EN 1500:2013
(Main)Chemical disinfectants and antiseptics - Hygienic handrub - Test method and requirements (phase 2/step 2)
Chemical disinfectants and antiseptics - Hygienic handrub - Test method and requirements (phase 2/step 2)
This European Standard specifies a test method simulating practical conditions for establishing whether a product for hygienic handrub reduces the release of transient microbial flora on hands when rubbed onto the artificially contaminated hands of volunteers.
NOTE 1 Attention is drawn to the fact that tests on human volunteers are the subject of legal provisions in certain European countries/regions.
This European Standard applies to products for hygienic handrub 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 2 This method corresponds to a phase 2, step 2 test.
Chemische Desinfektionsmittel und Antiseptika - Hygienische Händedesinfektion - Prüfverfahren und Anforderungen (Phase 2/Stufe 2)
Diese Europäische Norm legt ein Prüfverfahren fest, das praktische Bedingungen simuliert um festzustellen, ob ein Produkt für die hygienische Händedesinfektion die Abgabe der auf den Händen befindlichen transienten mikrobiellen Flora verringert, wenn es auf den künstlich kontaminierten Händen von freiwilligen Probanden verrieben wird.
ANMERKUNG 1 Es wird darauf hingewiesen, dass Versuche mit menschlichen Probanden in bestimmten europäischen Ländern/Regionen gesetzlichen Bestimmungen unterliegen.
Diese Europäische Norm gilt für Produkte zur hygienischen Händedesinfektion, die in Bereichen und unter Bedingungen angewendet werden, wo eine Desinfektion aus medizinischen Gründen angezeigt ist. Indikationen dieser Art liegen z. B. bei der Patientenbetreuung in
Krankenhäusern, kommunalen medizinischen Einrichtungen und im Dentalbereich;
medizinischen Einrichtungen in Schulen, Kindergärten und Heimen
vor und können auch am Arbeitsplatz und im häuslichen Bereich gegeben sein. Eingeschlossen sein können auch Einrichtungen wie Wäschereien und Küchen, die der direkten Versorgung von Patienten dienen.
EN 14885 legt im Einzelnen die Beziehungen der verschiedenen Prüfungen untereinander und zu den „Anwendungsempfehlungen“ fest.
ANMERKUNG 2 Das Verfahren entspricht einer Prüfung der Phase 2, Stufe 2.
Antiseptiques et désinfectants chimiques - Traitement hygiénique de mains par frictions - Méthode d'essai et prescriptions (phase 2/étape 2)
La présente Norme européenne décrit une méthode d’essai simulant des conditions pratiques afin d’établir si
un produit pour le traitement hygiénique des mains par frictions réduit la flore microbienne transitoire des
mains lorsqu’il est utilisé en frictions sur les mains artificiellement contaminées de volontaires.
NOTE 1 L’attention du lecteur est attirée sur le fait que les essais sur des sujets humains sont soumis à des
dispositions légales dans certains pays/régions d’Europe.
La présente Norme européenne s’applique aux produits destinés au traitement hygiénique des mains par
frictions utilisés dans les zones et les situations où la désinfection est médicalement préconisée. De telles
indications se rencontrent dans le cadre des soins apportés aux patients, par exemple :
⎯ dans des hôpitaux, dans des centres de soins médicaux et des cabinets dentaires,
⎯ dans des infirmeries d’écoles, de jardins d’enfants et de maisons de retraite ;
et peuvent aussi se rencontrer sur les lieux de travail ou à domicile. Elles peuvent également concerner des
secteurs tels que des blanchisseries et des cuisines qui fournissent des produits directement aux patients.
L’EN 14885 spécifie de manière détaillée la relation des différents essais entre eux et par rapport aux
« recommandations d’usage ».
NOTE 2 La présente méthode correspond à un essai de type phase 2, étape 2.
Kemična razkužila in antiseptiki - Higiensko razkuževanje rok - Preskusna metoda in zahteve (faza 2, stopnja 2)
Ta evropski standard določa preskusno metodo s simuliranjem praktičnih pogojev za ugotovitev, ali izdelek za higiensko drgnjenje rok zmanjša prenos prehodne mikrobiološke flore na roke, ki se uporablja za drgnjenje načrtno onesnaženih rok prostovoljcev. OPOMBA 1: Opozoriti je treba na dejstvo, da so preskusi s človeškimi prostovoljci predmet predpisov v določenih evropskih državah. Ta evropski standard velja za izdelke za higiensko drgnjenje rok za uporabo za področja in primere, ko obstajajo zdravstvene indikacije za dezinfekcijo. Te indikacije se pojavljajo pri negi bolnikov, na primer:
v bolnišnicah, skupnih zdravstvenih in zobozdravstvenih ustanovah;
v klinikah šol, vrtcev in domov za starejše;
in lahko nastanejo na delovnem mestu ali doma. Vključujejo lahko tudi storitvene prostore, kot so pralnice in kuhinje, ki proizvode neposredno dostavljajo bolniku. EN 14885 podrobno določa razmerje med različnimi preskusi in priporočili za uporabo. OPOMBA 2: Ta metoda ustreza preskusu stopnje 2 faze 2.
