• EN 14476:2013+A1:2015

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    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)

    Available format(s): 

    Superseded date:  25-07-2019

    Language(s): 

    Published date:  09-09-2015

    Publisher:  Comite Europeen de Normalisation

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    Table of Contents - (Show below) - (Hide below)

    European foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Requirements
    5 Test methods
    Annex A (informative) - Examples of viruses sorted
            according to their presence in the human
            body in case of virus infection
    Annex B (informative) - Detoxification of test mixtures
            by molecular sieving
    Annex C (informative) - Calculation of the viral
            infectivity titre
    Annex D (informative) - Presentation of test results of
            one active concentration
    Annex E (informative) - Quantitative determination of
            formaldehyde concentrations
    Annex ZA (informative) - Relationship between this European
             Standard and the Essential Requirements of
             EU Directive 93/42/EEC'
    Bibliography

    Abstract - (Show below) - (Hide below)

    This European Standard specifies a test method and the minimum requirements for virucidal activity of chemical disinfectant and antiseptic products that form a homogeneous physically stable preparation when diluted with hard water or in the case of ready-to-use products, i. e, products that are not diluted when applied, with water. Products can only be tested at a concentration of 80 % (97 %, with a modified method for special cases) as some dilution is always produced by adding the test organisms and interfering substance.This European Standard applies to products that are used in the medical area in the fields of hygienic handrub, hygienic handwash, instrument disinfection by immersion, surface disinfection by wiping, spraying, flooding or other means and textile disinfection.This European Standard applies to areas and situations where disinfection is medically indicated. Such indications occur in patient care, for example:-in hospitals, in community medical facilities, and in dental institutions;-in clinics of schools, of kindergartens, and of nursing homes;and may occur in the workplace and in the home. It may also include services such as laundries and kitchens supplying products directly for the patients.NOTE 1The method described is intended to determine the activity of commercial formulations or active substances under the conditions in which they are used.NOTE 2This method corresponds to a phase 2, step 1 test.NOTE 3EN 14885 specifies in detail the relationship of the various tests to one another and to "use recommendations".

    General Product Information - (Show below) - (Hide below)

    Committee CEN/TC 216
    Development Note 2013 Edition Re-Issued in September 2015 & incorporates AMD 1 2015. (09/2015)
    Document Type Standard
    Publisher Comite Europeen de Normalisation
    Status Superseded
    Superseded By

    Standards Referenced By This Book - (Show below) - (Hide below)

