SIST EN 14885:2022
(Main)Chemical disinfectants and antiseptics - Application of European Standards for chemical disinfectants and antiseptics
Chemical disinfectants and antiseptics - Application of European Standards for chemical disinfectants and antiseptics
This European Standard specifies the European Standards to which products have to conform in order to support the claims for microbicidal activity which are referred to in this European Standard.
This European Standard also specifies terms and definitions which are used in European Standards.
It is applicable to products for which activity is claimed against the following microorganisms: vegetative bacteria (including mycobacteria and Legionella), bacterial spores, yeasts, fungal spores and viruses (including bacteriophages).
It is intended to:
a) enable manufacturers of products to select the appropriate standards to be used in order to provide data which support their claims for a specific product;
b) enable users of the product to assess the information provided by the manufacturer in relation to the use for which they intend to use the product;
c) assist regulatory authorities in assessing claims made by the manufacturer or by the person responsible for placing the product on the market.
It is applicable to products to be used in the area of human medicine, the veterinary area and in food, industrial, domestic and institutional areas.
In the area of human medicine (Working Group 1, i. e. WG 1), it is applicable to chemical disinfectants and antiseptics to be used in areas and situations where disinfection or antisepsis is medically indicated. Such indications occur in patient care
— in hospitals, in community medical facilities and dental institutions,
— in clinics of schools, of kindergartens and of nursing homes,
— and may also occur in the workplace and in the home. It may also include services such as in laundries and kitchens supplying products directly for the patient.
In the veterinary area (WG 2) it is applicable to chemical disinfectants and antiseptics to be used in the areas of breeding, husbandry, veterinary care facilities, production, transport and disposal of animals. It is not applicable to chemical disinfectants used in the food chain following death and entry to the processing industry.
In food, industrial, domestic and institutional areas (WG 3) it is applicable to chemical disinfectants and antiseptics to be used in processing, distribution and retailing of food of animal or vegetable origin. It is also applicable to products for all public areas where disinfection is not medically indicated (homes, catering, schools, nurseries, transports, hotels, offices etc.) and products used in packaging, biotechnology, pharmaceutical, cosmetic etc. industries.
This European Standard is also applicable to active substances and products under development for which no area of application has yet been specified.
This standard will be periodically updated to reflect the current published versions of each standard developed in CEN/TC 216. Independent of this update newly published standards should be used, even if they are not yet mentioned in EN 14885.
This European Standard does not refer to methods for testing the toxicological and ecotoxicological properties of products or active substances.
Chemische Desinfektionsmittel und Antiseptika - Anwendung Europäischer Normen für chemische Desinfektionsmittel und Antiseptika
In diesem Dokument sind die Europäischen Normen festgelegt, denen Produkte entsprechen müssen, um die Auslobungen hinsichtlich der mikrobiziden Wirkung abzusichern, auf die in diesem Dokument verwiesen wird.
In diesem Dokument sind auch Begriffe festgelegt, die in Europäischen Normen verwendet werden.
Es gilt für Produkte, für die eine Wirkung gegen die folgenden Mikroorganismen augelobt wird: vegetative Bakterien (einschließlich Mykobakterien und Legionella), Bakteriensporen, Hefen, Pilzsporen und Viren (einschließlich Bakteriophagen).
Es dient dazu:
a) Hersteller von Produkten zu befähigen, die einschlägigen Normen auszuwählen, die anzuwenden sind, um Daten bereitzustellen, die Auslobungen für ein bestimmtes Produkt absichern;
b) Anwender des Produkts zu befähigen, die vom Hersteller gelieferten Angaben hinsichtlich des Gebrauchs, für den sie die Anwendung des Produkts beabsichtigen, zu beurteilen;
c) verantwortliche Aufsichtsbehörden bei der Beurteilung von Auslobungen zu unterstützen, die durch den Hersteller oder die für das Inverkehrbringen des Produkts verantwortliche Person gemacht werden.
Es gilt für Produkte, die in den Bereichen Humanmedizin, Veterinärmedizin sowie Lebensmittel, Industrie, Haushalt und öffentliche Einrichtungen angewendet werden.
Im Bereich der Humanmedizin (Arbeitsgruppe 1, d. h. WG 1, en: Working Group) gilt es für chemische Desinfektionsmittel und Antiseptika, die in Bereichen und Situationen angewendet werden sollen, wo die Desinfektion oder Antisepsis medizinisch angezeigt ist. Solche Indikationen bestehen bei der Patientenbetreuung
— in Krankenhäusern, kommunalen medizinischen Einrichtungen, im zahnmedizinischen Bereich oder in medizinischen Analytik oder Forschungslaboratorien,
— in medizinischen Einrichtungen in Schulen, Kindergärten und Heimen,
— und können auch am Arbeitsplatz und im häuslichen Bereich gegeben sein. Einbezogen sein können auch Einrichtungen wie Wäschereien und Küchen, die der direkten Versorgung von Patienten dienen.
Im Bereich der Veterinärmedizin (WG 2) gilt es für chemische Desinfektionsmittel und Antiseptika, die bei der Aufzucht, Haltung, in veterinärmedizinischen Pflegeeinrichtungen, bei der Produktion, beim Transport und bei der Tierkörperbeseitigung sowie in veterinärmedizinischen Analytik und Forschungslaboratorien angewendet werden. Es gilt nicht für chemische Desinfektionsmittel, die in der Nahrungsmittelkette nach dem Schlachten und dem Eingang in die verarbeitende Industrie angewendet werden.
In den Bereichen Lebensmittel, Industrie, Haushalt und öffentliche Einrichtungen (WG 3) gilt es für chemische Desinfektionsmittel und Antiseptika, die bei Verarbeitung, Vertrieb und im Einzelhandel von Nahrungsmitteln tierischer oder pflanzlicher Herkunft angewendet werden. Es gilt auch für Produkte für alle öffentlichen Bereiche, in denen eine Desinfektion nicht medizinisch angezeigt ist (Wohnungen, Lebensmittellieferanten, Schulen, Kinderkrippen, Transportwesen, Hotels, Büros usw.), sowie für Produkte, die in der Verpackungsindustrie, Biotechnologie, Laboratorien (ausgenommen veterinärmedizinische und medizinische Analytik und Forschungslaboratorien) sowie der pharmazeutischen, kosmetischen usw. Industrie verwendet werden.
