EN 12791:2016/prA1
(Amendment)Chemical disinfectants and antiseptics - Surgical hand disinfection - Test method and requirements (phase 2, step 2)
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
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN 12791:2016/oprA1:2017
01-marec-2017
.HPLþQDUD]NXåLODLQDQWLVHSWLNL5D]NXåLOD]DURNHYNLUXUJLML3UHVNXVQDPHWRGD
LQ]DKWHYH ID]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.
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SIST EN 12791:2016/oprA1:2017
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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.
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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
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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
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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
...
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