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7Z44 94'3 Doc.No. HYST/QR2.25.06 <br /> )�t*A1'Version No.: 0/B <br /> HunN'llsnuiaznnoN Certification of EO Sterilization ±OHM Effective date: 2021-04-05 <br /> IK S'_-`,fie s Report no.:2022090432 <br /> Customer Yiwu Limem tattoo equipment co.,Ltd <br /> /"nab V Product name Specification Rt-q Batch Quantity <br /> �C 9C° tf tattoo cartridge needle 500 box E0822 5 T", <br /> Sterilization mode 5T,Z ZA EO gas X_M40A S Sterilizer no. HYST/ST-05 <br /> {[� Sterilization date 2022-08-26 XMR S Sterilization batch 2022082605A <br /> VE R-*Requirements �VT'l Actual <br /> T�WIM Sterilization parameters <br /> Unit Validated Min. Max. Min. Max. <br /> 11'RJA kfft�MI I Loading tem.prior to preconditioning °C >_10.0 10.0 / 30.8 <br /> N1 ±311 1 Preconditioning temperature °C 48.0 44.0 52.0 45.5 49.7 <br /> fftWRef_ Preconditioning RH %RH 55.0 30.0 80.0 47.3 64.7 <br /> N�001I7 Preconditioning time Minute 360 340 380 360 <br /> JJ4. 17 Transfer time Minute :560 / 60 / <br /> JA-A_15�Initial evacuation depth kPa -24.0 -26.0 -22.0 -22.7 <br /> N!�A'49 Evacuation rate kPa/min :54.0 / 4.0 2.3 <br /> RIIn Pressure holding time Minute 20 10 30 20 <br /> '(�ff;IEjj5lEk Leak test pressure rise n P kPa 51.0 / 1.0 0.7 <br /> V%Alf r,13 (r-ZA3) Moisture injection time(if used) Minute 10 10 <br /> EO 4P-Ail-rV- EO injection rate kPa/min 0.5 0.3 0.7 0.5 <br /> XM j2j:R EO Injection weight kg 20.0 19.5 20.5 20.0 <br /> S:22.0 E:15.3 <br /> EO I�FI jj 2(��Pressure rising after EO injection 'P kPa z31.0 31.0 / <br /> 0 P:37.3 <br /> EO M6E EO concentration commence of exposure(theorical) mg/I 600 400 800 608 <br /> k_ffiMfJ Exposure temperature °C 52.0 49.0 55.0 51.0 54.2 <br /> TC MjH)A Exposure RH %RH 55.0 30.0 80.0 52.2 69.7 <br /> fff(Ol Exposure time Minute 720 700 740 720 <br /> � j Post-evacuation depth kPa -15.0 -17.0 -13.0 -15.1 -14.9 <br /> AMIX j Inflation pressure kPa -5.0 -7.0 -3.0 -5.1 -5.0 <br /> � . [Number of repetition Times >_4.0 4 / 4 <br /> Wi0tfi Duration of flushing Minute 150 120 180 162 <br /> BI test of sterility X at Conformity; ❑T A 4 non-conformity. <br /> Ai�Conclusion: <br /> X1� ,03"�P N BI 5EM69 I`J o ISO 11135:2014 f R,SAL(10.6)%Y'R0Z- k fCi+ kfr> <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 _r, <br /> Zhejiang Huanyi Sterilization Technology Co.,Ltd. (stamp) <br /> Tf ia'A QUALITY RFrnRn 1/2 <br />