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}�\ ! / �.i,.•,-ra.r�q }'t:�} ' Doc.No. HYST/QR2-25-06 <br /> &*-`A 15'Version No.: 0/B <br /> xunNr1sn:ruuzn110N Certification of EO Sterilization tt3ck C3PA Effective date: 2021-04-05 <br /> A Report no.:2022090430 <br /> WJ21 Customer Yiwu Limem tattoo equipment co.,Ltd <br /> Y�cpp'p Tl1,Product named Specification " 'Batch flit Quantity <br /> `1( fjC-"f tattoo cartridge needle 800 box E0822 8 <br /> TC �J Sterilization model Zrt EO gas X-MWN0�Sterilizer no. HYST/ST-05 <br /> Q Sterilization date 2022-08-26 XMf ✓ Sterilization batch 2022082605A <br /> ,. ,( Requirements {SiT•'W Actual <br /> �CM��s�yx Sterilization parameters <br /> Unit i validated Min. Max. Min. Max. <br /> jg), ��91 1Loadingtem.priortopreconditioning °C >_10.0 10.0 / 30.8 <br /> ft L3E9 f Preconditioning temperature °C 48.0 44.0 52.0 45.5 49.7 <br /> N Lam- k Preconditioning RH %RH 55.0 30.0 80.0 47.3 64.7 <br /> TAAAO_Rff, Preconditioning time Minute 360 340 380 360 <br /> Wfl7 Transfertime Minute 560 / 60 / <br /> T _W�initial evacuation depth kPa -24.0 -26.0 -22.0 -22.7 <br /> JIJI!�3t-41 Evacuation rate kPa/min :54.0 / 4.0 2.3 <br /> '�`icJEvffl7 Pressure holding time Minute 20 10 30 20 <br /> Leak test pressure rise 4�113 kPa :51.0 / 1.0 0.7 <br /> Y �Rf(7 ( iePr3) Moisture injection time(if used) Minute 10 10 <br /> EO.i'�i <fl EO injection rate kPa/min 0.5 0.3 0.7 0.5 <br /> XMPJ1ftf17 EO Injection weight kg 20.0 19.5 20.5 20.0 <br /> 5:-22.0 E:15.3 <br /> EO ehFJI)JIEf �Pressure rising after EO injection OP kPa z31.0 31.0 / <br /> L P:37.3 <br /> EO�Rj EO concentration commence of exposure(theorical) mg/I 600 400 800 608 <br /> x-M!MJt Exposure temperature °C 52.0 49.0 55.0 51.0 54.2 <br /> TcM�AJY'Exposure RH %RH 55.0 30.0 80.0 52.2 69.7 <br /> TcMRflfF Exposure time Minute 720 700 740 720 <br /> A2=(AA-5!A Post-evacuation depth kPa -15.0 -17.0 -13.0 -15.1 -14.9 <br /> �t"�JE)7 Inflation pressure kPa -5.0 -7.0 -3.0 -5.1 -5.0 <br /> &'�JZXYt Number of repetition Times >A.0 4 / 4 <br /> WWfIEJ Duration of flushing Minute 150 120 180 162 <br /> BI 9EiAi pc BI test of sterility `/, A $ Conformity; ❑T a non-conformity. <br /> Mit Conclusion: <br /> XV12NOWn BI ISO 11135:2014 JIlAi�k-N*, !as SAL(10-914 IJLE_It, Tc fiff�i'1-JtTTo <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 /> 4 <br /> �mr$l� Prepator: Q Da <br /> %( Approval(OA): Q Da <br /> Zhejiang Huanyi Sterilization Technology Co.,Ltd. (stamp) <br /> tff-ff-W,,:R QUALITY RECORD 1/2 <br />