EN 14561:2006

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Test method
  5.1 Principle
  5.2 Materials and reagents
  5.3 Apparatus and glassware
  5.4 Preparation of test organism suspensions and product
       test solutions
  5.5 Procedure for assessing the bactericidal 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) 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 bactericidal 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. This European Standard applies to products that are used in the medical area for disinfecting instruments by immersion - even if they are not covered by the EEC/93/42 Directive on Medical Devices.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 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.NOTEThis method corresponds to a phase 2, step 2 test (see Annex E).