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 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.
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
Overview
EN 14885:2022 - "Chemical disinfectants and antiseptics - Application of European Standards for chemical disinfectants and antiseptics" - is the CEN guidance document that specifies which European standards manufacturers, users and regulators should apply to support microbicidal efficacy claims. Prepared by CEN/TC 216 and published in 2022, it replaces earlier editions and consolidates the relationship between test standards, terms and definitions, and claim-making for products and active substances under development.
Key topics and technical requirements
- Scope of microorganisms covered: vegetative bacteria (including mycobacteria and Legionella), bacterial spores, yeasts, fungal spores and viruses (including bacteriophages).
- Standards mapping: identifies which CEN standards are required to substantiate specific efficacy claims across different application areas (medical, veterinary, food/industrial/domestic/institutional).
- Terms and definitions: standardises key terminology used across European standards (e.g., active substance, contact time, test organism, product).
- Procedures for claiming activity: describes categories of tests and the test data needed to support label claims and use recommendations.
- Phase testing and performance assessment: includes guidance on phase 2 and phase 3 testing and other means of assessing efficacy (Annex D).
- Ancillary guidance: annexes cover differentiation of active vs non-active ingredients (A), recommendations on terminology (B), claim formulation (C), concentration selection for testing (E) and standards under revision (F).
- Limitations: does not prescribe methods for toxicological or ecotoxicological testing of products or active substances.
Practical applications - who uses this standard
- Manufacturers and R&D teams: to select appropriate European test methods and design test programs that substantiate microbicidal claims for soaps, surface disinfectants, antiseptics, sterilants and actives in development.
- Regulatory authorities and notified bodies: to assess the validity of efficacy claims and labelling information submitted for clearance or market surveillance.
- Procurement/specification writers and end users: healthcare facilities, veterinary services, food processors, and institutional buyers use the standard to interpret manufacturer claims and choose suitable products for their specific application (medical, veterinary, food/industrial/domestic/institutional).
- Testing laboratories: to align test performance with the accepted CEN methods and reporting expectations.
Related standards and governance
- Developed under CEN/TC 216; the document references and maps multiple EN standards for chemical disinfectants and antiseptics. EN 14885:2022 supersedes EN 14885:2018 and is intended to be updated periodically - newly published standards in CEN/TC 216 should be followed as they appear. For implementation and national adoption, consult your national standards body or the CEN website.
Keywords: EN 14885:2022, chemical disinfectants and antiseptics, European Standards, microbicidal activity, CEN/TC 216, efficacy claims, medical disinfection, veterinary disinfection, food and industrial disinfection, phase 2 test, phase 3 test, labelling.
Frequently Asked Questions
EN 14885:2022 is a standard published by the European Committee for Standardization (CEN). Its full title is "Chemical disinfectants and antiseptics - Application of European Standards for chemical disinfectants and antiseptics". This standard covers: 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.
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.
EN 14885:2022 is classified under the following ICS (International Classification for Standards) categories: 11.080.20 - Disinfectants and antiseptics; 71.100.35 - Chemicals for industrial and domestic disinfection purposes. The ICS classification helps identify the subject area and facilitates finding related standards.
EN 14885:2022 has the following relationships with other standards: It is inter standard links to CEN/TR 17296:2018, EN 14885:2018, EN 14885:2022/AC:2023, prEN 14885. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 14885:2022 is associated with the following European legislation: EU Directives/Regulations: 2017/745; Standardization Mandates: M/575. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
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Standards Content (Sample)
SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
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
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
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);
— 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.
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.
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.
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)
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)
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 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 B.
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 3.3.11)
3.1.3
chemical disinfectant
product that is capable of chemical disinfection
3.1.4
chemical disinfection
reduction of the number of microorganisms in or on an inanimate or animate matrix, achieved by the
irreversible action of a product on their structure or metabolism, to a level judged to be appropriate for
a defined purpose
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 3.3.11)
Note 2 to entry: Products for antisepsis are excluded
3.1.5
hygienic handrub
treatment of hands by rubbing a product without the addition of water, that is directed against
transiently contaminating microorganisms to prevent their transmission regardless of the resident skin
flora
3.1.6
hygienic handwash
treatment of hands by washing with product and water, that is directed against transiently
contaminating microorganisms to prevent their transmission regardless of the resident skin flora
3.1.7
instrument disinfection
chemical disinfection of certain instrument surfaces in the medical and veterinary areas by immersion
3.1.8
surface disinfection
chemical disinfection of a solid surface, including those of certain medical and veterinary instruments
which cannot be immersed, by the application of a product with or without mechanical action
Note 1 to entry: The application includes e.g. wiping, mopping, circulation, flooding, spraying, fogging, etc.
