EN 16616:2022
(Main)Chemical disinfectants and antiseptics - Chemical-thermal textile disinfection - Test method and requirements (phase 2, step 2)
Chemical disinfectants and antiseptics - Chemical-thermal textile disinfection - Test method and requirements (phase 2, step 2)
This document specifies a test method and the minimum requirements for the microbicidal activity of a specified disinfection process for the treatment of contaminated textile. This procedure is carried out by using a washing machine as specified in 5.3.2.18 and refers to the disinfection step without prewash. This procedure is not limited to certain types of textile. The suppliers' instructions are expected to be sufficient if they content the process parameters identified in the test (e.g. dosing disinfectant in whatever washing phase e.g. main wash, rinsing, disinfecting at 40 °C).
This document applies to 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 could occur in the workplace and in the home.
It could also include services such as laundries and kitchens supplying products directly for the patients.
The method described is intended to determine the activity of a product or product combination under the conditions in which they are used. This is a phase 2, step 2 laboratory test that simulates the conditions of application of the product.
EN 14885 specifies in detail the relationship of the various tests to one another and to “use recommendations”.
Chemische Desinfektionsmittel und Antiseptika - Chemothermische Wäschedesinfektion - Prüfverfahren und Anforderungen (Phase 2, Stufe 2)
Dieses Dokument legt ein Prüfverfahren für und die Mindestanforderungen an die mikrobizide Wirkung eines festgelegten Desinfektionsprozesses zur Behandlung von kontaminierten Textilien fest. Dieses Ver-fahren wird unter Einsatz einer in 5.3.2.18 festgelegten Waschmaschine durchgeführt und bezieht sich auf den Desinfektionsschritt ohne Vorwaschen. Dieses Verfahren ist nicht auf bestimmte Arten von Textilien beschränkt. Die Anweisungen des Lieferanten werden als ausreichend angenommen, wenn sie die im Prüfverfahren angegebenen Prozessparameter (z. B. Dosierung des Desinfektionsmittels in einer beliebigen Waschphase, z. B. Haupt¬waschgang, Spülen, Desinfektion bei 40 °C) enthalten.
Dieses Dokument ist anzuwenden für Bereiche und unter Bedingungen, wo eine Desinfektion aus medizinischen Gründen angezeigt ist. Indikationen dieser Art liegen bei der Patientenbetreuung vor, z. B.:
- in Krankenhäusern, kommunalen medizinischen Einrichtungen und im Dentalbereich;
- in medizinischen Einrichtungen von Schulen, Kindergärten und Heimen;
und könnten auch am Arbeitsplatz und im häuslichen Bereich gegeben sein.
Eingeschlossen sein könnten auch Einrichtungen wie Wäschereien und Küchen, die der direkten Versorgung der Patienten dienen.
Das beschriebene Verfahren dient der Bestimmung der Wirksamkeit eines Produkts oder einer Kombination von Produkten unter den Bedingungen, unter denen es/sie angewendet wird/werden. Es ist eine Labor¬prüfung der Phase 2, Stufe 2, die die Bedingungen der Produktanwendung simuliert.
EN 14885 legt im Einzelnen die Beziehungen der verschiedenen Prüfungen untereinander und zu den „Anwendungsempfehlungen“ fest.
Désinfectants chimiques et antiseptiques - Désinfection thermochimique du textile - Méthode d’essai et exigences (phase 2, étape 2)
Le présent document spécifie une méthode d’essai et les exigences minimales relatives à l’activité microbicide d’un processus spécifié de désinfection destiné au traitement de textile contaminé. Cette procédure consiste à utiliser une machine à laver comme spécifié en 5.3.2.18 et se rapporte à l’étape de désinfection sans prélavage. Cette procédure ne se limite pas à certains types de textile. Il est escompté que les instructions du fournisseur seront suffisantes si elles comprennent les paramètres de processus identifiés pour l’essai (par exemple, le dosage du désinfectant quelle que soit l’étape de lavage, par exemple, le lavage, le rinçage, la désinfection à 40 °C).
Le présent document s’applique aux secteurs et situations pour lesquels la désinfection est médicalement préconisée. Ces préconisations touchent les soins délivrés aux patients, par exemple :
— dans les hôpitaux, les cabinets médicaux et dentaires ;
— dans les infirmeries des écoles, des écoles maternelles et des maisons de repos ;
et pourraient concerner les lieux de travail et le domicile des particuliers.
