Laserfiche WebLink
7L+'tV''Doc.No. HYST/QR2-25-06 <br /> �I <br /> Version No.: 0/B <br /> CertificationUhof EO`ISt7e7riClization0 <br /> 1 HIAM9 S110.17.6nON ±-O B M Effective date: 2021-04-05 <br /> lR A s Report no.:2022090120 <br /> 4 P Customer Yiwu Limem tattoo equipment co.,Ltd <br /> l A4'L i',Product name ,Ni,�' Specification W Batch J�jk Quantity <br /> 67( fSC �1' tattoo cartridge needle 2700 box E0822 27 T <br /> XM S4,Sterilization mode FTtZ,A EO gas XMV_Aps Sterilizer no. HYST/ST-05 <br /> TC Q Sterilization date 2022-08-23 k ' Sterilization batch 2022082305A <br /> Requirements �fVF'(t Actual <br /> k��� Sterilization parameters <br /> Unit b Validated Min. Max. Min. Max. <br /> 1"na7 � lJi)IJ Loading tem.priorto preconditioning °C >_10.0 10.0 / 30.1 <br /> NAOMI Preconditioning temperature °C 48.0 44.0 52.0 46.3 50.1 <br /> f,rAA3V_9fA Preconditioning RH %RH 55.0 30.0 80.0 48.8 62.6 <br /> Preconditioning time Minute 360 340 380 360 <br /> 11, I ]Transfer time Minute 560 / 60 / <br /> RA S�_Initial evacuation depth kPa -24.0 -26.0 -22.0 -25.3 <br /> tf!�31-519 Evacuation rate kPa/min 154.0 / 4.0 2.5 <br /> UR.[ a fq Pressure holding time Minute 20 10 30 20 <br /> WEIE)JIEft Leak test pressure rise z�,P kPa 451.0 / 1.0 0.5 <br /> (9­itM) Moisture injection time(if used) Minute 10 10 <br /> EO EO injection rate kPa/min 0.5 0.3 0.7 0.6 <br /> XMPJAX EO injection weight kg 20.0 19.5 20.5 20.0 <br /> 5:24,8 E:12.2 <br /> EO Pressure rising after EO injection �P kPa z31.0 31.0 / <br /> 0 P:37.0 <br /> EO MA EO concentration commence of exposure(theorical) mg/I 600 400 800 603 <br /> XMIm)JE Exposure temperature °C 52.0 49.0 55.0 50.5 54.2 <br /> X-M&S-Exposure RH %RH 55.0 30.0 80.0 52.5 67.2 <br /> kM0117 Exposure time Minute 720 700 740 720 <br /> IME MM Post-evacuation depth kPa -15.0 -17.0 -13.0 -15.1 -14.9 <br /> 3t`4(I,)J inflation pressure kPa -5.0 -7.0 -3.0 -5.1 -4.9 <br /> Alt >M(Number ofrepetition Times >_4.0 4 / 4 <br /> WllflI•ul Duration of flushing Minute 150 120 180 1 144 <br /> Ell 5 MI AY-,BI test of sterility ;<A Conformity; ❑T o non-conformity. <br /> Mit conclusion: <br /> �kSLif9A,tM BI ISO 11135:2014 fATA�k7c*, jean SAL(10-6)T49I1119Z-, Tcf f S�if fcTTo <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 /> �Jy <br /> yip l� Prepator: Dat p, / > <br /> I �L <br /> r <br /> Approval(QA): Q Daft. <br /> - <br /> Y�lT7S�Z��C� ����2�� (�) <br /> Zhejiang Huanyi Sterilization Technology Co.,Ltd. (stamp) <br /> f�i 2 VA QUALITY RECORD 1/2 <br />