SIST EN 12791:2016+A1:2018

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Chemische Desinfektionsmittel und Antiseptika - Chirurgische Händedesinfektionsmittel - Prüfverfahren und Anforderungen (Phase 2, Stufe 2)Antiseptiques et désinfectants chimiques - Désinfection chirurgicale des mains - Méthodes d'essai et prescriptions (phase 2/étape 2)Chemical disinfectants and antiseptics - Surgical hand disinfection - Test method and requirements (phase 2, step 2)11.080.20Dezinfektanti in antiseptikiDisinfectants and antisepticsICS:Ta slovenski standard je istoveten z:EN 12791:2016+A1:2017SIST EN 12791:2016+A1:2018en,fr,de01-januar-2018SIST EN 12791:2016+A1:2018SLOVENSKI
STANDARDSIST EN 12791:20161DGRPHãþD

EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 12791:2016+A1
November
t r s y ICS
s sä r z rä t r Supersedes EN
s t y { sã t r s xEnglish Version
Chemical disinfectants and antiseptics æ Surgical hand Antiseptiques et désinfectants chimiques æ Désinfection chirurgicale des mains æ Méthodes d 5essai et
Chemische Desinfektionsmittel und Antiseptika æ Chirurgische Händedesinfektionsmittel æ Prüfverfahren This European Standard was approved by CEN on
s u December
t r s w and includes Amendment
s approved by CEN on
t r July
t r s yä
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 y CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Membersä Refä Noä EN
s t y { sã t r s x ªA sã t r s y ESIST EN 12791:2016+A1:2018

Standard surgical handrub/-wash procedure . 17 Annex B (informative)
Quality control of soft soap . 18 Annex C (informative)
Examples of reporting of results and significance testing . 19 Annex D (informative)
WILCOXON'S matched-pairs signed-ranks test . 30 Bibliography . 31
7,0 parts by weight Hot distilled water (75 °C ± 5 °C) as needed Prepare a solution of 9,5 parts potassium hydroxide in 15 parts water (5.2.2.2) and add 50 parts linseed oil. Heat up to approximately 70 °C while constantly stirring. Add the ethanol and continue heating while stirring until the saponification process is completed and a sample dissolves clearly in water and almost clearly in alcohol. The weight of the soft soap is then brought up to 100 parts by addition of water (5.2.2.2), heated up to 75 °C ± 5 °C to dilute the soft soap. Take 200 g of the soft soap, fill up to 1000 g with water (5.2.2.2) and sterilize in the autoclave [5.3.2.1a)]. The pH of the final diluted soft soap shall range between 10,0 and 11,0. For quality control of the soft soap see Annex B. 5.2.2.7 Hard water for dilution of products For the preparation of 1 l of hard water, the procedure is as follows: — prepare solution A: dissolve 19,84 g magnesium chloride (MgCl2) and 46,24 g calcium chloride (CaCl2) in water (5.2.2.2) and dilute to 1000 ml. Sterilize by membrane filtration (5.3.2.7) or in the autoclave [5.3.2.1a)]. Autoclaving – if used - may cause a loss of liquid. In this case make up to 1000 ml with water (5.2.2.2) under aseptic conditions. Store the solution in the refrigerator (5.3.2.8) for no longer than one month; SIST EN 12791:2016+A1:2018

1) Disposable sterile equipment is an acceptable alternative to reusable glassware. SIST EN 12791:2016+A1:2018

2) Vortex® in 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 12791:2016+A1:2018

−+===×+×01(29931)3303000cfu/ml0,110,1100,110Z sampling fluid If colony counts of different dilution steps are grossly disproportional (e.g. countable results in each of three dilution steps), insufficient neutralization of the product should be taken into consideration. See also 5.7.2. All viable counts per ml sampling fluid are transformed to decimal logarithms (lg). For computational reasons values of “0” (lg 0 = -o be set “1” (lg 1 = 0). NOTE Since “0”-values should be found only among postvalues and should occur only with the most active products, this adjustment can, at worst, introduce a conservative bias of underestimating the antimicrobial efficacy of a product. From the difference between the lg prevalue and the lg postvalue assessed per hand (one hand: immediate, the other hand: 3 h effect), a lg reduction (lg R) is established for each volunteer’s hand. SIST EN 12791:2016+A1:2018

10 « s dilution: 161 cfu/ml;
10 « t dilution: 28 cfu/ml;
(161) / (28) = 5,75, i.e. between 5 and 15. 5.8 Statistical evaluation (significance testing), expression of results and precision If the quality of the data has been found to be acceptable (5.7.1), they shall be used for the evaluation of the product under test by applying the following pass criterion: a) Neither the immediate effect nor the 3 h effect of the product (PP) shall be inferior to the respective effects of the reference product, propan-1-ol (RP). b) For testing the performance of PP against that of RP, a non-parametric test for non-inferiority such as that of Hodges and Lehmann [2] shall be applied to the lg reductions in each evaluation. The statistical method described in Annex C should be used. NOTE Computer programs exist for this method, for instance: StatXact™ or SAS™ (with macro). Other methods are acceptable if they have the same or superior power and their applicability can be demonstrated by suitable statistical methods (e.g. given there is no significant deviation from a normal distribution of the differences of RP – PP parametric methods may be used). c) The level of significance is set at P = 0,025 (one-sided) for the statistical evaluation of the immediate effect and the 3h effect of PP. SIST EN 12791:2016+A1:2018
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