![header thumbnail](/images/img-default-logo.png)
EN 14348:2005
Current
The latest, up-to-date edition.
![header thumbnail](/images/img-default-logo.png)
Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of mycobactericidal activity of chemical disinfectants in the medical area including instrument disinfectants - Test methods and requirements (phase 2, step 1)
19-01-2005
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Test methods
5.1 Principle
5.2 Materials and reagents
5.3 Apparatus and glassware
5.4 Preparation of test organism suspensions and
product test solutions
5.5 Procedure for assessing the mycobactericidal
activity of the product
5.6 Experimental data and calculation
5.7 Verification of methodology
5.8 Expression of results and precision
5.9 Interpretation of results - conclusion
5.10 Test report
Annex A (informative) Referenced strains in national
collections
Annex B (informative) Suitable neutralizers
Annex C (informative) Graphical representations of the
test method
Annex D (informative) Example of a typical test report
Annex E (informative) Information on the application
and interpretation of European standards
on chemical disinfectants and antiseptics
Annex ZA (informative) Clauses of this document addressing
essential requirements or other
provisions of EU Directives
Bibliography
This document specifies a test method and the minimum requirements for mycobactericidal (or tuberculocidal) activity of chemical disinfectant 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 as some dilution is always produced by adding the test organisms and interfering substance.This document applies to products that are used in the medical area including those that are covered by the EEC/93/42 Directive on Medical Devices.This document 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 kindergardens 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 (see Annex E).
Committee |
CEN/TC 216
|
DocumentType |
Standard
|
PublisherName |
Comite Europeen de Normalisation
|
Status |
Current
|
Standards | Relationship |
UNI EN 14348 : 2005 | Identical |
NF EN 14348 : 2005 | Identical |
NBN EN 14348 : 2005 | Identical |
NEN EN 14348 : 2005 | Identical |
SN EN 14348 : 2005 | Identical |
DIN EN 14348 E : 2005 | Identical |
I.S. EN 14348:2005 | Identical |
UNE-EN 14348:2005 | Identical |
NS EN 14348 : 1ED 2005 | Identical |
BS EN 14348:2005 | Identical |
PN EN 14348 : 2006 | Identical |
DIN EN 14348:2005-04 | 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) |
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 |
BS EN 16616:2015 | Chemical disinfectants and antiseptics. Chemical-thermal textile disinfection. 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 |
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 14885:2015-11 | CHEMICAL DISINFECTANTS AND ANTISEPTICS - APPLICATION OF EUROPEAN STANDARDS FOR CHEMICAL DISINFECTANTS AND ANTISEPTICS |
DIN EN ISO 15883-4:2016-07 (Draft) | WASHER-DISINFECTORS - PART 4: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING CHEMICAL DISINFECTION FOR THERMOLABILE ENDOSCOPES |
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) |
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 |
BS EN 14885:2015 | Chemical disinfectants and antiseptics. Application of European Standards for chemical disinfectants and antiseptics |
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 |
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) |
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 ISO 15883-4:2009 | Washer-disinfectors Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes |
07/30090385 DC : 0 | ISO 13408-1 - ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS |
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) |
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 |
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 |
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 |
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) |
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/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) |
EN 16616:2015 | Chemical disinfectants and antiseptics - Chemical-thermal textile disinfection - Test method and requirements (phase 2, step 2) |
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 16616:2015 | Chemical disinfectants and antiseptics - Chemical-thermal textile disinfection - Test method and requirements (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 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) |
UNI EN ISO 15883-4 : 2009 | WASHER-DISINFECTORS - PART 4: REQUIREMENTS AND TESTS FOR WASHER- DISINFECTORS EMPLOYING CHEMICAL DISINFECTION FOR THERMOLABILE ENDOSCOPES |
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 |
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 14820:2004 | Single-use containers for human venous blood specimen collection |
Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.