Dieses Dokument gilt auch für Wirkstoffe und Produkte, die sich noch in der Entwicklung befinden und für die noch kein Anwendungsbereich festgelegt worden ist.
Dieses Dokument wird regelmäßig aktualisiert, damit es die neuesten vom CEN/TC 216 publizierten Versionen widerspiegelt. Unabhängig von dieser Aktualisierung sind die neu publizierten Normen zu verwenden, selbst wenn Sie in EN 14885 noch nicht erwähnt werden.
Dieses Dokument verweist nicht auf Verfahren zur Prüfung der toxikologischen und ökotoxischen Eigenschaften von Produkten oder Wirkstoffen.
Antiseptiques et désinfectants chimiques - Application des Normes européennes sur les antiseptiques et désinfectants chimiques
Le présent document spécifie les Normes européennes auxquelles les produits doivent se conformer afin de soutenir les revendications d’activité microbicide auxquelles il est fait référence dans le présent document.
Le présent document spécifie également les termes et définitions utilisés dans les Normes européennes.
Il s’applique aux produits pour lesquels une activité est revendiquée contre les microorganismes suivants : bactéries végétatives (y compris mycobactéries et Legionella), spores bactériennes, levures, spores de champignons et virus (y compris les bactériophages).
Il a pour objet :
a) de permettre aux fabricants de produits de choisir les normes à utiliser pour obtenir des données venant supporter leurs revendications pour un produit spécifique ;
b) de permettre aux utilisateurs du produit d’évaluer l’information fournie par le fabricant en fonction de l’usage prévu du produit ;
c) d’aider les autorités règlementaires à évaluer les revendications du fabricant ou de la personne responsable de la mise sur le marché du produit.
Il est applicable aux produits destinés à être utilisés dans les domaines de la médecine humaine, vétérinaire et dans les secteurs agro alimentaire, industriel, domestique et en collectivité.
Dans le domaine de la médecine humaine (Groupe de travail 1, ou WG 1), il est applicable aux antiseptiques et désinfectants chimiques à utiliser dans les secteurs et les situations où la désinfection ou l’antisepsie est médicalement préconisée. Ces indications relèvent des soins aux patients :
— dans les hôpitaux, les établissements médicaux, les centres de soins dentaires et les laboratoires de recherche et d’analyses médicales ;
— dans les infirmeries d’écoles, de jardins d’enfants et de crèches ;
— et peuvent également concerner le lieu de travail et le domicile. Il peut également s’agir de services, comme des blanchisseries ou des cuisines, fournissant directement des produits pour le patient.
Dans le domaine vétérinaire (WG 2), il est applicable aux antiseptiques et désinfectants chimiques destinés à être utilisés dans les zones de reproduction et d’élevage, les établissements de soins vétérinaires, la production, le transport et l’abattage des animaux et dans les laboratoires de recherche et d’analyses vétérinaires. Il n’est pas applicable aux désinfectants chimiques utilisés dans la chaîne alimentaire après la mort de l’animal et son traitement par l’industrie de transformation.
Dans les secteurs agro alimentaire, industriel, domestique et en collectivité (WG 3), il est applicable aux antiseptiques et désinfectants chimiques utilisés dans les locaux de transformation, de distribution et de vente au détail de denrées alimentaires d’origine animale ou végétale. Il est également applicable aux produits destinés à être utilisés dans des zones tous publics où la désinfection n’est pas médicalement prescrite (domiciles, établissements de restauration, écoles, crèches, moyens de transport, hôtels, bureaux, etc.) et aux produits utilisés pour l’emballage, les biotechnologies, les laboratoires (sauf ceux de recherche et d’analyses vétérinaires et médicales), les industries pharmaceutiques ou cosmétiques, etc.
Le présent document est également applicable aux substances actives et produits en cours de développement pour lesquels aucun domaine d’application n’a encore été précisé.
Le présent document sera régulièrement mis à jour pour refléter les versions actuelles publiées de chaque norme du CEN/TC 216. Indépendamment de cette mise à jour, il faut utiliser les normes nouvellement publiées, même si elles ne sont pas encore mentionnées dans l’EN 14885.
Le présent document ne fait pas référence à des méthodes d’essai des propriétés toxicologiques et écotoxicologiques des produits ou substances actives.
Kemična razkužila in antiseptiki - Uporaba evropskih standardov za kemična razkužila in antiseptike
Ta evropski standard določa evropske standarde, s katerimi morajo biti skladni izdelki za dokazovanje trditev o mikrobicidnem delovanju, zajetih v tem evropskem standardu.
Ta evropski standard določa tudi izraze in definicije, ki se uporabljajo v evropskih standardih.
Uporablja se za izdelke, ki delujejo proti naslednjim mikroorganizmom: vegetativnim bakterijam (vključno z mikobakterijami in legionelo), bakterijskim sporam, glivam, glivnim sporam in virusom (vključno z bakteriofagi).
Nameni standarda so:
a) omogočanje proizvajalcem izdelkov, da izberejo primerne standarde za zagotavljanje podatkov, ki podpirajo njihove trditve za določen izdelek;
b) omogočanje uporabnikom izdelkov, da ocenijo informacije, ki jih zagotovi proizvajalec, glede na namen uporabe izdelka;
c) pomoč regulativnim organom pri ocenjevanju trditev proizvajalca ali osebe, ki izdelek da na trg.
Uporablja se za izdelke, ki se uporabljajo v humani medicini in veterini ter živilski in drugih industrijah, javnih ustanovah in gospodinjstvu.