Le présent document pourrait également s’appliquer aux textiles entretenus par des blanchisseries et aux articles textiles de cuisine en contact direct avec les patients.
La méthode décrite a pour objet de déterminer l’activité d’un produit ou d’une combinaison de produits dans leurs conditions d’emploi. Il s’agit d’un essai en laboratoire de phase 2, étape 2 qui simule les conditions d’application du produit.
L’EN 14885 spécifie en détail la relation entre les divers essais et la façon « d’appliquer les recommandations ».
Kemična razkužila in antiseptiki - Termokemično razkuževanje tekstila - Preskusna metoda in zahteve (faza 2, stopnja 2)
Ta dokument določa preskusno metodo in minimalne zahteve za mikrobicidno delovanje definiranega postopka razkuževanja pri obdelavi kontaminiranega tekstila. Ta postopek se izvaja z uporabo pralnega stroja, kot je določeno v točki 5.3.2.18, in se navezuje na korak razkuževanja brez predpranja. Ta postopek ni omejen na določene vrste tekstila. Navodila dobavitelja zadoščajo za popolno izvedbo metode iz standarda (npr. odmerjanje razkužila v kateri koli fazi pranja, npr. glavno pranje, izpiranje, razkuževanje pri 40 °C). Ta dokument se uporablja za področja in primere, ko obstajajo zdravniške indikacije za razkuževanje. 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 nastanejo na delovnem mestu ali doma. Vključujejo lahko tudi storitve, kot so pralnice in kuhinje, ki proizvode dostavljajo neposredno bolnikom. Opisana metoda je namenjena določevanju dejavnosti izdelka ali kombinacije izdelkov pod pogoji, v katerih se uporabljajo. To je 2. stopnja laboratorijskega preskusa faze 2, ki simulira pogoje uporabe izdelka. OPOMBA: Ta metoda ustreza 2. stopnji preskusa faze 2 (glej standard EN 14885). EN 14885 podrobno določa razmerje med različnimi preskusi in priporočili za uporabo.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-november-2022
Nadomešča:
SIST EN 16616:2015
Kemična razkužila in antiseptiki - Termokemično razkuževanje tekstila - Preskusna
metoda in zahteve (faza 2, stopnja 2)
Chemical disinfectants and antiseptics - Chemical-thermal textile disinfection - Test
method and requirements (phase 2, step 2)
Chemisches Desinfektionsmittel und Antiseptika - Chemothermische
Wäschedesinfektion - Prüfverfahren und Anforderungen (Phase 2, Stufe 2)
Désinfectants chimiques et antiseptiques - Désinfection thermochimique du textile -
Méthode d'essai et prescriptions (phase 2, étape 2)
Ta slovenski standard je istoveten z: EN 16616:2022
ICS:
11.080.20 Dezinfektanti in antiseptiki Disinfectants and antiseptics
71.100.35 Kemikalije za dezinfekcijo v Chemicals for industrial and
industriji in doma domestic disinfection
purposes
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN 16616
EUROPEAN STANDARD
NORME EUROPÉENNE
August 2022
EUROPÄISCHE NORM
ICS 11.080.20 Supersedes EN 16616:2015
English Version
Chemical disinfectants and antiseptics - Chemical-thermal
textile disinfection - Test method and requirements (phase
2, step 2)
Désinfectants chimiques et antiseptiques - Désinfection Chemische Desinfektionsmittel und Antiseptika -
thermochimique du textile - Méthode d'essai et Chemothermische Wäschedesinfektion - Prüfverfahren
prescriptions (phase 2, étape 2) und Anforderungen (Phase 2, Stufe 2)
This European Standard was approved by CEN on 27 June 2022.
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, Turkey 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
© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 16616:2022 E
worldwide for CEN national Members.
