Chemical disinfectants and antiseptics - Hygienic handrub virucidal - Test method and requirements (phase 2/step 2)

This document specifies a test method simulating practical conditions for establishing whether a product for hygienic handrub reduces the release of virus contamination 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 document 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 kindergardens and of nursing homes;
and-can occur in the workplace and in the home. It can 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.
- in clinics of schools, of kindergardens 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 - Viruzide hygienische Händedesinfektion - Prüfverfahren und Anforderungen (Phase 2, Stufe 2)

Dieses Dokument legt ein Prüfverfahren fest, das praktische Bedingungen simuliert um festzustellen, ob ein Produkt für die hygienische Händedesinfektion die Abgabe der auf den Händen befindlichen Virenkontamination 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.
Dieses Dokument 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 des 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 virucide des mains par frictions - Méthode d'essai et prescriptions (phase 2/étape 2)

Le présent document spécifie une méthode d’essai simulant les conditions pratiques permettant de déterminer si un produit pour traitement hygiénique des mains par frictions réduit la libération d’une contamination virale sur les mains lorsqu’il est frotté sur les mains de volontaires contaminées artificiellement.
NOTE 1 L’attention est attirée sur le fait que les essais sur des volontaires humains sont soumis à des dispositions légales dans certains pays/certaines régions d’Europe.
Le présent document s’applique aux produits pour traitement hygiénique des mains par frictions à utiliser dans les domaines et situations où la désinfection est indiquée en médecine humaine. De telles indications se produisent pour les soins des patients, par exemple :
- dans les hôpitaux, les centres médicaux communautaires et les institutions dentaires ;
- dans les cliniques d’écoles, de jardins d’enfants et de maisons de soins infirmiers ;
et peuvent se produire sur le lieu de travail et à la maison. Elles peuvent également inclure les services tels que les blanchisseries et les cuisines fournissant directement des produits au patient.
L’EN 14885 spécifie de façon détaillée les relations des différents essais entre eux et avec les « recommandations d’emploi ».
NOTE 2 Cette méthode correspond à un essai de phase 2, étape 2.

Kemična razkužila in antiseptiki - Higiensko virucidno razkuževanje rok - Preskusna metoda in zahteve (faza 2, stopnja 2)

General Information

Status
Not Published
Publication Date
28-Feb-2021
Current Stage
4098 - Decision to abandon - Enquiry
Completion Date
23-Apr-2021

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Standards Content (Sample)

SLOVENSKI STANDARD
oSIST prEN 17430:2019
01-september-2019
Kemična razkužila in antiseptiki - Higiensko virucidno razkuževanje rok -
Preskusna metoda in zahteve (faza 2, stopnja 2)
Chemical disinfectants and antiseptics - Hygienic handrub virucidal - Test method and
requirements (phase 2/step 2)
Chemische Desinfektionsmittel und Antiseptika - Viruzide hygienische
Händedesinfektion - Prüfverfahren und Anforderungen (Phase 2, Stufe 2)
Désinfectants chimiques et antiseptiques - Traitement hygiénique virucide de mains par
frictions - Méthode d'essai et prescriptions (phase 2, étape 2)
Ta slovenski standard je istoveten z: prEN 17430
ICS:
11.080.20 Dezinfektanti in antiseptiki Disinfectants and antiseptics
oSIST prEN 17430:2019 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
oSIST prEN 17430:2019

---------------------- Page: 2 ----------------------
oSIST prEN 17430:2019


DRAFT
EUROPEAN STANDARD
prEN 17430
NORME EUROPÉENNE

EUROPÄISCHE NORM

August 2019
ICS 11.080.20
English Version

Chemical disinfectants and antiseptics - Hygienic handrub
virucidal - Test method and requirements (phase 2/step 2)
Désinfectants chimiques et antiseptiques ¿ Traitement Chemische Desinfektionsmittel und Antiseptika -
hygiénique virucide de mains par frictions ¿ Méthode Viruzide hygienische Händedesinfektion -
d'essai et prescriptions (phase 2, étape 2) Prüfverfahren und Anforderungen (Phase 2, Stufe 2)
This draft European Standard is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee
CEN/TC 216.

If this draft becomes a European Standard, 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.

This draft European Standard 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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, 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: Rue de la Science 23, B-1040 Brussels
© 2019 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 17430:2019 E
worldwide for CEN national Members.

---------------------- Page: 3 ----------------------
oSIST prEN 17430:2019
prEN 17430:2019 (E)
Contents Page
European foreword . 3
1 Scope . 4
2 Normative references . 4
3 Terms and definitions . 4
4 Requirements . 4
5 Test methods . 5
5.1 Principle . 5
5.2 Materials and reagents . 5
5.2.1 Test organism . 5
5.2.2 Culture medi
...

SLOVENSKI STANDARD
oSIST prEN 17430:2022
01-september-2022
Kemična razkužila in antiseptiki - Higiensko razkuževanje rok z drgnjenjem z
virucidnim sredstvom - Preskusna metoda in zahteve (faza 2, stopnja 2)
Chemical disinfectants and antiseptics - Hygienic handrub virucidal - Test method and
requirements (phase 2, step 2)
Chemische Desinfektionsmittel und Antiseptika - Viruzide hygienische Händedesinfektion
- Prüfverfahren und Anforderungen (Phase 2, Stufe 2)
Désinfectants chimiques et antiseptiques - Traitement hygiénique de mains par frictions
virucide - Méthode d'essai et prescriptions (phase 2, étape 2)
Ta slovenski standard je istoveten z: prEN 17430
ICS:
11.080.20 Dezinfektanti in antiseptiki Disinfectants and antiseptics
oSIST prEN 17430:2022 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
oSIST prEN 17430:2022

---------------------- Page: 2 ----------------------
oSIST prEN 17430:2022


DRAFT
EUROPEAN STANDARD
prEN 17430
NORME EUROPÉENNE

EUROPÄISCHE NORM

August 2022
ICS 11.080.20
English Version

Chemical disinfectants and antiseptics - Hygienic handrub
virucidal - Test method and requirements (phase 2, step 2)
Désinfectants chimiques et antiseptiques ¿ Traitement Chemische Desinfektionsmittel und Antiseptika -
hygiénique de mains par frictions virucide ¿ Méthode Viruzide hygienische Händedesinfektion -
d'essai et prescriptions (phase 2, étape 2) Prüfverfahren und Anforderungen (Phase 2, Stufe 2)
This draft European Standard is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee
CEN/TC 216.

If this draft becomes a European Standard, 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.

This draft European Standard 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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, 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: Rue de la Science 23, B-1040 Brussels
© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 17430:2022 E
worldwide for CEN national Members.

---------------------- Page: 3 ----------------------
oSIST prEN 17430:2022
prEN 17430:2022 (E)
Contents Page
European foreword . 3
1 Scope . 4
2 Normative references . 4
3 Terms and definitions . 4
4 Requirements . 5
5 Test methods . 5
5.1 Principle . 5
5.2 Materials and reagents . 5
5.2.1 Test organism .
...

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