Complex Content with Practical Relevance European Standards in the Field of Disinfectants Standards are not exactly easy for most people to understand, being technical, comprehensive, and detailed. Nevertheless, many professional groups in the healthcare sector need to familiarise themselves with the basics of various standards. European standards are essential for ensuring consistent disinfectant standards across Europe. They provide a binding framework for manufacturers, testing laboratories, and users. Without uniform specifications, different national requirements would apply, making it difficult to compare products and hindering trade. European standards therefore ensure transparency and create a consistent level of quality, guaranteeing health protection and safety. Efficacy testing under realistic conditions The efficacy of a disinfectant can only be ensured when it is tested according to clearly defined procedures, under realistic conditions, against a wide range of relevant pathogens. Disinfectants should therefore be tested against a wide range of relevant pathogens under conditions that are as close to real life as possible. For this purpose, a two-stage test procedure is usually used. Step 1 tests are quantitative suspension tests, which determine the effectiveness against various microorganisms under protein load. Step 2 tests are based on real-life conditions and are therefore carried out on the relevant surface. Since this involves hands in the case of hand disinfectants, only non-pathogenic organisms are used here so as not to endanger the health of test subjects. Two new Level 2 standards were published in 2024: EN 17430 for prehygienic hand disinfection, and EN 17846 for sporicidal surface disinfection. EN 17430: Virucidal hygienic hand disinfection For several years, a two-stage procedure in accordance with EN 13727 (step 1) and EN 1500 (step 2) has been used to verify bactericidal hygienic hand disinfection. In contrast, there were only step 1 tests for virucidal hygienic hand disinfection until recently. It was not until May 2024 that a step 2 test for virucidal activity was published in EN 17430 [2]. This test uses murine norovirus (MNV), which is harmless to humans. As MNV is an non-enveloped virus, EN 17430 can be used to verify a limited spectrum virucidal activity and a virucidal activity. For efficacy claims against enveloped viruses (virucidal activity against enveloped viruses), testing in accordance with EN 14476 (step 1) is sufficient. The EN 17430 test is carried out with 18–22 subjects, who wash their hands beforehand. The test is then performed as illustrated in Figure 1. First, the hands are artificially contaminated with KNOWLEDGE Hands are artificially contaminated with the surrogate murine norovirus. 1 After drying, the finger tips are sampled (pre-value). 2 Finger tips are sampled again (post-value). 4 The efficacy in virus inactivation is compared between reference and test product. 5 Hand disinfection is performed for 2x 30 s with 2x 3 mL 70% ethanol. 3 2x 2x 3 mL 30 s Hand disinfection is performed with the test product for 30-60 s. 3 X mL ≥30 s Reference Tested rub Fig 1: Procedure for testing virucidal hygienic hand disinfection in accordance with EN 17430. 14
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