EN 13727:2012: Chemical disinfectants and antiseptics – Quantitative suspension test for the evaluation of bactericidal activity in the medical area – Test method and requirements (phase 2, step 1)
DIN EN 13727:2014-03 (E)
Chemical disinfectants and antiseptics – Quantitative suspension test for the
evaluation of bactericidal activity in the medical area – Test method and requirements
(phase 2, step 1) (includes Amendment A1:2013)
Contents Page
Foreword ………………………………………………………………………………………………………………………………………. 4
Introduction …………………………………………………………………………………………………………………………………… 5
1 Scope …………………………………………………………………………………………………………………………….. 6
2 Normative references ……………………………………………………………………………………………………… 6
3 Terms and definitions …………………………………………………………………………………………………….. 6
4 Requirements ………………………………………………………………………………………………………………… 7
5 Test method …………………………………………………………………………………………………………………… 8
5.1 Principle ………………………………………………………………………………………………………………………… 8
5.2 Materials and reagents …………………………………………………………………………………………………… 8
5.2.1 Test organisms ………………………………………………………………………………………………………………. 8
5.2.2 Culture media and reagents ……………………………………………………………………………………………. 9
5.3 Apparatus and glassware ……………………………………………………………………………………………… 12
5.3.1 General ………………………………………………………………………………………………………………………… 12
5.3.2 Usual microbiological laboratory equipment …………………………………………………………………. 12
5.4 Preparation of test organism suspensions and product test solutions …………………………… 13
5.4.1 Test organism suspensions (test and validation suspension) ……………………………………….. 13
5.4.2 Product test solutions ………………………………………………………………………………………………….. 15
5.5 Procedure for assessing the bactericidal activity of the product ……………………………………. 15
5.5.1 General ………………………………………………………………………………………………………………………… 15
5.5.2 Dilution-neutralization method ……………………………………………………………………………………… 17
5.5.3 Membrane filtration method ………………………………………………………………………………………….. 19
5.5.4 Modified method for ready-to-use products ………………………………………………………………….. 21
5.6 Experimental data and calculation ………………………………………………………………………………… 22
5.6.1 Explanation of terms and abbreviations ………………………………………………………………………… 22
5.6.2 Calculation …………………………………………………………………………………………………………………… 23
5.7 Verification of methodology ………………………………………………………………………………………….. 28
5.7.1 General ………………………………………………………………………………………………………………………… 28
5.7.2 Control of weighted mean counts …………………………………………………………………………………. 28
5.7.3 Basic limits ………………………………………………………………………………………………………………….. 28
5.8 Expression of results and precision ……………………………………………………………………………… 29
5.8.1 Reduction …………………………………………………………………………………………………………………….. 29
5.8.2 Control of active and non-active product test solution (5.4.2) ………………………………………… 29
5.8.3 Limiting test organism and bactericidal concentration ………………………………………………….. 29
5.8.4 Precision, repetitions ……………………………………………………………………………………………………. 29
5.9 Interpretation of results – conclusion …………………………………………………………………………….. 30
5.9.1 General ………………………………………………………………………………………………………………………… 30
5.9.2 Bactericidal activity for handrub and handwash products ……………………………………………… 30
5.9.3 Bactericidal activity for instrument disinfection products ……………………………………………… 30
5.9.4 Bactericidal activity for surface disinfection products …………………………………………………… 30
5.9.5 Qualification for certain fields of application …………………………………………………………………. 30
5.10 Test report ……………………………………………………………………………………………………………………. 30
Annex A (informative) Referenced strains in national collections …………………………………………………. 33
Annex B (informative) Neutralizers and rinsing liquids …………………………………………………………………. 34
Annex C (informative) Graphical representation of test procedures ……………………………………………… 36
Annex D (informative) Example of a typical test report …………………………………………………………………. 44
Annex E (informative) Precision of the test result ………………………………………………………………………… 48
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC ……………………………………………………………………… 51
Bibliography ……………………………………………………………………………………………………………………………….. 52