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SLOVENSKI STANDARD
01-december-2022
Kemična razkužila in antiseptiki - Kvantitativna preskusna metoda za vrednotenje
baktericidnega delovanja in delovanja na kvasovke in/ali fungicidnega in/ali
tuberkulocidnega in/ali mikobaktericidnega delovanja na neporoznih površinah z
mehanskim delovanjem z odvzemom brisa v medicini (4-področni preskus) -
Preskusna metoda in zahteve (faza 2, stopnja 2)
Chemical disinfectants and antiseptics - Quantitative test method for the evaluation of
bactericidal and yeasticidal and/or fungicidal and/or tuberculocidal and/or
mycobactericidal activity on non-porous surfaces with mechanical action employing
wipes or mops in the medical area (4- field test) - Test method and requirements (phase
2, step 2)
Chemische Desinfektion und Antiseptika - Quantitativer Prüfversuch zur Bestimmung der
bakteriziden und levuriziden und/oder fungiziden und/oder tuberkuloziden und/oder
mykobakteriziden Wirkung auf nicht-porösen Oberflächen mit mechanischer Einwirkung
mit Hilfe von Tüchern oder Mops im humanmedizinischen Bereich (4-Felder-Test) -
Prüfverfahren und Anforderungen (Phase 2, Stufe 2)
Antiseptiques et désinfectants chimiques - Méthode d’essai quantitative pour l’évaluation
de l’activité bactéricide et levuricide et/ou fongicide et/ou tuberculocide et/ou
mycobactéricide des surfaces non poreuses, avec action mécanique à l’aide de lingettes
ou de serpillières dans le domaine médical (essai à 4 zones) - Méthode d'essai et
prescriptions (phase 2, étape 2)
Ta slovenski standard je istoveten z: prEN 16615
ICS:
11.080.20 Dezinfektanti in antiseptiki Disinfectants and antiseptics
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
DRAFT
EUROPEAN STANDARD
NORME EUROPÉENNE
EUROPÄISCHE NORM
November 2022
ICS 11.080.20 Will supersede EN 16615:2015
English Version
Chemical disinfectants and antiseptics - Quantitative test method
for the evaluation of bactericidal and yeasticidal and/or
fungicidal and/or tuberculocidal and/or mycobactericidal
activity on non-porous surfaces with mechanical action
employing wipes or mops in the medical area (4- field test) - Test
method and requirements (phase 2, step 2)
Antiseptiques et désinfectants chimiques - Méthode d'essai Chemische Desinfektionsmittel und Antiseptika - Quantitatives
quantitative pour l'évaluation de l'activité bactéricide et Prüfverfahren zur Bestimmung der bakteriziden und
levuricide et/ou fongicide et/ou tuberculocide et/ou levuroziden und/oder fungiziden und/oder tuberkuloziden
mycobactéricide sur des surfaces non poreuses, avec action und/oder mykobakteriziden Wirkung auf nicht-porösen
mécanique à l'aide de lingettes ou de serpillières dans le Oberflächen mit mechanischer Einwirkung mit Hilfe von
domaine médical (essai à 4 zones) - Méthode d'essai et Tüchern oder Mops im humanmedizinischen Bereich (4-
exigences (phase 2, étape 2) Felder-Test) - 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, Türkiye 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 NORMALISATIO N
EUROPÄISCHES KOMITEE FÜR NORMUN G
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 16615:2022 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
Introduction . 4
1 Scope . 5
2 Normative references . 6
3 Terms and definitions . 6
4 Requirements . 6
5 Test methods . 7
5.1 Principle . 7
5.2 Materials and reagents . 8
5.2.1 Test organism . 8
5.2.2 Culture media and reagents . 9
5.3 Apparatus and glassware . 13
5.4 Preparation of test organism suspensions and product test solutions . 17
5.4.1 Test organism suspensions . 17
5.4.2 Product test solution . 22
5.5 Procedure for assessing the bactericidal and yeasticidal and/or fungicidal and/or
tuberculocidal and/or mycobactericidal activity of the product . 23
5.5.1 General . 23
5.5.2 Method . 25
5.6 Experimental data and calculation . 28
5.6.1 Explanation of terms and abbreviations . 28
5.6.2 Calculation . 29
5.7 Verification of methodology . 34
5.7.1 General . 34
5.7.2 Control of weighted mean counts . 34
5.7.3 Basic limits . 35
5.8 Expression of results and precision . 35
5.8.1 Overview of the different suspensions/test mixtures . 35
5.8.2 V -values . 36
c
5.8.3 Limiting test organism and bactericidal and yeasticidal concentration. 36
5.8.4 Precision, repetitions . 37
5.9 Interpretation of results – conclusion . 38
5.10 Test report . 39
Annex A (informative) Referenced strains in national collections . 41
Annex B (informative) Neutralizers . 42
Annex C (informative) Graphical representations of the test method . 43
Annex D (informative) Example of a typical test report . 46
Annex E (informative) Alternative drying endpoint . 50
Annex F (informative) Additional test temperature . 52
Bibliography . 53
European foreword
This document (prEN 16615:2022) 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.
This document will supersede EN 16615:2015.
The document was revised to adapt it to the latest state of science, to correct errors and ambiguities, to
harmonize the structure and wording with other tests of CEN/TC 216 existing or in preparation and to
improve the readability of the standard and thereby make it more understandable.
The following is a list of significant technical changes since the last edition:
— Annex ZA was deleted, the document was de-harmonized;
— N was deleted;
— Harmonization of the text with EN 13727;
— Implementation of different applications forms;
— Implementation different swab material;
— Implementation of the definition of room temperature;
— Water control always be carried out with hard water (= process and method validation);
— Polysorbate 80 should be weighed 1 g instead 1 ml;
— Implementation of Apparatus Pre-cleaning of surfaces with 2-Propanol instead of n-Propanol;
— Correction of calculation and editorial mistakes;
— Implementation of additional test surfaces;
— Implementation of standard wiping cloth (wipe) and specified wiping cloth;
— Implementation of fungicidal, tuberculocidal and mycobactericidal activity;
— Water control: Test field 1 to be taken into account for calculation of the water control;
— Implementation of Annex E and Annex F.
The changes of this revision have no impact on the test results obtained with reference to the version
EN 16615:2015. Those results are still valid.
Introduction
This document specifies a carrier test for establishing whether a chemical disinfectant for use on surfaces
administered with wipes has a bactericidal and yeasticidal activity in the fields described in the scope.
The laboratory test closely simulates practical conditions of application such as contact time,
temperature and interfering substances, including pre-drying specified test organisms on a test-surface
as carrier and wiping the product on the test-surface with a wipe. The conditions are intended to cover
general purposes. However, if for some applications the recommendations of use of a product differ
additional test conditions may be used or may need to be used.
Each utilization concentration of the product found by this test corresponds to defined experimental
conditions.
1 Scope
This document specifies a test method and the minimum requirements for bactericidal and yeasticidal,
fungicidal, tuberculocidal and/or mycobactericidal activity of chemical disinfectant products that form a
homogeneous, physically stable preparation when diluted with hard water – or in the case of ready-to-
use products – with water.
This document applies to products that are used in the medical area for disinfecting non-porous surfaces
including surfaces of medical devices by wiping or mopping – regardless if they are covered by the
93/42/EEC Directive on Medical Devices or not.
Due to the new methods of application of surface disinfectants like pre-impregnated wipes this standard
was established to cover the different application method.
...