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91 y ter: M®t �,{ pial Doc. No. HYST/QR2-25-06 <br />[1x CertificationofEO Sterilization X* 9' Version No.: 0/B <br />HUANYI5IEF�.IZATION +--lC B Jm Effective date: 2021-04-05 <br />JM A ; Report no.:2022060235 <br />4P Customer <br />Yiwu Limem tattoo equipment co., Ltd <br />1'01,'88 Product name <br />04 Specification <br />4M' Batch <br />( Quantity <br />_000Asl tattoo cartridge needle <br />700 box <br />E0522 <br />7 T&r <br />T _ffi;' A Sterilization mode <br />3TAZA EO gas <br />XIN � Sterilizer no. <br />HYST/ST-05 <br />TC Q Sterilization date <br />2022-05-24 <br />Sterilization batch <br />2022052405A <br />Sterilization parameters <br />Unit <br />0* Requirements <br />9:-FT'L Actual <br />Validated <br />Min. <br />Max. <br />Min. <br />Max. <br />l�nu7% 1(i Loadingtem. prior to preconditioning <br />°C <br />210.0 <br />10.0 <br />/ <br />23.6 <br />% Preconditioning temperature <br />°C <br />48.0 <br />44.0 <br />52.0 <br />46.5 <br />49.4 <br />j Preconditioning RH <br />%RH <br />55.0 <br />30.0 <br />80.0 <br />49.8 <br />1 58.6 <br />T+ k3KRtno Preconditioning time <br />Minute <br />360 <br />340 <br />380 <br />360 <br />"ift e� Transfertime <br />Minute <br /><_60 <br />/ <br />60 <br />/ <br />NA -2Z initial evacuation depth <br />kPa <br />-24.0 <br />-26.0 <br />-22.0 <br />-24.1 <br />#_5!A_-3JK Evacuation rate <br />kPa/min <br />54.0 <br />/ <br />4.0 <br />3.0 <br />WROOR] Pressure holding time <br />Minute <br />20 <br />10 <br />30 <br />20 <br />*ffiffit5E t Leak test pressure rise LP <br />kPa <br />:51.0 <br />/ <br />1.0 <br />0.7 <br />W`QtAR I1 ("Pl) Moisture injection time (if used) <br />Minute <br />10 <br />10 <br />EOEO injection rate <br />kPa/min <br />0.5 <br />0.3 <br />0.7 <br />0.7 <br />XMPI-12 EO Injection weight <br />kg <br />20.0 <br />19.5 <br />20.5 <br />19.9 <br />EO 4iA)�iJFjJ3MTt Pressure rising after EO injection LP <br />kPa <br />231.0 <br />31.0 <br />/ <br />S:-23.4 <br />E:12.7 <br />OP:36.1 <br />EO �&1E EO concentration commence of exposure (theorical) <br />mg/I <br />600 <br />400 <br />800 <br />588 <br />X_ffi9fJ Exposure temperature <br />°C <br />52.0 <br />49.0 <br />55.0 <br />51.4 <br />54.8 <br />x-M&I Exposure RH <br />%RH <br />55.0 <br />30.0 <br />80.0 <br />53.6 <br />62.4 <br />x_ffiflfn13 Exposure time <br />Minute <br />720 <br />700 <br />740 <br />720 <br />WTA!�A Post-evacuation depth <br />kPa <br />-15.0 <br />-17.0 <br />-13.0 <br />-15.1 <br />-15.0 <br />A"TA-)i Inflation pressure <br />kPa <br />-5.0 <br />-7.0 <br />-3.0 <br />-5.0 <br />-4.9 <br />�.0 Number of repetition <br />Times <br />24.0 <br />4 <br />/ <br />4 <br />A'ttRf(e] Duration of flushing <br />Minute <br />150 <br />120 <br />180 <br />120 <br />BI )G_ffii4kM;R Bl test of sterility <br />®2 4 Conformity; El Tet non -conformity. <br />M%Q Conclusion: <br />T( 'InSWA BI )EVMW�A ISO 11135:2014 fQA!kR*, !"ua SAL(J0-6)f yJJ E�t, fi f>;i 1 CT7° <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 />$d Prepator: � Q Date _ <br />1 �~ <br />Mfg Approval(QA): Date JR <br />Zhejiang Huanyi Sterilization Technology Co., Ltd. (stamp) <br />91OR QUALITY RECORD 1/2 <br />