EN 1499: 2013. Hygienic handwash.Test method and requirements (phase 2/step 2).
Test accredited by ENAC (Spanish National Accreditation Entity).
Test with the Certificate of Good Laboratory Practices (GLPs).
This assay tests the activity of the product for hygienic hand washing, with wet hands, used in the hospital environment, medical institutions, school clinics, dental clinics and similar. For this purpose, hands from 12 to 15 persons, at least 18 years old, without any cut or lesions in the hands, clean and short nails, are washed and contaminated with an Escherichia coli K12 suspension. Participants are divided in two groups that alternatively will participate the same day as the control group washing their hands with a fluid soft soap, and as the assay group washing their hands with the product under assay. The control group, after contamination of hands with the bacterial suspension will wash their hands with 5 mL during 60 seconds of liquid soft soap not containing any antimicrobial component. The assay group will wash their hands with the product under assay with the volume and frequency recommended by the manufacturer, and between 30 to 60 seconds, depending on the manufacturer recommendations, without the final clearance. In both cases, hands will be wet with tap water before application of the liquid soap or the product under assay (if the manufacturer wishes any particular procedure for wetting hands, this must be stated), and after application they will wash their hands with tap water during 10 seconds immediately after the time of contact (the manufacturer must indicate if it recommends other clearance time, o no clearance at all). The time of clearance and drying according to guideline is 15 ± 1 seconds. To consider effective the action of the product under assay, an statistically significant difference in the reduction of the number of bacteria present in the subjects that had hands washed with the product under assay, compared with the hands washed with the soft soap without any antimicrobial component must be demonstrated through the statistical Wilcoxon test.