SIST EN 14885:2015
(Main)Chemical disinfectants and antiseptics - Application of European Standards for chemical disinfectants and antiseptics
Chemical disinfectants and antiseptics - Application of European Standards for chemical disinfectants and antiseptics
This European Standard specifies the European Standards to which products have to conform in order to support the claims for microbicidal activity which are referred to in this European Standard.
This European Standard also specifies terms and definitions which are used in European Standards.
It is applicable to products for which activity is claimed against the following microorganisms: vegetative bacteria, bacterial spores, yeasts, fungal spores and viruses.
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, 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 it is applicable to chemical disinfectants and antiseptics to be used in the areas of breeding, husbandry, 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 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 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 dieser Europäischen Norm sind die Europäischen Normen festgelegt, denen Produkte entsprechen müssen, um die Auslobungen hinsichtlich der mikrobioziden Wirkung abzusichern, auf die in dieser Europäischen Norm verwiesen wird.
In dieser Europäischen Norm sind auch Begriffe festgelegt, die in Europäischen Normen verwendet werden.
Sie gilt für Produkte, für die eine Wirkung gegen die folgenden Mikroorganismen beansprucht wird: vegetative Bakterien, Bakteriensporen, Hefen, Pilzsporen und Viren.
Sie 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 In Verkehr Bringen des Produkts verantwortliche Person gemacht werden.
Sie gilt für Produkte, die in den Bereichen Humanmedizin, Veterinärmedizin sowie Lebensmittel, Industrie, Haushalt und öffentliche Einrichtungen angewendet werden.
Im Bereich der Humanmedizin gilt sie 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 und im Dentalbereich,
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 gilt sie für chemische Desinfektionsmittel und Antiseptika, die bei Zucht, Haltung, Produktion, Transport und Entsorgung von Tieren angewendet werden. Sie 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 gilt sie für chemische Desinfektionsmittel und Antiseptika, die bei Verarbeitung, Vertrieb und im Einzelhandel von Nahrungsmitteln tierischer oder pflanzlicher Herkunft angewendet werden. Sie 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 Verpackungs , biotechnischen, pharmazeutischen, kosmetischen usw. Industrie verwendet werden.
Diese Europäische Norm gilt auch für Wirkstoffe und Produkte, die sich noch in der Entwicklung befinden und für die noch kein Anwendungsbereich festgelegt ist.
Diese Europäische Norm 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
La présente Norme européenne spécifie les Normes européennes auxquelles les produits doivent être conformes afin de soutenir les revendications d’activité microbicide auxquelles il est fait référence dans la présente norme.
La présente Norme européenne spécifie également les termes et définitions utilisés dans les Normes européennes.
Elle est applicable aux produits déclarés actifs contre les micro-organismes suivants : bactéries végétatives, spores bactériennes, levures, spores de champignons et virus.
Elle a pour objet :
a) de permettre aux fabricants de produits de choisir les normes à utiliser pour obtenir des données à l’appui de 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 organismes de réglementation à évaluer les revendications du fabricant ou de la personne responsable de la mise sur le marché du produit.
Elle est applicable aux produits destinés à être utilisés dans les domaines de la médecine humaine, vétérinaire et dans les secteurs alimentaire, industriel, domestique et collectivité.
Dans le domaine de la médecine humaine, elle 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, établissements médicaux et centres de soins dentaires ;
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, elle est applicable aux antiseptiques et désinfectants chimiques à utiliser pour la reproduction, l’élevage, la production ou le transport et l'abattage d’animaux. Elle 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 alimentaire, industriel, domestique et collectivité, elle est applicable aux antiseptiques et désinfectants chimiques à utiliser dans les locaux de transformation, de distribution et de vente au détail de denrées alimentaires d’origine animale ou végétale. Elle est également applicable aux produits destinés à être utilisés dans des zones tous publics où la désinfection n’est pas médicalement prescrite (domicile, établissement de restauration, école, crèche, moyen de transport, hôtel, bureau, etc.) et aux produits utilisés pour l’emballage, les biotechnologies, les industries pharmaceutiques ou cosmétiques, etc.
