EN 14348:2005

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).