SIST EN 12791:2016/oprA1:2017

Chemical disinfectants and antiseptics - Surgical hand disinfection - Test method and requirements (phase 2, step 2)

This European Standard specifies a test method simulating practical conditions for establishing whether a product for surgical handrub and handwash reduces the release of resident and eventually present transient microbial flora on hands when used for the treatment of clean hands of volunteers.
This European Standard applies to products for surgical handrub or handwash for use in areas and situations where disinfection 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 patient.
EN 14885 specifies in detail the relationship of the various tests to one another and to “use recommendations”.
NOTE   This method corresponds to a phase 2, step 2 test.

Chemische Desinfektionsmittel und Antiseptika - Chirurgische Händedesinfektionsmittel - Prüfverfahren und Anforderungen (Phase 2, Stufe 2)

Diese Europäische Norm legt ein Prüfverfahren fest, das praktische Bedingungen simuliert, um festzustellen, ob ein Produkt zur chirurgischen Händedesinfektion und Händewaschung die Abgabe der residenten mikrobiellen Flora auf den Händen verringert, wenn es zur Behandlung der sauberen Hände von Probanden verwendet wird.
Die vorliegende Europäische Norm gilt für Produkte zur chirurgischen Händedesinfektion und Hände-waschung zur Anwendung in Gebieten und Situationen, in denen eine Desinfektion medizinisch indiziert ist. Zu diesen Indikationen kommt es bei der Patientenversorgung, zum Beispiel:
   in Krankenhäusern, medizinischen Gemeinschaftseinrichtungen und zahnmedizinischen Einrichtungen;
   in Kliniken von Schulen, Kindergärten und Pflegeheimen;
und eine Notwendigkeit kann am Arbeitsplatz und im Haushalt auftreten. Es können auch Einrichtungen wie Wäschereien und Küchen betroffen sein, die Produkte direkt an die Patienten abgeben.
EN 14885 gibt im Einzelnen die Beziehung der verschiedenen Prüfungen untereinander und „die Anwendungsempfehlungen“ an.
ANMERKUNG   Das vorliegende Verfahren entspricht einer Prüfung Phase 2, Stufe 2.

Antiseptiques et désinfectants chimiques - Désinfection chirugicale des mains - Méthodes d'essai et prescriptions (phase 2/étape 2)

La présente Norme européenne spécifie une méthode d'essai simulant des conditions pratiques afin d'établir si un produit destiné à la friction chirurgicale ou au lavage chirurgical des mains réduit la flore microbienne résidente et éventuellement la flore microbienne transitoire détectée sur les mains lorsqu'il est utilisé pour le traitement des mains propres de volontaires.
La présente Norme européenne s’applique aux produits destinés à la friction chirurgicale ou au lavage chirurgical des mains qui sont utilisés dans des secteurs et situations pour lesquels la désinfection est médicalement préconisée. Ces préconisations touchent les soins délivrés aux patients, par exemple :
-   dans les hôpitaux, les cabinets médicaux et dentaires ;
-   dans les infirmeries d’écoles, d’écoles maternelles et de maisons de repos ;
et peuvent concerner aussi bien les lieux de travail que les domiciles. Elles peuvent également concerner des services, tels que les blanchisseries et les cuisines délivrant des produits directement au patient.
L’EN 14885 spécifie en détail la relation liant les divers essais entre eux aux « recommandations d’utilisation ».
NOTE   La présente méthode correspond à un essai de phase 2, étape 2.