Na področju humane medicine (delovna skupina 1, tj. WG 1) se uporablja za kemična razkužila in antiseptike, ki se uporabljajo na področjih in v primerih, kjer obstajajo zdravstvene indikacije za razkuževanje ali antisepso. Te indikacije se pojavljajo pri negi bolnikov
– v bolnišnicah, javnih zdravstvenih in zobozdravstvenih ustanovah,
– v ambulantah šol, vrtcev in domov za starejše,
– in lahko nastanejo tudi na delovnem mestu ali doma. Vključujejo lahko tudi storitvene prostore, kot so pralnice in kuhinje, ki proizvode dostavljajo neposredno bolnikom.
Na področju veterine (WG 2) se uporablja za kemična razkužila in antiseptike, ki se uporabljajo na področjih vzreje, živinoreje, veterinarskih ustanov, proizvodnje, prevoza in odstranjevanja živali. Ne uporablja se za kemična razkužila, ki se uporabljajo v prehrambeni verigi po smrti in so del predelovalne industrije.
V živilski in drugih industrijah, gospodinjstvu ter javnih ustanovah (WG 3) se uporablja za kemična razkužila in antiseptike, ki se uporabljajo pri predelavi, distribuciji in prodaji živil živalskega ali rastlinskega izvora. Uporablja se tudi za izdelke za vsa javna področja, kjer ni zdravstvenih indikacij za dezinfekcijo (domovi, gostinstvo, šole, vrtci, prevozna sredstva, hoteli, pisarne itd.), in za izdelke, ki se uporabljajo v industriji pakiranja, biotehnologije, farmacevtski industriji, kozmetični industriji itd.
Ta evropski standard se uporablja tudi za aktivne snovi in izdelke v razvoju, za katere področje uporabe še ni bilo določeno.
Ta standard bo redno posodobljen, da bo odražal trenutno objavljene različice vsakega standarda, pripravljenega v CEN/TC 216. Neodvisno od teh posodobitev je treba uporabiti novo objavljene standarde, tudi če v standardu EN 14885 še niso omenjeni.
Ta evropski standard se ne navezuje na metode za preskušanje toksikoloških in ekotoksikoloških lastnosti izdelkov ali aktivnih snovi.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN 14885:2022
01-november-2022
Nadomešča:
SIST EN 14885:2019
SIST-TP CEN/TR 17296:2019
Kemična razkužila in antiseptiki - Uporaba evropskih standardov za kemična
razkužila in antiseptike
Chemical disinfectants and antiseptics - Application of European Standards for chemical
disinfectants and antiseptics
Chemische Desinfektionsmittel und Antiseptika - Anwendung Europäischer Normen für
chemische Desinfektionsmittel und Antiseptika
Antiseptiques et désinfectants chimiques - Application des Normes européennes sur les
antiseptiques et désinfectants chimiques
Ta slovenski standard je istoveten z: EN 14885:2022
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
SIST EN 14885:2022 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN 14885:2022
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SIST EN 14885:2022
EN 14885
EUROPEAN STANDARD
NORME EUROPÉENNE
July 2022
EUROPÄISCHE NORM
ICS 11.080.20; 71.100.35 Supersedes EN 14885:2018, CEN/TR 17296:2018
English Version
Chemical disinfectants and antiseptics - Application of
European Standards for chemical disinfectants and
antiseptics
Antiseptiques et désinfectants chimiques - Application Chemische Desinfektionsmittel und Antiseptika -
des Normes européennes sur les antiseptiques et Anwendung Europäischer Normen für chemische
désinfectants chimiques Desinfektionsmittel und Antiseptika
This European Standard was approved by CEN on 20 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 14885:2022 E
worldwide for CEN national Members.
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SIST EN 14885:2022
EN 14885:2022 (E)
Contents Page
European foreword . 4
Introduction . 6
1 Scope . 7
2 Normative references . 8
3 Terms and definitions . 10
3.1 Chemical disinfectant or antiseptic procedures and product types. 10
3.2 Chemical disinfectant or antiseptic action . 12
3.3 General terms . 14
4 Procedures for claiming activity . 16
4.1 Category of tests . 16
4.2 General . 17
4.3 Chemical disinfectants and antiseptics for use in the medical area . 19
4.3.1 General . 19
4.3.2 Fields of application / Standards necessary to be passed for basic and additional
label claims. 21
4.3.3 Overview of the standards relevant for the medical area and their main features . 24
4.4 Chemical disinfectants and antiseptics for use in the veterinary area . 38
4.4.1 General . 38
4.4.2 Overview of the standards relevant for the veterinary area and their main features . 40
4.5 Chemical disinfectants and antiseptics for use in food, industrial, domestic and
institutional areas . 47
4.5.1 General . 47
4.5.2 Overview of the standards relevant in food, industrial, domestic and institutional
areas and their main features . 49
5 Precision of the test methods (Repetitions) . 56
6 Proficiency testing . 56
7 Minimum information for the user including labelling regarding efficacy claims and
use recommendations . 57
8 Changes in European Standards . 57
8.1 Revision of European Standards . 57
8.2 Impact of changes of EN 14885 on other European Standards . 58
Annex A (normative) Differentiation of active and non-active substances in a product . 59
A.1 General . 59
A.2 Test Strategy . 59
A.3 Description of the tests . 59
A.4 Interpretation of test results . 60
Annex B (informative) Recommendations on the use of terms and definitions in the area of
disinfection and antisepsis . 61
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SIST EN 14885:2022
EN 14885:2022 (E)
Annex C (informative) Recommendations on claims of efficacy on the basis of activity tests . 63
Annex D (informative) Phase 3 tests and other means of assessing efficacy . 64
D.1 General . 64
D.2 Comparison with phase 2 tests . 64
D.3 Other means of assessing efficacy . 65
D.4 Requirement for a phase 3 test . 66
D.5 Safety . 66
D.6 Design of a phase 3 test . 66
D.7 Performance of a phase 3 test . 68
D.8 Results of a phase 3 test . 68
Annex E (informative) Choice of meaningful concentrations when testing products
according to the standards . 69
Annex F (informative) CEN/TC 216 standards in preparation or under revision. 70
F.1 Medical area . 70
F.2 Veterinary area . 70
F.3 Food, industrial, domestic and institutional areas . 70
F.4 Others . 71
Bibliography . 72
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SIST EN 14885:2022
EN 14885:2022 (E)
European foreword
This document (EN 14885:2022) 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 January 2023, and conflicting national standards shall
be withdrawn at the latest by January 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 14885:2018 and CEN/TR 17296:2018.