La présente Norme européenne est également applicable aux substances actives et produits en cours de développement pour lesquels aucun domaine d'application n'a encore été précisé.
Elle 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 standardu.
Ta evropski standard določa tudi izraze in definicije, ki se uporabljajo v dveh ali več evropskih standardih.
Uporablja se za izdelke, ki delujejo proti naslednjim mikroorganizmom: vegetativnim bakterijam, bakterijskim sporam, glivam, glivnim sporam in virusom.
Nameni standarda so:
a) omogočanje proizvajalcem izdelkov, da izberejo primerne standarde za pridobivanje 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 pristojnim 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 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 se uporablja za kemična razkužila in antiseptike, ki se uporabljajo na področjih vzreje, živinoreje, proizvodnje, prevoza in odstranjevanja živali. Ne uporablja se za kemična razkužila, ki se uporabljajo v prehrambeni verigi po smrti in so del predelovalne industrije.
General Information
Relations
Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Chemische Desinfektionsmittel und Antiseptika - Anwendung Europäischer Normen für chemische Desinfektionsmittel und AntiseptikaAntiseptiques et désinfectants chimiques - Application des Normes européennes sur les antiseptiques et désinfectants chimiquesChemical disinfectants and antiseptics - Application of European Standards for chemical disinfectants and antiseptics71.100.35Kemikalije za dezinfekcijo v industriji in domaChemicals for industrial and domestic disinfection purposes11.080.20Dezinfektanti in antiseptikiDisinfectants and antisepticsICS:Ta slovenski standard je istoveten z:EN 14885:2015SIST EN 14885:2015en,fr,de01-oktober-2015SIST EN 14885:2015SLOVENSKI
STANDARDSIST EN 14885:20071DGRPHãþD
SIST EN 14885:2015
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 14885
August 2015 ICS 71.100.35 Supersedes EN 14885:2006English Version
Chemical disinfectants and antiseptics - Application of European Standards for chemical disinfectants and antiseptics
Antiseptiques et désinfectants chimiques - Application des Normes européennes sur les antiseptiques et désinfectants chimiques
Chemische Desinfektionsmittel und Antiseptika - Anwendung Europäischer Normen für chemische Desinfektionsmittel und Antiseptika This European Standard was approved by CEN on 3 July 2015.
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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, 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:
Avenue Marnix 17,
B-1000 Brussels © 2015 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 14885:2015 ESIST EN 14885:2015
EN 14885:2015 (E) 2 Contents Page European foreword .3 Introduction .5 1 Scope .6 2 Normative references .7 3 Terms and definitions .8 3.1 Chemical disinfectant or antiseptic procedures and product types .8 3.2 Chemical disinfectant or antiseptic action .9 3.3 General terms . 12 4 Procedures for claiming activity . 12 4.1 Category of tests. 12 4.2 General . 13 4.3 Chemical disinfectants and antiseptics for use in the medical area . 14 4.3.1 General . 14 4.3.2 Fields of application / Standards necessary to be passed for basic and additional label claims . 15 4.4 Chemical disinfectants and antiseptics for use in the veterinary area . 25 4.5 Chemical disinfectants and antiseptics for use in food, industrial, domestic and institutional areas . 32 5 Precision of the test methods (Repetitions) . 50 6 Proficiency testing . 50 7 Minimum information for the user including labelling regarding efficacy claims and use recommendations . 50 8 Changes in European Standards . 51 8.1 Revision of European Standards . 51 8.2 Impact of changes of EN 14885 on other European Standards . 51 Annex A (informative)
Recommendations on the use of terms and definitions in the area of disinfection and antisepsis . 52 Annex B (informative)
Recommendations on claims of activity on the basis of tests additional to or other than the tests specified in this European Standard . 54 Annex C (informative)
Phase 3 tests . 55 C.1 General . 55 C.2 Comparison with phase 2 tests . 55 C.3 Requirement for a Phase 3 Test . 55 C.4 Scope of Phase 3 tests . 56 C.5 Safety . 56 C.6 Design of a Phase 3 Test . 57 C.7 Performance of a Phase 3 Test . 58 C.8 Results of a Phase 3 Test . 58 Bibliography . 59
SIST EN 14885:2015
