EN 12791: 2016 + A1: 2018. Surgical hand disinfection. Test method and requirement- (phase 2, step 2).
Test accredited by ENAC (Spanish National Accreditation Entity).
Test with the certificate of GLPs.
The test evaluates whether a product for surgical hands disinfection reduces the release of flora from clean hands. This test is used both for the products used in the surgical hands disinfection by friction (handrub), as well as for a hygienic hand washing. First, a preparatory handwash is performed to eliminate the transient flora and foreign material, and then determine the bacterial count before the disinfection treatment. Secondly, the test product is applied, and subsequently, the counting is performed immediately after the disinfection procedure and 3 hours after the disinfection procedure. In this way, the quotient of the resulting values before and after the disinfection treatment corresponding to the reduction factor is obtained, immediately and after 3 hours. The results obtained should be compared with those obtained with a procedure of surgical hands disinfection using a reference product (with propanol-1 60%) carried out in parallel with the same individuals. An experimental cross design should be performed with 23 to 28 healthy people (we use 24 volunteers) with healthy skin hands, without cuts or abrasions, divided into two large groups of volunteers of the same size, including some in the reference group (disinfection with propanol-1 60%) and others in which you use the test product. The test should be repeated crosswise after 1 week to allow the reconstitution of the cutaneous flora. Neither the immediate effect, nor the effect at 3 hours of the product under test (PP), must be less than the effects obtained at the same times with the reference product (propanol-1 60%) (RP). To check the differences in the results between both PP and RP products, a study of statistical significance is carried out. The client must choose the volume that will be applied with the product under test, the total application time that must be between 60 seconds and 5 minutes, the frequency of application during that time, and the indication, if necessary, of using water. For surgical handwashing products, a final rinse with water will always be carried out.