    ISO 15883-7:2016 Washer-disinfectors — Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment
    DIN EN ISO 15883-7 E : 2016 WASHER-DISINFECTORS - PART 7: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING CHEMICAL DISINFECTION FOR NON-INVASIVE, NON-CRITICAL THERMOLABILE MEDICAL DEVICES AND HEALTHCARE EQUIPMENT (ISO 15883-7:2016)
    14/30303000 DC : 0 BS EN 16777 - 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)
    13/30267713 DC : 0 BS ISO 18184 - TEXTILES - DETERMINATION OF ANTIVIRAL ACTIVITY ASSAY OF TEXTILE PRODUCTS
    16/30348955 DC : 0 BS EN 16777 - 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)
    UNI EN 12353 : 2013 CHEMICAL DISINFECTANTS AND ANTISEPTICS - PRESERVATION OF TEST ORGANISMS USED FOR THE DETERMINATION OF BACTERICIDAL (INCLUDING LEGIONELLA), MYCOBACTERICIDAL, SPORICIDAL, FUNGICIDAL AND VIRUCIDAL (INCLUDING BACTERIOPHAGES) ACTIVITY
    DIN EN ISO 15883-4:2009-09 WASHER-DISINFECTORS - PART 4: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING CHEMICAL DISINFECTION FOR THERMOLABILE ENDOSCOPES
    17/30357507 DC : DRAFT SEP 2017 BS ISO 18184 - TEXTILES - DETERMINATION OF ANTIVIRAL ACTIVITY OF TEXTILE PRODUCTS
    DIN EN ISO 15883-4:2016-07 (Draft) WASHER-DISINFECTORS - PART 4: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING CHEMICAL DISINFECTION FOR THERMOLABILE ENDOSCOPES
    BS EN ISO 15883-7:2016 Washer-disinfectors Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment
    PREN 14885 : DRAFT 2014 CHEMICAL DISINFECTANTS AND ANTISEPTICS - APPLICATION OF EUROPEAN STANDARDS FOR CHEMICAL DISINFECTANTS AND ANTISEPTICS
    CAN/CSA-ISO 15883-7:17 Washer-disinfectors — Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment (Adopted ISO 15883-7:2016, first edition, 2016-02-01)
    CSA Z15883-5:2009 WASHER-DISINFECTORS - PART 5: TEST SOILS AND METHODS FOR DEMONSTRATING CLEANING EFFICACY
    UNI EN ISO 15883-4 : 2009 WASHER-DISINFECTORS - PART 4: REQUIREMENTS AND TESTS FOR WASHER- DISINFECTORS EMPLOYING CHEMICAL DISINFECTION FOR THERMOLABILE ENDOSCOPES
    EN 12353:2013 Chemical disinfectants and antiseptics - Preservation of test organisms used for the determination of bactericidal (including Legionella), mycobactericidal, sporicidal, fungicidal and virucidal (including bacteriophages) activity
    DIN EN 12353:2013-04 Chemical disinfectants and antiseptics - Preservation of test organisms used for the determination of bactericidal (including Legionella), mycobactericidal, sporicidal, fungicidal and virucidal (including bacteriophages) activity
    BS EN 12353:2013 Chemical disinfectants and antiseptics. Preservation of test organisms used for the determination of bactericidal (including Legionella), mycobactericidal, sporicidal, fungicidal and virucidal (including bacteriophages) activity
    UNE-EN 12353:2013 Chemical disinfectants and antiseptics - Preservation of test organisms used for the determination of bactericidal (including Legionella), mycobactericidal, sporicidal, fungicidal and virucidal (including bacteriophages) activity
    I.S. EN 12353:2013 CHEMICAL DISINFECTANTS AND ANTISEPTICS - PRESERVATION OF TEST ORGANISMS USED FOR THE DETERMINATION OF BACTERICIDAL (INCLUDING LEGIONELLA), MYCOBACTERICIDAL, SPORICIDAL, FUNGICIDAL AND VIRUCIDAL (INCLUDING BACTERIOPHAGES) ACTIVITY
    DIN EN 14885 E : 2015 CHEMICAL DISINFECTANTS AND ANTISEPTICS - APPLICATION OF EUROPEAN STANDARDS FOR CHEMICAL DISINFECTANTS AND ANTISEPTICS
    UNE-EN 14885:2016 Chemical disinfectants and antiseptics - Application of European Standards for chemical disinfectants and antiseptics
    CSA Z15883-5:09 (R2019) Washer-disinfectors - Part 5: Test soils and methods for demonstrating cleaning efficacy (Adopted ISO/TS 15883-5:2005, first edition, 2005-11-15)
    14/30235350 DC : 0 BS EN ISO 15883-7 - WASHER-DISINFECTORS - PART 7: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING CHEMICAL DISINFECTION FOR NON-INVASIVE, NON-CRITICAL THERMOLABILE MEDICAL DEVICES AND HEALTHCARE EQUIPMENT
