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EN 13624:2013

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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

Superseded date

11-18-2021

Published date

09-25-2013

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

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".

Committee
CEN/TC 216
DocumentType
Standard
PublisherName
Comite Europeen de Normalisation
Status
Superseded
SupersededBy

Standards Relationship
NBN EN 13624 : 2013 Identical
NEN EN 13624 : 2013 Identical
UNI EN 13624 : 2013 Identical
I.S. EN 13624:2013 Identical
SANS 53624 : 1ED 2011 Identical
NF EN 13624 : 2013 Identical
DIN EN 13624:2013-12 Identical
BS EN 13624:2013 Identical
UNE-EN 13624:2014 Identical
NS EN 13624 : 2013 Identical
PN EN 13624 : 2013 Identical
SN EN 13624:2013 Identical
ONORM EN 13624 : 2013 Identical

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)

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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