LABORATOIRE MIDAC RE20-0674-2Page 2 sur 7I.PRINCIPLE:The bactericidal activity has been evaluated according to the protocol of 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 produit lessiviels dédiés (Lavage N°4: Textile de type couleur souillé) 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 : /(Mix of products made by the MIDAC Laboratory with the addition of products in the vertical direction from top to bottom) Society:GACHES CHIMIE SPECIALITES Received at the laboratory: 17 June 2020 Storage conditions at the laboratory: Room temperature, in the darkness.Appearance of the product:Garosive deter is green liquidand others products are colorless liquid.Productdiluent recommended by the manufacturer:Undiluted. LABORATOIRE MIDAC RE20-0674-2Page 3 sur 7III.TEST METHOD AND ITS VALIDATION :-Neutralizationmethod:Dilution Neutralization.-Diluent neutralizer : Sodium thiosulphate neutralizer 14g/L.IV.EXPERIMENTAL CONDITIONS :Period of analysis: from 25 June 2020 to 27 June 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. Test temperature: 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 RE20-0674-2Page 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 : Nv0:646363.5Vc1 : Vc2 : NvB:61545.8 ×104Vc1 : Vc2 : A:505854Vc1 : Vc2 : B:413940Vc1 : Vc2 : C:606763.5Staphylococcus aureusDSM 799Vc1 : Vc2 : Nv0:597969Vc1 : Vc2 : NvB:77737.5×104Vc1 : Vc2 : A:466354.5Vc1 : Vc2 : B:364138.5Vc1 : Vc2 : C:939895.5Enterococcus hirae DSM 3320 Vc1 : Vc2 : Nv0:627066Vc1 : Vc2 : NvB:57575.7×104Vc1 : Vc2 : A:547564.5Vc1 : Vc2 : B:586461Vc1 : Vc2 : C:595557Escherichia coli K12DSM 11250 Vc1 : Vc2 : Nv0:819085.5Vc1 : Vc2 : NvB:66716.9x104Vc1 : Vc2 : A:756369Vc1 : Vc2 : B:475450.5Vc1 : Vc2 : C:538468.5Critères 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 RE20-0674-2Page 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)Test1Test2Test 3Pseudomonas aeruginosa DSM 939 10-6 Vc1:Vc2:10-7 Vc1:Vc2:N =N0 =log N0 =16818714241.8×1081.8×1077.2610-0 Vc1 : Vc2 : 10-1 Vc1 : Vc2 : Na:log Na:16316816151.68×1033.2010-0 Vc1 : Vc2 : 10-1 Vc1 : Vc2 : Na:log Na:0000<1.4×102<2.1510-0 Vc1 : Vc2 : 10-1 Vc1 : Vc2 : Na:log Na:0000<1.4×102<2.15Staphylococcus aureusDSM 79910-6 Vc1:Vc2:10-7 Vc1:Vc2:N =N0 =log N0 =29127919202.8×1082.8×1077.4510-0 Vc1 : Vc2 : 10-1 Vc1 : Vc2 : Na:log Na:>330>330>330>330>3.3×104>4.5210-0 Vc1 : Vc2 : 10-1 Vc1 : Vc2 : Na:log Na:9421<1.4×102<2.1510-0 Vc1 : Vc2 : 10-1 Vc1 : Vc2 : Na:log Na:0000<1.4×102<2.15Enterococcus hirae DSM 3320 10-6 Vc1:Vc2:10-7 Vc1:Vc2:N =N0 =log N0 =17518928201.9×1081.9×1077.2810-0 Vc1 : Vc2 : 10-1 Vc1 : Vc2 : Na:log Na:>330>330>330>330>3.3×104>4.5210-0 Vc1 : Vc2 : 10-1 Vc1 : Vc2 : Na:log Na:0000<1.4×102<2.1510-0 Vc1 : Vc2 : 10-1 Vc1 : Vc2 : Na:log Na:0000<1.4×102<2.15 LABORATOIRE MIDAC RE20-0674-2Page 6 sur 7Escherichia coli K12DSM 11250 10-6 Vc1:Vc2:10-7 Vc1:Vc2:N =N0 =log N0 =24626438392.7×1082.7×1077.4310-0 Vc1 : Vc2 : 10-1 Vc1 : Vc2 : Na:log Na:>330>330>330>330>3.3×104>4.5210-0 Vc1 : Vc2 : 10-1 Vc1 : Vc2 : Na:log Na:0000<1.4×102<2.1510-0 Vc1 : Vc2 : 10-1 Vc1 : Vc2 : Na:log Na:0000<1.4×102<2.15Critères 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 7.70Reduction of the number of viable cells at the concentration tested (m/v):Reduction (R) of the number of viable cells at the tested concentration (w/v) : Souche(s)/ Strain(s)Test 1Test 2Test 3Pseudomonas aeruginosa DSM 939 log R :4.06log R :>5.11log R :>5.11Staphylococcus aureusDSM 799log R :<2.93log R :>5.30log R :>5.30Enterococcus hirae DSM 3320 log R :<2.76log R :>5.13log R :>5.13Escherichia coli K12DSM 11250 log R :<2.91log R :>5.28log R :>5.28Critères 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 RE20-0674-2Page 7 sur 7Number of repetitions : The test was carried out once. VI.CONCLUSION:According to the protocol of the NF EN 13727 : 2015 standard, the product Processus global de lavage à froid, Générateur à ozone avec adjonction de produit lessiviels dédiés (Lavage N°4: Textile de type couleur souillé) Batch:/possesses a bactericidal activity attests 2 after7 minutes (± 10 seconds) at 20°C (± 1°C) in contact with 3g/l bovine albumin with 3mL/L sheep erythrocytes (dirty conditions).VII.REVISION HISTORYDateRevision description Versionn.an.an.a
We use cookies to ensure that we give you the best experience on our website. If you continue to use this site we will assume that you are happy with it.Ok