EN 13624:2003: Chemical disinfectants and antiseptics – Quantitative suspension test for the evaluation of fungicidal activity of chemical disinfectants for instruments used in the medical area – Test method and requirements (phase 2, step 1)
DIN EN 13624:2013-12 (E)
Chemical disinfectants and antiseptics – Quantitative suspension test for the
evaluation of fungicidal or yeasticidal activity in the medical area – Test method and
requirements (phase2, step 1)
Contents Page
Foreword ………………………………………………………………………………………………………………………………………. 3
Introduction …………………………………………………………………………………………………………………………………… 4
1 Scope …………………………………………………………………………………………………………………………….. 5
2 Normative references ……………………………………………………………………………………………………… 5
3 Terms and definitions …………………………………………………………………………………………………….. 5
4 Requirements ………………………………………………………………………………………………………………… 5
5 Test method …………………………………………………………………………………………………………………… 7
5.1 Principle ………………………………………………………………………………………………………………………… 7
5.2 Materials and reagents …………………………………………………………………………………………………… 7
5.3 Apparatus and glassware ……………………………………………………………………………………………… 10
5.4 Preparation of test organism suspensions and product test solutions …………………………… 12
5.5 Procedure for assessing the fungicidal and yeasticidal activity of the product ………………. 17
5.6 Experimental data and calculation ………………………………………………………………………………… 24
5.7 Verification of methodology ………………………………………………………………………………………….. 30
5.8 Expression of results and precision ……………………………………………………………………………… 30
5.9 Interpretation of results – conclusion …………………………………………………………………………….. 31
5.10 Test report ……………………………………………………………………………………………………………………. 32
Annex A (informative) Referenced strains in national collections …………………………………………………. 35
Annex B (informative) Neutralizers and rinsing liquids …………………………………………………………………. 36
Annex C (informative) Graphical representation of test procedures ………………………………………………. 38
C.1 Dilution-neutralization method ……………………………………………………………………………………… 38
C.2 Membrane filtration method ………………………………………………………………………………………….. 40
C.3 Dilution-neutralization method (modified method for ready-to-use products) …………………. 42
C.4 Membrane filtration method (modified method for ready-to-use products) …………………….. 44
Annex D (informative) Example of a typical test report …………………………………………………………………. 46
Annex E (informative) Precision of the test result …………………………………………………………………………. 50
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC ………………………………………………………………………. 53
Bibliography ………………………………………………………………………………………………………………………………… 54