European norms in hand hygiene.
In the area of hand hygiene, European Norms exist, or are under development, with regard to protective gloves and for assessing the antimicrobial efficacy of hand disinfectants. Important norms for gloves are EN 420 (General requirements), EN 374 (Protective gloves against chemicals and microorganisms) and EN 455 (Medical gloves for single use). A suspension test for the demonstration of bactericidal activity (prEN 12054) is obligatory for hand disinfectants in all fields of application; a test to prove activity against yeasts applies only to hygienic hand rub. (Optional) Claims for virucidal activities can be substantiated by prEN 1476 and, in future, for mycobactericidal capacity by a test which is still under development. In vivo tests exist for post-contamination treatments, hygienic hand wash and hygienic hand rub (EN 1499 and EN 1500 respectively), and for the preoperative surgical hand rub/wash (prEN 12791). The two former tests employ artificially contaminated hands, the latter test is done with clean hands. All in vivo tests use reference hand treatments (with unmedicated soap or 2-propanol 60% (vol.) or 1-propanol 60% (vol.), respectively) against the results of which are compared with those achieved with the product under test and with the same volunteers. An antiseptic soap needs to be significantly more efficacious than unmedicated soap, a product for hygienic hand rub must not be inferior to the reference treatment with 2-propanol, and a surgical hand disinfectant must not cause a smaller bacterial reduction than the reference preparation with 1-propanol, immediately, and after 3 h. An (optional) claim for sustained activity of a surgical disinfectant needs to be demonstrated by achieving a significantly stronger bacterial reduction after 3 h than the reference preparation.
Rotter
M L
ML
Division of Hygiene and Medical Microbiology, University of Vienna, Kinderspitalgasse 15, A-1095 Vienna, Austria.
D004202:Disinfectants / Q000592:standards*; D005060:Europe; D017575:Gloves, Protective / Q000592:standards*; D006235:Hand Disinfection / Q000592:standards*; D006801:Humans; D017053:Infection Control / Q000592:standards*; D008422:Materials Testing; D012015:Reference Standards
D004202:Disinfectants