SIST EN 14885:2007
(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 standard.
This European Standard also specifies the terms and definitions which are used in two or more of the European Standards.
It is applicable to products for which activity is claimed against the following micro-organisms: vegetative bacteria, bacterial spores, fungi, 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 competent bodies in assessing claims made by the manufacturer or 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 are 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 ch
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 Ansprüche an die mikrobiozide Wirkung zu untermauern, auf die in dieser Norm verwiesen wird.
In dieser Europäischen Norm sind auch die Begriffe festgelegt, die in zwei oder mehr der Europäischen Normen verwendet werden.
Sie gilt für Produkte, für die eine Wirkung gegen die folgenden Mikroorganismen beansprucht wird: vegetative Bakterien, Bakteriensporen, Pilze, Pilzsporen und Viren.
Sie dient dazu:
a) Hersteller von Produkten zu befähigen, die einschlägigen Normen auszuwählen, die anzuwenden sind, um Daten zu erarbeiten, die deren Ansprüche an ein bestimmtes Produkt untermauern;
b) Anwender des Produkts zu befähigen, die vom Hersteller gelieferten Angaben hinsichtlich des Gebrauchs zu beurteilen, bei dem sie die Anwendung des Produkts beabsichtigen;
c) verantwortliche Körperschaften bei der Beurteilung von Behauptungen zu unterstützen, die durch den Hersteller oder die für das In-Verkehr-Bringen des Produkts verantwortliche Person aufgestellt werden.
Sie gilt für Produkte, die in Bereichen Humanmedizin, Veterinärmedizin sowie Lebensmittel, Industrie, Haushalt und öffentliche Einrichtungen angewendet werden sollen.
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 in Wäschereien und Küchen, die der direkten Versorgung von Patienten dienen.
Antiseptiques et désinfectants chimiques - Application des Normes européennes relatives aux antiseptiques et désinfectants chimiques
La présente Norme européenne spécifie les Normes européennes auxquelles les produits doivent etre conformes afin de soutenir les revendications d’activité microbicide auxquelles il est fait référence dans la présente norme.
Elle spécifie également les termes et définitions utilisés dans au moins deux Normes européennes.
Elle est applicable aux produits déclarés actifs contre les micro-organismes suivants : bactéries végétatives, spores bactériennes, champignons, spores de champignons et virus.
Elle a pour objet :
a) de permettre aux fabricants de produits de choisir les normes a utiliser pour obtenir des données a 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 compétents a évaluer les revendications du fabricant ou de la personne responsable de la mise sur le marché du produit.
Elle est applicable aux produits destinés a etre utilisés dans les domaines de la médecine humaine, vétérinaire et dans les secteurs alimentaire, industriel, domestique et professionnel.
Dans le domaine de la médecine humaine, elle est applicable aux antiseptiques et désinfectants chimiques a utiliser dans les secteurs et les situations ou la désinfection ou l’antisepsie est médicalement préconisée. Ces indications relevent 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 creches ;
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 a utiliser pour la reproduction, l’élevage, la production ou le transport et l'abattage d’animaux.
Kemična razkužila in antiseptiki - Uporaba evropskih standardov za kemična razkužila in antiseptike
General Information
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Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Chemical disinfectants and antiseptics - Application of European Standards for chemical disinfectants and antisepticsAntiseptiques et désinfectants chimiques - Application des Normes européennes relatives aux antiseptiques et désinfectants chimiquesChemische Desinfektionsmittel und Antiseptika - Anwendung Europäischer Normen für chemische Desinfektionsmittel und AntiseptikaTa slovenski standard je istoveten z:EN 14885:2006SIST EN 14885:2007en;fr;de71.100.35Kemikalije za dezinfekcijo v industriji in domaChemicals for industrial and domestic disinfection purposes11.080.20Dezinfektanti in antiseptikiDisinfectants and antisepticsICS:SLOVENSKI
STANDARDSIST EN 14885:200701-april-2007
EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN 14885November 2006ICS 11.080.20; 71.100.35 English VersionChemical disinfectants and antiseptics - Application of EuropeanStandards for chemical disinfectants and antisepticsAntiseptiques et désinfectants chimiques - Application desNormes européennes sur les antiseptiques et désinfectantschimiquesChemische Desinfektionsmittel und Antiseptika -Anwendung Europäischer Normen für chemischeDesinfektionsmittel und AntiseptikaThis European Standard was approved by CEN on 6 August 2006.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the Central Secretariat or to any CEN member.This European Standard exists in three official versions (English, French, German). A version in any other language made by translationunder the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the officialversions.CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania,Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre: rue de Stassart, 36