EN 14885:2018 was revised to update the information on existing standards, to include standards
published since 2018 and to give more details how to use the standards for making claims. CEN/TC 216
has prepared a series of standards on chemical disinfectants and antiseptics specifying requirements
and test methods. The purpose of this document is to specify the relationship of the various standards
to one another and to claims and use recommendations.
To allow for different requirements in different areas of application, separate tests and pass criteria
have been or will be prepared for each of the following three areas of application: medical, veterinary,
and a group comprising food, industrial, domestic and institutional areas.
This document only refers to test methods which are currently included in the work programme of
CEN/TC 216 and which are described in Clause 2. It is likely that additional standards which relate to
specific situations will be produced at a later time.
This document was revised to adapt it to the latest state of CEN/TC 216, to correct errors and
ambiguities. The following is a list of significant changes since the last edition:
— Scope (Clause 1): the different working groups added; safety issues when performing the tests
addressed as well as the information that EN 14885 is periodically updated;
— Normative references (2) updated, the standards revised after the last revision of EN 14885 are
signposted;
— Terms and definitions (3) deleted: “bactericide”, “fungicide” and similar ones; added: “active
substance”, “contact time”, “limiting test organism”, “test”; changed: “antisepsis”, “chemical
disinfection”, “virucidal activity”, “microbistatic activity” defined for all other deleted ” -static”
definitions, “product”, ”test organism”;
— Clarification of the text in 4.2.4 as well as in 4.2.5 (former “4.2.5” to “4.2.8”);
— New: clarification, that in all standards EN 12353 has to be followed (new 4.2.6);
— Special guidance for certain cases of chemo-thermal disinfection (new 4.2.7);
— Information about concentrations to be tested (new 4.2.8);
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SIST EN 14885:2022
EN 14885:2022 (E)
— Medical area (4.3), Veterinary area (4.4) and Food, industrial, domestic and institutional areas (4.5)
tables and text updated including the clarification for disinfectants used in veterinary care facilities
(medical or veterinary);
— Clarification of the text in Clauses 5, 6, 7 and 8;
— The text of Annexes B and C are significantly changed;
— New Annex A “Differentiation of active and non-active substances in a product”;
— New Annex E “Choice of meaningful concentrations when testing products according to the
standards”;
— New Annex F “CEN /TC 216 standards in preparation or under revision”;
The changes mentioned above have no impact on the use of test results obtained with reference to the
former version of EN 14885 if a standard has not been revised in the meantime. Those results are still
valid. If there is a new edition in Clause 2 cited (standard revised) refer to the information in Clause 8.
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, Turkey and the
United Kingdom.
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SIST EN 14885:2022
EN 14885:2022 (E)
Introduction
This document specifies the laboratory methods to be used for testing the activity of products, i.e.
chemical disinfectants and antiseptics in order to support claims that they have specific properties
appropriate to their intended application. These laboratory methods may also be used for active
substances and products under development. This document is not intended to represent disinfection
policy guidelines, i.e. guidelines for choosing and assessing the suitability of products for particular
situations.
The CEN standards relate to only a limited range of microbial species. These have been chosen as
representative species taking into account their relative resistance and their relevance to practical use.
The handling properties and the microbiological safety have also been considered in choosing the test
organisms.
The test methods in this document are based on the current scientific state of the art. It is recognized
that at the present time there is only limited knowledge regarding the relationship between the activity
of products as determined by suspension as compared with surface tests, and the relevance of the
results of both tests to conditions of use.
Chemical disinfectants and antiseptics need to be always be used responsibly. This need to take into
account the environmental impact of inappropriate product in-use concentrations (too high or too low)
and of unnecessary use.
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SIST EN 14885:2022
EN 14885:2022 (E)
1 Scope
This document specifies the European Standards to which products have to conform in order to support
the claims for microbicidal activity which are referred to in this document.
This document also specifies terms and definitions which are used in European Standards.
It is applicable to products for which activity is claimed against the following microorganisms:
vegetative bacteria (including mycobacteria and Legionella), bacterial spores, yeasts, fungal spores and
viruses (including bacteriophages).
It is intended to:
a) enable manufacturers of products to select the appropriate standards to be used in order to
provide data which support their claims for a specific product;
b) enable users of the product to assess the information provided by the manufacturer in relation to
the use for which they intend to use the product;
c) assist regulatory authorities in assessing claims made by the manufacturer or by the person
responsible for placing the product on the market.
It is applicable to products to be used in the area of human medicine, the veterinary area and in food,
industrial, domestic and institutional areas.
In the area of human medicine (Working Group 1, i.e. WG 1), it is applicable to chemical disinfectants
and antiseptics to be used in areas and situations where disinfection or antisepsis is medically
indicated. Such indications occur in patient care
— in hospitals, in community medical facilities, dental institutions and medical laboratories for
analyses and research,
— in clinics of schools, of kindergartens and of nursing homes,
— and may also occur in the workplace and in the home. It may also include services such as in
laundries and kitchens supplying products directly for the patient.
In the veterinary area (WG 2) it is applicable to chemical disinfectants and antiseptics to be used in the
areas of breeding, husbandry, veterinary care facilities, production, transport and disposal of animals
and veterinary laboratories for analyses and research. It is not applicable to chemical disinfectants used
in the food chain following death and entry to the processing industry.
In food, industrial, domestic and institutional areas (WG 3) it is applicable to chemical disinfectants and
antiseptics to be used in processing, distribution and retailing of food of animal or vegetable origin. It is
also applicable to products for all public areas where disinfection is not medically indicated (homes,
catering, schools, nurseries, transports, hotels, offices etc.) and products used in packaging,
biotechnology, laboratories (except laboratories for veterinary and medical analyses and research),
pharmaceutical, cosmetic etc. industries.
