococcus faecium, ATCC 6057
NOTE See Annex A for strain reference in some other culture collections. The required incubation temperature for these test organisms is 36 °C ± 1 °C or 37 °C ± 1 °C (5.3.2.3). The same temperature (either 36 °C or 37 °C) shall be used for all incubations performed during a test and its control and validation. If additional test organisms are used, they shall be incubated under optimum growth conditions (temperature, time, atmosphere, media) noted in the test report. If the additional test organisms selected do not correspond to the specified strains, their suitability for supplying the required inocula shall be verified. If these additional test organisms are not classified at a reference centre, their identification characteristics shall be stated. In addition, they shall be held by the testing laboratory or national culture collection under a reference for five years.
1) The NCTC and ATCC numbers are the collection numbers of strains supplied by these culture collections. 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. SIST EN 13727:2012+A2:2016
2) Disposable sterile equipment is an acceptable alternative to reusable glassware. 3) Vortex® is an example of a suitable product available commercially. This information is given for the convenience of users of this European Standard and does not constitute an endorsement by CEN of this product. SIST EN 13727:2012+A2:2016
4) cfu/ml = colony forming unit(s) per millilitre. SIST EN 13727:2012+A2:2016
(in °C): The temperatures to be tested are specified in Clause 4, Table 1.
The allowed deviation for each chosen temperature is ± 1 °C . b) contact time t (in min): SIST EN 13727:2012+A2:2016
[5.5.1.1 a)] for 2 min ± 10 s. b) At the end of this time, add 8,0 ml of one of the product test solutions (5.4.2). Restart the stopwatch at the beginning of the addition. Mix [5.3.2.6 a)] and place the tube in a water bath controlled at
for the chosen contact time t [5.5.1.1 b)]. Just before the end of t, mix [5.3.2.6 a)] again. c) At the end of t, take a 1,0 ml sample of the test mixture Na and transfer into a tube containing 8,0 ml neutralizer (5.2.2.5) and 1,0 ml water (5.2.2.2). Mix [5.3.2.6 a)] and place in a water bath controlled at 20 °C ± 1 °C. After a neutralization time of 5 min ± 10 s (in case of contact times of 10 min or shorter only 10 s ± 1 s), mix [5.3.2.6 a)] and immediately take a sample of 1,0 ml of the neutralized test mixture Na (containing neutralizer, product test solution, interfering substance and test suspension) in duplicate and inoculate using the pour plat
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