• EN 13624:2013

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 fungicidal or yeasticidal activity in the medical area - Test method and requirements (phase 2, step 1)

    Available format(s): 

    Superseded date:  18-11-2021

    Language(s): 

    Published date:  25-09-2013

    Publisher:  Comite Europeen de Normalisation

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Requirements
    5 Test method
    Annex A (informative) - Referenced strains in national
            collections
    Annex B (informative) - Neutralizers and rinsing liquids
    Annex C (informative) - Graphical representation of test
            procedures
    Annex D (informative) - Example of a typical test
            report
    Annex E (informative) - Precision of the test result
    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 fungicidal or yeasticidal 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 - with water. Products can only be tested at a concentration of 80 % or less (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, surgical handrub, surgical handwash, instrument disinfection by immersion, and surface disinfection by wiping, spraying, flooding or other means.This European Standard applies to areas and situations where disinfection or antisepsis 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.EN 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
    Document Type Standard
    Publisher Comite Europeen de Normalisation
    Status Superseded
    Superseded By

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

    DIN EN 16615 E : 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)
    BS EN 16616:2015 Chemical disinfectants and antiseptics. Chemical-thermal textile disinfection. Test method and requirements (phase 2, step 2)
    DIN EN ISO 16212:2011-08 COSMETICS - MICROBIOLOGY - ENUMERATION OF YEAST AND MOULD (ISO 16212:2017)
    07/30136068 DC : 0 BS ISO 16212 - COSMETICS - MICROBIOLOGY - ENUMERATION OF YEAST AND MOULD
    BS ISO 16212 : 2008 COSMETICS - MICROBIOLOGY - ENUMERATION OF YEAST AND MOULD
    CSA Z15883-5:2009 WASHER-DISINFECTORS - PART 5: TEST SOILS AND METHODS FOR DEMONSTRATING CLEANING EFFICACY
    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
    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
    DIN EN ISO 15883-4:2009-09 WASHER-DISINFECTORS - PART 4: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING CHEMICAL DISINFECTION FOR THERMOLABILE ENDOSCOPES
    DIN EN ISO 15883-4:2016-07 (Draft) WASHER-DISINFECTORS - PART 4: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING CHEMICAL DISINFECTION FOR THERMOLABILE ENDOSCOPES
    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)
    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
    13/30281507 DC : 0 BS EN 16615 - 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)
    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)
    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)
    BS EN 14885:2015 Chemical disinfectants and antiseptics. Application of European Standards for chemical disinfectants and antiseptics
    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
    I.S. EN 12791:2016 CHEMICAL DISINFECTANTS AND ANTISEPTICS - SURGICAL HAND DISINFECTION - TEST METHOD AND REQUIREMENT (PHASE 2/STEP 2)
    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
    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
    13/30281963 DC : 0 BS EN 16616 - CHEMICAL DISINFECTANTS AND ANTISEPTICS - CHEMICAL-THERMAL TEXTILE DISINFECTION - TEST METHOD AND REQUIREMENTS (PHASE 2, STEP 2)
    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
    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
    BS 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)
    PREN 12791 : DRAFT 2013 CHEMICAL DISINFECTANTS AND ANTISEPTICS - SURGICAL HAND DISINFECTION - TEST METHOD AND REQUIREMENT (PHASE 2/STEP 2)
    BS EN ISO 16212:2017 Cosmetics. Microbiology. Enumeration of yeast and mould
    07/30090385 DC : 0 ISO 13408-1 - ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS
    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
    CEN ISO/TS 15883-5:2005 Washer-disinfectors - Part 5: Test soils and methods for demonstrating cleaning efficacy (ISO/TS 15883-5:2005)
    UNE-EN 14885:2016 Chemical disinfectants and antiseptics - Application of European Standards for chemical disinfectants and antiseptics
    I.S. EN 14885:2015 CHEMICAL DISINFECTANTS AND ANTISEPTICS - APPLICATION OF EUROPEAN STANDARDS FOR CHEMICAL DISINFECTANTS AND ANTISEPTICS
