EN 1275:2005
Current
The latest, up-to-date edition.
Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of basic fungicidal or basic yeasticidal activity of chemical disinfectants and antiseptics - Test method and requirements (phase 1)
07-12-2005
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Test method
5.1 Principle
5.2 Materials and reagents
5.2.1 Test organisms
5.2.2 Culture media and reagents
5.3 Apparatus and glassware
5.3.1 General
5.3.2 Usual microbiological laboratory equipment and,
in particular, the following:
5.4 Preparation of test organism suspensions and product
test solutions
5.4.1 Test organism suspensions (test and validation
suspension)
5.4.2 Product test solutions
5.5 Procedure for assessing the fungicidal or yeasticidal
activity of the product
5.5.1 General
5.5.2 Dilution-neutralization method
5.5.3 Membrane filtration method
5.6 Experimental data and calculation
5.6.1 Explanation of terms and abbreviations
5.6.2 Calculation
5.7 Verification of methodology
5.7.1 General
5.7.2 Control of weighted mean counts
5.7.3 Basic limits
5.8 Expression of results and precision
5.8.1 Reduction
5.8.2 Control of active and non-active product test
solution
5.8.3 Limiting test organism and fungicidal/yeasticidal
concentration
5.8.4 Precision, replicates
5.9 Interpretation of results - conclusion
5.9.1 General
5.9.2 Fungicidal activity
5.9.3 Yeasticidal activity
5.10 Test report
Annex A (informative) Referenced strains in national collections
Annex B (informative) Suitable 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 F (informative) Information on the application and
interpretation of European Standards on
chemical disinfectants and antiseptics
Bibliography
This European Standard specifies a test method and the minimum requirements for basic fungicidal or basic yeasticidal activity of chemical disinfectant and antiseptic products that form a homogeneous, physically stable preparation when diluted with water. Products can only be tested at a concentration of 80 percent or less as some dilution is always produced by adding the test organisms and water.This European Standard applies to active substances (antifungal biocides) and to formulations under development that are planned to be used in food, industrial, domestic and institutional, medical and veterinary areas. It applies also to the evaluation of fungicidal or yeasticidal activity of chemical antiseptics and disinfectants when appropriate European Standards are not available.NOTE 1This European Standard does not evaluate the activity of a product for an intended use.NOTE 2This method corresponds to a phase 1 test (Annex F).
Committee |
CEN/TC 216
|
DocumentType |
Standard
|
PublisherName |
Comite Europeen de Normalisation
|
Status |
Current
|
Standards | Relationship |
UNE-EN 1275:2007 | Identical |
I.S. EN 1275:2006 | Identical |
PN EN 1275 : 2006 | Identical |
BS EN 1275:2005 | Identical |
NBN EN 1275 : 2006 | Identical |
NS EN 1275 : 2ED 2006 | Identical |
UNI EN 1275 : 2006 | Identical |
NEN EN 1275 : 2005 | Identical |
SN EN 1275 : 2006 | Identical |
NF EN 1275 : 2006 | Identical |
DIN EN 1275:2006-03 | Identical |
UNE-EN 1275:2005 | Identical |
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 |
BS EN ISO 14534:2015 | Ophthalmic optics. Contact lenses and contact lens care products. Fundamental requirements |
EN 60601-2-16:2015 | Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment |
DIN EN 14885:2015-11 | CHEMICAL DISINFECTANTS AND ANTISEPTICS - APPLICATION OF EUROPEAN STANDARDS FOR CHEMICAL DISINFECTANTS AND ANTISEPTICS |
