SIST EN 17430:2024
(Main)Chemical disinfectants and antiseptics - Hygienic handrub virucidal - Test method and requirements (phase 2, step 2)
Chemical disinfectants and antiseptics - Hygienic handrub virucidal - 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 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 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 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 Virenkontami
nation verringert, wenn es auf den künstlich kontaminierten Händen von freiwilligen Probanden verrieben wird.
ANMERKUNG1 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 Bedingun
gen 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.
EN14885 legt im Einzelnen die Beziehungen der verschiedenen Prüfungen untereinander und zu den „Anwen
dungsempfehlungen“ fest.
ANMERKUNG2 Das Verfahren entspricht einer Prüfung der Phase2, Stufe2.
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 razkuževanje rok z drgnjenjem z virucidnim sredstvom - 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 kontaminacije z virusom na roke, če 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 se uporablja 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, javnih zdravstvenih in zobozdravstvenih ustanovah;
– v ambulantah šol, vrtcev in domov za starejše;
ter 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 2: Ta metoda ustreza 2. stopnji preskusa faze 2.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-junij-2024
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)
Antiseptiques et désinfectants chimiques - Traitement hygiénique virucide des mains par
frictions - Méthode d'essai et prescriptions (phase 2, étape 2)
Ta slovenski standard je istoveten z: EN 17430:2024
ICS:
11.080.20 Dezinfektanti in antiseptiki Disinfectants and antiseptics
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN 17430
EUROPEAN STANDARD
NORME EUROPÉENNE
March 2024
EUROPÄISCHE NORM
ICS 11.080.20
English Version
Chemical disinfectants and antiseptics - Hygienic handrub
virucidal - Test method and requirements (phase 2/step 2)
Antiseptiques et désinfectants chimiques - Traitement Chemische Desinfektionsmittel und Antiseptika -
hygiénique virucide des mains par frictions - Méthode Viruzide hygienische Händedesinfektion -
d'essai et prescriptions (phase 2/étape 2) Prüfverfahren und Anforderungen (Phase 2/Stufe 2)
This European Standard was approved by CEN on 19 February 2024.
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, 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, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2024 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 17430:2024 E
worldwide for CEN national Members.
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 media and reagents . 6
5.3 Apparatus and glassware . 8
5.3.1 General . 8
5.3.2 Usual microbiological laboratory equipment and, in particular, the following: . 8
5.4 Preparation of test organism suspensions and product test solutions . 9
5.4.1 Test virus suspension (test organisms suspensions, contamination fluid) . 9
5.4.2 Cell lines . 10
5.5 Cell culture preparation for virucidal testing . 10
5.6 Infectivity assay . 10
5.6.1 Quantal tests (end point titration). 10
5.6.2 Plaque assay . 10
5.6.3 Product test solutions . 11
5.7 Procedure for assessing the virucidal activity of the product on volunteers' hands . 11
5.7.1 General . 11
5.7.2 Test procedure with volunteers . 12
6 Experimental data and calculation . 14
6.1 Protocol of the results . 14
6.2 Calculation of virus titre . 14
6.3 Calculation of PFU . 14
6.4 Calculation of the lg reduction R (lg prevalue minus lg postvalue) . 14
6.5 Verification of the methodology — Test validation . 14
6.6 Statistical evaluation (significance testing), expression of results and precision . 15
6.7 Conclusion. 15
6.8 Test report . 15
Annex A (normative) Standard handrub procedure . 17
Annex B (informative) Calculation of the viral infectivity titre . 18
determination by the Spearman-Kärber method . 18
B.1 Example of TCID
B.2 Calculation of plaque-forming units (PFU) . 18
Annex C (informative) Quality control of soft soap . 20
Annex D (informative) Examples of reporting of results and significance testing . 21
Annex E (normative) Test for non-inferiority . 27
Bibliography . 29
European foreword
This document (EN 17430:2024) has been prepared by Technical Committee CEN/TC 216 “Chemical
disinfectants and antiseptics”, the secretariat of which is held by AFNOR.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by September 2024, and conflicting national standards shall
be withdrawn at the latest by September 2024.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
Any feedback and questions on this document should be directed to the users’ national standards body.
A complete listing of these bodies can be found on the CEN website.
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, 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, Türkiye and the United
Kingdom.
1 Scope
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 is applicable 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 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.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. 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.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
• ISO Online browsing platform: available at https://www.iso.org/obp
• IEC Electropedia: available at https://www.electropedia.org/
4 Requirements
When tested in accordance with Clause 5, the mean reduction of the test organism murine norovirus
strain S99 Berlin 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 (70 % volume concentration of
ethanol).
Table 1 — Minimum and additional test conditions
Hygienic handrub
a
Virucidal activity
Murine norovirus
Test virus
b
Limited spectrum virucidal activity
Murine norovirus
Test temperature room temperature of 21,5 °C ± 3,5 °C
according to the manufacturer’s recommendation, but between
Contact time
30 s and 60 s
Additional
Further contact time(s)
conditions
a
To claim the virucidal activity the product shall pass standards EN 14476 with Poliovirus,
Adenovirus and Murine Norovirus.
b
To claim limited spectrum virucidal activity the product shall pass EN 14476 with Adenovirus
and Murine Norovirus.
5 Test methods
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 two resulting values (virus titres) represents a measure for the virucidal activity of the
product tested. The necessary precision is achieved by repeating the test on 18 to 22 volunteers. To
compensate for extraneous influences, it is compared with the reduction obtained by a reference handrub
which is performed with the same volunteers, on the same day and under comparable environmental
conditions.
5.2 Materials and reagents
5.2.1 Test organism
Murine norovirus strain S99 Berlin
This test organism has been specifically chosen to meet health and safety guidance and ethical committee
considerations. According to German Ordinance on Biological Substances (BiostoffV)/TRBA 462 Murine
Norovirus is
...
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