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7L +'tV'' Doc. No. HYST/QR2-25-06 <br />�I Certii'filcatioonnhof E%OIStte7riillization 0 version No.: 0/B <br />uunN�� sn:wiaznnoN ±- 0 B M Effective date: 2021-04-05 <br />JRC A s Report no.:2022090120 <br />'Xp Customer <br />Yiwu Limem tattoo equipment co., Ltd <br />1 pp�L7S, Product name <br />Specification <br />WBatch <br />AM Quantity <br />67( fjC�1' tattoo cartridge needle <br />2700 box <br />E0822 <br />27 T <br />XM S4, Sterilization modeT <br />kit EO gas <br />XMgAAS Sterilizer no.71 <br />HYST/ST-05 <br />TCS Q Sterilization date <br />2022-08-23 <br />k' Sterilization batch <br />2022082305A <br />k���[ Sterilization parameters <br />Unit <br />Requirements <br />9 IfVTIt Actual <br />b Validated <br />Min. <br />Max. <br />Min. <br />Max. <br />pgj�i(ji)IJ Loading tem. priorto preconditioning <br />°C <br />>_10.0 <br />10.0 <br />/ <br />30.1 <br />NAOMI Preconditioning temperature <br />°C <br />48.0 <br />44.0 <br />52.0 <br />46.3 <br />50.1 <br />f,rAA3V_9fA Preconditioning RH <br />%RH <br />55.0 <br />30.0 <br />80.0 <br />48.8 <br />62.6 <br />N!J AE911,f17 Preconditioning time <br />Minute <br />360 <br />340 <br />380 <br />360 <br />Rff5] Transfer time <br />Minute <br />5560 <br />/ <br />60 <br />/ <br />RA S�_ Initial evacuation depth <br />kPa <br />-24.0 <br />-26.0 <br />-22.0 <br />-25.3 <br />tf!�31-519 Evacuation rate <br />kPa/min <br />154.0 <br />/ <br />4.0 <br />2.5 <br />UR.[ RIR Pressure holding time <br />Minute <br />20 <br />10 <br />30 <br />20 <br />WEIE)JIEft Leak test pressure rise z�,P <br />kPa <br />451.0 <br />/ <br />1.0 <br />0.5 <br />(9­itM) Moisture injection time (if used) <br />Minute <br />10 <br />10 <br />EO %i EO injection rate <br />kPa/min <br />0.5 <br />0.3 <br />0.7 <br />0.6 <br />TCM. PJAX EO injection weight <br />kg <br />20.0 <br />19.5 <br />20.5 <br />20.0 <br />EO%��j7L (% Pressure rising after EO injection �P <br />kPa <br />231.0 <br />31.0 <br />/ <br />S:-24.8 <br />E:12.2 <br />0 P:37.0 <br />EO MA EO concentration commence of exposure (theorical) <br />mg/1 <br />600 <br />400 <br />800 <br />603 <br />XMIm)JE Exposure temperature <br />°C <br />52.0 <br />49.0 <br />55.0 <br />50.5 54.2 <br />X -Ma - Exposure RH <br />%RH <br />55.0 <br />30.0 <br />80.0 <br />52.5 67.2 <br />k_ffiA117 Exposure time <br />Minute <br />720 <br />700 <br />740 <br />720 <br />4V2W?A- Post-evacuation depth <br />kPa <br />-15.0 <br />-17.0 <br />-13.0 <br />-15.1 <br />-14.9 <br />3t`4t(I, t Inflation pressure <br />kPa <br />-5.0 <br />-7.0 <br />-3.0 <br />-5.1 <br />-4.9 <br />AbMtk Number of repetition <br />Times <br />>_4.0 <br />4 <br />/ <br />4 <br />W1111Irul Duration of flushing <br />Minute <br />150 <br />120 <br />180 <br />1 144 <br />BI 5Gff i5U1 AY-, BI test of sterility <br />;< A Conformity; ❑ T o non -conformity. <br />Mit Conclusion: <br />xkS if9A,tM BI ISO 11135:2014 fQTA k7c*, leap SAL(10-6)14£Ij1119Z-, TCf f S�if fCTT= <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 106 is achieved and products can be released from sterilization process. _ <br />AM Prepator: i4� HM <br />W9 Approval(QA): AtL1111 Q M <br />Zhejiang Huanyi Sterilization Technology Co., Ltd. (stamp) <br />ffi, Mii,A QUALITY RECORD 1/2 <br />