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 sollten die neu publizierten Normen verwendet werden, 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 GT 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 (GT 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 (GT 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 convient d’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

General Information

Status
Not Published
Current Stage
4060 - Closure of enquiry - Enquiry
Due Date
07-Jan-2021
Completion Date
07-Jan-2021

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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

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oSIST prEN 14885:2020
prEN 14885:2020 (E)

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

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oSIST prEN 14885:2020
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
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oSIST prEN 14885:2020
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.

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oSIST prEN 14885:2020
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.
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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.
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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

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)

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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)

---------------------- Page: 11 ----------------------
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

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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