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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
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)
18-11-2021
25-09-2013
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 |
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 |
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 |
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) |
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) |
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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