3.1.9
surgical handrub
preoperative treatment of hands by rubbing a product without the addition of water, that is directed
against the flora of microorganisms on hands to prevent the transmission of microorganisms into the
surgical wound
3.1.10
surgical handwash
preoperative treatment of hands by washing with product and water, that is directed against the flora of
microorganisms on hands to prevent the transmission of microorganisms into the surgical wound
3.1.11
textile disinfection
chemical disinfection of textiles through the application of a product by either immersion in a solution
or by processing in a washing machine
3.2 Chemical disinfectant or antiseptic action
3.2.1
algaecidal activity
capability of a product to reduce the quantity of algae as test organisms, specified in the corresponding
standard(s), under defined conditions
3.2.2
bactericidal activity
capability of a product to reduce the number of viable bacterial cells of relevant test organisms,
specified in the corresponding standard(s), under defined conditions
3.2.3
fungicidal activity
capability of a product to reduce the number of viable yeast cells and mould spores of relevant test
organisms, specified in the corresponding standard(s), under defined conditions
3.2.4
microbicidal activity
microbiocidal activity
capability of a product to reduce the number of relevant test organisms including viable bacterial cells
and/or viable yeast cells and/or mould spores and/or viable bacterial endospores and/or infectious
virus particles and/or infectious bacteriophage particles and/or algae and/or oocysts, specified in the
corresponding standard(s)
Note 1 to entry: The above term is a general term, not to be used for claims according to Clause 7 c).
3.2.5
microbistatic activity
microbiostatic activity
capability of a product to inhibit the growth of relevant test organisms, including viable bacterial cells
and/or viable yeast cells and/or mould spores and/or viable bacterial endospores and/or infectious
virus particles and/or infectious bacteriophage particles and/or algae and/or oocysts under defined
conditions
Note 1 to entry: The above term and related terms like “bacteriostatic”, “fungistatic” are used in CEN / TC 216
standards but cannot be used for claims according to the scope (Clause 1).
3.2.6
mycobactericidal activity
capability of a product to reduce the number of viable mycobacterial cells of relevant test organisms,
specified in the corresponding standard(s), under defined conditions
3.2.7
oocysticidal activity
capability of a product to reduce the number of oocysts of relevant test organisms, specified in the
corresponding standard(s), under defined conditions
3.2.8
phagocidal activity
capability of a product to reduce the number of infectious bacteriophage particles of relevant test
organisms, specified in the corresponding standard(s), under defined conditions
3.2.9
sporicidal activity levels
different levels of sporicidal activity with various gradations against aerobic and/or anaerobic bacterial
endospores
Note 1 to entry: The x different levels are: sporicidal activity (3.2.9.1), Sporicidal activity against C. difficile in
human medicine (3.2.9.2).
3.2.9.1
sporicidal activity
capability of a product to reduce the number of viable aerobic and anaerobic bacterial endospores of
relevant test organisms, specified in the corresponding standard(s), under defined conditions
3.2.9.2
sporicidal activity against C. difficile in human medicine
capability of a product to reduce the number of viable bacterial endospores of C. difficile, specified in the
corresponding standard(s), under defined conditions
3.2.10
tuberculocidal activity
capability of a product to reduce the number of viable cells of relevant Mycobacteria as test organism,
specified in the corresponding standard(s), under defined conditions
3.2.11
virucidal activity levels
different levels of virucidal activity with various gradations
Note 1 to entry: The three different levels are: virucidal activity (3.2.11.1), limited spectrum virucidal activity
(3.2.11.2) and virucidal activity against enveloped viruses (3.2.11.3)
3.2.11.1
virucidal activity
capability of a product to reduce the number of infectious virus particles of relevant test organisms,
specified in the corresponding standard(s), under defined conditions
Note 1 to entry: virucidal activity covers enveloped and non-enveloped viruses
3.2.11.2
limited spectrum virucidal activity
capability of a product to reduce the number of infectious virus particles using certain non-enveloped
viruses as test organisms, specified in the corresponding standard(s), under defined conditions, thus
covering virucidal activity against these test organisms, and additionally defined other non-enveloped
virus(es) and all enveloped viruses
3.2.11.3
virucidal activity against enveloped viruses
capability of a product to reduce the number of infectious virus particles using relevant enveloped
viruses as test organism, specified in the corresponding standard(s), thus covering activity against all
enveloped viruses
3.2.12
yeasticidal activity
capability of a product to reduce the number of viable yeast cells of relevant test organisms, specified in
the corresponding standard(s), under defined conditions
3.3 General terms
3.3.1
active substance
substance or microorganism that has an action on or against harmful organisms
[SOURCE: Biocide Product Regulation (EU) 528/2012, Article 3(1)(c)]
Note 1 to entry: In standards developed by CEN/TC 216 only chemical substances are used as active substances.