Kemična razkužila in antiseptiki - Razkužila za roke v kirurgiji - Preskusna metoda in zahteve (faza 2, stopnja 2) - Dopolnilo A1

General Information

• Status: Not Published
• Public Enquiry End Date: 04-Apr-2017
• Publication Date: 08-Oct-2017
• ICS: 11.080.20 - Disinfectants and antiseptics
• Technical Committee: KDS - Cosmetics, chemical disinfectants and surface active agents
• Current Stage: 98 - Abandoned project (Adopted Project)
• Start Date: 24-Nov-2017
• Due Date: 29-Nov-2017
• Completion Date: 24-Nov-2017
• Ref Project: EN 12791:2016/prA1 - Chemical disinfectants and antiseptics - Surgical hand disinfection - Test method and requirements (phase 2, step 2)

Relations

• Consolidated By: SIST EN 12791:2016+A1:2018 - Chemical disinfectants and antiseptics - Surgical hand disinfection - Test method and requirements (phase 2, step 2)
• Effective Date: 18-Jan-2023
• Amends: SIST EN 12791:2016 - Chemical disinfectants and antiseptics - Surgical hand disinfection - Test method and requirement (phase 2/step 2)
• Effective Date: 01-Nov-2017
• Consolidated By: SIST EN 12791:2016+A1:2018 - Chemical disinfectants and antiseptics - Surgical hand disinfection - Test method and requirements (phase 2, step 2)
• Effective Date: 01-Jan-2018
• Consolidated By: SIST EN 12791:2016+A1:2018 - Chemical disinfectants and antiseptics - Surgical hand disinfection - Test method and requirements (phase 2, step 2)
• Effective Date: 19-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 12791:2016/oprA1:2017
01-marec-2017
.HPLþQDUD]NXåLODLQDQWLVHSWLNL5D]NXåLOD]DURNHYNLUXUJLML3UHVNXVQDPHWRGD
LQ]DKWHYHID]DVWRSQMD
Chemical disinfectants and antiseptics - Surgical hand disinfection - Test method and
requirements (phase 2, step 2)
Chemische Desinfektionsmittel und Antiseptika - Chirurgische Händedesinfektionsmittel -
Prüfverfahren und Anforderungen (Phase 2, Stufe 2)
Antiseptiques et désinfectants chimiques - Désinfection chirugicale des mains -
Méthodes d'essai et prescriptions (phase 2/étape 2)
Ta slovenski standard je istoveten z: EN 12791:2016/prA1:2017
ICS:
11.080.20 Dezinfektanti in antiseptiki Disinfectants and antiseptics
SIST EN 12791:2016/oprA1:2017 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

SIST EN 12791:2016/oprA1:2017

---------------------- Page: 2 ----------------------

SIST EN 12791:2016/oprA1:2017


DRAFT
EUROPEAN STANDARD
EN 12791:2016
NORME EUROPÉENNE

EUROPÄISCHE NORM
prA1
February 2017
ICS 11.080.20
English Version

Chemical disinfectants and antiseptics - Surgical hand
disinfection - Test method and requirements (phase 2,
step 2)
Antiseptiques et désinfectants chimiques - Désinfection Chemische Desinfektionsmittel und Antiseptika -
chirugicale des mains - Méthodes d'essai et Chirurgische Händedesinfektionsmittel - Prüfverfahren
prescriptions (phase 2/étape 2) und Anforderungen (Phase 2, Stufe 2)
This draft amendment is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee CEN/TC 216.

This draft amendment A1, if approved, will modify the European Standard EN 12791:2016. If this draft becomes an amendment,
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of
this amendment into the relevant national standard without any alteration.

This draft amendment was established by CEN 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.

Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are
aware and to provide supporting documentation.

Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without
notice and shall not be referred to as a European Standard.


EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2017 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 12791:2016/prA1:2017:2017 E
worldwide for CEN national Members.

