Laserfiche WebLink
Doc.No. HYST/QR2-25-06 <br /> T�l� (->•/ %C 7VC #A*WJ'Version No.: 01B <br /> I o MIST urazenoN Certification of EO Sterilization t­0EJM Effective date: 2021-04-05 <br /> Report no.:2022090638 <br /> �t Customer Yiwu Limem tattoo equipment co.,Ltd <br /> 7'4G;t8, Product name ' Specification -5'Batch al Quantity <br /> fjCMR;t1' tattoo cartridge needle 800 box E0822 8 T <br /> XM�X_�Sterilization mode ALAI EO gas Sterilizer no. HYST/ST-05 <br /> XN Q Sterilization date 2022-08-28 TC }5 Sterilization batch 2022082805A <br /> R*Requirements g FiTJ Actual <br /> Sterilization parameters <br /> Unit i6tZ Validated Min. Max. Min. Max. <br /> 1'�a°pi7�llnJ�f Loading tem.prior to preconditioning °C >_10.0 10.0 / 31.2 <br /> NSCh_MI Preconditioning temperature °C 48.0 44.0 52.0 45.6 50.4 <br /> FM3M C Preconditioning RH %RH 55.0 30.0 80.0 46.3 55.1 <br /> Nl Egllftal Preconditioning time Minute 360 340 380 360 <br /> A 3 Transfertime Minute 560 / 60 / <br /> 1AM!Initial evacuation depth kPa -24.0 -26.0 -22.0 -25.9 <br /> 41115-131A Evacuation rate kPa/min 154.0 / 4.0 2.6 <br /> Will, (7 Pressure holding time Minute 20 10 30 20 <br /> ffif)J3c-I, Leak test pressure rise OP kPa 151.0 / 1.0 0.6 <br /> f "CaANftq (X'iiKjA) Moisture injection time(if used) Minute 10 10 <br /> EO eAA*EO injection rate kPa/min 0.5 0.3 0.7 0.5 <br /> X-MMER EO Injection weight kg 20.0 19.5 20.5 20.1 <br /> 5:-253 E:10.7 <br /> EO e�IAf-Ji�VM Pressure rising after EO injection AP kPa >_31.0 31.0 / <br /> OP:36.0 <br /> EO 9fJ EO concentration commence of exposure(theorical) mg/I 600 400 800 586 <br /> T(MMI Exposure temperature °C 52.0 49.0 55.0 51.2 54.3 <br /> T(Mfffk Exposure RH %RH 55.0 30.0 80.0 51.2 59.3 <br /> T(MR 1 Exposure time Minute 720 700 740 720 <br /> W=W�fA Post-evacuation depth kPa -15.0 -17.0 -13.0 -15.1 -14.9 <br /> 3t1L1 JJ Inflation pressure kPa -5.0 -7.0 -3.0 -5.1 -4.9 <br /> A'Qk*Number of repetition Times >_4.0 4 / 4 <br /> A'�'(lrflpJ Duration offlushing Minute 150 120 180 174 <br /> BI 5EMiAe MA BI test of sterility ©a Conformity; ❑T A non-conformity. <br /> Wi Conclusion: <br /> X,M LIV-20 A BI 5cMWR o ISO 11135:201410MV,5*, j=`ap SAL(10-6)44Y'Rj t-> TM MV--MTo <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 /> i <br /> f,)g if Prepator: <br /> Approval(QA): t Q Date <br /> i rM3TZ,Tc_M4 7qM FJ C ) <br /> Zhejiang Huanyi Sterilization Technology Co.,Ltd. (stamp) <br /> ffij:Riat. rlt IAI ITV RFfnRD 1/2 <br />