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7 � q 7Z q:M �• Doc. No. HYST/QR2-25-06 <br />R <br />U l` JYf ; Version No.: 0/B <br />uuws,.rn:� u.iznnox Certification of EO Sterilization ¢ H Aq Effective date: 2021-04-05 <br />Sterility Testing of Bis Record <br />IP 1801 <br />Customer <br />Yiwu Limem tattoo equipment co., Ltd <br />� <br />-9-1 <br />Str��ilizat n date <br />2022-08-26 <br />on batch <br />XMA <br />2022082605A <br />PCD <br />X EPCD; ❑ IPCD <br />13IgiJ)'l'�%F��aA���4�� <br />PCD Type <br />Manufacturer <br />Hangzhou Fujie Disinfection Products Co., Ltd <br />M# <br />ATCC9372 <br />BI A-9-3 <br />Strain <br />Bacillus atrophaeus <br />Lot no. <br />20220615 <br />fARMH <br />�E-Mr2ell <br />&NOWS (PCS) <br />Test Item <br />Sterility testing <br />Test Qty. <br />20 <br />tAl M4VN <br />i&CM <br />MWWA <br />Test basis <br />15011138-2:2017 <br />Test method <br />Direct immersion <br />AI�4medium <br />JAA9t�.��%&'(�lA-4 (TSB) <br />M d _AW <br />201214 <br />ture <br />batch <br />AprrAfA <br />A.rr�013 <br />35`C <br />7 days <br />Y <br />Incubation temp. <br />Incubation period <br />ft'AA1'i)Cf <br />*,%1_ff ffifn-j Electric Constant -temp Incubation Container; <br />Apparatus <br />I,bfIT <br />Q Ultra -Clean Bench; <br />42"M H M <br />Test date <br />2022-08-27^2022-09-03 <br />�%1#aTAF��LiG BI incubation and examination record <br />BI# <br />1 2 3 4 5 6 7 8 <br />9 10 11 12 13 14 15 16 17 18 19 20 <br />24h— <br />— — — — — — — <br />— — — — — — — — — — — — <br />48h— <br />— — — — — — — <br />— — — — — — — — — — — — <br />72h— <br />— — — — — — — <br />— — — — — — — — — — — — <br />96h— <br />— I — — — — — — <br />— — — — — — — — — — — — <br />120h <br />— — — — — — — — <br />— — — — — — — — — — — — <br />144h <br />— — — — — I — — — <br />— — — — I — I — I — — — — — — <br />168h <br />— — — — — — — — <br />— — — — — — — — — — — — <br />BI# <br />Positive control Negative control <br />Note: <br />24h + — <br />48h + — <br />72h + <br />is meaning <br />no growth"; "+" is meaning "growth". <br />96h + — <br />120h + — <br />144h + — <br />168h + — <br />M A <br />Result <br />There are no growth with testing items and negative control, while positive control is growth well after specific Incubation <br />period. <br />^ A 4 Conformity; El T A non -conformity. <br />Conclusion <br />Gln <br />t1, 9q Inspector: depa <br />Reviewer: <br />d . <br />QMD:t ) <br />Date: , ' ; <br />J 1:R1Z-• Q11A1.ITY RECORD 2/2 <br />