---------------------- Page: 3 ----------------------

SIST EN 12791:2016/oprA1:2017
EN 12791:2016/prA1:2017 (E)
Contents Page
European foreword . 3
1 Modification to Annex C, Examples of reporting of results and significance testing . 4



2

---------------------- Page: 4 ----------------------

SIST EN 12791:2016/oprA1:2017
EN 12791:2016/prA1:2017 (E)
European foreword
This document (EN 12791:2016/prA1:2017) has been prepared by Technical Committee CEN/TC 216
“Chemical disinfectants and antiseptics”, the secretariat of which is held by AFNOR.
This document is currently submitted to the CEN Enquiry.
3

---------------------- Page: 5 ----------------------

SIST EN 12791:2016/oprA1:2017
EN 12791:2016/prA1:2017 (E)
1 Modification to Annex C, Examples of reporting of results and significance
testing
Replace Annex C (informative) "Examples of reporting of results and significance testing" by the following:
"
Table C.1 — Reference surgical hand disinfection procedure – Experimental results
Preparation: “RP” (propan-1-ol 60 % v/v)
Dates of experiment: 15 July 2011 / 22 July 2011
Application: rubbing hands during 3 min
x
Volunteer Number of cfu per plate from dilution 10
  Hand Prevalues Immediate postvalues 3 h postvalues
Sequence left or
No right −1 −2 −3 0 −1 −2 0 −1 −2
1 RP- > PP l > 330 > 330 188 > 330 39 1
  r > 330 > 330 226    > 330 184 11
2 RP- > PP l > 330 > 330 71    > 330 184 11
  r > 330 > 330 43 47 4 1
3 PP- > RP l > 330 > 330 121    > 330 215* 25*
  r > 330 > 330 147 105* 17* 3
4 RP- > PP l > 330 > 330 48    > 330 > 330 232
  r > 330 > 330 45 > 330 124 9
5 PP- > RP l > 330 > 330 56 > 330 36 8
  r > 330 > 330 38    > 330 > 330 43
6 PP- > RP l > 330 67 4    > 330 > 330 58
  r > 330 46 2 20** 2** 0**
7 RP- > PP l > 330 175 12    214* 19* 3
  r > 330 310* 31* 143* 14* 0
8 PP- > RP l > 330 > 330 73 > 330 134* 17*
  r > 330 131* 16*    > 330 84 5
9 RP- > PP l > 330 > 330 81    > 330 188* 18*
  r > 330 > 330 54 > 330 151* 16*
10 RP- > PP l > 330 181* 18* 193* 22* 2
  r > 330 243* 26*    96 8 1
11 RP- > PP l > 330 272* 34*    > 330 42 3
  r > 330 231* 33* 42 4 0
12 PP- > RP l > 330 > 330 86 102 12 0
4

---------------------- Page: 6 ----------------------

SIST EN 12791:2016/oprA1:2017
EN 12791:2016/prA1:2017 (E)
x
Volunteer Number of cfu per plate from dilution 10
  Hand Prevalues Immediate postvalues 3 h postvalues
Sequence left or
No right −1 −2 −3 0 −1 −2 0 −1 −2
  r > 330 > 330 181    > 330 > 330 53
13 PP- > RP l > 330 > 330 106    > 330 > 330 37
  r > 330 201* 17* 68 9 0
14 PP- > RP l > 330 161* 28* 122 12 1
  r > 330 208* 23*    > 330 > 330 76
15 RP- > PP l > 330 141* 16* > 330 > 330 102
  r > 330 122 12    > 330 > 330 87
16 PP- > RP l 320* 32* 5    44 4 0
  r > 330 35 1 0 0 0
17 PP- > RP l > 330 > 330 148 6 0 0
  r > 330 > 330 71    > 330 69 9
18 RP- > PP l > 330 > 330 145    > 330 243* 32*
  r > 330 > 330 126 > 330 80 12
19 PP- > RP l > 330 195* 25* > 330 52 7
  r > 330 116 12    242* 26* 1
20 PP- > RP l > 330 > 330 71    > 330 92 6
  r > 330 > 330 37 28 3 0
21 RP- > PP l > 330 > 330 61 > 330 62 8
  r > 330 > 330 153    32 3 0
22 RP- > PP l > 330 > 330 131 32 7 0
  r > 330 > 330 320    > 330 93 5
23 PP- > RP l > 330 > 330 97    192* 26* 1
  r > 330 > 330 31 119 13 2
24 RP- > PP l > 330 > 330 278 > 330 > 330 156
  r > 330 > 330 136    > 330 61 3
Underlined = count used for further computation
* indicates adjacent dilutions used for computation
**values cannot be used for further computation (infringement of control of weighted mean counts 5.7.2 for PP,
s. table C2)
5

