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CEN

EN 12791:2016+A1:2017

(Main + 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)

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

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

Ta evropski standard določa preskusno metodo s simuliranjem praktičnih pogojev za ugotavljanje, ali izdelek za kirurško drgnjenje in umivanje rok zmanjša prenos prisotne prehodne mikrobiološke flore na roke, ko se uporablja za čiščenje čistih rok prostovoljcev.
Ta evropski standard se uporablja za izdelke za kirurško drgnjenje ali umivanje rok za uporabo na področjih in v primerih, ko obstajajo zdravstvene indikacije za dezinfekcijo. Te indikacije se pojavljajo pri negi bolnikov, na primer:
– v bolnišnicah, javnih zdravstvenih in zobozdravstvenih ustanovah;
– v ambulantah šol, vrtcev in domov za starejše;
in lahko se pojavljajo na delovnem mestu ali doma. Vključujejo lahko tudi storitvene prostore, kot so pralnice in kuhinje, ki proizvode neposredno dostavljajo bolniku.
Standard EN 14885 podrobno določa razmerje med različnimi preskusi in »priporočili za uporabo«.
OPOMBA: Ta metoda ustreza preskusu stopnje 2 faze 2.

General Information

Status
Published
Publication Date
31-Oct-2017
ICS
11.080.20 - Disinfectants and antiseptics
Technical Committee
CEN/TC 216 - Chemical disinfectants and antiseptics
Drafting Committee
CEN/TC 216/WG 1 - Human medicine
Current Stage
9093 - Decision to confirm - Review Enquiry
Completion Date
11-Apr-2022
Ref Project
SIST EN 12791:2016+A1:2018 - Chemical disinfectants and antiseptics - Surgical hand disinfection - Test method and requirements (phase 2, step 2)

Relations

Merged From
EN 12791:2016 - Chemical disinfectants and antiseptics - Surgical hand disinfection - Test method and requirements (phase 2, step 2)
Effective Date
18-Jan-2023
Merged From
EN 12791:2016/prA1 - Chemical disinfectants and antiseptics - Surgical hand disinfection - Test method and requirements (phase 2, step 2)
Effective Date
18-Jan-2023

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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
CEN members are the national standards bodies of Austriaá Belgiumá Bulgariaá Croatiaá Cyprusá Czech Republicá Denmarká Estoniaá Finlandá Former Yugoslav Republic of Macedoniaá Franceá Germanyá Greeceá Hungaryá Icelandá Irelandá Italyá Latviaá Lithuaniaá Luxembourgá Maltaá Netherlandsá Norwayá Polandá Portugalá Romaniaá Serbiaá Slovakiaá Sloveniaá Spainá Swedená Switzerlandá Turkey and United Kingdomä
EUROPEAN COMMITTEE FOR STANDARDIZATION COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre:
Avenue Marnix 17,
B-1000 Brussels
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
...

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