General Information
Relations
Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Chemische Desinfektionsmittel und Antiseptika - Hygienische Händedesinfektion - Prüfverfahren und Anforderungen (Phase 2/Stufe 2)Antiseptiques et désinfectants chimiques - Traitement hygiénique de mains par frictions - Méthode d'essai et prescriptions (phase 2/étape 2)Chemical disinfectants and antiseptics - Hygienic handrub - Test method and requirements (phase 2/step 2)71.100.35Kemikalije za dezinfekcijo v industriji in domaChemicals for industrial and domestic disinfection purposes11.080.20Dezinfektanti in antiseptikiDisinfectants and antisepticsICS:Ta slovenski standard je istoveten z:EN 1500:2013SIST EN 1500:2013en,fr,de01-julij-2013SIST EN 1500:2013SLOVENSKI
STANDARDSIST EN 1500:20011DGRPHãþD
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 1500
April 2013 ICS 11.080.20; 71.100.35 Supersedes EN 1500:1997English Version
Chemical disinfectants and antiseptics - Hygienic handrub - Test method and requirements (phase 2/step 2)
Antiseptiques et désinfectants chimiques - Traitement hygiénique de mains par frictions - Méthode d'essai et prescriptions (phase 2/étape 2)
Chemische Desinfektionsmittel und Antiseptika - Hygienische Händedesinfektion - Prüfverfahren und Anforderungen (Phase 2/Stufe 2) This European Standard was approved by CEN on 1 March 2013.
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 CEN-CENELEC Management Centre 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 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.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre:
Avenue Marnix 17,
B-1000 Brussels © 2013 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 1500:2013: ESIST EN 1500:2013
Standard handrub procedure . 22 Annex B (informative)
Neutralizers and rinsing liquids . 23 Annex C (informative)
Control and validation of neutralization . 25 Annex D (informative)
Quality control of soft soap . 26 Annex E (informative)
Examples of reporting of results and significance testing . 27 Annex F (normative)
Test for non-inferiority
................................................................................................ 35 Bibliography ..................................................................................................................................................... 37
The following technical changes have been made:
Neutralization (5.5.1.2).
The number of volunteers (5.5.1.4).
The statistical evaluation (5.8).
The annexes have been completely revised. Data obtained using the former version of EN 1500 may still be used, if it is supplemented by data on neutralization, additional results from more volunteers and the new statistical evaluation of the “mixed” (old and new) set of data. The additional results will be obtained preferably in the same laboratory and with volunteers not having participated in the previous (“old”) study. If the neutralizer used in the test using the former version is not sufficiently neutralizing, a complete new test will be run. The changed procedure in Annex A is regarded as having no (or negligible) influence on the results. According to the CEN-CENELEC Internal Regulations, the national standards organisations of the following countries are bound to implement this European Standard: 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 the United Kingdom. SIST EN 1500:2013
NOTE 1 Attention is drawn to the fact that tests on human volunteers are the subject of legal provisions in certain European countries/regions. This European Standard applies to products for hygienic handrub 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 2 This method corresponds to a phase 2, step 2 test. 2 Normative references The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. EN 12353, Chemical disinfectants and antiseptics — Preservation of test organisms used for the determination of bactericidal (including Legionella), mycobactericidal, sporicidal, fungicidal and virucidal (including bacteriophages) activity
EN 14885, Chemical disinfectants and antiseptics — Application of European Standards for chemical disinfectants and antiseptics 3 Terms and definitions For the purposes of this document, the terms and definitions given in EN 14885 apply. 4 Requirements
When tested in accordance with Clause 5, the mean reduction of the release of the test organism Escherichia coli K12 achieved by the hygienic handrub with the product under test shall be at least not inferior to that achieved by a specified reference hygienic handrub (60 % volume concentration of propan-2-ol). 5 Test method
5.1 Principle Hands of volunteers are artificially contaminated with test organisms. The number of test organisms released from their fingertips into sampling fluids is assessed before and after the hygienic handrub. The ratio of the SIST EN 1500:2013
5.2.1 Test organism Escherichia coli
K12
NCTC 10538; CIP 54.117; NCIMB 100831) NOTE This test organism has been specifically chosen to meet health and safety guidance and ethical committee considerations. It is a K12 strain of E. coli of normal flora origin internationally recognised as being non-pathogenic. According to the UK catalogue of the National Collections of Industrial & Marine Bacteria (see [2]), NCIMB strain 10083 is classified as a risk group 1 organism. The German Safety Ordinance on Gene Technology [3] also assigns the K12 strain to group 1.
Directive 93/88/EEC [4] (Annex III to Directive 90/679/EEC [5]) explicitly states that non-pathogenic strains of Escherichia coli are excluded from the group 2 assignment.
5.2.2 Culture media and reagents 5.2.2.1 General All weights of chemical substances given in this European Standard refer to the anhydrous salts. Hydrated forms may be used as an alternative, but the weights required shall be adjusted to allow for consequent molecular weight differences. The reagents shall be of analytical grade and/or appropriate for microbiological purposes. They shall be free from substances that are
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