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}�\ I/ �.i,.•,-ra.r� q }'t:�}' Doc. No. HYST/QR2-25-06 <br />4 J J� jpZ1 &.*!Am ' Version No.: 0/B <br />xunNYMERuuzn•noN Certification of EO Sterilization tt. 3ck C3PA Effective date: 2021-04-05 <br />#R 0 4A -Fs Report no.:2022090430 <br />WJE Customer <br />Yiwu Limem tattoo equipment co., Ltd <br />Y�cpp'p T�1, Product named <br />Specification <br />M'q Batch? <br />Quantity <br />`1( fjC -"f tattoo cartridge needle <br />800 box <br />E0822 <br />8 <br />TC �J Sterilization mode <br />"T Z- [. rt EO gas <br />XG_MW_40� Sterilizer no. <br />HYST/ST-05 <br />X -M Q Sterilization date <br />2022-08-26 <br />XMf ✓ Sterilization batch <br />2022082605A <br />,. <br />�C���s�yx Sterilization parameters <br />Unit <br />Requirements <br />5:-F'W Actual <br />b Validated <br />Min. <br />Max. <br />Min. <br />Max. <br />/''4AAjg% ��91 1Loadingtem.priortopreconditioning <br />°C <br />>_10.0 <br />10.0 <br />/ <br />30.8 <br />ft L3E9 f Preconditioning temperature <br />°C <br />48.0 <br />44.0 <br />52.0 <br />45.5 <br />49,7 <br />NLam- k Preconditioning RH <br />%RH <br />55.0 <br />30.0 <br />80.0 <br />47.3 <br />64.7 <br />TAAAO_Rff, Preconditioning time <br />Minute <br />360 <br />340 <br />380 <br />360 <br />Wfl7Transfertime <br />Minute <br />5560 <br />/ <br />60 <br />/ <br />TAWinitial evacuation depth <br />kPa <br />-24.0 <br />-26.0 <br />-22.0 <br />-22.7 <br />M!l 3t-41 Evacuation rate <br />kPa/min <br />:54.0 <br />/ <br />4.0 <br />2.3 <br />�1-cJEvRfRHI Pressure holding time <br />Minute <br />20 <br />10 <br />30 <br />20 <br />Leak test pressure rise 4�113 <br />kPa <br />:51.0 <br />/ <br />1.0 <br />0.7 <br />Y�Rf(7 (iej€j) Moisture injection time (if used) <br />Minute <br />10 <br />10 <br />EO .i' Ai EO injection rate <br />kPa/min <br />0.5 <br />0.3 <br />0.7 <br />0.5 <br />XMPJ1ftf17 EO Injection weight <br />kg <br />20.0 <br />19.5 <br />20.5 <br />20.0 <br />EO ehFJI)JIEf � Pressure rising after EO injection OP <br />kPa <br />231.0 <br />31.0 <br />/ <br />5:-22.0 <br />E:15.3 <br />L P:37.3 <br />EO �Rj EO concentration commence of exposure (theorical) <br />mg/I <br />600 <br />400 <br />800 <br />608 <br />x-M!MJt Exposure temperature <br />°C <br />52.0 <br />49.0 <br />55.0 <br />51.0 <br />54.2 <br />TcM�AJY' Exposure RH <br />%RH <br />55.0 <br />30.0 <br />80.0 <br />52.2 <br />69.7 <br />XMITtfF Exposure time <br />Minute <br />720 <br />700 <br />740 <br />720 <br />A2=(AA-5!A Post-evacuation depth <br />kPa <br />-15.0 <br />-17.0 <br />-13.0 <br />-15.1 <br />-14.9 <br />�t"�JE)7 Inflation pressure <br />kPa <br />-5.0 <br />-7.0 <br />-3.0 <br />-5.1 <br />-5.0 <br />&'�JZXYA Number of repetition <br />Times <br />24.0 <br />4 <br />/ <br />4 <br />WWfIEJ Duration of flushing <br />Minute <br />150 <br />120 <br />180 <br />162 <br />BI 9EiAi pc BI test of sterility <br />`/, A Conformity;❑ T a non -conformity. <br />Mit Conclusion: <br />XM>lltYAO Wo BI ISO 11135:2014 JIlAi�k-N*, �caa SAL(10'6)449IHE-1t, XMdff5tA'- CTTo <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" is achieved and products can be released from sterilization process. <br />MUT Prepator: �t" <br />t4 Approval(OA): <br />1 �, - •. <br />Q Da <br />Zhejiang Huanyi Sterilization Technology Co., Ltd. (stamp) <br />,ff -2-WR QUALITY RECORD 1/2 <br />