EN 14885:2015 (E) 3 European foreword This document (EN 14885:2015) has been prepared by Technical Committee CEN/TC 216 “Chemical disinfectants and antiseptics”, the secretariat of which is held by AFNOR. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by February 2016, and conflicting national standards shall be withdrawn at the latest by February 2016. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights. This document supersedes EN 14885:2006. EN 14885:2006 was revised to update the information on existing standards, to include standards published since 2006 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 European Standard 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 European Standard 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, e.g. chemical disinfection of textiles, will be produced at a later time. This document was revised to adapt it to the latest state of science, to correct errors and ambiguities, to harmonize the structure and wording and to improve its readability and thereby make it more understandable. The following is a list of significant changes since the last edition: — some definitions were added, some were changed; — the relevance of phase 1 tests was clarified; — the relationship between claims for a given product and test results is described in greater detail; — the use of standards outside their defined scope is now defined; — the fields of application in the different areas are described in much greater detail; — recommendations how to deal with the imprecision of the test methods are given; — recommendations how to use the standards for proficiency testing (quality control) are given; — the impact of changes of standards are defined; — the main aims, scope, safety aspects, design, performance and evaluation of results of phase 3 tests (field tests) are described. The changes mentioned above have no impact on the use of test results obtained with reference to the former version of EN 14885. SIST EN 14885:2015
EN 14885:2015 (E) 4 According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. SIST EN 14885:2015
EN 14885:2015 (E) 5 Introduction This European Standard 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 European Standard 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 European Standard 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. SIST EN 14885:2015
EN 14885:2015 (E) 6 1 Scope 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, 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 it is applicable to chemical disinfectants and antiseptics to be used in the areas of breeding, husbandry, 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 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 European Standard does not refer to methods for testing the toxicological and ecotoxicological properties of products or active substances. SIST EN 14885:2015
EN 14885:2015 (E) 7 2 Normative references The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. EN 1276, 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, Chemical disinfectants and antiseptics — Hygienic handwash — Test method and requirements (phase 2/step 2) EN 1500, Chemical disinfectants and antiseptics — Hygienic handrub — Test method and requirements (phase 2/step 2) EN 1650, Chemical disinfectants and antiseptics — Quantitative suspension test for the evaluation of fungicidal activity of chemical disinfectants and antiseptics used in food, industrial, domestic, and institutional areas — Test method and requirements (phase 2, step 1) EN 1656, 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, 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 12791, Chemical disinfectants and antiseptics — Surgical hand disinfection - Test method and requirement (phase 2/step 2) EN 13610, 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, 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, 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, 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, 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, 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, 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) SIST EN 14885:2015
EN 14885:2015 (E) 8 EN 14348, 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, 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, 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, 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, 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, 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, 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 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 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) 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 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 3.1.3 chemical disinfectant product that is capable of chemical disinfection SIST EN 14885:2015
EN 14885:2015 (E) 9 3.1.4 chemical disinfection reduction of the number of microorganisms in or on an inanimate 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 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. circulation, flooding, spraying, fogging, wiping 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 bactericide product that irreversibly inactivates vegetative bacteria under defined conditions Note 1 to entry: The adjective derived from “bactericide” is “bactericidal”. 3.2.2 bactericidal activity capability of a product or active substance to produce a reduction in the number of viable bacterial cells of relevant test organisms under defined conditions SIST EN 14885:2015
