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EN 1275:2005

Current
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)
Published date

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
DIN EN 14885 E : 2015 CHEMICAL DISINFECTANTS AND ANTISEPTICS - APPLICATION OF EUROPEAN STANDARDS FOR CHEMICAL DISINFECTANTS AND ANTISEPTICS
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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