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Y4a y {�p jC'(TAi Doc.No. HYST/QR2-25-06 <br /> x u ll 7 j,`�7���Version No.: 0/B <br /> InJn n1,rn:x��.iznnon Certification of EO Sterilization ±'&EPA Effective date: 2021-04-05 <br /> Report no.:2022090221 <br /> Customer Yiwu Limem tattoo equipment co.,Ltd <br /> /7'A-8#J,Product name specification "5 Batch ttl Quantity <br /> 9(A�3'CeW- tattoo cartridge needle 700 box E0822 7 4t� <br /> XC SA,Sterilization mode Lrt EO gas X_MOA 5'Sterilizer no. HYST/ST-05 <br /> Sterilization date 2022-08-24 Sterilization batch 2022082405A <br /> R*Requirements -t- T�J Actual <br /> TCM��y�C Sterilization parameters <br /> Unit Validated Min. Max. Min. Max. <br /> )Y'nuA1\fft99JAJ-Loading tem.prior to preconditioning °C >_10.0 10.0 / 30.3 <br /> fftgfia Preconditioning temperature °C 48.0 44.0 52.0 46.4 49.6 <br /> �1J�LaMfk Preconditioning RH %RH 55.0 30.0 80.0 47.7 57.3 <br /> f 3EFIT(' Preconditioning time Minute 360 340 380 360 <br /> trt1�7 Transfertime Minute <_60 / 60 / <br /> R-W` Initial evacuation depth kPa -24.0 -26.0 -22.0 -24.5 <br /> Evacuation rate kPa/min 54.0 / 4.0 2.5 <br /> Pressure holding time Minute 20 10 30 20 <br /> QT[JE)75ck Leak test pressure rise OP kPa 51.0 / 1.0 0.8 <br /> 4'WHA11,01 (;-A ZM) Moisture injection time(if used) Minute 10 10 <br /> EO e-A73t'--TK EO injection rate kPa/min 0.5 0.3 0.7 0.4 <br /> XMPJJ_2 EO Injection weight kg 20.0 19.5 20.5 19.9 <br /> 5:-23.7 E:12.7 <br /> EO P����j7 i��Pressure rising after EO injection AP kPa >_31.0 31.0 / <br /> A P:36.4 <br /> EO Afk EO concentration commence of exposure(theorical) mg/I 600 400 800 593 <br /> TCMRIA Exposure temperature °C 52.0 49.0 55.0 52.0 54.4 <br /> TCFMagf ExposureRH %RH 55.0 30.0 80.0 50.8 61.9 <br /> xMIf1J3 Exposure time Minute 720 700 740 720 <br /> AA�A_2�1 Post-evacuation depth kPa -15.0 -17.0 -13.0 -15.1 -14.9 <br /> V-%107 Inflation pressure kPa -5.0 -7.0 -3.0 -5.1 -4.9 <br /> �{� (Number of repetition Times >:4.0 4 / 4 <br /> iWUT 1 Duration of flushing Minute 150 120 180 156 <br /> BI TrMWK pA BI test ofsterility <A Conformity; ❑T 4 non-conformity. <br /> Wii Conclusion: <br /> XIJ 2tf.�AWn BI 51EVAI 1R o ISO 11135:2014*P4AikN*, 1'`aa SAL(10"6)T4YI�i!M-, XI "i =k!1F1A4To <br /> Above all,sterilization process and BI sterility testing are meeting with EN ISO 11135:2014 and validated requirements,and Sterile Assurance <br /> Level(SAL)of 10-6 is achieved and products can be released from sterilization process. <br /> 'i <br /> Prepator: � [ a Q� Date�'�; <br /> tl Approval(QA): <br /> Zhejiang Huanyi Steri(itatiooTechnology Co.,Ltd. (stamp) <br /> ffi id QI.IAI Iry RFrnRD 1/2 <br />