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jZ1+�u-,Doc.No. HYST/QR2-25-06 <br /> AMM-9-Version NO.: <br /> <r 0/B <br /> ❑UAm1sn:xuaznnon Certification of EO Sterilization 2p1UJ Effective date: 2021-04-OS <br /> Report no.:2022090740 <br /> Customer Yiwu Limem tattoo equipment co.,Ltd <br /> 1'"'na47iV,Product name fiRM Specification Batch ftli Quantity <br /> 43C4 tattoo cartridge needle 700 box E0822 7 T$ <br /> TC_ffi)J Xj Sterilization mode fTZ 7- E0 gas TMV W4' Sterilizer no. HYST/ST-05 <br /> X-M Q M Sterilization date 2022-08-29 TC $� Sterilization batch 2022082905A <br /> 0*Requirements �FTTl Actual <br /> TCM00C Sterilization parameters <br /> Unit *5�!Validated Min. Max. Min. Max. <br /> ld!:na7A/\J1�3MJRfA Loading tem.prior to preconditioning °C 210.0 10.0 / 31.6 <br /> Nl hg&a' Preconditioning temperature °C 48.0 44.0 52.0 46.1 49.0 <br /> f�gffla Preconditioning RH %RH 55.0 30.0 80.0 49.1 1 62.7 <br /> FAAWI JI Preconditioning time Minute 360 340 380 360 <br /> JJ411fful Transfer time Minute 560 / 60 / <br /> Initial evacuation depth kPa -24.0 -26.0 -22.0 -24.2 <br /> M'ii! * Evacuation rate kPa/min 54.0 J 4.0 3.0 <br /> Q ERV113 Pressure holding time Minute 20 10 30 20 <br /> VINN)J5M Leak test pressure rise DP kPa :51.0 / 1.0 0.6 <br /> a"%ARff� (Via l) Moisture injection time(if used) Minute 10 10 <br /> EO Ak EO injection rate kPa/min 0.5 0.3 0.7 0.4 <br /> 7CMMS-111 EO Injection weight kg 20.0 19.5 20.5 19.9 <br /> 5:-23.6 E:13.0 <br /> EO Pressure rising after EO injection AP kPa 231.0 31.0 / <br /> A P:36.6 <br /> EO WA EO concentration commence of exposure(theorical) mg/1 600 400 800 596 <br /> XGM°&AE Exposure temperature °C 52.0 49.0 55.0 50.1 54.7 <br /> XM?gf5E Exposure RH %RH 55.0 30.0 80.0 53.3 1 66.1 <br /> Tcf1af(ol Exposure time Minute 720 700 740 720 <br /> W(A-271 Post-evacuation depth kPa -15.0 -17.0 -13.0 -15.1 -15.0 <br /> A'IX)j Inflation pressure kPa -5.0 -7.0 -3.0 -5.1 -4.9 <br /> SINumber ofrepetition Times zA.0 4 / 4 <br /> WVVIII Duration offlushing Minute 150 120 180 150 <br /> BI 9EMi MA BI test ofsterility X f6l'4 Conformity; ❑T A non-conformity. <br /> nibconclusion: ® } <br /> k f f A BI 5EM�+lfljo ISO 11135:2014*[Wk-5*, ( uA T` SAL(10�6)T*JPNE-c, <br /> Above all,sterilization process and BI sterility testing are meeting with EN ISO 11135:2014 and validated-reyoirements,and Sterile Assurance <br /> Level(SAL)of 10"is achieved and products can be released from sterilization process. <'- r_: :'_' <br /> ------------- <br /> I� Prepator: Q M Dates.--:-. r <br /> Approval(QA): Q Date: ' ' ?91'►° ` <br /> Zhejiang Huanyi Sterilization Technology Co.,Ltd. (stamp) <br /> fili33A QUALITY RECORD 1/2 <br />