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%iMFP 3cf"F Wuxi Zhushi Sterilization Factory <br /> �Cft -q File Number SZLF/ST01_05-02 1 Version/revision number I B/1 <br /> T N±VA4'W T*KM*AgiZA <br /> Original Record of BI Growth Test after sterilization <br /> # ' Customer: Suzhou Lengfeng Medical Instruments Co. , Ltd <br /> r'6c as;�;# Product Name: NEEDLES <br /> Y�cp"Utk� Product Lot: 1215 1216 1224 1228 1229 <br /> *MORA Test Quantity: 158CTNS &AM,H Test Item: BI Growth Test Record <br /> X-NQ M Sterilization date: 2021-01-05 X-ffifft-g- Sterilization Lot: 20210105 <br /> &;(qQ M Test Date: 2021-01-06- 2021-01-13 <br /> ,,_,l►Jt��* Test Standard: ISO 11737-2:2009 <br /> &AgfX,99 Test Equipment: <br /> *1Aj1--UPm*rF*ff Electric Constant temp Incubation Container, V- Zf A UItra-Clean-Bench. <br /> 11�1iZ —r� �c Test Record and Result: <br /> 1. DEU4 u4* Sample Prepared:V#T $11-* 4*, iAA Make Incubation Medium, Test Liquid <br /> according to standards <br /> 2. ftgq; 'A Test Method: 149M#&, %H R 9,iZA Direct Inoculation,View and Record Everyday <br /> AaT1J�cl�%Zc BI Growth Test Record Time Table <br /> *J-:ft A Strain: 'rte '33 1 i $�1z5--A BI Manufacturer: <br /> Bocillus Otrophoeus ATCC9372 Hangzhou Future Biotech Co. ,Ltd <br /> BI W� Lot NO. :200825 Nominal Population:1.7x 106cfu/unit <br /> t, 1n Incubation Temperature: 36°C i4rFRIN Culture time: 7days <br /> f -ig4� Strip No(1-26#) <br /> (1-13#) 1 2 3 4 5 6 7 8 9 10 11 12 13 <br /> 24 hour - - - - - - - - - - - - - <br /> 48 hour - - - - - - - - - - - - - <br /> 168hour - - - - - - - - - - - - - <br /> (11-26#) 14 15 16 17 18 19 20 21 22 23 24 25 26 <br /> 24 hour - - - - - - - - - - - - + <br /> 48 hour - - - - - - - - - - - - + <br /> 168hour - - - - - - - - - - - - + <br /> MT, Result: (1-25#)�E*rr ' Ec, PMAIRRV (26#) aXrF 24-48 /1,.fr11A;'f't-rco <br /> After 168 hours Incubation,The(I-25#)are no bacteria growth.Positive(26#)b.scteria growth well. <br /> { Note: (-) : *,TRJjt represent negative, (+): 7T { : represent positive <br /> A1j lit Detection conclusion: <br /> iAa&Xf-lf t M IS011135:2014 U*M- inrrjRM-MA BI (1-25#) )Etftic, <br /> All testing Bis no bacteria growth except the positive control growth well.It sho a�, i of this Lot <br /> is qualified.For this lot,the placement of BI and to aM based on IS011135:20 T yresults irf ' a d that. <br /> 9 Test by: tt <-; °j# Review b l #Bc q Q M Dat <br /> Com pattamp <br /> ✓'y Page 2 of 2 <br />