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DLT+WI Doc.No. HYST/QR2-25-06 <br /> �I� F7L%C 7Uc j�, AA'J,Version No.: 0/B <br /> HUANYI sn:RUA N110N Certification of EO Sterilization EI jjR Effective date: 2021-04-05 <br /> Report no.:2022090844 <br /> ' f 3�customer Yiwu Limem tattoo equipment co.,Ltd <br /> pp Product name PUM Specification ' 'Batch f(A Quantity <br /> tj( $jC tattoo cartridge needle 600 box E0822 6 Tr$ <br /> x_ffi)j Xt Sterilization mode T�KZA EO gas xffoFS Sterilizer no. HYST/ST-05 <br /> TCi Sterilization date 2022-08-30 TCpS Sterilization batch 2022083005A <br /> .yy,. R*Requirements 9Z FT,'1 Actual <br /> k �yt Sterilization parameters <br /> Unit Validated Min. Max. Min. Max. <br /> Loadingtem.prior to preconditioning °C >_10.0 10.0 / 32.0 <br /> Nj hhg&J' Preconditioning temperature °C 48.0 44.0 52.0 45,8 50.1 <br /> BrIk3EM& Preconditioning RH %RH 55.0 30.0 80.0 45.3 61.6 <br /> NkORf17 Preconditioning time Minute 360 340 380 360 <br /> 04RVOI Transfer time Minute 560 / 60 / <br /> NWT Initial evacuation depth kPa -24.0 -26.0 -22.0 -22.9 <br /> Evacuation rate kPa/min 54.0 / 4.0 2.3 <br /> R5:Rfl,1l Pressure holding time Minute 20 10 30 20 <br /> Nffl Cfi)j!cM Leak test pressure rise z,P kPa 51.0 / 1.0 0.6 <br /> j � �Jtrh7 (3ZA) Moisture injection time(if used) Minute 10 10 <br /> EO '�i EO injection rate kPa/min 0.5 0.3 0.7 1 0.6 <br /> TcMIPJAZI EO Injection weight kg 20.0 19.5 20.5 20.0 <br /> 5:-22.3 E:14.0 <br /> ECI Pressure rising after EO injection nP kPa >_31.0 31.0 / <br /> AP:36.3 <br /> EO Mfk EO concentration commence of exposure(theorical) mg/I 600 400 800 591 <br /> X-MMI Exposure temperature °C 52.0 49.0 55.0 51.8 54.6 <br /> kM&YE Exposure RH %RH 55.0 30.0 80.0 49.6 66.1 <br /> XMITf I[H]Exposure time Minute 720 700 740 720 <br /> W�M�l Post-evacuation depth kPa -15.0 -17.0 -13.0 -15.1 -14.9 <br /> A"�(jEfj Inflation pressure kPa -5.0 -7.0 -3.0 -5.1 -4.9 <br /> &A && f Number of repetition Times >A.0 4 / 4 <br /> Alt VTRI Duration of flushing Minute 150 120 180 150 <br /> BI TM 4 4d&MA BI test of sterility FX a Conformity; non-conformity. <br /> ni�•Conclusion: <br /> kt l BI�EM6 Jl1M 4 ISO 11135:2014 fQ0bW5*. 7"a SAL(10`)*9INE 1, kM f-25Gi4f-WT. <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: Q Date..-- �k2li l t V <br /> Approval(CW): Y G Q M Date,` ,�,,.I _ _ <br /> iI <br /> Zhejiang Huanyi Sterilization Technology Co.,Ltd. (stamp) <br /> j� (11 JAI.IlY RECORD 1/2 <br />