Note 2 to entry: The term “harmful organism” encompasses bacteria (including mycobacteria and bacterial
endospores), fungi (including moulds, fungal spores and yeasts) and viruses (including bacteriophages), algae and
oocysts.
Note 3 to entry: In standards developed by CEN/TC 216 the term “product” encompasses “active substance”.
3.3.2
additional test conditions
test conditions in a standard that are optional and not obligatory, that may be used for further specific
product claims and/or applications
Note 1 to entry: Such test conditions can be found in the same or in an additional standard.
3.3.3
contact time
time period during application of the product in a test that elapses between its first contact with the test
organisms, and its neutralization
3.3.4
interfering substance
soiling
additional substances simulating the conditions of the soiling level in the test
Note 1 to entry: Two levels of soiling are used in the standards see clean conditions (3.3.4.1) and dirty conditions
(3.3.4.2)
3.3.4.1
clean conditions
conditions representative of surfaces which have been cleaned satisfactorily and/or are known to
contain minimal levels of organic and/or inorganic substances
Note 1 to entry: In the veterinary area, these conditions are called “low level soiling”. The term “low level soiling”
has been introduced to avoid confusion in the veterinary area where the respective levels of soiling are higher.
3.3.4.2
dirty conditions
conditions representative of surfaces which are known to or potentially contain organic and/or
inorganic substances
Note 1 to entry: In the veterinary area, these conditions are called “high level soiling”. The term “high level
soiling” has been introduced to avoid confusion in the veterinary area where the respective levels of soiling are
higher.
3.3.5
limiting test organism
test organism that requires the highest concentration to give the specified decimal logarithm (lg)
reduction (it is the least susceptible test organism to the product in the chosen experimental
conditions)
3.3.6
neutralization
process that suppresses the residual microbicidal activity of a product or active substance within a
specific test but does not inactivate or inhibit the test organism using neutralizer and/or dilution (e.g.
membrane filtration)
3.3.7
neutralizer
chemical agent or formulation that is used for neutralization
3.3.8
product
formulation used as a chemical disinfectant or antiseptic
Note 1 to entry: A ready-to-use product is a product used undiluted.
Note 2 to entry: The term “product” encompasses “active substance(s)”
3.3.9
product claim
any claim derived from results of one or more test(s) (3.3.10)
3.3.10
test
technical operation that consists of the determination of one or more characteristics or performance of
a given product or process according to a specified procedure based on the requirements for a specific
intended use or application
[SOURCE: EN ISO 16484-2:2004-08, modified deleted “material, equipment, organism, physical
phenomenon and service” and added in the end ” based on the requirements for a specific intended use
or application” and EN ISO 9000:2015-11, modified replaced “determination (311.1) according to
requirements (3.6.4) for” by “technical operation that consists of the determination of one or more
characteristics or performance of a given product or process according to a specified procedure based
on the requirements for”
3.3.11
test organism
strain of a microorganism selected for testing a product within a standardized test
Note 1 to entry: For the purpose of this document, the term microorganism includes vegetative bacteria, bacterial
spores, yeasts, mould spores and viruses (including bacteriophages), algae and oocysts.
4 Procedures for claiming activity
4.1 Category of tests
The tests are categorized on a modular basis as follows:
— Phase 1 tests are quantitative suspension tests to establish that a product under development has
bactericidal, fungicidal, yeasticidal or sporicidal activity without regard to specific areas of
application. Phase 1 tests cannot be used for any product claim.
