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BS EN 13624:2021:2022 Edition

BS EN 13624:2021:2022 Edition

$183.59

Chemical disinfectants and antiseptics. Quantitative suspension test for the evaluation of fungicidal or yeasticidal activity in the medical area. Test method and requirements (phase 2, step 1)

Published By Publication Date Number of Pages
BSI 2022 56
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This document specifies a test method and the minimum requirements for fungicidal or yeasticidal activity of chemical disinfectant and antiseptic 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 (97 % with a modified method for special cases) 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 in the fields of hygienic handrub, hygienic handwash, surgical handrub, surgical handwash, instrument disinfection by immersion, and surface disinfection by wiping, spraying, flooding or other means. This document applies to areas and situations where disinfection or antisepsis 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 kindergartens and of nursing homes; and can occur in the workplace and in the home. It can also include services such as laundries and kitchens supplying products directly for the patients. NOTE 1 The method described is intended to determine the activity of commercial formulations or active substances under the conditions in which they are used. NOTE 2 This method corresponds to a phase 2 step 1 test. EN 14885 specifies in detail the relationship of the various tests to one another and to “use recommendations”.

PDF Catalog

PDF Pages PDF Title
2 National foreword
6 European foreword
7 Introduction
8 1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
10 5 Test method
5.1 Principle
5.2 Materials and reagents
5.2.1 Test organisms
5.2.2 Culture media and reagents
13 5.3 Apparatus and glassware
5.3.1 General
15 5.4 Preparation of test organism suspensions and product test solutions
5.4.1 Test organism suspensions (test and validation suspension)
19 5.4.2 Product test solutions
5.5 Procedure for assessing the fungicidal and yeasticidal activity of the product
5.5.1 General
21 5.5.2 Dilution-neutralization method
23 5.5.3 Membrane filtration method
25 5.5.4 Modified method for ready-to-use products
27 5.6 Experimental data and calculation
5.6.1 Explanation of terms and abbreviations
28 5.6.2 Calculation
33 5.7 Verification of methodology
5.7.1 General
5.7.2 Control of weighted mean counts
5.7.3 Basic limits
5.7.4 Additional limits for Aspergillus brasiliensis
34 5.8 Expression of results and precision
5.8.1 Reduction
5.8.2 Control of active and non-active product test solution (5.4.2)
5.8.3 Limiting test organism and fungicidal and yeasticidal concentration
5.8.4 Precision, repetitions
35 5.9 Interpretation of results – conclusion
5.9.1 General
5.9.2 Fungicidal activity for instrument disinfection products
5.9.3 Fungicidal activity for surface disinfection products
5.9.4 Fungicidal activity for textile disinfection products
5.9.5 Yeasticidal activity for handrub and handwash products
5.9.6 Yeasticidal activity for instrument disinfection products
5.9.7 Yeasticidal activity for surface disinfection products
36 5.9.8 Yeasticidal activity for textile disinfection products
5.9.9 Qualification for certain fields of application
5.10 Test report
38 Annex A (informative) Referenced strains in national collections
39 Annex B (informative) Neutralizers and rinsing liquids
41 Annex C (informative) Graphical representation of test procedures
47 Annex D (informative) Example of a typical test report
52 Annex E (informative) Precision of the test result
55 Bibliography

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BS EN 13624:2021
$183.59