    DIN EN 14562:2006-08 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)
    BS 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 14885:2015 Chemical disinfectants and antiseptics - Application of European Standards for chemical disinfectants and antiseptics
    DIN EN 16616:2015-10 Chemical disinfectants and antiseptics - Chemical-thermal textile disinfection - Test method and requirements (phase 2, step 2)
    14/30294479 DC : 0 BS EN 14885 - CHEMICAL DISINFECTANTS AND ANTISEPTICS - APPLICATION OF EUROPEAN STANDARDS FOR CHEMICAL DISINFECTANTS AND ANTISEPTICS
    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)
    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 14885:2015-11 CHEMICAL DISINFECTANTS AND ANTISEPTICS - APPLICATION OF EUROPEAN STANDARDS FOR CHEMICAL DISINFECTANTS AND ANTISEPTICS
    UNE-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)
    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
    I.S. EN 16616:2015 CHEMICAL DISINFECTANTS AND ANTISEPTICS - CHEMICAL-THERMAL TEXTILE DISINFECTION - TEST METHOD AND REQUIREMENTS (PHASE 2, STEP 2)
    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)
    ISO 16212:2017 Cosmetics — Microbiology — Enumeration of yeast and mould
    EN 12791:2016+A1:2017 Chemical disinfectants and antiseptics - Surgical hand disinfection - Test method and requirements (phase 2, step 2)
    I.S. EN ISO 16212:2017 COSMETICS - MICROBIOLOGY - ENUMERATION OF YEAST AND MOULD (ISO 16212:2017)
    DIN EN 14562 E : 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)
    ISO/TS 15883-5:2005 Washer-disinfectors Part 5: Test soils and methods for demonstrating cleaning efficacy
    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 ISO 16212:2017 Cosmetics - Microbiology - Enumeration of yeast and mould (ISO 16212:2017)
    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)
    EN 16616:2015 Chemical disinfectants and antiseptics - Chemical-thermal textile disinfection - Test method and requirements (phase 2, step 2)
    EN 16615:2015 Chemical disinfectants and antiseptics - Quantitative test method for the evaluation of bactericidal and yeasticidal activity on non-porous surfaces with mechanical action employing wipes in the medical area (4- field test) - Test method and requirements (phase 2, step 2)
    UNE-EN 16616:2015 Chemical disinfectants and antiseptics - Chemical-thermal textile disinfection - Test method and requirements (phase 2, step 2)
    I.S. EN 16615:2015 CHEMICAL DISINFECTANTS AND ANTISEPTICS - QUANTITATIVE TEST METHOD FOR THE EVALUATION OF BACTERICIDAL AND YEASTICIDAL ACTIVITY ON NONPOROUS SURFACES WITH MECHANICAL ACTION EMPLOYING WIPES IN THE MEDICAL AREA (4- FIELD TEST) - TEST METHOD AND REQUIREMENTS (PHASE 2, STEP 2)
    DIN EN 16615:2015-06 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)
    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)
    13/30283770 DC : 0 BS EN 12791 - CHEMICAL DISINFECTANTS AND ANTISEPTICS - SURGICAL HAND DISINFECTION - TEST METHOD AND REQUIREMENT (PHASE 2/STEP 2)
    DIN EN 16616 E : 2015 CHEMICAL DISINFECTANTS AND ANTISEPTICS - CHEMICALTHERMAL TEXTILE DISINFECTION - TEST METHOD AND REQUIREMENTS (PHASE 2, STEP 2)
    UNE-EN ISO 16212:2017 Cosmetics - Microbiology - Enumeration of yeast and mould (ISO 16212:2017)
    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 EN 12791 : 2016 CHEMICAL DISINFECTANTS AND ANTISEPTICS - SURGICAL HAND DISINFECTION - TEST METHOD AND REQUIREMENT (PHASE 2/STEP 2)
    UNI EN ISO 16212 : 2011 COSMETICS - MICROBIOLOGY - ENUMERATION OF YEAST AND MOULD
    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
    UNE-EN 12791:2016 Chemical disinfectants and antiseptics - Surgical hand disinfection - Test method and requirements (phase 2, step 2)
    DIN EN ISO 16212:2017-09 Cosmetics - Microbiology - Enumeration of yeast and mould (ISO 16212:2017)

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

    ISO 4793:1980 Laboratory sintered (fritted) filters — Porosity grading, classification and designation
    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
    EN 1040:2005 Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of basic bactericidal activity of chemical disinfectants and antiseptics - Test method and requirements (phase 1)
    1997/23/EC : 1997 DIRECTIVE 97/23/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL OF 29 MAY 1997 ON THE APPROXIMATION OF THE LAWS OF THE MEMBER STATES CONCERNING PRESSURE EQUIPMENT
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