---------------------- Page: 7 ----------------------

SIST EN 12791:2016/oprA1:2017
EN 12791:2016/prA1:2017 (E)
Table C.2 — Surgical hand rub procedure with test product – Experimental results
Preparation: “PP”
Dates of experiment: 15 July 2011 / 22 July 2011
Application: rubbing hands with 3 × 3 ml during 2 min
x
Volunteer Number of cfu per plate from dilution 10
  Hand Prevalues Immediate postvalues 3 h postvalues
Sequence left or
No right −1 −2 −3 0 −1 −2 0 −1 −2
1 RP - > PP l > 330 > 330 186 > 330 133* 16*
  r > 330 > 330 68    > 330 > 330 153
2 RP - > PP l 80 8 0    > 330 251* 40*
  r 156* 23* 4 201* 27* 0
3 PP - > RP l > 330 > 330 95    > 330 > 330 329
  r > 330 > 330 73 > 330 69 9
4 RP - > PP l > 330 > 330 121    > 330 > 330 320
  r > 330 > 330 171 > 330 > 330 81
5 PP - > RP l > 330 > 330 66 > 330 106 12
  r > 330 > 330 71    > 330 > 330 143
6 PP - > RP l > 330 36 1    > 330 > 330 47
  r 171 12 1 109** 34** 1
7 RP - > PP l > 330 176* 27*    > 330 > 330 124
  r > 330 > 330 85 > 330 54 5
8 PP - > RP l > 330 > 330 131 > 330 143* 20*
  r > 330 > 330 176    > 330 249* 21*
9 RP - > PP l > 330 > 330 54    > 330 > 330 74
  r > 330 > 330 53 > 330 103 8
10 RP - > PP l > 330 > 330 57 > 330 104 7
  r > 330 146 12    > 330 128* 15*
11 RP - > PP l > 330 191 12    > 330 143* 15*
  r > 330 118* 14* > 330 77 13
12 PP - > RP l > 330 > 330 115 > 330 96* 14*
  r > 330 > 330 110    > 330 > 330 245
13 PP - > RP l > 330 > 330 146    > 330 > 330 101
  r > 330 > 330 93 > 330 > 330 34
14 PP - > RP l > 330 242* 23* > 330 103 12
6

---------------------- Page: 8 ----------------------

SIST EN 12791:2016/oprA1:2017
EN 12791:2016/prA1:2017 (E)
x
Volunteer Number of cfu per plate from dilution 10
  Hand Prevalues Immediate postvalues 3 h postvalues
Sequence left or
No right −1 −2 −3 0 −1 −2 0 −1 −2
  r > 330 310* 31*    > 330 > 330 144
15 RP - > PP l > 330 59 7 > 330 > 330 155
  r > 330 59 5    > 330 > 330 320
16 PP - > RP l > 330 > 330 54    > 330 206* 29*
  r > 330 41 4 78 12 1
17 RP - > PP l > 330 > 330 43 125 13 1
  r > 330 > 330 81    > 330 114* 14*
18 RP - > PP l > 330 > 330 126    > 33 > 33 268
0 0
  r > 330 > 330 114 > 330 191* 18*
19 PP - > RP l > 330 > 330 42 > 330 > 330 35
  r > 330 > 330 56    > 33 > 33 61
0 0
20 PP - > RP l > 330 149* 18*    > 33 > 33 216
0 0
  r > 330 174* 21* > 330 > 330 81
21 RP - > PP l > 330 121* 14* 237* 21* 3
  r > 330 > 330 69    > 33 133* 17*
0
22 RP - > PP l > 330 > 330 143 193* 29* 2
  r > 330 > 330 298    > 33 > 33 39
0 0
23 PP - > RP l > 330 > 330 179    > 33 > 33 329
0 0
  r > 330 > 330 128 > 330 237* 24*
24 RP - > PP l > 330 > 330 262 > 330 107 7
  r > 330 > 330 321    > 33 > 33 103
0 0
Underlined = count used for further computation
* indicates adjacent dilutions used for computation
**values cannot be used for further computation (infringement of control of weighted mean counts
5.7.2)
7

