prEN 17430: 2022. Hygienic handrub virucidal. Test method and requirements (phase 2, step 2).
Test with the Certificate of Good Laboratory Practices (GLPs).
The prEN 17430: 2022 standard 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. This test applies for products for hygienic hand rub for use in areas and situations where disinfection is medically indicated, such as hospitals, community medical facilities, dental institutions, clinics of schools, kindergardens and nursing homes, and also in the workplace and home. For this purpose, hands from 18 to 22 volunteers, at least 18 years old, without any cut or lesions in the hands, clean and short nails, are prepared with an initial wash with diluted soft soap and subsequently contaminated with a Murine Norovirus suspension. In our laboratory the test is performed with 20 volunteers. The titre of the test virus per hand is evaluated before treatment. Participants are divided in two groups that alternatively will participate the same day as the control group, rubbing their hands with the reference handrub product (ethanol 70% v:v), and as the assay group rubbing their hands with the product under test. The control group, after contamination of hands with the viral suspension will rub their hands in two consecutives steps with 3 mL for 30 seconds, to give a total rubbing time of 60 seconds. The assay group will rub their hands with the product under assay with the volume and frequency recommended by the manufacturer, for between 30 and 120 seconds, depending on the manufacturer recommendations. Immediately after treatment, the titre of the test organism per hand is determined. To consider effective the action of the product under test, the mean reduction of the release of the test organism (Murine Norovirus) achieved by the hygienic handrub with the product under test shall be at least not inferior statistically to that achieved by the reference hygienic handrub product (ethanol 70% v:v).
According to the prEN 17430: 2022 standard, to claim virucidal activity, the product shall also pass EN 14476 with Poliovirus, Adenovirus and Murine Norovirus and EN 16777 with Adenovirus and Murine Norovirus, whereas, to claim Limited spectrum virucidal activity, the product shall also pass EN 14476 with Adenovirus and Murine Norovirus. If required, please do not hesitate to ask us for information about these standards.