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TGWV*fc ff*MP F Wuxi Zhushi Sterilization Factory <br /> 3Z#W� File Number SZLF/ST01_05-02 1 Version/revision number I B/1 <br /> 3TAZ.QXffii!EH)J Certification of EO Gas Sterilization <br /> A Report No:20210105 <br /> 4;P Customer Suzhou Lengfeng Medical Instruments Co. , Ltd <br /> a $i Product codes tom`a$ Product name ,L 4 #0t Lot No VCR Quantity <br /> Specification <br /> / NEEDLES 1215 1216 1224 158CTNS <br /> 1228 1229 <br /> Sterilization mode Chamber NO. Sterilization date Ster.Lot No. <br /> EO `U*TC-ffi EO-Gas i 2# 2021-01-05 20210105 <br /> XINMA Sterilization parameters *5i� Validated kl�FfQg Tolerance 2Z-WT, Actual <br /> fAIM&I Preconditioning Temperature(°C) 50 ±4 50.5-53.5 <br /> RAllI.� PreconditioningRH (%RH) 55 ±10 49-55 <br /> Yj�ARIN, Preconditioning Time(min) 360 ±20 350 <br /> XIj JW� Initial Evacuation Vacuum(kpa) -25 ±2 -25.0 <br /> f9ffiRVal Keep Pressure(min) 20 ±10 15 <br /> 7cM3'`iiOHAR' Weight of EO Injection(kg/25m3) 15 ±1.25 15 <br /> TcfPJhnAj* Rate of EO Injection(kpa/min) 0.5 ±0.2 0.50 <br /> Tc-ffi'=LfVkfk EO-Concentration(mg/L) 600 ±50 600 <br /> EO i1IkliHr3h0jiit EO Injection Pressure Changed(kpa) >25 // S:-25.OE:8.0 <br /> TMff fal Exposure Time(min) 720 ±20 720 <br /> X MAIC Sterilization Temperature(°C) 52 ±3 50.5-53.5 <br /> X-M&I Chamber RH of Sterilization(%RH) 55 ±10 49.5-55.5 <br /> A'LJ!�j Post Evacuation Vacuum(kpa) -20 ±2 -20.5 <br /> 4W 7 3&The Number of Ventilator(times) 6 // 6 <br /> Wrifil Aeration Temperature(°C) 42 ±5 38.5-40.5 <br /> SWUl fal Aeration Time (day) 7 // 7 <br /> Strain Bocillus Ptrophoeus ATCC9372 VAS i ift Nominal Population(cfu/,unit) 1.7x 106 <br /> BI 9 Lot NO. 200825 D I D-Value(min) 3.0 <br /> IAMt911 Culture Temperat 36°C AMM- 1i Culture time(days) 7 <br /> MHrr H M Culture Date 2021-01-06^-2021-01-13 <br /> ti;-rrtCulture time(day) is` 2nd 3rd 4th 5th 6th 7th <br /> 3A"V,2Ak Observed item - - - - - - - <br /> MitAtf1R Positive control + + + + + + + <br /> tV#a%r•M1-Tctfii4*f,% BI test of sterility A A conformity <br /> -Mit Conclusion: <br /> �I�pa7 T7 1 `' Zic7C �&JAX PME- -4, %-ffi*T106Njj "-ij, 1lt alpzaiT <br /> The sterilization cycles were performed as per the validated par am enQ,, viations. <br /> The Sterile Assurance Level (SAL) of 106 is assured. i 4- <br /> NUf <br /> Approved by: er A H M R ate: <br /> NO# Comp t mp: - .L <br /> Pagel oft <br />