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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
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)
25-07-2019
09-09-2015
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
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".
Committee |
CEN/TC 216
|
DevelopmentNote |
2013 Edition Re-Issued in September 2015 & incorporates AMD 1 2015. (09/2015)
|
DocumentType |
Standard
|
PublisherName |
Comite Europeen de Normalisation
|
Status |
Superseded
|
SupersededBy |
Standards | Relationship |
UNI EN 14476:2015 | Identical |
NBN EN 14476 : 2013 + A1 2015 | Identical |
PN EN 14476 : 2013 + A1 2015 | Identical |
ONORM EN 14476 : 2016 | Identical |
NS EN 14476 : 2013 + A1 2015 | Identical |
BS EN 14476 : 2013 | Identical |
NEN EN 14476 : 2013 + A1 2015 | Identical |
UNI EN 14476 : 2013 | Identical |
I.S. EN 14476:2013 | Identical |
SN EN 14476 : 2013 + A1 2015 | Identical |
DIN EN 14476:2015-12 | Identical |
NF EN 14476 : 2013 + A1 2015 | Identical |
I.S. EN 14476:2013+A2:2019 | Identical |
UNE-EN 14476:2014+A1:2015 | Identical |
I.S. EN 14476:2013+A1:2015 | Identical |
UNE-EN 14476:2014 | Identical |
BS EN 14476:2013+A1:2015 | Identical |
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 |
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) |
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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