EN 14885:2015 (E) 10 3.2.3 bacteriostatic activity capability of a product to inhibit the growth of viable bacterial cells of relevant test organisms under defined conditions Note 1 to entry: The above term is used in a standard but cannot be used for claims according to Clause 7 c). 3.2.4 fungicide product that irreversibly inactivates fungi (moulds and yeasts) and their spores under defined conditions Note 1 to entry: The adjective derived from “fungicide” is “fungicidal”. 3.2.5 fungicidal activity capability of a product or active substance to produce a reduction in the number of viable yeast cells and mould spores of relevant test organisms under defined conditions 3.2.6 fungistatic activity capability of a product to inhibit the germination of mould spores and/or the growth of viable yeast cells of relevant test organisms under defined conditions Note 1 to entry: The above term is used in a standard but cannot be used for claims according to Clause 7 c). 3.2.7 microbicide product that irreversibly inactivates vegetative bacteria and/or bacterial endospores and/or fungi (moulds and/or yeasts, including fungal spores) and/or viruses under defined conditions Note 1 to entry: The above term is a general term, not to be used for claims (see Clause 7, c)). 3.2.8 microbicidal activity capability of a product or active substance to produce under defined test conditions a reduction in the number of relevant test organisms including viable bacterial cells and/or viable vegetative yeast cells and/or mould spores and/or viable bacterial endospores and/or infectious virus particles Note 1 to entry: The above term is a general term, not to be used for claims according to Clause 7, c). 3.2.9 mycobactericide product that irreversibly inactivates mycobacteria under defined conditions Note 1 to entry: The adjective derived from “mycobactericide” is “mycobactericidal”. 3.2.10 mycobactericidal activity capability of a product or active substance to produce a reduction in the number of viable mycobacterial cells of relevant test organisms under defined conditions 3.2.11 phagocidal activity capability of a product or active substance to produce a reduction in the number of infectious bacteriophage particles of relevant test organisms under defined conditions SIST EN 14885:2015
EN 14885:2015 (E) 11 3.2.12 sporicide product that irreversibly inactivates bacterial endospores under defined conditions Note 1 to entry: The adjective derived from “sporicide” is “sporicidal”. 3.2.13 sporicidal activity capability of a product or active substance to produce a reduction in the number of viable bacterial endospores of relevant test organisms under defined conditions 3.2.14 sporistatic activity capability of a product to inhibit the germination of bacterial endospores under defined conditions Note 1 to entry: The above term is used in a standard but cannot be used for claims according to Clause 7. 3.2.15 tuberculocide product that irreversibly inactivates Mycobacterium tuberculosis under defined conditions Note 1 to entry: The adjective derived from “tuberculocide” is “tuberculocidal”. Note 2 to entry: The test organism used for demonstrating the activity is Mycobacterium terrae. 3.2.16 tuberculocidal activity capability of a product or active substance to produce a reduction in the number of viable cells of the test organism Mycobacterium terrae under defined conditions 3.2.17 virucide product that irreversibly inactivates viruses under defined conditions Note 1 to entry: The adjective derived from “virucide” is “virucidal”. Note 2 to entry: The term virucide includes the inactivation of vertebrate viruses and/ or bacteriophages. 3.2.18 virucidal activity capability of a product or active substance to produce a reduction in the number of infectious virus particles of relevant test organisms under defined conditions Note 1 to entry: Limited spectrum virucidal activity is a claim for hygienic handrub and hygienic handwash products using Adenovirus and Murine Norovirus as test organisms, thus including activity against the test viruses and all enveloped viruses. 3.2.19 yeasticide product that irreversibly inactivates yeasts under defined conditions Note 1 to entry: The adjective derived from “yeasticide” is “yeasticidal”. 3.2.20 yeasticidal activity capability of a product or active substance to produce a reduction in the number of viable yeast cells of relevant test organisms under defined conditions SIST EN 14885:2015
EN 14885:2015 (E) 12 3.3 General terms 3.3.1 additional test conditions test conditions that are optional and not obligatory, that may be used for additional product claims and that may be found in the same standard or in an additional standard 3.3.2 Interfering substance see “soiling” 3.3.3 neutralizer chemical agent or formulation 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 3.3.4 product formulation used as a chemical disinfectant or antiseptic Note 1 to entry: A ready-to-use product is a product used undiluted. 3.3.5 soiling the term “soiling” is represented in the standards by the term “interfering substance” 3.3.5.1 clean conditions conditions representative of surfaces which have been cleaned satisfactorily and/or are
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