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` t p� k1T tltl Doc. No. HYST/QRZ-75-06 <br /> �'I� �1 %\ [fiTa "I' 9�6l, NGhF><17Yc i-i r$#Ctj Version No. : 0/8 <br /> MAW F11MIA 1.,Y Certification of EO Sterilization <br /> 'r 1R H WI Effective date, 2021.0405 <br /> ACi ! i1# irfhlrci #aNEA <br /> Original Record of BI Growth Test after sterilization <br /> ;s )' 111flT Customer : ilfiY1 X 1i / i1fN t] t7 � 7 YIWU CITY SOLONG IMP&EXP CO LTD <br /> i� Product Name : } — Uk41 Tattoo Needle Cartridge <br /> i, I'M lit li Product Lot : 2021/06 <br /> t.). X it K Test Quantity : _ 20Pieces l 'R114 p Test Item : BI Growth Test Record <br /> A M p #11 Sterilization date : 2021-06-23 Atilt g Sterilization Lot. : 2021062302A <br /> 6*1 Test Date: 2021-06-242021-07-01 <br /> 111 #144 Test Standard : IS011138-2:2017 <br /> MN&Rul Test Equipment : <br /> LINtri4h,1Y'r )rMElectric Constant-temp incubation Container , OtIf -EW Ultra-Clean-Bench , <br /> K1-'Aia3R4 APR Test Record and Result : <br /> 1Ait' an71EtiW Sample Prepared : i irtf€iliti ; flf . ii>A Make Incubation Medium , Test Liquid according <br /> to standards <br /> 2 , lU'.11, M Test Method : Atli?OMP X p JQWL t Direct Inoculation,View and Record Everyday <br /> /13 7 /1'YzC ltt fn) id BI Growth Test Record Time Table <br /> M ±-- V17'i'Ac Strain : 4MPrf(1ffffi ATCC9372 @iMA BI Manufacturer: fnl'tih 6@ifi )fjn 1 1� �� 7 <br /> Bacillus atrophaeus ATCC9372 Hangzhou Future Disinfection Products Limited Company <br /> BI Lot No : 20210302 VIRE I Nominal Population : 2.2x106 cfu/unit <br /> MAMA Incubation Temperature: 35 'C 1$ EIri (BI Culture time : 7days <br /> f 1 ti ki Strip No ( 1-2011 ) <br /> ( 1—lOJf ) 1 2 3 4 5 6 7 8 9 10 <br /> 24 hour <br /> 48 hour <br /> 168 hour — <br /> ( 11-2011 ) 11 12 13 14 15 16 17 18 19 20 <br /> 24 hour <br /> 48 hour — — — — — <br /> + <br /> 168 hour <br /> MA Result : ( 1-1911 ) 7t1f rii )Mttc , 1111 r IPAW ( 20x1 ) iVarF 242J aMnl ' fliEo <br /> After 168 hours Incubation, The (1-1911) are no bacteria growth, Positive(20k) bacteria growth well. <br /> it Note : ( - ) : *;J'% 9Att represent negative, ( + ) : NirI1H ('1 represent positive. <br /> &NJ Ail Detection conclusions <br /> ii$:WXX#Jrh )`itiIS011135 :201417fi (r] �c Ji/iL � AJQ � , f Jp (17f Fi B1 ( 1- 198 ) <br /> I�[1t'� xJHi; '� fuii� � tt � #f , iiEaA �itk7% At'�JP'` s�, At"$ A #� . <br /> all testing Bls no bacteria growth except the positive control growtLReport <br /> at sterilization <br /> of this Lot is qualified. For this Iot,The placement of BI and test are5 :2:114 , The <br /> results indkated that. <br /> &&i Test by: JUA Review by: fR , <br /> id'R 212 <br /> QUALITY RECORD <br />