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BS EN 17430:2024

BS EN 17430:2024

$142.49

Chemical disinfectants and antiseptics. Hygienic handrub virucidal. Test method and requirements (phase 2/step 2)

Published By Publication Date Number of Pages
BSI 2024 32
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This document specifies a test method simulating practical conditions for establishing whether a product for hygienic handrub reduces the release of virus contamination on hands when rubbed onto the artificially contaminated hands of volunteers. NOTE 1 Attention is drawn to the fact that tests on human volunteers are the subject of legal provisions in certain European countries/regions. This document is applicable to products for hygienic handrub for use in areas and situations where disinfection 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 patient. EN 14885 specifies in detail the relationship of the various tests to one another and to “use recommendations”. NOTE 2 This method corresponds to a phase 2, step 2 test.

PDF Catalog

PDF Pages PDF Title
2 undefined
6 1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
7 5 Test methods
5.1 Principle
5.2 Materials and reagents
5.2.1 Test organism
8 5.2.2 Culture media and reagents
5.2.2.1 General
5.2.2.2 Water
5.2.2.3 Phosphate buffered saline (PBS)
5.2.2.4 Neutral Red (1:1000 solution) or crystal violet solution
5.2.2.5 Fetal calf serum (FCS)
5.2.2.6 Trichloroacetic acid (10 % solution) (TCA)
9 5.2.2.7 Hard water
5.2.2.8 Growth and maintenance media
5.2.2.9 Diluted soft soap
10 5.2.2.10 Ethanol as reference handrub [volume fraction of 70 % at 21,5 °C ± 3,5 °C]
5.3 Apparatus and glassware
5.3.1 General
5.3.2 Usual microbiological laboratory equipment and, in particular, the following:
11 5.4 Preparation of test organism suspensions and product test solutions
5.4.1 Test virus suspension (test organisms suspensions, contamination fluid)
12 5.4.2 Cell lines
5.5 Cell culture preparation for virucidal testing
5.6 Infectivity assay
5.6.1 Quantal tests (end point titration)
5.6.1.1 Virus titration on cells in suspension
5.6.1.2 Virus titration on cell monolayers
5.6.2 Plaque assay
13 5.6.3 Product test solutions
5.7 Procedure for assessing the virucidal activity of the product on volunteers’ hands
5.7.1 General
5.7.1.1 Experimental conditions
5.7.1.2 Equilibration of temperature
14 5.7.1.3 Selection of volunteers
5.7.1.4 Experimental design
5.7.2 Test procedure with volunteers
5.7.2.1 Preparation of volunteers’ hands
5.7.2.2 Application of the test virus suspension
15 5.7.2.3 Sampling of the test organisms before treatment (“Prevalue”)
5.7.2.4 Hygienic handrub procedure
16 5.7.2.5 Decontamination of hands after virus inoculation
6 Experimental data and calculation
6.1 Protocol of the results
6.2 Calculation of virus titre
6.3 Calculation of PFU
6.4 Calculation of the lg reduction R (lg prevalue minus lg postvalue)
6.5 Verification of the methodology — Test validation
17 6.6 Statistical evaluation (significance testing), expression of results and precision
6.7 Conclusion
6.8 Test report
19 Annex A (normative)Standard handrub procedure
20 Annex B (informative)Calculation of the viral infectivity titre
B.1 Example of TCID50 determination by the Spearman-Kärber method
B.2 Calculation of plaque-forming units (PFU)
22 Annex C (informative)Quality control of soft soap
23 Annex D (informative)Examples of reporting of results and significance testing
29 Annex E (normative)Test for non-inferiority

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BS EN 17430:2024
$142.49