    ISO 15883-4:2008 Washer-disinfectors Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes
    I.S. CEN ISO TS 15883-5:2006 WASHER-DISINFECTORS - PART 5: TEST SOILS AND METHODS FOR DEMONSTRATING CLEANING EFFICACY
    I.S. EN ISO 15883-7:2016 WASHER-DISINFECTORS - PART 7: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING CHEMICAL DISINFECTION FOR NON-INVASIVE, NON-CRITICAL THERMOLABILE MEDICAL DEVICES AND HEALTHCARE EQUIPMENT (ISO 15883-7:2016)
    CEN ISO/TS 15883-5:2005 Washer-disinfectors - Part 5: Test soils and methods for demonstrating cleaning efficacy (ISO/TS 15883-5:2005)
    PREN 17111 : DRAFT 2017 CHEMICAL DISINFECTANTS AND ANTISEPTICS - QUANTITATIVE CARRIER TEST FOR THE EVALUATION OF VIRUCIDAL ACTIVITY FOR INSTRUMENTS USED IN THE MEDICAL AREA - TEST METHOD AND REQUIREMENTS (PHASE 2, STEP 2)
    I.S. EN 14885:2015 CHEMICAL DISINFECTANTS AND ANTISEPTICS - APPLICATION OF EUROPEAN STANDARDS FOR CHEMICAL DISINFECTANTS AND ANTISEPTICS
    EN 14885:2015 Chemical disinfectants and antiseptics - Application of European Standards for chemical disinfectants and antiseptics
    14/30294479 DC : 0 BS EN 14885 - CHEMICAL DISINFECTANTS AND ANTISEPTICS - APPLICATION OF EUROPEAN STANDARDS FOR CHEMICAL DISINFECTANTS AND ANTISEPTICS
    DIN EN 14885:2015-11 CHEMICAL DISINFECTANTS AND ANTISEPTICS - APPLICATION OF EUROPEAN STANDARDS FOR CHEMICAL DISINFECTANTS AND ANTISEPTICS
    BS EN 14885:2015 Chemical disinfectants and antiseptics. Application of European Standards for chemical disinfectants and antiseptics
    16/30288024 DC : 0 BS EN ISO 15883-4 - WASHER-DISINFECTORS - PART 4: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING CHEMICAL DISINFECTION FOR THERMOLABILE ENDOSCOPES
    CSA Z15883-4 : 2009 Washer-disinfectors — Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes (ISO 15883-4:2008, IDT)
    BS EN ISO 15883-4:2009 Washer-disinfectors Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes
    I.S. EN ISO 15883-4:2009 WASHER-DISINFECTORS - PART 4: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING CHEMICAL DISINFECTION FOR THERMOLABILE ENDOSCOPES
    PREN 16777 : DRAFT 2016 BS EN 16777 - 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 ISO 15883-4:2009 Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes (ISO 15883-4:2008)
    ISO 18184:2014 Textiles Determination of antiviral activity of textile products
    ISO/TS 15883-5:2005 Washer-disinfectors Part 5: Test soils and methods for demonstrating cleaning efficacy
    EN ISO 15883-7:2016 Washer-disinfectors - Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment (ISO 15883-7:2016)
    DIN EN ISO 15883-7:2016-10 WASHER-DISINFECTORS - PART 7: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING CHEMICAL DISINFECTION FOR NON-INVASIVE, NON-CRITICAL THERMOLABILE MEDICAL DEVICES AND HEALTHCARE EQUIPMENT (ISO 15883-7:2016)
    UNE-EN ISO 15883-7:2016 Washer-disinfectors - Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment (ISO 15883-7:2016)
    BS ISO 18184:2014 Textiles. Determination of antiviral activity of textile products
    CSA Z15883-4 : 2009 : R2014 WASHER-DISINFECTORS - PART 4: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING CHEMICAL DISINFECTION FOR THERMOLABILE ENDOSCOPES
    CSA Z15883-5 : 2009 : R2014 WASHER-DISINFECTORS - PART 5: TEST SOILS AND METHODS FOR DEMONSTRATING CLEANING EFFICACY
    17/30354236 DC : 0 BS EN 17111 - CHEMICAL DISINFECTANTS AND ANTISEPTICS - QUANTITATIVE CARRIER TEST FOR THE EVALUATION OF VIRUCIDAL ACTIVITY FOR INSTRUMENTS USED IN THE MEDICAL AREA - TEST METHOD AND REQUIREMENTS (PHASE 2, STEP 2)

    Standards Referencing This Book - (Show below) - (Hide below)

    EN 12353:2013 Chemical disinfectants and antiseptics - Preservation of test organisms used for the determination of bactericidal (including Legionella), mycobactericidal, sporicidal, fungicidal and virucidal (including bacteriophages) activity
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