This document is also applicable to active substances and products under development for which no
area of application has yet been specified.
This document will be periodically updated to reflect the current published versions of each standard
developed in CEN/TC 216. Independent of this update newly published standards are to be used, even if
they are not yet mentioned in EN 14885.
This document does not refer to methods for testing the toxicological and ecotoxicological properties of
products or active substances.
7
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SIST EN 14885:2022
EN 14885:2022 (E)
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 1040:2005, Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of
basic bactericidal activity of chemical disinfectants and antiseptics - Test method and requirements (phase
1)
EN 1275:2005, Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of
basic fungicidal or basic yeasticidal activity of chemical disinfectants and antiseptics - Test method and
requirements (phase 1)
EN 1276:2019, Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of
bactericidal activity of chemical disinfectants and antiseptics used in food, industrial, domestic and
institutional areas - Test method and requirements (phase 2, step 1)
EN 1499:2013, Chemical disinfectants and antiseptics - Hygienic handwash - Test method and
requirements (phase 2/step 2)
EN 1500:2013, Chemical disinfectants and antiseptics - Hygienic handrub - Test method and requirements
(phase 2/step 2)
EN 1650:2019, Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of
fungicidal or yeasticidal activity of chemical disinfectants and antiseptics used in food, industrial, domestic
and institutional areas - Test method and requirements (phase 2, step 1)
EN 1656:2019, Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of
bactericidal activity of chemical disinfectants and antiseptics used in the veterinary area - Test method
and requirements (phase 2, step 1)
EN 1657:2016, Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of
fungicidal or yeasticidal activity of chemical disinfectants and antiseptics used in the veterinary area - Test
method and requirements (phase 2, step 1)
EN 12353:2021, 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 12791:2016+A1:2017, Chemical disinfectants and antiseptics - Surgical hand disinfection - Test
method and requirements (phase 2, step 2)
EN 13610:2002, Chemical disinfectants - Quantitative suspension test for the evaluation of virucidal
activity against bacteriophages of chemical disinfectants used in food and industrial areas - Test method
and requirements (phase 2, step 1)
EN 13623:2020, Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of
bactericidal activity against Legionella of chemical disinfectants for aqueous systems - Test method and
requirements (phase 2, step 1)
EN 13624:2013, Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of
fungicidal or yeasticidal activity in the medical area - Test method and requirements (phase 2, step 1)
8
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SIST EN 14885:2022
EN 14885:2022 (E)
EN 13697:2015+A1:2019, Chemical disinfectants and antiseptics - Quantitative non-porous surface test
for the evaluation of bactericidal and/or fungicidal activity of chemical disinfectants used in food,
industrial, domestic and institutional areas - Test method and requirements without mechanical action
(phase 2, step 2)
EN 13704:2018, Chemical disinfectants - Quantitative suspension test for the evaluation of sporicidal
activity of chemical disinfectants used in food, industrial, domestic and institutional areas - Test method
and requirements (phase 2, step 1)
EN 13727:2012+A2:2015, Chemical disinfectants and antiseptics - Quantitative suspension test for the
evaluation of bactericidal activity in the medical area - Test method and requirements (phase 2, step 1)
EN 14204:2012, Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of
mycobactericidal activity of chemical disinfectants and antiseptics used in the veterinary area - Test
method and requirements (phase 2, step 1)
EN 14347:2005, Chemical disinfectants and antiseptics - Basic sporicidal activity - Test method and
requirements (phase 1)
EN 14348:2005, Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of
mycobactericidal activity of chemical disinfectants in the medical area including instrument disinfectants -
Test methods and requirements (phase 2, step 1)
EN 14349:2012, Chemical disinfectants and antiseptics - Quantitative surface test for the evaluation of
bactericidal activity of chemical disinfectants and antiseptics used in the veterinary area on non-porous
surfaces without mechanical action - Test method and requirements (phase 2, step 2)
EN 14476:2013+A2:2019, Chemical disinfectants and antiseptics - Quantitative suspension test for the
evaluation of virucidal activity in the medical area - Test method and requirements (Phase 2/Step 1)
EN 14561:2006, Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of
bactericidal activity for instruments used in the medical area - Test method and requirements (phase 2,
step 2)
EN 14562:2006, Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of
fungicidal or yeasticidal activity for instruments used in the medical area - Test method and requirements
(phase 2, step 2)
EN 14563:2008, Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of
mycobactericidal or tuberculocidal activity of chemical disinfectants used for instruments in the medical
area - Test method and requirements (phase 2, step 2)
EN 14675:2015, Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of
virucidal activity of chemical disinfectants and antiseptics used in the veterinary area - Test method and
requirements (Phase 2, step 1)
EN 16437:2014+A1:2019, Chemical disinfectants and antiseptics - Quantitative surface test for the
evaluation of bactericidal activity of chemical disinfectants and antiseptics used in veterinary area on
porous surfaces without mechanical action - Test method and requirements (phase 2, step 2)
EN 16438:2014, Chemical disinfectants and antiseptics - Quantitative surface test for the evaluation of
fungicidal or yeasticidal activity of chemical disinfectants and antiseptics used in the veterinary area on
non-porous surfaces without mechanical action - Test method and requirements (phase 2, step 2)
9
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EN 14885:2022 (E)
EN 16615:2015, Chemical disinfectants and antiseptics - Quantitative test method for the evaluation of
bactericidal and yeasticidal activity on non-porous surfaces with mechanical action employing wipes in
the medical area (4- field test) - Test method and requirements (phase 2, step 2)
EN 16616:2015, Chemical disinfectants and antiseptics - Chemical-thermal textile disinfection - Test
method and requirements (phase 2, step 2)
EN 16777:2018, Chemical disinfectants and antiseptics - Quantitative non-porous surface test without
mechanical action for the evaluation of virucidal activity of chemical disinfectants used in the medical area
- Test method and requirements (phase 2/step 2)
EN 17111:2018, Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of
virucidal activity for instruments used in the medical area - Test method and requirements (phase 2, step
2)
EN 17122:2019, Chemical disinfectants and antiseptics - Quantitative non-porous surface test for the
evaluation of virucidal activity of chemical disinfectants and antiseptics used in the veterinary area - Test
method and requirements - Phase2, step2
EN 17126:2018, Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of
sporicidal activity of chemical disinfectants in the medical area - Test method and requirements (phase 2,
step 1)
EN 17272:2020, Chemical disinfectants and antiseptics - Methods of airborne room disinfection by
automated process - Determination of bactericidal, mycobactericidal, sporicidal, fungicidal, yeasticidal,
virucidal and phagocidal activities
EN 17387:2021, Chemical disinfectants and antiseptics - Quantitative test for the evaluation of
bactericidal and yeasticidal and/or fungicidal activity of chemical disinfectants in the medical area on
non-porous surfaces without mechanical action - Test method and requirements (phase 2, step 2)
3 Terms and definitions
For the pu
...