— Phase 2 comprises two steps:
a) Phase 2, step 1 tests are quantitative suspension tests to establish that a product has
bactericidal, fungicidal, yeasticidal, mycobactericidal, tuberculocidal, sporicidal, virucidal,
phagocidal, algaecidal or oocysticidal activity under simulated practical conditions appropriate
to its intended use;
b) Phase 2, step 2 tests are quantitative laboratory tests to establish that a product has
bactericidal, fungicidal, yeasticidal, mycobactericidal, tuberculocidal, sporicidal, virucidal or
phagocidal, algaecidal or oocysticidal activity when applied to a surface or skin under
simulated practical conditions (e.g. surface, instrument, laundry, handwash and handrub tests);
— Phase 3 tests are field tests under practical conditions. Applicable methodologies for this type of
test are not yet available, but could be developed in the future. Guidance on the design of phase 3
tests and the use of data from phase 3 tests is provided in Annex D.
NOTE In the following phase 2, step 1 is mostly shortened to “2,1” or “2/1” and phase 2, step 2 to “2,2” or
“2/2”.
Phase 2, step 1 tests prove the irreversible inactivation of microorganisms. This test design provides
relevant information about the activity of the product against microorganisms in suspension.
Desiccated microorganisms can be stressed and can pose different challenges.
Phase 2, step 2 tests provide information about the activity against desiccated microorganisms on
inanimate surfaces or on living tissues or against non-desiccated microorganisms on living tissues.
Tests shall be carried out under the minimum requirements/obligatory conditions as specified in the
standards. According to the claimed use of the product, tests under additional conditions (test
organisms, temperature, contact time and interfering substances) shall be carried out as specified in the
standard.
Phase 2, step 1 and phase 2, step
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この記事は、EN 14885:2022についてのもので、化学的な殺菌剤や抗菌剤に関するヨーロッパの標準を取り上げています。この文書は、この文書で言及される微生物殺菌活性の主張をサポートするために製品が適合しなければならない標準を指定します。また、ヨーロッパの標準で使用される用語や定義も指定します。これは、以下の微生物に対する活性が主張される製品に適用されます：細菌（結核菌やレジオネラを含む）、細菌の胞子、酵母、真菌の胞子、ウイルス（バクテリオファージを含む）。 これにより、製品のメーカーが特定の製品の主張を支持するためのデータを提供するために使用する適切な標準を選択できるようにすることが目的です。 また、ユーザーが製品の使用に関連してメーカーから提供された情報を評価することができるようにすること、規制当局が製品を市場に投入する責任者またはメーカーが行っている主張を評価するための支援となることも目的としています。 これは、人間の医学領域、獣医学領域、食品、産業、家庭、施設などの領域で使用される製品に適用されます。人間の医学領域では、医療的に必要な消毒や殺菌が必要な領域や状況で使用される化学的な殺菌剤や抗菌剤に適用されます。具体的な応用分野には、病院、地域医療施設、歯科施設、医学研究所などがあります。 獣医学領域では、畜産、飼育、獣医ケア施設、動物の生産、輸送、処理、獣医研究所に使用される化学的な殺菌剤や抗菌剤に適用されます。ただし、死後および加工業界への入場後の食品連鎖で使用される化学的な殺菌剤には適用されません。 食品、産業、家庭、施設などの領域では、動物または植物由来の食品の加工、流通、小売りに使用される化学的な殺菌剤や抗菌剤に適用されます。また、医療的に必要でないすべての公共エリア（家庭、飲食店、学校、保育園、交通機関、ホテル、オフィスなど）や、包装、バイオテクノロジー、研究所（獣医や医学の分析および研究用の研究所を除く）、製薬、化粧品などの産業で使用される製品にも適用されます。 この文書は、まだ適用分野が指定されていない開発中の有効成分や製品にも適用されます。 この文書は、CEN/TC 216で開発された各標準の最新版を反映するため、定期的に更新されます。この更新とは独立して、まだEN 14885で言及されていない最新の標準が使用されるべきです。 この文書は、製品または有効成分の毒性および生態毒性の特性をテストする方法について言及していません。
The article discusses EN 14885:2022, which outlines the European Standards for chemical disinfectants and antiseptics. The document specifies the standards that products must adhere to in order to support claims of microbicidal activity. It also provides terms and definitions used in these standards. The standards apply to products claiming activity against various microorganisms including bacteria, yeasts, fungal spores, and viruses. The purpose of the document is to guide manufacturers in selecting appropriate standards to support product claims, help users assess the provided information, and assist regulatory authorities in evaluating claims. The standards are applicable in human medicine, veterinary care, as well as food, industrial, domestic, and institutional areas. Specific applications include hospitals, schools, nursing homes, veterinary care facilities, and food processing. The document also mentions that it can be used for active substances and products under development. However, it does not cover methods for testing toxicological and ecotoxicological properties of products or active substances. The document will be regularly updated to reflect the latest standards developed in CEN/TC 216.
