EN 13727:2012+A2:2015

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
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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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