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jZ1+�u-, Doc. No. HYST/QR2-25-06 <br />fM7VC �,t Version No.: 0/B <br />❑UAm1sn:xuaznnon Certification of EO Sterilization<rY2EJM Effective date: 2021-04-05 <br />JK(q `- 4j Report no.:2022090740 <br />Customer <br />Yiwu Limem tattoo equipment co., Ltd <br />na47iVi, Product name <br />Specification <br />A� Batch Rik Quantity <br />4SC 9C€�th tattoo cartridge needle <br />700 box <br />E0822 7 T+$ <br />TC_ffi%7 SC Sterilization mode <br />f i Z EO gas <br />T(M1Cr y Sterilizer no. <br />HYST/ST-05 <br />TC -M Q M Sterilization date <br />2022-08-29 <br />Sterilization batch <br />2022082905A <br />TCM00C Sterilization parameters <br />Unit <br />0* Requirements <br />�FTTl Actual <br />*5�! Validated <br />Min. <br />Max. <br />Min. <br />Max. <br />ld!:na7A/\J1�3M191A Loading tem. prior to preconditioning <br />°C <br />210.0 <br />10.0 <br />/ <br />31.6 <br />N1 hg&a' Preconditioning temperature <br />°C <br />48.0 <br />44.0 <br />52.0 <br />46.1 <br />49.0 <br />f�gffla Preconditioning RH <br />%RH <br />55.0 <br />30.0 <br />80.0 <br />49.1 1 <br />62.7 <br />FAAWI JI Preconditioning time <br />Minute <br />360 <br />340 <br />380 <br />360 <br />JJ40f ul Transfer time <br />Minute <br />5560 <br />/ <br />60 <br />/ <br />NA_! T Initial evacuation depth <br />kPa <br />-24.0 <br />-26.0 <br />-22.0 <br />-24.2 <br />M'iii * Evacuation rate <br />kPa/min <br />54.0 <br />/ <br />4.0 <br />3.0 <br />Q EAff1 Pressure holding time <br />Minute <br />20 <br />10 <br />30 <br />20 <br />Leak test pressure rise DP <br />kPa <br />:51.0 <br />/ <br />1.0 <br />0.6 <br />a"%AAffi�l (Via l) 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 />0.4 <br />7CMMS-111 EO Injection weight <br />kg <br />20.0 <br />19.5 <br />20.5 <br />19.9 <br />EO�>AjJ (�� Pressure rising after EO injection AP <br />kPa <br />231.0 <br />31.0 <br />/ <br />5:-23.6 <br />E:13.0 <br />A P:36.6 <br />EO WA EO concentration commence of exposure (theorical) <br />mg/1 <br />600 <br />400 <br />800 <br />596 <br />TGM'&AEExposure temperature <br />°C <br />52.0 <br />49.0 <br />55.0 <br />50.1 <br />54.7 <br />XM?g)5E Exposure RH <br />%RH <br />55.0 <br />30.0 <br />80.0 <br />53.3 <br />1 66.1 <br />Tcfia$(ol Exposure time <br />Minute <br />720 <br />700 <br />740 <br />720 <br />W (A-271 Post-evacuation depth <br />kPa <br />-15.0 <br />-17.0 <br />-13.0 <br />-15.1 <br />-15.0 <br />A'IX)] Inflation pressure <br />kPa <br />-5.0 <br />-7.0 <br />-3.0 <br />-5.1 <br />-4.9 <br />�7�SINumberofrepetition <br />Times <br />24.0 <br />4 <br />/ <br />4 <br />WVVIII Duration of flushing <br />Minute <br />150 <br />120 <br />180 <br />150 <br />BI TGMiftMA BI test of sterility <br />X f6l'4 Conformity; ❑ T, -M'-4 non -conformity. <br />nibconclusion: ®T } <br />k f f A BI 5EM4!a lflj o ISO 11135:2014 *[Wk -5*, (uA T`SAL(10�6)T*JPNE- c, iLi} CIT= <br />Above all, sterilization process and BI sterility testing are meeting with EN ISO 11135:2014 and validated-reyoirements, and Sterile Assurance <br />r <br />Level (SAL) of 10" is achieved and products can be released from sterilization process.------------- <br />�A$IJ Prepator: iki <br />Itl Approval(QA): <br />Zhejiang Huanyi Sterilization Technology Co., Ltd. (stamp) <br />f� i3A QUALITY RECORD 1/2 <br />