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7C1 W-, Doc.No. HYST/QR2-25-06 <br />Certification of E0 Sterilization ��� Version No.: 0/B <br />IIUtiNYI sl}:uUZA110N ±�1t Q JW Effective date: 2021-(M05 <br />toMTt51F,M&Agtia:R <br />Sterility Testing of Bls Record <br />8 8 <br />Customer <br />Yiwu Limem tattoo equipment co., Ltd <br />5terMilizHat'iM date <br />2022-08-30 <br />STterMili2�ation batch <br />2022083005A <br />PCD _4M <br />X EPCD; ❑ IPCD <br />BI $lute_) <br />M0111 P11P <br />PCD Type <br />Manufacturer <br />Hangzhou fujie Disinfection Products Co., Ltd <br />Vp`i <br />#TM -M ATCC9372 <br />BI M-�— <br />Strain <br />Bacillus atrophaeus <br />Lot no. <br />20220615 <br />�R lqH <br />)EMI q, ani <br />eAIl A (PCs) <br />Test Item <br />Sterility testing <br />Test Qty. <br />20 <br />&MR9 <br />&A»'- <br />it <br />Test basis <br />ISO 11138-2:2017 <br />Test method <br />Direct immersion <br />Culture <br />(TSB) <br />201214 <br />medium��YVtAF <br />Medium batch <br />ArFaA <br />t.0a-tlul <br />Incubation temp. <br />35°C <br />I Incubation period <br />7 days <br />ft's agg <br />F WRHAAPMS Electric Constant -temp Incubation Container; <br />Apparatus <br />Wf V"P A Ultra -Clean Bench; <br />t9il Fi M <br />Test date <br />2022-08-31^2022-09-07 <br />JJaTIJtpi'ts 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 />— — — — — — — <br />— — — — — — — — — — — — <br />120h <br />— — — — — — — — <br />— — — — — — — — — — — — <br />144h <br />— — — — — — — — <br />— — — — — — — — — — — — <br />168h <br />— — — — — — — — <br />— — — — — — — — — — — — <br />BI# <br />Positive control Negative control <br />%Note: <br />24h + — <br />48h + — <br />72h + _ <br />„+„4t*,LMt%° „_„ is meaning <br />• "growth”. <br />no growth”; +„ Is meaning growth . <br />96h + —„ <br />12oh + — <br />144h + — <br />168h + — <br />�h f7muEmt-k: <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 />L p Conformity; ❑ T A non -conformity. <br />conclusion <br />*TkIllnspector: \� <br />Y_� Reviewer:y^Y <br />2. <br />Dat <br />Q Date: <br />:MjZ 7 QUALITY RECORD <br />2/2 <br />