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I 5C1+tA7 Doc. No. HYST/QR2-2S-06 <br />l 7lx N*tW; Version No.: 0/B <br />IWANYI 9I1:RUIZA110N Certification of EO Sterilization I±,kB to Effective date: 2021-04-05 <br />#M A;rm s Report no.:2022090431 <br />4,P Customer <br />Yiwu Limem tattoo equipment co., Ltd <br />7'�A41, T�.n Prod uct n me <br />Specification <br />ft's- Batch <br />SL Quantity <br />6�( 9Ct1 tattoo cartridge needle <br />1000 box <br />E0822 <br />10 T { <br />TC_CJ 74 Sterilization mode <br />}T Z Xio EO gas <br />Sterilizer no. <br />HYST/ST-05 <br />k -M Q M Sterilization date <br />2022-08-26 <br />TCXa S Sterilization batch <br />2022082605A <br />TC���( Sterilization parameters <br />, f <br />Unit <br />3 �* Requirements <br />9 IFTI L Actual <br />*,i -F Validated <br />Min. <br />Max. <br />Min. <br />Max. <br />j�Pr'pjkAM��_ n!i ?rfA Loading tem. prior to preconditioning <br />°C <br />>_10.0 <br />10.0 <br />/ <br />30.8 <br />fM319.Im I Preconditioning temperature <br />°C <br />48.0 <br />44.0 <br />52.0 <br />45.5 <br />49.7 <br />Nj �tgigl Preconditioning RH <br />%RH <br />55.0 <br />30.0 <br />80.0 <br />47.3 <br />64.7 <br />fA�EWfl7 Preconditioning time <br />Minute <br />360 <br />340 <br />380 <br />360 <br />041IT1113 Transfer time <br />Minute <br />560 <br />/ <br />60 <br />/ <br />NAl ! Initial evacuation depth <br />kPa <br />-24.0 <br />-26.0 <br />-22.0 <br />-22.7 <br />41hiA_029 Evacuation rate <br />kPa/min <br />54.0 <br />/ <br />4.0 <br />2.3 <br />%EI11131 Pressure holding time <br />Minute <br />20 <br />10 <br />30 <br />20 <br />Leak test pressure rise OP <br />kPa <br /><1.0 <br />/ <br />1.0 <br />0.7 <br />��'� Afrtl7 ("J� ) Moisture injection time (if used) <br />Minute <br />10 <br />10 <br />EO q-,kJ4$ EO injection rate <br />kPa/min <br />0.5 <br />0.3 <br />0.7 <br />0.5 <br />xffjll EO Injection weight <br />kg <br />20.0 <br />19.5 <br />20.5 <br />20.0 <br />EO 9Ar6JVj55Mff Pressure rising after EO injection AP <br />kPa <br />>_31.0 <br />31.0 <br />/ <br />5:-22.0 <br />I E:15.3 <br />0P:37.3 <br />EO �Rl EO concentration commence of exposure (theorical) <br />mg/I <br />600 <br />400 <br />800 <br />608 <br />TCM'&J Exposure temperature <br />°C <br />52.0 <br />49.0 <br />55.0 <br />51.0 <br />54.2 <br />XMiR/A Exposure RH <br />%RH <br />55.0 <br />30.0 <br />80.0 <br />52.2 <br />1 69.7 <br />XMI[fNI Exposure time <br />Minute <br />720 <br />700 <br />740 <br />720 <br />Post-evacuation depth <br />kPa <br />-15.0 <br />-17.0 <br />-13.0 <br />-15.1 <br />-14.9 <br />A'�'C)j Inflation pressure <br />kPa <br />-5.0 <br />-7.0 <br />-3.0 <br />-5.1 <br />-5.0 <br />V,0%&f( Number of repetition <br />Times <br />>A.0 <br />4 <br />/ <br />4 <br />YA' It(gj7 Duration of flushing <br />Minute <br />150 <br />120 <br />180 <br />162 <br />BI 7JE_"2k,,* BI test of sterility <br />X A 4 Conformity; ❑ T A4 non -conformity. <br />ai$ Conclusion: <br />Tcf lif BI 5EVAWIo ISO 11135:2014 A 1kleap SAL(106) I�%1E7E 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 />X011 Prepator: / <br />tE4 Approval(QA): c <br />Q� Date:_. <br />Q Date. <br />Zhejiang Huanyi Sterilization Technology Co., Ltd. (stamp) <br />BUVEA QUALITY RECORD )/2 <br />