Contents Page
European foreword . 4
Introduction . 6
1 Scope . 7
2 Normative references . 7
3 Terms and definitions . 7
4 Requirements . 8
5 Test methods . 9
5.1 Principle . 9
5.2 Materials and reagents . 9
5.2.1 Test organisms . 9
5.2.2 Culture media and reagents . 10
5.3 Apparatus and glassware . 12
5.3.1 General . 12
5.3.2 Usual microbiological laboratory equipment . 13
5.4 Preparation of test organism suspensions (test suspension) . 15
5.4.1 General . 15
5.4.2 Preservation and stock cultures of test organisms. 15
5.4.3 Working culture and test organisms . 16
5.4.4 Test suspension (N) . 16
5.4.5 Inoculation of the carriers . 20
5.5 Procedure for assessing the microbicidal activity of the product . 21
5.5.1 General . 21
5.5.2 Test procedure . 22
5.6 Experimental data and calculation . 24
5.6.1 Explanation of terms and abbreviations . 24
5.6.2 Calculation . 25
5.7 Verification of methodology . 27
5.7.1 General . 27
5.7.2 Control of weighted mean counts . 28
5.7.3 Basic limits . 28
5.8 Expression of results and precision . 28
5.8.1 Reduction . 28
5.8.2 Repetitions . 29
5.9 Interpretation of results – conclusion . 29
5.9.1 General . 29
5.9.2 Microbicidal activity . 29
5.10 Test report . 30
Annex A (informative) Referenced strains in national collections . 32
Annex B (informative) Suitable neutralizers . 34
B.1 General . 34
B.2 Neutralizers . 34
B.3 Neutralizer added to the agar for counting . 35
Annex C (informative) Graphical representations of the test method . 36
Annex D (informative) Example of washing machine specification . 37
Annex E (informative) Preparation of hard water for using in the test and reference
procedures . 38
Annex F (informative) Test report (example) . 39
Annex G (informative) Example for loading the washing machine . 46
Bibliography . 48
European foreword
This document (EN 16616:2022) 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 February 2023, and conflicting national standards shall
be withdrawn at the latest by February 2023.
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.
This document supersedes EN 16616:2015.
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 document and thereby make it more understandable. The following is a
list of significant technical changes since the last edition, EN 16616:2015:
— the scope is adapted to the scope of the WG 1;
— in Clause 4 the requirements for phase 2, step 1 tests are deleted;
— addition of water for the test and reference control (5.2.2.4);
— the example for washing machines in 5.3.2.18 of the previous version is switched to Annex D;
— addition of Potter S 1 apparatus (5.3.2.22);
— adaption of 5.4.3.1 to 5.4.3.3 to other current standards;
— review of 5.4.4 (editorial changes and better description);
— re-wording of the description of the neutralization (5.5.1.2) and addition of a reference to phase 2,
step 1 tests;
— addition of an information on using a spectrophotometer for counting cell numbers of mycobacteria
in 5.4.4.3 (NOTE);
— addition of the documentation and justification of the choice of the neutralizer in the test report
(5.5.1.2);
— addition of a new NOTE in 5.5.2.1;
— addition of a NOTE and the reference to Annex G in 5.5.2.2;
— addition of the reference control (5.5.2.3);
— RII is deleted;
— a reference to phase 2, step 1 tests was added;
— correction and adaption to the current tests of Table 2 (5.6.1.1);
— addition of two paragraphs in 5.6.2.1 (former 5.6.2.3);
— in 5.6.2.2 the V -values will be expressed per carrier (former per ml);
C
— addition of N and N in the calculation (5.6.2.3);
— in 5.6.2.4 the calculation is changed to values per carrier, the formula is corrected and the weighted
mean is added in all calculations;
— in 5.6.2.5 calculation is changed: only N will be calculated, RI is not counted and RII, B and C are no
w
longer used in the standard;
— correction of the example in 5.7.2;
— adaption of 5.7.3 to the tests in the current version;
— addition of the requirements of the test report in 5.10;
— adaption of Annex A to EN 12353;
— correction of Annex C;
— addition of a new Annex D “Example of washing machine specification”;
— addition of a new Annex E “Preparation of hard water for using in the test and reference procedures”;
— addition of a new Annex F “Test report (example)”;
— addition of a new Annex G “Example for loading the washing machine”;
— document editorially revised, clauses not applied (from the old version) deleted;
— de-harmonization of the standard, Annex ZA deleted.
The changes of this revision have no impact on the test results obtained with reference to the version
EN 16616:2015. Those results are still valid except the reduction of the reference control N was higher
w
than 3 lg and/or the calculation of the results followed the wrong way of version 2015.
Any feedback and questions on this document should be directed to the users’ national standards body.
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