SLOVENSKI STANDARD
oSIST prEN 14885:2020
01-november-2020
Kemična razkužila in antiseptiki - Uporaba evropskih standardov za kemična
razkužila in antiseptike
Chemical disinfectants and antiseptics - Application of European Standards for chemical
disinfectants and antiseptics
Chemische Desinfektionsmittel und Antiseptika - Anwendung Europäischer Normen für
chemische Desinfektionsmittel und Antiseptika
Antiseptiques et désinfectants chimiques - Application des Normes européennes sur les
antiseptiques et désinfectants chimiques
Ta slovenski standard je istoveten z: prEN 14885
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
oSIST prEN 14885:2020 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN 14885:2020
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oSIST prEN 14885:2020
DRAFT
EUROPEAN STANDARD
prEN 14885
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2020
ICS 11.080.20; 71.100.35 Will supersede EN 14885:2018
English Version
Chemical disinfectants and antiseptics - Application of
European Standards for chemical disinfectants and
antiseptics
Antiseptiques et désinfectants chimiques - Application Chemische Desinfektionsmittel und Antiseptika -
des Normes européennes sur les antiseptiques et Anwendung Europäischer Normen für chemische
désinfectants chimiques Desinfektionsmittel und Antiseptika
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
© 2020 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 14885:2020 E
worldwide for CEN national Members.
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oSIST prEN 14885:2020
prEN 14885:2020 (E)
Contents Page
European foreword . 4
Introduction . 6
1 Scope . 7
2 Normative references . 8
3 Terms and definitions . 10
3.1 Chemical disinfectant or antiseptic procedures and product types . 10
3.2 Chemical disinfectant or antiseptic action . 12
3.3 General terms . 13
4 Procedures for claiming activity. 15
4.1 Category of tests . 15
4.2 General . 16
4.3 Chemical disinfectants and antiseptics for use in the medical area . 18
4.3.1 General . 18
4.3.2 Fields of application / Standards necessary to be passed for basic and additional
label claims . 19
4.3.3 Overview of the standards relevant for the medical area and their main features . 22
4.4 Chemical disinfectants and antiseptics for use in the veterinary area . 35
4.4.1 General . 35
4.4.2 Overview of the standards relevant for the veterinary area and their main features . 36
4.5 Chemical disinfectants and antiseptics for use in food, industrial, domestic and
institutional areas . 43
4.5.1 General . 43
4.5.2 Fields of application / Standards necessary to be passed for basic and additional
label claims . 45
4.5.3 Overview of the standards relevant in food, industrial, domestic and institutional
areas and their main features . 57
5 Precision of the test methods (Repetitions) . 62
6 Proficiency testing . 63
7 Minimum information for the user including labelling regarding efficacy claims and
use recommendations . 63
8 Changes in European Standards . 64
8.1 Revision of European Standards . 64
8.2 Impact of changes of EN 14885 on other European Standards. 64
Annex A (informative) Recommendations on the use of terms and definitions in the area of
disinfection and antisepsis . 66
Annex B (informative) Recommendations on claims of efficacy on the basis of activity tests. 68
Annex C (informative) Phase 3 tests and other means of assessing efficacy . 69
C.1 General . 69
C.2 Comparison with phase 2 tests . 69
C.3 Other means of assessing efficacy . 70
2
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C.4 Requirement for a phase 3 test . 71
C.5 Safety . 71
C.6 Design of a phase 3 test . 72
C.7 Performance of a phase 3 test . 73
C.8 Results of a phase 3 test . 73
Annex D (normative) Differentiation of active and non-active substances in a product. 75
D.1 General . 75
D.2 Test Strategy . 75
D.3 Description of the tests . 75
D.4 Interpretation of test results . 76
Annex E (informative) Choice of meaningful concentrations when testing products
according to the standards . 77
Annex F (informative) CEN/TC 216 standards in preparation or under revision. 78
F.1 Medical area . 78
F.2 Veterinary area . 78
F.3 Food, industrial, domestic and institutional areas . 78
F.4 Others . 79
Bibliography . 80
3
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prEN 14885:2020 (E)
European foreword
This document (prEN 14885:2020) 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 14885:2018.
EN 14885:2018 was revised to update the information on existing standards, to include standards
published since 2018 and to give more details how to use the standards for making claims. CEN/TC 216
has prepared a series of standards on chemical disinfectants and antiseptics specifying requirements
and test methods. The purpose of this document is to specify the relationship of the various standards
to one another and to claims and use recommendations.
To allow for different requirements in different areas of application, separate tests and pass criteria
have been or will be prepared for each of the following three areas of application: medical, veterinary,
and a group comprising food, industrial, domestic and institutional areas.
This document only refers to test methods which are currently included in the work programme of
CEN/TC 216 and which are described in Clause 2. It is likely that additional standards which relate to
specific situations will be produced at a later time.
