EN 12791-Surgical hand disinfection. UNE-EN 12791:2016. Chemical disinfectants and antiseptics. Surgical hand disinfection. Test method and requirement (phase 2, step 2).
Test accredited by ENAC (National Accreditation Entity).
The test assesses whether a product for surgical hand disinfection reduces the release of the flora of clean hands. This test is used both for products used in surgical hand disinfection by friction, as for hygienic handwashing. First, a preparatory washing of hands is performed to remove transient flora and foreign material, and then determine the bacterial count before disinfection treatment. Second, the test product is applied, and subsequently, counting is performed immediately after the disinfection procedure and 3 hours after the disinfection procedure. Thus, the ratio of the resulting values before and after the disinfection treatment corresponding to the reduction factor, immediately and after 3 hours is obtained. The results should be compared with those obtained with a reference method of surgical hand disinfection using propanol-1 to 60%, made in parallel with the same individuals. An experimental crossed desing with 20 or 24 healthy persons with hands of healthy skin, without cuts or abrasions, divided into two groups of volunteers of the same size, including some in the reference group (disinfection with propanol-1) and other in using the test product. The test repeated crosswise after 1 week to allow the reconstitution of skin flora. Neither immediate effect or effect at 3 hours, the test product (PP) should be less than the effects the same time product of reference propanol-1 60% (RP). To check the differences in results between the two products PP and RP, a study of statistical significance is done. The customer must choose the volume to be applied with the test product, the total application time must be between 60 seconds and 5 minutes, the frequency of application during that time, and the indication, if necessary, using water . For surgical scrub products, always a final water rinse will be performed.