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91 L X -N® �lrr' FA 7 U,V�<-r. M 7Uc l_ DLT+�' I Doc. No. HYST/QR2-25-06 <br />f ECI jR,C*NA'J, Version No.: 0/B <br />HUANYI sn:RUA N110N Certification of EO Sterilization ±�k HAA Effective date: 1 2021-04-05 <br />fK A A4 Report no.:2022090844 <br />9f customer <br />Yiwu Limem tattoo equipment co., Ltd <br />P'PIM Product name <br />PUM Specification <br />a4� Batch <br />f(A Quantity <br />tattoo cartridge needle <br />600 box <br />E0822 <br />6 Tr$ <br />x_ffi%j xt Sterilization mode <br />T�KZA EO gas <br />XMMWF Sterilizer no. <br />HYST/ST-05 <br />T<M Sterilization date <br />2022-08-30 <br />TC 5 Sterilization batch <br />2022083005A <br />.yy,. Sterilization parameters <br />Unit <br />R* Requirements <br />9ZFTil1 Actual <br />y Validated <br />Min. <br />Max. <br />Min. <br />Max. <br />Loadingtem. prior to preconditioning <br />°C <br />2_10.0 <br />10.0 <br />/ <br />32.0 <br />Nj hhg&%' Preconditioning temperature <br />°C <br />48.0 <br />44.0 <br />52.0 <br />45,8 <br />50.1 <br />NWEM& Preconditioning RH <br />%RH <br />55.0 <br />30.0 <br />80.0 <br />45.3 <br />61.6 <br />NkON117 Preconditioning time <br />Minute <br />360 <br />340 <br />380 <br />360 <br />04iVOI Transfer time <br />Minute <br />560 <br />/ <br />60 <br />/ <br />_A!� Initial evacuation depth <br />kPa <br />-24.0 <br />-26.0 <br />-22.0 <br />-22.9 <br />Evacuation rate <br />kPa/min <br />54.0 <br />/ <br />4.0 <br />2.3 <br />R5:11117 Pressure holding time <br />Minute <br />20 <br />10 <br />30 <br />20 <br />'R-,ILfCfij7!ct Leak test pressure rise z,P <br />kPa <br />51.0 <br />/ <br />1.0 <br />0.6 <br />(3ZA) Moisture injection time (if used) <br />Minute <br />10 <br />10 <br />EO EO injection rate <br />kPa/min <br />0.5 <br />0.3 <br />0.7 <br />0.6 <br />XMIPJAZI EO Injection weight <br />kg <br />20.0 <br />19.5 <br />20.5 <br />20.0 <br />EO hFr%j2 (%� Pressure rising after EO injection nP <br />kPa <br />2_31.0 <br />31.0 <br />/ <br />5:-22.3 <br />E:14.0 <br />AP:36.3 <br />EO Mfk EO concentration commence of exposure (theorical) <br />mg/I <br />600 <br />400 <br />800 <br />591 <br />X -MMI Exposure temperature <br />°C <br />52.0 <br />49.0 <br />55.0 <br />51.8 <br />54.6 <br />kM&YE Exposure RH <br />%RH <br />55.0 <br />30.0 <br />80.0 <br />49.6 <br />66.1 <br />XMR$I[0 Exposure time <br />Minute <br />720 <br />700 <br />740 <br />720 <br />W�M�l Post-evacuation depth <br />kPa <br />-15.0 <br />-17.0 <br />-13.0 <br />-15.1 -14.9 <br />A"�(jEjj Inflation pressure <br />kPa <br />-5.0 <br />-7.0 <br />-3.0 <br />-5.1 -4.9 <br />&A�&�W Numberof repetition <br />Times <br />2_4.0 <br />4 <br />/ <br />4 <br />alt VTRI Duration of flushing <br />Minute <br />150 <br />120 <br />180 <br />150 <br />BI TM 4 4d &MA BI test of sterility <br />FX� a Conformity; non-conformity. <br />ni�• conclusion: <br />k BI TGMI6i91M 4 ISO 11135:2014 fQ0b 5*, YN SAL(10`)*9NE9:-, XM f2`IGi4f- T= <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 />A*IJ Prepator: iA& <br />1�1 Approval(QA): <br />Q� Date., r �7�i/:lit <br />Q M Date, ,,.� <br />i II. <br />Zhejiang Huanyi Sterilization Technology Co., Ltd. (stamp) <br />j1:2jZ-;P (11JAI .IlY RECORD 1/2 <br />