B-1050 Brussels© 2006 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN 14885:2006: E
EN 14885:2006 (E) 2 Contents Page Foreword.3 Introduction.4 1 Scope.5 2 Normative references.6 3 Terms and definitions.7 3.1 Chemical disinfectant or antiseptic procedures and product types.7 3.2 Chemical disinfectant or antiseptic action.8 3.3 General terms.10 4 Category of tests.11 5 Procedures for claiming activity.11 5.1 General.11 5.2 Chemical disinfectants and antiseptics for use in the medical area.11 5.3 Chemical disinfectants and antiseptics for use in the veterinary area.12 5.4 Chemical disinfectants and antiseptics for use in food, industrial, domestic and institutional areas.12 5.5 Products for which no particular area of application is specified.12 6 Labelling regarding claims and use recommendations.12 Annex A (informative)
Recommendations on the use of terms and definitions in the area of disinfection and antisepsis.32 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.33 Bibliography.34
EN 14885:2006 (E) 3 Foreword This document (EN 14885:2006) 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 May 2007, and conflicting national standards shall be withdrawn at the latest by May 2007. 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. The 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 laundry, will be produced at a later time. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EN 14885:2006 (E) 4 Introduction This European Standard specifies the laboratory methods to be used for testing the activity of products, i.e. chemical disinfectants, antiseptics including active substances, in order to support claims that they have specific properties appropriate to their intended application. It 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 called up in this European Standard are based on current scientific knowledge. It is recognised 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.
EN 14885:2006 (E) 5 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 standard. This European Standard also specifies the terms and definitions which are used in two or more of the European Standards. It is applicable to products for which activity is claimed against the following micro-organisms: vegetative bacteria, bacterial spores, fungi, 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 competent bodies in assessing claims made by the manufacturer or 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 are 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 products for which no particular area of application is specified (e.g. active substances under development). The European Standard does not refer to methods for testing the toxicological and ecotoxicological properties of products.
EN 14885:2006 (E) 6 2 Normative references The following referenced documents are indispensable for the application 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, 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, 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, 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 veterinary field — 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) prEN 120541), Chemical disinfectants and antiseptics — Quantitative suspension test for the evaluation of bactericidal activity of products for hygienic and surgical handrub and handwash used in human medicine – Test method and requirements (phase 2, step 1) EN 12791, Chemical disinfectants and antiseptics — Surgical hand disinfection — Test method and requirements (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 13624, Chemical disinfectants and antiseptics — Quantitative suspension test for the evaluation of fungicidal activity of chemical disinfectants for instruments used 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)
1) Under development.
EN 14885:2006 (E) 7 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 of chemical disinfectants for instruments used 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) EN 14347, Chemical disinfectants and antiseptics — Basic sporicidal activity — Test method and requirements (phase 1) 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 field on non-porous surfaces without mechanical action — Test method and requirements (phase 2, step 2) EN 14476, Chemical disinfectants and antiseptics — Virucidal quantitative suspension test for chemical disinfectants and antiseptics used in human medicine — Test method and requirements (phase 2, step 1) EN 14561, Chemical disinfectants and antiseptics — Quantitative carrier test for the evaluation of bactericidal activity of chemical disinfectants 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) 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
