Virucidal activity under the specific conditions for PT4 products [EN 14476: 2013 + A2: 2019. Quantitative suspension test for the evaluation of virucidal activity in the medical area. Test method and requirements (Phase 2, step 1), under the specific conditions of the BPR Guidance: 2023 (Biocidal Products Regulation - BPR- Guidance. ECHA. Version 6.0, August, 2023].
Test accredited in our laboratory.
This test is performed according to EN 14476 standard adapted according to the specific conditions of the BPR Guidance for PT4 for disinfection of surfaces. The test is performed with the mandatory virus Murine Norovirus (or Murine Parvovirus for temperatures ≥ 40ºC). The assay temperature depends on the intended use of the PT4 product. PT4 disinfectants are generally used at room temperature (test temperature 20°C), but for some uses and claims lower temperatures (for example, for surfaces in cold storage rooms), or higher temperatures (for example, for incubation rooms or warewash disinfection) are relevant and should be tested. The test temperature should be according to the use instructions on the label. The contact time must be the claimed for the intended use of the product. The soiling conditions must be dirty (3 g/L of bovine serum albumin) or clean (0.3 g/L of bovine serum albumin). Clean conditions are conditions representative of surfaces which have been cleaned satisfactorily before disinfection and/or are known to contain minimal levels of organic and/or inorganic substances. For specific uses of PT4, other interference substances must be used: 10 g/L skimmed milk for milk industry, and 3 g/L bovine serum albumin + 3 mL/L sheep erythrocytes for slaughterhouses and other processes with blood in the meat industry.
The product must be assayed at least at three concentrations, including one in the non-active concentration range and another in the active concentration range (these two last concentrations are selected by the testing laboratory). To consider the product as virucidal a 4 logarithmic reduction in the infectivity of viruses must be obtained.