PREN 13697 : DRAFT 2012 | CHEMICAL DISINFECTANTS AND ANTISEPTICS - QUANTITATIVE NON-POROUS SURFACE TEST FOR THE EVALUATION OF BACTERICIDAL AND/OR FUNGICIDAL ACTIVITY OF CHEMICAL DISINFECTANTS USED IN FOOD, INDUSTRIAL, DOMESTIC AND INSTITUTIONAL AREAS - TEST METHOD AND REQUIREMENTS WITHOUT MECHANICAL ACTION (PHASE 2, STEP 2) |
04/30110411 DC : DRAFT MARCH 2004 | EN 14885 - CHEMICAL DISINFECTANTS AND ANTISEPTICS - APPLICATION OF EUROPEAN STANDARDS FOR CHEMICAL DISINFECTANTS AND ANTISEPTICS |
16/30323461 DC : 0 | BS EN 60601-2-16 ED 5.0 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-16: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HAEMODIALYSIS, HAEMODIAFILTRATION AND HAEMOFILTRATION EQUIPMENT |
PREN 14885 : DRAFT 2014 | CHEMICAL DISINFECTANTS AND ANTISEPTICS - APPLICATION OF EUROPEAN STANDARDS FOR CHEMICAL DISINFECTANTS AND ANTISEPTICS |
AAMI IEC 60601-2-16 : 2012 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-16: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HEMODIALYSIS, HEMODIAFILTRATION AND HEMOFILTRATION EQUIPMENT |
I.S. EN 60601-2-16:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-16: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HAEMODIALYSIS, HAEMODIAFILTRATION AND HAEMOFILTRATION EQUIPMENT |
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 ISO 14534:2015 | OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - FUNDAMENTAL REQUIREMENTS (ISO 14534:2011) |
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 |
09/30207531 DC : 0 | BS EN ISO 14534 - OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - FUNDAMENTAL REQUIREMENTS |
BS EN 14885:2015 | Chemical disinfectants and antiseptics. Application of European Standards for chemical disinfectants and antiseptics |
07/30090385 DC : 0 | ISO 13408-1 - ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS |
I.S. EN 14885:2015 | CHEMICAL DISINFECTANTS AND ANTISEPTICS - APPLICATION OF EUROPEAN STANDARDS FOR CHEMICAL DISINFECTANTS AND ANTISEPTICS |
BS EN 60601-2-16:2015 | Medical electrical equipment Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment |
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 |
17/30351682 DC : 0 | BS EN ISO 20150 - FOOTWEAR AND FOOTWEAR COMPONENTS - QUANTITATIVE CHALLENGE TEST METHOD TO ASSESS ANTIFUNGAL ACTIVITY |
UNE-EN 14885:2016 | Chemical disinfectants and antiseptics - Application of European Standards for chemical disinfectants and antiseptics |
DIN EN ISO 14534:2015-08 | Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011) |
ISO 14534:2011 | Ophthalmic optics Contact lenses and contact lens care products Fundamental requirements |
UNE-EN ISO 14534:2015 | Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011) |
EN ISO 14534:2015 | Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011) |
12/30262905 DC : 0 | BS EN 13697 - CHEMICAL DISINFECTANTS AND ANTISEPTICS - QUANTITATIVE NON-POROUS SURFACE TEST FOR THE EVALUATION OF BACTERICIDAL AND/OR FUNGICIDAL ACTIVITY OF CHEMICAL DISINFECTANTS USED IN FOOD, INDUSTRIAL, DOMESTIC AND INSTITUTIONAL AREAS - TEST METHOD AND REQUIREMENTS WITHOUT MECHANICAL ACTION (PHASE 2, STEP 2) |
02/564187 DC : DRAFT OCT 2002 | BS EN 14562 - CHEMICAL DISINFECTANTS - QUANTITATIVE CARRIER TEST FOR EVALUATION OF FUNGICIDAL ACTIVITY OF CHEMICAL DISINFECTANTS FOR INSTRUMENTS USED IN MEDICAL AREA - TEST METHOD AND REQUIREMENTS (PHASE 2/STEP 2) |
CSA C22.2 No. 60601.2.16 : 2014(R2019) | MEDICAL ELECTRICAL EQUIPMENT - PART 2-16: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HAEMODIALYSIS, HAEMODIAFILTRATION AND HAEMOFILTRATION EQUIPMENT |
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 |
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