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/� ` ® 3TA 7 AXffi Jn q 7Z44194'3- Doc. No. HYST/QR2.25.06 <br />� J`� TTJ��I�s U x j'(� )�t*A1' Version No.: 0/B <br />HunN'llstuiazntioN Certification of EO Sterilization i�HM Effective date: 2021-04-05 <br />IK SI__ `,fie s Report no.:2022090432 <br />9P Customer <br />Yiwu Limem tattoo equipment co., Ltd <br />)" Rai V, Product name <br />PL4 Specification <br />Rt -q Batch <br />Quantity <br />C 9CA� f tattoo cartridge needle <br />500 box <br />E0822 <br />5 T", <br />Sterilization mode <br />5T,Z Zr EO gas <br />TC6 S Sterilizer no. <br />HYST/ST-05 <br />{ [� Sterilization date <br />2022-08-26 <br />XMR S Sterilization batch <br />2022082605A <br />����( Sterilization parameters <br />VE <br />Unit <br />2W.:* Requirements <br />�VT'� Actual <br />y Validated <br />Min. <br />Max. <br />Min. <br />Max. <br />1"OPA kf 1t MIMI Loading tem. prior to preconditioning <br />°C <br />>_10.0 <br />10.0 <br />/ <br />30.8 <br />N1 ±3181 Preconditioning temperature <br />T <br />48.0 <br />44.0 <br />52.0 <br />45.5 <br />49.7 <br />fftW el E Preconditioning RH <br />%RH <br />55.0 <br />30.0 <br />80.0 <br />47.3 <br />64.7 <br />N�001I7 Preconditioning time <br />Minute <br />360 <br />340 <br />380 <br />360 <br />JJ4. 17Transfer time <br />Minute <br />:560 <br />/ <br />60 <br />/ <br />JAA_Ij� Initial evacuation depth <br />kPa <br />-24.0 <br />-26.0 <br />-22.0 <br />-22.7 <br />N!�A'49 Evacuation rate <br />kPa/min <br />:54.0 <br />/ <br />4.0 <br />2.3 <br />RIIn Pressure holding time <br />Minute <br />20 <br />10 <br />30 <br />20 <br />'(�ILIEjj5lEk Leak test pressure rise n P <br />kPa <br />551.0 <br />/ <br />1.0 <br />0.7 <br />V%Al1j'(7 (r-ZA3) Moisture injection time (if used) <br />Minute <br />10 <br />10 <br />EO 4P-Aili-V EO injection rate <br />kPa/min <br />0.5 <br />0.3 <br />0.7 <br />0.5 <br />XMPJ2j:R EO Injection weight <br />kg <br />20.0 <br />19.5 <br />20.5 <br />20.0 <br />EO %Fl jj 2 (�� Pressure rising after EO injection n P <br />kPa <br />231.0 <br />31.0 <br />/ <br />S:-22.0 <br />E:15.3 <br />0P:37.3 <br />EO M6E EO concentration commence of exposure (theorical) <br />mg/I <br />600 <br />400 <br />800 <br />608 <br />k_ffiMfJ Exposure temperature <br />T <br />52.0 <br />49.0 <br />55.0 <br />51.0 <br />54.2 <br />TC MjH)A Exposure RH <br />%RH <br />55.0 <br />30.0 <br />80.0 <br />52.2 <br />69.7 <br />fff(Ol Exposure time <br />Minute <br />720 <br />700 <br />740 <br />720 <br />�j Post-evacuation depth <br />kPa <br />-15.0 <br />-17.0 <br />-13.0 <br />-15.1 <br />-14.9 <br />AMIX j Inflation pressure <br />kPa <br />-5.0 <br />-7.0 <br />-3.0 <br />-5.1 <br />-5.0 <br />&�J Zkt[ Number of repetition <br />Times <br />>_4.0 <br />4 <br />/ <br />4 <br />Wi0tfi Duration of flushing <br />Minute <br />150 <br />120 <br />180 <br />162 <br />BI TGMiCin't 4�-h 2% BI test of sterility <br />X at Conformity; ❑ A 4 non -conformity. <br />Ai� Conclusion: <br />XM,03"�PMN BI 5EM69Mo ISO 11135:2014 ItiA , J R°, SAL(10-6)%Y'R0Z-, Tcf l 1`l it iT> <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 />4011 Prepator: Q Dat r <br />f Approval(QA): Datafy <br />INV41fllf 1441 t=t <br />Zhejiang Huanyi Sterilization Technology Co., Ltd. (stamp) <br />f lia'A QUALITY RFrnRn 1/2 <br />