이 기사는 EN 14885:2022, 화학 소독제 및 살균제에 대한 유럽 표준을 다루고 있다. 이 문서는 제품이 이 문서에서 언급된 미생물 살균 작용을 지원하기 위해 준수해야 하는 유럽 표준을 명시한다. 이 문서는 또한 유럽 표준에서 사용되는 용어 및 정의를 명시한다. 이 문서는 다음 미생물에 대한 작용이 주장되는 제품에 적용된다: 산황박균 (미코박테리아 및 레지오넬라 포함), 세균 포자, 효모, 곰팡이 포자 및 바이러스 (박테리오파지 포함). 이 문서의 목적은 다음과 같다: a) 제품 제조업체가 특정 제품의 주장을 지원하는 데이터를 제공하기 위해 사용할 적절한 표준을 선택할 수 있도록 하기 위함 b) 사용자가 제조업체가 제공한 정보를 사용하려는 용도와 관련하여 제품을 평가할 수 있도록 하기 위함 c) 규제 당국이 제조업체나 시장에 제품을 출시한 담당자가 한 주장을 평가하는 데 도움을 주기 위함 이 문서는 인간 의료, 수의학 및 식품, 산업, 가정 및 제도 영역에서 사용될 제품에 적용된다. 인간 의료 분야에서 (작업 그룹 1, WG 1)는 의료적으로 지시된 멸균 또는 소독이 필요한 영역 및 상황에서 사용하기 위한 화학 소독제 및 살균제에 적용된다. 이러한 지침은 환자 치료에서 다음과 같이 발생한다. - 병원, 사회 의료 시설, 치과 기관, 분석 및 연구용 의료 연구소 등에서 - 학교, 유치원 및 양로원의 클리닉 등에서 - 직장 및 가정에서 발생할 수도 있으며, 환자에게 직접 공급되는 세탁소 및 주방과 같은 서비스를 포함할 수도 있다. 수의학 영역 (WG 2)에서는 동물 사육, 양식, 수의학적 치료 시설, 동물의 생산, 운송 및 처리, 그리고 수의학 연구와 분석을 위한 동물 실험실에 사용되는 화학 소독제 및 살균제에 적용된다. 그러나 처리 및 가공 산업에서 사망 후 식품 연쇄에 사용되는 화학 소독제에는 적용되지 않는다. 식품, 산업, 가정 및 제도 영역 (WG 3)에서는 동물 또는 식물 기원의 식품의 가공, 유통 및 소매에 사용되는 화학 소독제 및 살균제에 적용된다. 또한 의학적으로 필수적이지 않은 모든 공공 영역의 제품 (가정, 외식업, 학교, 유치원, 교통, 호텔, 사무실 등) 및 포장, 생명공학, 연구실 (수의학 및 의학 분석 및 연구용 연구실 제외), 제약, 화장품 등 산업에 사용되는 제품에 적용된다. 이 문서는 아직 적용 영역이 지정되지 않은 개발 중인 활성물질 및 제품에도 적용된다. 이 문서는 CEN/TC 216에서 개발된 각 표준의 현재 발행 버전을 반영하기 위해 주기적으로 업데이트된다. 이 업데이트와는 독립적으로 현재 발행된 표준은 EN 14885에서 언급되지 않았더라도 사용되어야 한다. 이 문서는 제품이나 활성물질의 독성 및 생태독성 특성을 시험하는 방법에 대한 언급이 없다.
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