消毒產品歐盟滅菌測試

•category of tests 測試類別
•the tests are categorized on a modular basis as follows: 這些測試按模塊化進行分類，如下所示：
•— phase 1 tests are quantitative suspension tests to establish that active substances or products under development have bactericidal, fungicidal or sporicidal activity without regard to specific areas of application. phase 1 tests cannot be used for any product claim. 第1階段測試是定量懸浮測試，旨在確定正在開發的活性物質或產品具有殺菌，殺真菌或殺孢子活性，而無需考慮特定的應用領域。第1階段測試不能用于任何產品聲明。
•— phase 2 comprises two steps: 第二階段包括兩個步驟：
•a) phase 2, step 1 tests are quantitative suspension tests to establish that a product has bactericidal, fungicidal, yeasticidal, mycobactericidal, tuberculocidal, sporicidal or virucidal activity under simulated practical conditions appropriate to its intended use; 第2階段第1步測試是定量懸浮測試，以確定產品在適合其預期用途的模擬實際條件下具有殺菌，殺真菌，殺菌，分枝桿菌，殺結核，殺孢子或殺病毒活性;
•b) phase 2, step 2 tests are quantitative laboratory tests to establish that a product has bactericidal, fungicidal, yeasticidal, mycobactericidal, tuberculocidal, sporicidal or virucidal activity when applied to a surface or skin under simulated practical conditions (e.g. surface, instrument, handwash and handrub tests); 第2步，第2步測試是定量的實驗室測試，以確定在模擬實際條件下（例如表面，儀器，洗手液）施用于表面或皮膚時，產品具有殺菌，殺真菌，殺菌，分枝桿菌殺滅，殺結核，殺孢子或殺病毒活性和手擦測試）；
•— phase 3 tests are field tests under practical conditions. applicable methodologies for this type of test are not yet available, but may be developed in the future. guidance on the design of phase 3 tests and the use of data from phase 3 tests is provided in annex c. 第三階段的測試是在實際條件下的現場測試。這種類型的測試的適用方法尚不可用，但可能會在將來開發。附件c中提供了有關第3階段測試的設計指南以及第3階段測試的數據使用的指南。