Chemical disinfectants and antiseptics – Quantitative carrier test for the evaluation of bactericidal activity for instruments used in the medical area – Test method and requirements (phase 2, step 2)
DIN EN 14561:2006-08 (E)
Chemical disinfectants and antiseptics – Quantitative carrier test for the evaluation of
bactericidal 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 ……………………………………………………………………………………………………6
5.3 Apparatus and glassware ………………………………………………………………………………………………..9
5.4 Preparation of test organism suspensions and product test solutions ……………………………11
5.5 Procedure for assessing the bactericidal activity of the product …………………………………….13
5.6 Experimental data and calculation …………………………………………………………………………………16
5.7 Verification of methodology …………………………………………………………………………………………..22
5.8 Expression of results and precision ………………………………………………………………………………22
5.9 Interpretation of results – conclusion ……………………………………………………………………………..23
5.10 Test report …………………………………………………………………………………………………………………….24
Annex A (informative) Referenced strains in national collections …………………………………………………..26
Annex B (informative) Suitable neutralizers …………………………………………………………………………………..27
Annex C (informative) Graphical representations of the test method ……………………………………………..29
Annex D (informative) Example of a typical test report ………………………………………………………………….31
Annex E (informative) Information on the application and interpretation of European Standards on
chemical disinfectants and antiseptics ………………………………………………………………………….34
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC ……………………………………………………………………….36
Bibliography …………………………………………………………………………………………………………………………………37