Chemical disinfectants and antiseptics – Quantitative carrier test for the evaluation of fungicidal or yeasticidal activity for instruments used in the medical area – Test method and requirements (phase 2, step 2)
DIN EN 14562:2006-08 (E)
Chemical disinfectants and antiseptics – Quantitative carrier test for the evaluation
of fungicidal or yeasticidal activity for instruments used in the medical area – Test
method and requirements (phase 2, step 2)
Contents Page
Foreword ……………………………………………………………………………………………………………………………………….3
Introduction ……………………………………………………………………………………………………………………………………4
1 Scope ……………………………………………………………………………………………………………………………..5
2 Normative references ……………………………………………………………………………………………………..5
3 Terms and definitions ……………………………………………………………………………………………………..5
4 Requirements …………………………………………………………………………………………………………………6
5 Test method ……………………………………………………………………………………………………………………6
5.1 Principle …………………………………………………………………………………………………………………………6
5.2 Materials and reagents ……………………………………………………………………………………………………7
5.3 Apparatus and glassware ………………………………………………………………………………………………..9
5.5 Procedure for assessing the fungicidal / yeasticidal activity of the product ……………………14
5.6 Experimental data and calculation …………………………………………………………………………………17
5.7 Verification of methodology …………………………………………………………………………………………..23
5.8 Expression of results and precision ………………………………………………………………………………23
5.9 Interpretation of results – conclusion ……………………………………………………………………………..24
5.10 Test report …………………………………………………………………………………………………………………….25
Annex A (informative) Referenced strains in national collections …………………………………………………..27
Annex B (informative) Suitable neutralizers …………………………………………………………………………………..28
Annex C (informative) Graphical representations of the test method ……………………………………………..30
Annex D (informative) Example of a typical test report ………………………………………………………………….32
Annex E (informative) Information on the application and interpretation of European Standards on
chemical disinfectants and antiseptics ………………………………………………………………………….36
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC ……………………………………………………………………….38
Bibliography …………………………………………………………………………………………………………………………………39