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XM %ri1 IE Iiii� gid11
<br />Original Record of BI Growth Test after sterilization
<br />M --?MN Customer: Suzhou Lengfeng Medical Instruments Co. Ltd
<br />Iia°n��f Product Name: IMADRON NEEDLE,
<br />1j-nanj1
<br />5 Product Lot:. O101,
<br />VVSZLF/STOl-05-02
<br />0114,
<br />0120, 0219 0225, 0302UT 0303 0304 030G 0311UT 031v 0312B 0317UT 0320
<br />038,033007 0407,0407B, 0410,0510,05159 0515131 0523 0525,0530q OGOG 060613p 0610 061011 0613 0618 0618131 0619
<br />0701., 0700,0709,070911,071% 0717B4O72010720130801 080111 0802.0811 0815 0820 082211 0822PT 08260906UT
<br />0909,0915,0915ATS,0915MZ,09157M,092OU1;0925 0930ATS 0930TH 10059 100511 1010t 101011 IOIOKT5 1010TH,
<br />V+ s File
<br />1205, 1207, 1210,
<br />Number
<br />1215UA, 1219, 1223 122511 1226 1230 1231, 0108 0110 0111 0115 0117-&1
<br />s
<br />0128,0130 0201,
<br />(1-13#)r14
<br />Version/revision`
<br />number
<br />e/1
<br />XM %ri1 IE Iiii� gid11
<br />Original Record of BI Growth Test after sterilization
<br />M --?MN Customer: Suzhou Lengfeng Medical Instruments Co. Ltd
<br />Iia°n��f Product Name: IMADRON NEEDLE,
<br />1j-nanj1
<br />5 Product Lot:. O101,
<br />rCtVAWn
<br />0114,
<br />0120, 0219 0225, 0302UT 0303 0304 030G 0311UT 031v 0312B 0317UT 0320
<br />038,033007 0407,0407B, 0410,0510,05159 0515131 0523 0525,0530q OGOG 060613p 0610 061011 0613 0618 0618131 0619
<br />0701., 0700,0709,070911,071% 0717B4O72010720130801 080111 0802.0811 0815 0820 082211 0822PT 08260906UT
<br />0909,0915,0915ATS,0915MZ,09157M,092OU1;0925 0930ATS 0930TH 10059 100511 1010t 101011 IOIOKT5 1010TH,
<br />1015KTS, 101711, 10282 1108, 110SUT, 11099 1109139 111311 1116 111B, 1120UT, 1121,11224 1122Tw 112211T 11239 1127
<br />1205, 1207, 1210,
<br />1212,
<br />1215UA, 1219, 1223 122511 1226 1230 1231, 0108 0110 0111 0115 0117-&1
<br />s
<br />0128,0130 0201,
<br />(1-13#)r14
<br />2
<br />3
<br />��9�j1� Test Item: BI Growth Test Record
<br />!9� Test Date: 2019-2020
<br />'+1J?7T Test Standard: ISO 11737-2:2009
<br />9vC Test Equipment:
<br />01A Ym A- rFro Electric Constant temp Incubation Container, ZJ A Ultra-Clean-Bench.
<br />��Jid a Test Record and Result:
<br />1. flhi1Caaa-* Sample Prepared:-is�.A Make Incubation Medium, Test Liquid
<br />according to standards
<br />2. Test Method: A&WAW 14-HU11Vidac Direct InoculationViewand Record Everyday
<br />&'iJ� Air Detection conclusion:
<br />RiA,F9ti�%,}.pTzCMffim%r � {�,T*HTiJ *I`$CfL77�W�-r�Ay1> futFil`1 Mn Ae BI (1-25#) `FG�1/1=
<br />ISOyl{,I7135:y,201-/4, ,ems,
<br />!�`•I$J�aT�9Jt��7I�tT7id�c� BI Growth Test Record Time Table
<br />rCtVAWn
<br />Strain: M TAXt'3cr'I'I'VIlaSW
<br />Bocillus 0trophoeus ATCC9372
<br />IMM&A BI Manufacturer: rjiij
<br />Hangzhou Future Biotech Co.,Ltd
<br />BI ft -9 Lot NO.:200825
<br />Nominal Population:1,7x 106cfu/unit
<br />jnrrr629[
<br />Incubation Temperature: 36°C
<br />fp-irfHI, Culture time: 7days
<br />Mt
<br />s
<br />Strip No (1-26#)
<br />(1-13#)r14
<br />2
<br />3
<br />4
<br />5
<br />6
<br />7
<br />8
<br />9
<br />10
<br />11
<br />12
<br />13
<br />24 hour
<br />-
<br />-
<br />-
<br />-
<br />-
<br />-
<br />-
<br />-
<br />-
<br />-
<br />-
<br />-
<br />48 hour168hour(11-26#)
<br />15
<br />16
<br />17
<br />18
<br />19
<br />20
<br />21
<br />22
<br />23
<br />24
<br />25
<br />26
<br />24 hour
<br />-
<br />-
<br />-
<br />-
<br />-
<br />-
<br />-
<br />-
<br />-
<br />-
<br />-
<br />+
<br />48 hour
<br />-
<br />-
<br />-
<br />-
<br />-
<br />-
<br />-
<br />-
<br />-
<br />-
<br />-
<br />-
<br />+
<br />168hour
<br />-
<br />-
<br />-
<br />-
<br />-
<br />-
<br />-
<br />-
<br />-
<br />-
<br />-
<br />-
<br />ffiVR Result: (1-25#)jtturFF9ENJ-K9 aatIngRift (26#) ip 24-4$ d�aJT Ike
<br />After 168 hours Incubation,The(1-25#)are no bacteria growth.Positive(26#)bacteria growth well.
<br />a Note:
<br />(-); *TRAft represent negative,
<br />(+); *2Mj1t:
<br />represent positive
<br />.%,
<br />All testing Bis no bacteria growth except the positive control growth well. It showy that sterili ti of this Lot
<br />,
<br />is qualified. For this lot, the placement of BI and to based on IS011135 20[Y7 e results indicated that.
<br />&IIIJ Test by: . i3 i, a � Review by:� lR q #jj Rlleport Dai J
<br />M* Companystamp`
<br />
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