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� � ® _V+Aw Doc.No. HYST/QR2-2S-06 <br /> Nt*tW J Version No.: 0/B <br /> IWANYI 9I1:RUIZA110N Certification of EO Sterilization ,y p M Effective date: 2021-04-05 <br /> #R_T�m s Report no.:2022090431 <br /> 4,P Customer Yiwu Limem tattoo equipment co.,Ltd <br /> )'013,t Si,Product name Specification ft'S Batch SL Quantity <br /> 6�( 9Ct1 tattoo cartridge needle 1000 box E0822 10 T{ <br /> TC �J Sterilization mode }TZ Xio EO gas Sterilizer no. HYST/ST-05 <br /> k-M Q M Sterilization date 2022-08-26 TCXa S Sterilization batch 2022082605A <br /> ,f 3�*Requirements 9 FTT L Actual <br /> x�P�C Sterilization parameters <br /> Unit *,i-F Validated Min. Max. Min. Max. <br /> j�npjkAM)��_J?rJA Loading tem.prior to preconditioning °C >_10.0 10.0 / 30.8 <br /> fft319.Im V Preconditioning temperature °C 48.0 44.0 52.0 45.5 49.7 <br /> Nj�tgigfA Preconditioning RH %RH 55.0 30.0 80.0 47.3 64.7 <br /> fA�EW-17 Preconditioning time Minute 360 340 380 360 <br /> 040T1'dl Transfertime Minute 560 / 60 / <br /> NAl !Initial evacuation depth kPa -24.0 -26.0 -22.0 -22.7 <br /> thiA_029 Evacuation rate kPa/min 54.0 / 4.0 2.3 <br /> '(�1"cf fl I131 Pressure holding time Minute 20 10 30 20 <br /> Leak test pressure rise OP kPa <1.0 / 1.0 0.7 <br /> ('�a J� ) Moisture injection time(if used) Minute 10 10 <br /> EO q-,kJ4$EO injection rate kPa/min 0.5 0.3 0.7 0.5 <br /> Tcfffill EO Injection weight kg 20.0 19.5 20.5 20.0 <br /> 5:-22.0 E:15.3 <br /> EO 9Ar6JVj55Mlff Pressure rising after EO injection AP kPa >_31.0 31.0 / <br /> 0P:37.3 <br /> EO�&J}I EO concentration commence of exposure(theorical) mg/I 600 400 800 608 <br /> TCM'&A Exposure temperature °C 52.0 49.0 55.0 51.0 54.2 <br /> XMiRJA Exposure RH %RH 55.0 30.0 80.0 52.2 69.7 <br /> XMIffNI Exposure time Minute 720 700 740 720 <br /> ItJ€Post-evacuation depth kPa -15.0 -17.0 -13.0 -15.1 -14.9 <br /> AAME)i Inflation pressure kPa -5.0 -7.0 -3.0 -5.1 -5.0 <br /> V;�51:MA Number of repetition Times >A.0 4 / 4 <br /> 1A�fr1'17 Duration of flushing Minute 150 120 180 162 <br /> 131 TE_"2g*,*BI test of sterility >.A 4 Conformity; ❑T A4 non-conformity. <br /> ai$Conclusion: <br /> k ;f BI TcVAW o IS011135:2014 A 1k , ,'�a sAL(106) 9%1E 7E f 5tV_fRJf. <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� Prepator. /a Q )� Date: _ . <br /> Approval(QA): c Q Date. a y .- <br /> �= it <br /> Zhejiang Huanyi Sterilization Technology Co.,Ltd. (stamp) <br /> ft7d QUALITY RECORD )/2 <br />