This document was revised to adapt it to the latest state of CEN/TC 216, to correct errors and
ambiguities. The following is a list of significant changes since the last edition:
Scope (Clause 1): the different working groups added; safety issues when performing the tests
addressed as well as the information that EN 14885 is periodically updated
Normative references (2) updated, the standards revised after the last revision of EN 14885 are
signposted.
Terms and definitions (3) deleted: “bactericide”, “fungicide” and similar ones; added: “active substance”,
“contact time”, “limiting test organism”, “test”; changed: “antisepsis”, “chemical disinfection”, “virucidal
activity”, “microbistatic activity” defined for all other deleted ” -static” definitions, “product”, ”test
organism”
Clarification of the text in 4.2.4 as well as in 4.2.5 (former “4.2.5” to “4.2.8”)
New: clarification, that in all standards EN 12353 has to be followed (new 4.2.6)
Special guidance for certain cases of chemo-thermal disinfection (new 4.2.7)
Information about concentrations to be tested (new 4.2.8)
Medical area (4.3), Veterinary area (4.4) and Food, industrial, domestic and institutional areas (4.5)
tables and text updated including the clarification for disinfectants used in veterinary care facilities
(medical or veterinary)
Clarification of the text in Clauses 5, 6, 7 and 8
The text of Annexes B and C are significantly changed
4
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prEN 14885:2020 (E)
New Annex D “Differentiation of active and non-active substances in a product”
New Annex E “Choice of meaningful concentrations when testing products according to the standards”
New Annex F “CEN /TC 216 standards in preparation or under revision”
The changes mentioned above have no impact on the use of test results obtained with reference to the
former version of EN 14885 if a standard has not been revised in the meantime. Those results are still
valid. If there is a new edition in Clause 2 cited (standard revised) refer to the information in Clause 8.
5
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prEN 14885:2020 (E)
Introduction
This document specifies the laboratory methods to be used for testing the activity of products, i.e.
chemical disinfectants and antiseptics in order to support claims that they have specific properties
appropriate to their intended application. These laboratory methods may also be used for active
substances and products under development. This document is not intended to represent disinfection
policy guidelines, i.e. guidelines for choosing and assessing the suitability of products for particular
situations.
The CEN standards relate to only a limited range of microbial species. These have been chosen as
representative species taking into account their relative resistance and their relevance to practical use.
The handling properties and the microbiological safety have also been considered in choosing the test
organisms.
The test methods in this document are based on the current scientific state of the art. It is recognized
that at the present time there is only limited knowledge regarding the relationship between the activity
of products as determined by suspension as compared with surface tests, and the relevance of the
results of both tests to conditions of use.
Chemical disinfectants and antiseptics should always be used responsibly. This should take into account
the environmental impact of inappropriate product in-use concentrations (too high or too low) and of
unnecessary use.
6
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oSIST prEN 14885:2020
prEN 14885:2020 (E)
1 Scope
This document specifies the European Standards to which products have to conform in order to support
the claims for microbicidal activity which are referred to in this document.
This document also specifies terms and definitions which are used in European Standards.
It is applicable to products for which activity is claimed against the following microorganisms:
vegetative bacteria (including mycobacteria and Legionella), bacterial spores, yeasts, fungal spores and
viruses (including bacteriophages).
It is intended to:
a) enable manufacturers of products to select the appropriate standards to be used in order to
provide data which support their claims for a specific product;
b) enable users of the product to assess the information provided by the manufacturer in relation to
the use for which they intend to use the product;
c) assist regulatory authorities in assessing claims made by the manufacturer or by the person
responsible for placing the product on the market.
It is applicable to products to be used in the area of human medicine, the veterinary area and in food,
industrial, domestic and institutional areas.
In the area of human medicine (Working Group 1, i.e. WG 1), it is applicable to chemical disinfectants
and antiseptics to be used in areas and situations where disinfection or antisepsis is medically
indicated. Such indications occur in patient care
— in hospitals, in community medical facilities, dental institutions and medical laboratories for
analyses and research,
— in clinics of schools, of kindergartens and of nursing homes,
— and may also occur in the workplace and in the home. It may also include services such as in
laundries and kitchens supplying products directly for the patient.
In the veterinary area (WG 2) it is applicable to chemical disinfectants and antiseptics to be used in the
areas of breeding, husbandry, veterinary care facilities, production, transport and disposal of animals
and veterinary laboratories for analyses and research. It is not applicable to chemical disinfectants used
in the food chain following death and entry to the processing industry.
In food, industrial, domestic and institutional areas (WG 3) it is applicable to chemical disinfectants and
antiseptics to be used in processing, distribution and retailing of food of animal or vegetable origin. It is
also applicable to products for all public areas where disinfection is not medically indicated (homes,
catering, schools, nurseries, transports, hotels, offices etc.) and products used in packaging,
biotechnology, laboratories (except laboratories for veterinary and medical analyses and research),
pharmaceutical, cosmetic etc. industries.
This document is also applicable to active substances and products under development for which no
area of application has yet been specified.
This document will be periodically updated to reflect the current published versions of each standard
developed in CEN/TC 216. Independent of this update newly published standards should be used, even
if they are not yet mentioned in EN 14885.
This document does not refer to methods for testing the toxicological and ecotoxicological properties of
products or active substances.