EN 14885:2006 (E) 8 3.1.2 antisepsis application of an antiseptic on living tissues causing an action on the structure or metabolism of micro-organisms 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 3.1.4 chemical disinfection reduction of the number of micro-organisms 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 product used for post-contamination treatment that involves rubbing hands, without the addition of water, which is directed against transiently contaminating micro-organisms to prevent their transmission regardless of the resident skin flora 3.1.6 hygienic handwash product used for post-contamination treatment that involves washing hands, which is directed against transiently contaminating micro-organisms to prevent their transmission regardless of the resident skin flora 3.1.7 instrument disinfection (surface disinfection by immersion) chemical disinfection of certain instruments in the medical and veterinary areas by immersion 3.1.8 surface disinfection chemical disinfection of a solid surface, excluding those of certain medical and veterinary instruments (3.1.7) by the application of a product NOTE The application includes e.g. circulation, dipping, flooding, immersion, spraying, wiping. 3.1.9 surgical handrub product used for preoperative treatment that involves rubbing hands, without the addition of water, which is directed against the flora of micro-organisms on hands to prevent the transmission of micro-organisms into the surgical wound 3.1.10 surgical handwash product used for preoperative treatment that involves washing hands, which is directed against the flora of micro-organisms on hands to prevent the transmission of micro-organisms into the surgical wound 3.2 Chemical disinfectant or antiseptic action 3.2.1 bactericide product that kills vegetative bacteria under defined conditions NOTE The adjective derived from “bactericide” is “bactericidal”. 3.2.2 bactericidal activity capability of a product to produce a reduction in the number of viable bacterial cells of relevant test organisms under defined conditions
EN 14885:2006 (E) 9 3.2.3 bacteriostatic activity capability of a product to inhibit the growth of bacteria under defined conditions 3.2.4 fungicide product that kills fungi (moulds and yeasts) and their spores under defined conditions NOTE The adjective derived from “fungicide” is “fungicidal”. 3.2.5 fungicidal activity capability of a product to produce a reduction in the number of viable vegetative yeast cells and mould spores of relevant test organisms under defined conditions 3.2.6 fungistatic activity capability of a product to inhibit the growth of fungi (moulds and/or yeasts) under defined conditions 3.2.7 mycobactericide product that kills mycobacteria under defined conditions NOTE The adjective derived from “mycobactericide” is “mycobactericidal”. 3.2.8 mycobactericidal activity capability of a product to produce a reduction in the number of viable mycobacterial cells of relevant test organisms under defined conditions 3.2.9 sporicide product that kills dormant bacterial spores under defined conditions NOTE The adjective derived from “sporicide” is “sporicidal”. 3.2.10 sporicidal activity capability of a product to produce a reduction in the number of viable bacterial spores of relevant test organisms under defined conditions 3.2.11 sporistatic activity capability of a product to inhibit the germination of dormant bacterial spores under defined conditions 3.2.12 tuberculocide product that kills Mycobacterium tuberculosis under defined conditions NOTE The adjective derived from “tuberculocide” is “tuberculocidal”. 3.2.13 tuberculocidal activity capability of a product to kill Mycobacterium tuberculosis, demonstrated by the capability to produce a reduction in the number of viable cells of the test organism Mycobacterium terrae under defined conditions 3.2.14 virucide product that inactivates viruses under defined conditions
EN 14885:2006 (E) 10 NOTE The adjective derived from “virucide” is “virucidal”. 3.2.15 virucidal activity capability of a product to produce a reduction in the number of infectious virus particles of relevant test organisms under defined conditions 3.2.16 yeasticide product that kills yeasts under defined conditions NOTE The adjective derived from “yeasticide” is “yeasticidal”. 3.2.17 yeasticidal activity capability of a product to produce a reduction in the number of viable yeast cells of relevant test organisms under defined conditions 3.3 General terms 3.3.1 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 3.3.2 dirty conditions conditions representative of surfaces which are known to or may contain organic and/or inorganic substances 3.3.3 high-level soiling condition representative of surfaces with regard to the veterinary area, where heavy soiling can be expected NOTE This term has been introduced to avoid confusion in the veterinary area where two levels of soiling are relevant. 3.3.4 low-level soiling condition representative of surfaces, with regard to the veterinary area, where a level of soiling can be expected, that is equivalent to dirty conditions (3.3.2) NOTE This term has been introduced to avoid confusion in the veterinary area where two levels of soiling are relevant. 3.3.5 neutralizer chemical agent or formulation that suppresses the residual microbicidal activity of a product within a specific test but does not kill, inactivate or inhibit the test organisms 3.3.6 product chemical agent or formulation used as a chemical disinfectant or antiseptic 3.3.7 test organism strain of a micro-organism selected for testing products within a standardised test NOTE For the purpose of this European Standard the term micro-organism includes vegetative bacteria, bacterial spores, fungi, fungal spores and viruses.
