DIN EN 12791:2016-06

This European Standard specifies a test method simulating practical conditions for establishing whether a product for surgical handrub and handwash reduces the release of resident and eventually present transient microbial flora on hands when used for the treatment of clean hands of volunteers. This European Standard applies to products for surgical handrub or handwash 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 may occur in the workplace and in the home. It may 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". This method corresponds to a phase 2, step 2 test. The revision was made in order to adapt the document to the latest state of the art, to correct errors and ambiguities, to harmonize the structure and wording with other tests of CEN/TC 216 existing or in preparation, and to improve the readability of the standard and thus achieve better comprehensibility. The following technical changes have been made: - inclusion of a neutralization procedure (5.5.1.2); - change in the number of volunteers (5.5.1.4); - no rinsing after disinfection (5.5.3.2.2); - revision of the statistical evaluation (5.8); - annexes have been completely revised; - harmonization of the standard with the CEN/TC 216 standards. The data obtained using the previous version of EN 12791 may still be used, provided that there is an addition of data for neutralization, additional results from more volunteers (hereafter referred to as "test subjects"), and the new statistical evaluation of the "mixed" data set (from old and new data). The additional results should preferably be obtained in the same laboratory and from subjects who were not involved in the earlier ("old") study. If the neutralization medium used in the test using the previous version does not neutralize sufficiently, then a completely new test run should be performed. The committee responsible for this standard is NA 063-04-07 AA "Chemische Desinfektionsmittel und Antiseptika in der Humanmedizin" ("Chemical disinfectants and antiseptics in human medicine") at DIN Standards Committee Medicine (NAMed).