---------------------- Page: 9 ----------------------

SIST EN 12791:2016/oprA1:2017
EN 12791:2016/prA1:2017 (E)
Table C.3 — List of computed lg values and lg reductions
Preparation: “RP” (propan-1-ol 60 % v/v)
Volunteer Sequence Immediate effect 3 h effect
 lg lg
lg Postvalue lg lg Postvalue lg
No Prevalues s Reduction Prevalues s Reduction
1 RP- > PP 5,27 2,59 2,68 5,35 3,26 2,09
2 RP- > PP 4,63 1,67 2,96 4,85 3,26 1,59
3 PP- > RP 5,17 2,04 3,13 5,08 3,34 1,74
4 RP- > PP 4,65 3,09 1,56 4,68 4,37 0,31
5 PP- > RP 4,75 2,56 2,19 4,58 3,63 0,95
6 PP- > RP 3,66 1,30 2,36 3,83 3,76 0,07
7 RP- > PP 4,49 2,15 2,34 4,24 2,33 1,91
8 PP- > RP 4,86 3,14 1,72 4,13 2,92 1,21
9 RP- > PP 4,73 3,18 1,55 4,91 3,27 1,64
10 RP- > PP 4,26 2,29 1,97 4,39 1,98 2,41
11 RP- > PP 4,38 1,62 2,76 4,44 2,62 1,82
12 PP- > RP 4,93 2,01 2,92 5,26 3,72 1,54
13 PP- > RP 4,30 1,83 2,47 5,03 3,57 1,46
14 PP- > RP 4,24 2,09 2,15 4,32 3,88 0,44
15 RP- > PP 4,15 4,01 0,14 4,09 3,94 0,15
16 PP- > RP 3,54 0,00 3,54 3,51 1,64 1,87
17 PP- > RP 5,17 0,78 4,39 4,85 2,84 2,01
18 RP- > PP 5,10 2,90 2,20 5,16 3,40 1,76
19 PP- > RP 4,30 2,72 1,58 4,06 2,39 1,67
20 PP- > RP 4,57 1,45 3,12 4,85 2,96 1,89
21 RP- > PP 4,79 2,79 2,00 5,18 1,51 3,67
22 RP- > PP 5,12 1,51 3,61 5,51 2,97 2,54
23 PP- > RP 4,49 2,08 2,41 4,99 2,30 2,69
24 RP- > PP 5,44 4,19 1,25 5,13 2,79 2,34
Mean  4,67 2,29 2,38 4,68 3,03 1,66
Standard
deviation 0,44 0,95 0,91 0,52 0,74 0,84
N  23 23 23 24 24 24
8

---------------------- Page: 10 ----------------------

SIST EN 12791:2016/oprA1:2017
EN 12791:2016/prA1:2017 (E)
Table C.4 — List of computed lg values and lg reduction
Preparation: “PP”
Volunteer Sequence Immediate effect 3 h effect
 lg lg
lg Postvalue lg lg Postvalue lg
No Prevalues s Reduction Prevalues s Reduction
1 RP- > PP 5,27 3,13 2,14 4,83 4,18 0,65
2 RP- > PP 3,21 2,32 0,89 2,90 3,
...