EN 14885:2006 (E) 11 3.3.8 viral infectivity ability of a virus to express in cells its genetic information and/or multiply in them to produce infectious progeny 4 Category of tests The tests are categorised on a modular basis as follows: Phase 1 tests are quantitative suspension tests to establish that a product has bactericidal, fungicidal, or sporicidal activity without regard to specific conditions of intended use; Phase 2 comprises two steps: Phase 2, step 1 tests are quantitative suspension tests to establish that a product has bactericidal, fungicidal, mycobactericidal, sporicidal or virucidal activity simulating practical conditions appropriate to its intended use; Phase 2, step 2 tests are other quantitative laboratory tests simulating practical conditions e.g. surface, instruments, handwash and handrub tests to establish that a product has bactericidal, fungicidal, mycobactericidal, sporicidal or virucidal activity; Phase 3 tests are field tests under practical conditions. Validated methodology for this type of test is not yet available. Until such standards are prepared the responsibility for determining the acceptability of data derived from field trials in support of the claims made for a product will lie with the regulatory authority. 5 Procedures for claiming activity 5.1 General The methodology given in a standard specified in 5.2, 5.3, 5.4 or 5.5 may be used to make claims of activity on the basis of criteria other than those specified in that standard. However, if this is done conformity to this standard shall not be claimed nor suggested. For the medical area see 5.2, for the veterinary area see 5.3, for the food, industrial, domestic and institutional areas see 5.4 and where no particular area of application is specified see 5.5. 5.2 Chemical disinfectants and antiseptics for use in the medical area 5.2.1 In order to make a claim that a product has disinfectant properties, suitable for use in the medical area, the product shall be tested in accordance with and shall conform to the relevant European Standards as given in Table 1 as specified for the particular type of product and its spectrum of activity (e.g. bactericidal, fungicidal etc.). A summary of the test conditions and requirements for the relevant phase 2, step 1 and phase 2, step 2 tests is given in Tables 1a to 1d. NOTE Phase 1 tests are not required to support claims for chemical disinfectants and antiseptics used in human medicine. 5.2.2 Tests shall be carried out under the obligatory conditions as specified in the standards. According to the claimed use of the product, tests under additional conditions (test organisms, contact times, temperatures, diluents and interfering substances) shall be carried out as specified in the standard. Additional claims which can be made are given in Tables 1a to 1d. 5.2.3 Medical devices are subject to the European Directive 93/42/EEC [2] which requires that the product has to carry a CE mark. Disinfectants which are intended specifically by its manufacturer to be used together
EN 14885:2006 (E) 12 with medical devices are themselves regarded as medical devices and so these products, as well as conforming to the instrument disinfection standards in Table 1, are also required to carry a CE mark. 5.3 Chemical disinfectants and antiseptics for use in the veterinary area 5.3.1 In order to make a claim that a product has disinfectant properties, suitable for use in the veterinary area, the product shall be tested in accordance with and shall conform to the relevant European Standards as given in Table 2 as specified for the particular type of product and its spectrum of activity (e.g. bactericidal, fungicidal etc.). A summary of the test conditions and requirements for the relevant phase 2, step 1 and phase 2, step 2 tests is given in Tables 2a to 2d. NOTE Phase 1 tests are not required to support claims for chemical disinfectants and antiseptics used in the veterinary area.
5.3.2 Tests shall be carried out under the obligatory conditions as specified in the standards. According to the claimed use of the product, tests under additional conditions (test organisms, contact times, temperatures, diluents and interfering substances) shall be carried out as specified in the standard. Additional claims which can be made are given in Tables 2a to 2d. 5.4 Chemical disinfectants and antiseptics for use in food, industrial, domestic and institutional areas 5.4.1 In order to make a claim that a product has disinfectant properties, suitable for use in food, industrial, domestic and institutional areas, the product shall be tested in accordance with and shall conform to the relevant European Standards as given in Table 3 as specified for the particular type of product and its spectrum of activity (e.g. bactericidal, fungicidal etc.). A summary of the test conditions and requirements for the relevant phase 2, step 1 and phase 2, step 2 tests is given in Tables 3a to 3d. NOTE Phase 1 tests are not required to support claims for chemical disinfectants and antiseptics used in food, industrial, domestic and institutional areas. 5.4.2 Tests shall be carried out under the obligatory conditions as specified in the standards. According to the claimed use of the product, tests under additional conditions (test organisms, contact times, temperatures, diluents and interfering substances) shall be carried out as specified in the standard. Additional claims which can be made are given in Tables 3a to 3d. 5.5 Products for which no particular area of application is specified 5.5.1 In order to claim that a product, for which no particular area of application has been specified, has specific disinfectant properties (see Table 4), it shall be tested in accordance with and shall conform to the European standard or standards given in Table 4. A summary of the test conditions and requirements for the relevant phase 1 tests is given in Table 4. 5.5.2 Only phase 1 tests are required to support claims for active substances for which no particular area of application is specified. 6 Labelling regarding claims and use recommendations The manufacturer shall provide at least the following information: a) the type and/or purpose of the product (hygienic handwash, chemical disinfectant for surfaces etc.); b) the area and field of application: i) the area of application (medical, veterinary etc.);
EN 14885:2006 (E) 13 ii) the field
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