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g, C, X !zl ® 91A L A X M <br />* q V+TVf Doc. No. HYST/QR2-25-06 <br />Certification of EEO Sterilization Version No.: 0/B <br />1111 Effective date: 1 2021-04-05 <br />Sterility Testing of Bis Record <br />pll 01 <br />Customer <br />Yiwu Limem tattoo equipment co., Ltd <br />STterMilizH on date <br />2022-08-26 <br />X_Miz*ation batch <br />2022082605A <br />PCD Af <br />X EPCD; ❑IPCD <br />BI <br />rOH'I FAMMA*fflPori ifPR <br />PCD Type <br />Manufacturer <br />Hangzhou Fujie Disinfection Products Co., Ltd <br />M#3PL7 <br />ATCC9372 <br />BI 90, <br />Strain <br />Bacillus atrophaeus <br />Lot no. <br />20220615 <br />49J31)5HEMT^2M <br />MMIR (PCs) <br />Test Item <br />Sterility testing <br />Test Qty. <br />20 <br />4AHM <br />t gq;rf_ <br />ATOR /A <br />Test basis <br />ISO 11138-2:2017 <br />Test method <br />Direct immersion <br />A. <br />Cul <br />_ <br />Q A r fA F (TSB) <br />>r <br />e medium <br />Culture <br />Medium batch201214 <br />t&.rraI <br />farrfil107 <br />Incubation temp. <br />35°C <br />I Incubation period <br />7days <br />*911WR <br />am t J9 Electric Constant -temp Incubation Container; <br />Apparatus <br />r -PO V' m Ultra -Clean Bench; <br />WM H M <br />Test date <br />2022-08-27^2022-09-03 <br />4-: BI incubation and examination record <br />BI# <br />1 2 3 4 5 6 7 <br />8 <br />9 10 it 12 13 14 15 16 17 18 19 20 <br />24h- <br />- - - - - - <br />- <br />- - - - - - - - - - - - <br />48h- <br />- - - - - - <br />- <br />- - - - - - - - - - - - <br />72h- <br />- - - - - - <br />- <br />- - - - - - - - - - - - <br />96h- <br />- - - - - - <br />- <br />- - - - - - - - - - - - <br />120h <br />- - - - - - - <br />- <br />- - - - - - - - - - - - <br />144h <br />- - - - - - - <br />- <br />- - - - - - - - - - - - <br />168h- <br />- - - - - - <br />- <br />- - - - - - - - - - - - <br />BI# <br />Positive control Negative control <br />% Note: <br />is meaning <br />no growth"; "+" is meaning "growth". <br />24h + - <br />48h + - <br />72h + - <br />96h + - <br />120h + - <br />144h + - <br />168h + - <br />��' <br />There are no growth with testing items and <br />negative control, while positive control is growth well after specific Incubation <br />Result <br />period. <br />A Conformity; El T, A 4 non <br />-conformity. <br />Conclusion <br />X99 Inspector: )4M Q M <br />AeA Reviewer: Q <br />f$#i� QUALITY RECORn 2/2 <br />