LABORATOIRE MIDAC RE20-0677-2Page 2 sur 7I.PRINCIPLE:The bactericidal activity has been evaluated according to the NF EN 13727 standard: "Chemical disinfectants and antiseptics. Quantitative suspension test for the evaluation of bactericidal activity of chemical disinfectants for instruments used in the medical area. Test method and requirements (Phase 2, Step 1)." – December 2015.II.SAMPLE(S) IDENTIFICATION :Name(s):Processus global de lavage à froid, Générateur à ozone avec adjonction de produits lessiviel dédiés (Lavage N°7: Epidémie décontamination textile blanc) Machine OTEK Garosive deter– Batch : 200080001 – Manufacture date : 24/02/2020 – Expiry date : / Garo boost–Batch: 200101601 – Manufacture date: 05/03/2020 – Expiry date: / Peracid forte–Batch : 200015501 – Manufacture date: 15/01/2020 – Expiry date: / Cool Star–Batch : 190422801 – Manufacture date: 29/08/2019 – Expiry date: / Hypochlorite de sodium 12.5%–Batch : 4200401 – Manufacture date: / – Expiry date: / Asepsis ultra–Batch : 3474210348707 – Manufacture date: / – Expiry date: / LABORATOIRE MIDAC RE20-0677-2Page 3 sur 7(Mix of products made by the MIDAC Laboratory with the addition of products in the vertical direction from top to bottom)Society:GACHES CHIMIE SPECIALITESReceived at the laboratory: 17 June 2020 Storage conditions at the laboratory: Room temperature, in the darkness.Appearance of the product:Garosive deter is a green liquid, Asepsis ultra is a yellow liquid and the others productsare colorless liquid.Productdiluent recommended by the manufacturer:Undiluted.III.TEST METHOD AND ITS VALIDATION :-Neutralizationmethod:Dilution Neutralization.-Diluent neutralizer : 14 g/L Sodium thiosulfate.IV.EXPERIMENTAL CONDITIONS :Period of analysis: from 02 July 2020 to 04 July 2020 Test organism(s): see table(s) on next page(s).Preservation and stock cultures of test organisms following the requirements of the EN 12353 standard.Diluent used for product test solution:Undiluted.Product test concentration(s): see table(s) on next page(s).Appearance of product dilutions: Colorless liquid for test 1 and unclear suspension for test 2 and 3.Stability of the test mixture interfering substance / test product(s): No precipitate.Testtemperature:20°C (± 1°C).Contact time:7 minutes (± 10 seconds).Interfering substance(s): 3g/l bovine albumin with 3mL/L sheep erythrocytes (dirty conditions).Incubation temperature:37°C (± 1°C). LABORATOIRE MIDAC RE20-0677-2Page 4 sur 7V.TEST RESULTSControl and validations of the dilution-neutralization method in the test conditions (carried out in parallel with tests) Conclusion: The method is validated in the test conditions. Souche(s)/ Strain(s)Nombre de microorganismes / Enumeration of microorganisms (CFU/ml) Suspension de validation/ Validation suspensionNv0Suspension de validation / Validation suspensionNvBTémoin des conditions expérimentales/ Experimental conditions control ATémoin de neutralisation/ Neutralizer controlBValidation de la méthode de neutralisation / Method validation CPseudomonas aeruginosa DSM 939 Vc1 : Vc2 : Nv0:788280Vc1 : Vc2 : NvB:80818.1x104Vc1 : Vc2 : A:728176.5Vc1 : Vc2 : B:667168.5Vc1 : Vc2 : C:707070Staphylococcus aureusDSM 799Vc1 : Vc2 : Nv0:11098104Vc1 : Vc2 : NvB:1131121.1x105Vc1 : Vc2 : A:120122121Vc1 : Vc2 : B:118114116Vc1 : Vc2 : C:10398100.5Enterococcus hirae DSM 3320 Vc1 : Vc2 : Nv0:718477.5Vc1 : Vc2 : NvB:73757.4x104Vc1 : Vc2 : A:907884Vc1 : Vc2 : B:798381Vc1 : Vc2 : C:818281.5Escherichia coli K12DSM11250Vc1 : Vc2 : Nv0:139143141Vc1 : Vc2 : NvB:1361461.4x105Vc1 : Vc2 : A:150148149Vc1 : Vc2 : B:138144141Vc1 : Vc2 : C:151148149.5Critères de validation / Validation criteria: Nv0 entre/between 30 et/and 160 CFU A, B et/ and C ≥ 0.5 x Nv0B≥ 0.0005 x NvBNvB entre/ between 3.0 x 104et/and 1.6 x 105C: testé à la concentration maximale / tested at maximum concentration LABORATOIRE MIDAC RE20-0677-2Page 5 sur 7Actual test results Souche(s)/ Strain(s)Suspension d’essai/Test suspension N et/and N0Nombre de microorganismes / Enumeration of microorganisms Na(CFU/mL)à la concentration testée / at the tested concentration (w/v)Test 1Test 2Test3Pseudomonas aeruginosa DSM 939 10-6 Vc1:Vc2:10-7 Vc1:Vc2:N =N0 =log N0 =>330>33041384.0x1084.0x1077.6010-0 Vc1 : Vc2 : 10-1 Vc1 : Vc2 : Na:log Na:>330>330>330>330>3.3x104>4.5210-0 Vc1 : Vc2 : 10-1 Vc1 : Vc2 : Na:log Na:0000<1.4x102<2.1510-0 Vc1 : Vc2 : 10-1 Vc1 : Vc2 : Na:log Na:0000<1.4x102<2.15Staphylococcus aureusDSM 79910-6 Vc1:Vc2:10-7 Vc1:Vc2:N =N0 =log N0 =>330>33046384.2x1084.2x1077.6510-0 Vc1 : Vc2 : 10-1 Vc1 : Vc2 : Na:log Na:>330>330>330>330>3.3x104>4.5210-0 Vc1 : Vc2 : 10-1 Vc1 : Vc2 : Na:log Na:0000<1.4x102<2.1510-0 Vc1 : Vc2 : 10-1 Vc1 : Vc2 : Na:log Na:0000<1.4x102<2.15Enterococcus hirae DSM 3320 10-6 Vc1:Vc2:10-7 Vc1:Vc2:N =N0 =log N0 =>330>33048464.7x1084.7x1077.6710-0 Vc1 : Vc2 : 10-1 Vc1 : Vc2 : Na:log Na:>330>330>330>330>3.3x104>4.5210-0 Vc1 : Vc2 : 10-1 Vc1 : Vc2 : Na:log Na:0000<1.4x102<2.1510-0 Vc1 : Vc2 : 10-1 Vc1 : Vc2 : Na:log Na:0000<1.4x102<2.15Escherichia coli K12DSM1125010-6 Vc1:Vc2:10-7 Vc1:Vc2:N =N0 =log N0 =>330>33040434.2x1084.2x1077.6210-0 Vc1 : Vc2 : 10-1 Vc1 : Vc2 : Na:log Na:>330>330>330>330>3.3x104>4.5210-0 Vc1 : Vc2 : 10-1 Vc1 : Vc2 : Na:log Na:0000<1.4x102<2.1510-0 Vc1 : Vc2 : 10-1 Vc1 : Vc2 : Na:log Na:0000<1.4x102<2.15 LABORATOIRE MIDAC RE20-0677-2Page 6 sur 7Critères de validation / Validation criteria: N entre/between 1.5 x108 et/and 5.0 x108N0 entre/between 1.5 x107 et/and 5.0 x107 log N0 entre/between 7.17 et/and 7.70Réduction (R) du nombre de cellules viables à la concentration testée (m/v) : Reduction (R) of the number of viable cells at the tested concentration (w/v) : Souche(s)/ Strain(s)Test 1Test 2Test3Pseudomonas aeruginosa DSM 939 log R :<3.08log R :>5.45log R :>5.45Staphylococcus aureusDSM 799log R :<3.10log R :>5.47log R :>5.47Enterococcus hirae DSM 3320 log R :<3.15log R :>5.52log R :>5.52Escherichia coli K12DSM11250log R :<3.10log R :>5.47log R :>5.47Critères d’interprétation/Interpretation criteria:concentration active si /active concentration if log R ≥ 5 concentration non active si /non active concentration if log R < 5 LABORATOIRE MIDAC RE20-0677-2Page 7 sur 7Number of repetitions : The test was carried out once. VI.CONCLUSION:According to the NF EN 13727 : 2015 standard, the product Processus global de lavage à froid, Générateur à ozone avec adjonction de produits lessiviel dédiés (Lavage N°7: Epidémie décontamination textile blanc) Batch:/possesses a bactericidal activity at Test 2after7 minutes (± 10 seconds) at 20°C (± 1°C) in contact with 3g/l bovine albumin with 3mL/L sheep erythrocytes (dirty conditions).VII.REVISION HISTORY DateRevision description Versionn.an.an.a
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