7
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oSIST prEN 14885:2020
prEN 14885:2020 (E)
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 1040:2005, Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of
basic bactericidal activity of chemical disinfectants and antiseptics - Test method and requirements (phase
1)
EN 1275:2005, Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of
basic fungicidal or basic yeasticidal activity of chemical disinfectants and antiseptics - Test method and
requirements (phase 1)
EN 1276:2019, Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of
bactericidal activity of chemical disinfectants and antiseptics used in food, industrial, domestic and
institutional areas - Test method and requirements (phase 2, step 1)
EN 1499:2013, Chemical disinfectants and antiseptics - Hygienic handwash - Test method and
requirements (phase 2/step 2)
EN 1500:2013, Chemical disinfectants and antiseptics - Hygienic handrub - Test method and requirements
(phase 2/step 2)
EN 1650:2019, Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of
fungicidal or yeasticidal activity of chemical disinfectants and antiseptics used in food, industrial, domestic
and institutional areas - Test method and requirements (phase 2, step 1)
EN 1656:2019, Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of
bactericidal activity of chemical disinfectants and antiseptics used in the veterinary area - Test method
and requirements (phase 2, step 1)
EN 1657:2016, Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of
fungicidal or yeasticidal activity of chemical disinfectants and antiseptics used in the veterinary area - Test
method and requirements (phase 2, step 1)
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 12791:2016+A1:2017, Chemical disinfectants and antiseptics - Surgical hand disinfection - Test
method and requirements (phase 2, step 2)
EN 13610:2002, Chemical disinfectants - Quantitative suspension test for the evaluation of virucidal
activity against bacteriophages of chemical disinfectants used in food and industrial areas - Test method
and requirements (phase 2, step 1)
EN 13623:2010, Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of
bactericidal activity against Legionella of chemical disinfectants for aqueous systems - Test method and
requirements (phase 2, step 1)
EN 13624:2013, Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of
fungicidal or yeasticidal activity in the medical area - Test method and requirements (phase 2, step 1)
8
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oSIST prEN 14885:2020
prEN 14885:2020 (E)
EN 13697:2015+A1:2019, Chemical disinfectants and antiseptics - Quantitative non-porous surface test
for the evaluation of bactericidal and/or fungicidal activity of chemical disinfectants used in food,
industrial, domestic and institutional areas - Test method and requirements without mechanical action
(phase 2, step 2)
EN 13704:2018, Chemical disinfectants - Quantitative suspension test for the evaluation of sporicidal
activity of chemical disinfectants used in food, industrial, domestic and institutional areas - Test method
and requirements (phase 2, step 1)
EN 13727:2012, +A2:2015, Chemical disinfectants and antiseptics — Quantitative suspension test for
the evaluation of bactericidal activity in the medical area— Test method and requirements (phase 2,
step 1)
EN 14204:2012, Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of
mycobactericidal activity of chemical disinfectants and antiseptics used in the veterinary area - Test
method and requirements (phase 2, step 1)
EN 14347:2005, Chemical disinfectants and antiseptics - Basic sporicidal activity - Test method and
requirements (phase 1)
EN 14348:2005, Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of
mycobactericidal activity of chemical disinfectants in the medical area including instrument disinfectants -
Test methods and requirements (phase 2, step 1)
EN 14349:2012, Chemical disinfectants and antiseptics - Quantitative surface test for the evaluation of
bactericidal activity of chemical disinfectants and antiseptics used in the veterinary area on non-porous
surfaces without mechanical action - Test method and requirements (phase 2, step 2)
EN 14476:2013+A2:2019, Chemical disinfectants and antiseptics - Quantitative suspension test for the
evaluation of virucidal activity in the medical area - Test method and requirements (Phase 2/Step 1)
EN 14561:2006, Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of
bactericidal activity for instruments used in the medical area - Test method and requirements (phase 2,
step 2)
EN 14562:2006, Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of
fungicidal or yeasticidal activity for instruments used in the medical area - Test method and requirements
(phase 2, step 2)
EN 14563:2008, Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of
mycobactericidal or tuberculocidal activity of chemical disinfectants used for instruments in the medical
area - Test method and requirements (phase 2, step 2)
EN 14675:2015, Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of
virucidal activity of chemical disinfectants and antiseptics used in the veterinary area - Test method and
requirements (Phase 2, step 1)
EN 16437:2014+A1:2019, Chemical disinfectants and antiseptics - Quantitative surface test for the
evaluation of bactericidal activity of chemical disinfectants and antiseptics used in veterinary area on
porous surfaces without mechanical action - Test method and requirements (phase 2, step 2)
EN 16438:2014, Chemical disinfectants and antiseptics - Quantitative surface test for the evaluation of
fungicidal or yeasticidal activity of chemical disinfectants and antiseptics used in the veterinary area on
non-porous surfaces without mechanical action - Test method and requirements (phase 2, step 2)
9
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oSIST prEN 14885:2020
prEN 14885:2020 (E)
EN 16615:2015, Chemical disinfectants and antiseptics - Quantitative test method for the evaluation of
bactericidal and yeasticidal activity on non-porous surfaces with mechanical action employing wipes in
the medical area (4- field test) - Test method and requirements (phase 2, step 2)
EN 16616:2015, Chemical disinfectants and antiseptics - Chemical-thermal textile disinfection - Test
method and requirements (phase 2, step 2)
EN 16777:2018, Chemical disinfectants and antiseptics - Quantitative non-porous surface test without
mechanical action for the evaluation of virucidal activity of chemical disinfectants used in the medical area
- Test method and requirements (phase 2/step 2)
EN 17111:2018, Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of
virucidal activity for instruments used in the medical area - Test method and requirements (phase 2, step
2)
EN 17122:2019, Chemical disinfectants and antiseptics - Quantitative non-porous surface test for the
evaluation of virucidal activity of chemical disinfectants and antiseptics used in the veterinary area - Test
method and requirements - Phase2, step2
EN 17126:2018, Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of
sporicidal activity of chemical disinfectants in the medical area - Test method and requirements (phase 2,
step 1)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
• IEC Electropedia: available at http://www.electropedia.org/
• ISO Online browsing platform: available at https://www.iso.org/obp
NOTE Some recommendations on the use of terminology in the areas of chemical disinfection and antisepsis
are given in Annex A.
3.1 Chemical disinfectant or antiseptic procedures and product types
3.1.1
antiseptic
product – excluding antibiotics – that is used to bring about antisepsis
3.1.2
antisepsis
application of an antiseptic on living tissues causing an action on the structure or metabolism of
microorganisms to a level judged to be appropriate to prevent and/or limit and/or treat an infection of
those tissues
Note 1 to entry: The term microorganism encompasses bacteria (including mycobacteria and bacterial
endospores), fungi (including moulds, fungal spores and yeasts), viruses (including bacteriophages), algae and
oocysts (see also 3.3.10)
3.1.3
chemical disinfectant
product that is capable of chemical
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