EN 12791:2005

SLOVENSKI STANDARD
01-september-2005
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Chemical disinfectants and antiseptics - Surgical hand disinfection - Test method and
requirement (phase 2/step 2)
Chemische Desinfektionsmittel und Antiseptika - Chirurgische Händedesinfektionsmittel -
Prüfverfahren und Anforderungen (Phase 2/Stufe 2)
Antiseptiques et désinfectants chimiques - Désinfectants chirurgicaux pour les mains -
Méthodes d'essai et prescriptions (phase 2/étape 2)
Ta slovenski standard je istoveten z: EN 12791:2005
ICS:
11.080.20 Dezinfektanti in antiseptiki Disinfectants and antiseptics
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN 12791
NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2005
ICS 11.080.20
English Version
Chemical disinfectants and antiseptics - Surgical hand
disinfection - Test method and requirement (phase 2/step 2)
Antiseptiques et désinfectants chimiques - Désinfectants Chemische Desinfektionsmittel und Antiseptika -
chirurgicaux pour les mains - Méthodes d'essai et Chirurgische Händedesinfektionsmittel - Prüfverfahren und
prescriptions (phase 2/étape 2) Anforderungen (Phase 2/Stufe 2)
This European Standard was approved by CEN on 21 March 2005.
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 Central Secretariat 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 Central Secretariat has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,
Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2005 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 12791:2005: E
worldwide for CEN national Members.

Contents page
Foreword .4
1 Scope .5
2 Normative references .5
3 Terms and definitions.5
4 Requirements .6
5 Test methods.6
5.1 Principle.6
5.2 Experimental design.7
5.3 Volunteers .7
5.4 Media and reagents.7
5.4.1 General .7
5.4.2 Water.7
5.4.3 Tryptone soya agar (TSA).7

5.4.4 Tryptone soya broth (TSB).8
5.4.5 Neutralizer .8
5.4.6 Dilute soft soap, 200 g/1000 g .8
5.4.7 Propan-1-ol 60 % (volume concentration).9
5.5 Apparatus and glassware.9
5.5.1 General .9
5.5.2 Usual microbiological laboratory equipment.9
5.6 Procedure .9
5.6.1 Preparatory handwash .9
5.6.2 Prevalues.10
5.6.3 Surgical hand disinfection procedure .10
5.6.4 Postvalues.11
5.6.5 Incubation.11
5.7 Calculation.11
5.8 Test validation.12
5.9 Evaluation of P .12
5.10 Significance testing .13
5.11 Test report .13
Annex A (normative) Standard handwash/handrub procedure.14
Annex B (informative) Demonstration of antibacterial properties of surgical gloves.15
Annex C (informative) Examples of neutralizers.16
Annex D (informative) Preparation of a solution of propan-1-ol 60 % (volume concentration).17
Annex E (informative) Quality control of soft soap.18
Annex F (informative) Examples of reporting of results and significance testing .19
Annex G (informative) Information on the application and interpretation of the European
Standard on chemical disinfectants and antiseptics .27
G.1 Introduction.27
G.2 General guidelines for the application and interpretation of test methods in accordance
with European Standards for chemical disinfectants and antiseptics .27
G.3 Guide to interpretation of tests for chemical disinfectants and antiseptics .28
Bibliography.29

Foreword
This document (EN 12791:2005) 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 January 2006, and conflicting national standards shall be withdrawn at
the latest by January 2006.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Cyprus, Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland
and United Kingdom.
1 Scope
This European Standard specifies a test method simulating practical conditions for establishing whether a
product for surgical hand disinfection reduces the release of hand flora according to requirements described in
clause 4 when used for the disinfection of the clean hands of volunteers.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
prEN 12054, Chemical disinfectants and antiseptics — Quantitative suspension test for the evaluation of
bactericidal activity of products for hygienic and surgical handrub and handwash used in human medicine —
Test method and requirements (phase 2/step 1).
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
product
chemical agent or formulation used as a chemical disinfectant or antiseptic
3.2
surgical hand disinfection
preoperative treatment procedure that involves applying a bactericidal product directed against the bacterial
flora of hands to prevent the risk of transmission of bacteria into the surgical wound
NOTE This procedure may consist of a handrub alone or a handwash alone or a combination of both.
This treatment can be performed with products claiming or not claiming to have a sustained effect (see 3.5)
3.3
immediate effect
reduction of the release of skin flora from the hands as assessed immediately after surgical hand disinfection
3.4
3-hour effect
reduction of the release of skin flora from the hands as assessed after wearing surgical gloves for 3 h
following disinfection
3.5
sustained effect
3-hour effect of the product significantly larger than that of a reference disinfection procedure with propan-1-ol
60 % (volume concentration) (see 5.6.3.2)
3.6
prevalue (immediate)
number of colony-forming units (cfu) sampled immediately before treatment from the hand from which the
immediate effect has to be assessed
3.7
prevalue (3-hour)
number of colony-forming units (cfu) sampled immediately before treatment from the hand from which the
sustained effect has to be assessed
3.8
postvalue (immediate)
number of colony-forming units (cfu) sampled immediately after treatment from the hand sampled for the
prevalue (immediate)
3.9
postvalue (3-hour)
number of colony-forming units (cfu) sampled 3 h after treatment from the hand sampled for the prevalue
(sustained)
3.10
reduction factor (RF) (immediate)
ratio of prevalue (immediate) and postvalue (immediate), generally expressed by decimal logarithms:
lg RF(immediate) = lg prevalue (immediate) − lg postvalue (immediate)

3.11
reduction factor (3-hour)
ratio of prevalue (3-hour) and postvalue (3-hour), generally expressed by decimal logarithms:
lg RF (3-hour) = lg prevalue (3-hour) − lg postvalue (3-hour)
3.12
surgical glove
sterile, un-powdered medical latex glove free of antimicrobial activity, as demonstrated by agar diffusion test
on Mueller-Hinton agar (see Annex B) intended for use in invasive surgery
4 Requirements
When tested and evaluated in accordance with clause 5, the mean reduction factors for immediate (see 3.10)
and 3 hours (3.11) effects shall not be significantly smaller than the respective ones obtained with propan-1-ol
60 % (volume concentration).
If the explicit claim for a sustained effect exists, the mean reduction factor for the 3-hour effect shall,
additionally, be significantly larger than that obtained with propan-1-ol 60 % (volume concentration).
5 Test methods
5.1 Principle
A preparatory handwash (see 5.6.1) is carried-out in order to remove transient flora and foreign material, that
would otherwise influence the presample counts. Hand samples, for bacterial counts, are then taken:
 immediately after the prewash (before treatment);
 immediately after the disinfection procedure;
 3 h after the disinfection procedure.
The ratio of the resulting values before and after treatment is called the reduction factor. It represents a
measure for the antimicrobial activity of the disinfection product tested. The immediate effect is characterized
by the reduction factor (immediate), which is the ratio of the two values (prevalu
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