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k�� ��1�a r'•�l1-lE��$�iJi�s�
<br />Original Record of BI Growth Test after sterilization
<br />�XM/N Customer: Suzhou Lengfeng ]Medical Instruments Co.,Ltd
<br />i `uu U/ Product Name: KWADRONNEEDLES
<br />467105
<br />uzus, UL'LS, ULL6, U3'G8, u:w5, uays, ustz, 0322, u325, 04UG 0416 0423 042
<br />Product Lot: 0101,
<br />r°ro-�t'l #il
<br />0114,0120t
<br />0219t 0225,0302UT 03031 0304w 0306q 0311UT 0312 0312BO 0317UT 0320
<br />0328, 033013T 0407 0407B, 04107
<br />0510, 0515
<br />051513 0523.0525,0530 OGOG 060613 0610
<br />T m -v
<br />File
<br />Number
<br />SZLF/ST01'05-02
<br />Strip No(1-26#)
<br />(1-13#)[14
<br />hk*/ft'jC
<br />5
<br />Version/revision
<br />number
<br />B/1
<br />k�� ��1�a r'•�l1-lE��$�iJi�s�
<br />Original Record of BI Growth Test after sterilization
<br />�XM/N Customer: Suzhou Lengfeng ]Medical Instruments Co.,Ltd
<br />i `uu U/ Product Name: KWADRONNEEDLES
<br />467105
<br />uzus, UL'LS, ULL6, U3'G8, u:w5, uays, ustz, 0322, u325, 04UG 0416 0423 042
<br />Product Lot: 0101,
<br />r°ro-�t'l #il
<br />0114,0120t
<br />0219t 0225,0302UT 03031 0304w 0306q 0311UT 0312 0312BO 0317UT 0320
<br />0328, 033013T 0407 0407B, 04107
<br />0510, 0515
<br />051513 0523.0525,0530 OGOG 060613 0610
<br />061013,0613,0618,061813 0619
<br />0701,0705,0709.0709B4O712,071713, 0720, 0720131 0801 080113 08021081L 0815 0820 0822130822PT
<br />0515 0516 0520 0521 0522,
<br />082E O906UT
<br />Strip No(1-26#)
<br />(1-13#)[14
<br />0909,0915,0915ATS,0915MZ,0915TM,09201JT 0925 0930M 0930TH,
<br />1005 1005131 1010 101013 1010KTS
<br />3
<br />101OTNI
<br />5
<br />0627UA, 07013 0702, 0703 0706 0707 0710
<br />1015KTSI
<br />0720 0722 0723Y OU96
<br />101713 10289
<br />1108,
<br />1108UT,
<br />1109,
<br />12
<br />110913,
<br />1113B.
<br />1115
<br />111111
<br />0905 0906 0914t
<br />1120UT, 1121,11225
<br />1122TW
<br />1122UT
<br />1123 1127
<br />1205, 1207,
<br />1210,
<br />1201,1204KTS,1205
<br />12122
<br />1215UA,
<br />1219. 1223 IMBt
<br />1226 12302
<br />1231
<br />0108.0110 0111 0115 0117 -AL
<br />0128t 01309 0201
<br />1+$i)ti1BJ: Fi
<br />BI Growth Test Record Time Table
<br />r°ro-�t'l #il
<br />Strain: u lF 1 �3�C I i'�I]Yi
<br />Bocillus Otrophoeus ATCC9372
<br />flf fj BI Manufacturer:
<br />Hangzhou Future Biotech Co.,Ltd
<br />BI S Lot N0.:200825
<br />v Nominal Populalion:1.7x 10'efu/unit
<br />&A Incubation Temperature: 36°C
<br />AM III Culture time: 7days
<br />8 0506 0508 0512
<br />0515 0516 0520 0521 0522,
<br />052970530,0603,0608,
<br />Strip No(1-26#)
<br />(1-13#)[14
<br />06129
<br />0617,
<br />3
<br />06262
<br />5
<br />0627UA, 07013 0702, 0703 0706 0707 0710
<br />0718 0719
<br />0720 0722 0723Y OU96
<br />0730,0807,081090817,0818,09014090290904
<br />9
<br />10
<br />11
<br />12
<br />13
<br />24 hour48
<br />0905 0906 0914t
<br />09157
<br />0916s
<br />0917
<br />09219
<br />0923 09264 1006v 1007 1008 1009
<br />1010,1011,1012,10139101791021
<br />11307
<br />1201,1204KTS,1205
<br />1022,1023,1024,1030,1104,11094
<br />120711208 l2lOnI2 1211 12151121bvMo
<br />1111 1112 1113 1116TH 1120q 1121 1123 1124
<br />1219TTI 1221 1222 1229 1225 122ST 1231 F0728
<br />Test Item: BI Growth Test Record
<br />Test Date: 2019-2020
<br />tjImAgVTin fest Standard: ISO 11737-2:2009
<br />ft VA :5 Test Equipment:
<br />*,Af PNMElectric Constant temp Incubation Container, 91 Z I Y A UItra-Glean-Bench.
<br />WN-214POR Test Record and Result:
<br />1. #h11\•IPnyt;{�* Sample Prepared:**$ M-$IJWtq;im, 1AA Make Incubation Medium, Test Liquid
<br />according to standards
<br />2. &MIUM Test Method: -11NI M, * H ni.4.eiEA Direct Inoculation,View and Record Everyday
<br />OM Aid Detection conclusion:
<br />iAft%1.TtMV�RIS011135:2014�7f�1�1��tTv`Ci�j��+1JIJ, BI (1-25#) --VGM
<br />BI Growth Test Record Time Table
<br />r°ro-�t'l #il
<br />Strain: u lF 1 �3�C I i'�I]Yi
<br />Bocillus Otrophoeus ATCC9372
<br />flf fj BI Manufacturer:
<br />Hangzhou Future Biotech Co.,Ltd
<br />BI S Lot N0.:200825
<br />v Nominal Populalion:1.7x 10'efu/unit
<br />&A Incubation Temperature: 36°C
<br />AM III Culture time: 7days
<br />M1'iWf
<br />Strip No(1-26#)
<br />(1-13#)[14
<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 hour48
<br />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 />48 hour
<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 />nV Result:
<br />After 168
<br />fflflRj'Jl t (26#) ;04rf 24-48 /IN R r 'M!�*.
<br />hours Incubation,The(1-25#)are no bacteria growth.Positive(26#)bacteria growth well.
<br />7I Not-e-io-He
<br />*jRVAf1 represent negative,
<br />(+). �K;Nfjt:
<br />represent positive
<br />�41��/Jn:��W ��:. l-�LF,YTf 171i��fY7N,T%��1 Pn%LId7 �G 9tie ate.•""�.
<br />All testing His ti
<br />f1"-.%,
<br />no bacteria growth except the positive control growth well It show "I I . %l. of this Lot
<br />is qualified. For this lot, the placement of BI and to are-baseon resu
<br />d IS011135:209`/sT J�ltsirftca d that.
<br />.
<br />9 Test by: <7 ; s' MA Review by: ��, � * H Ad [>tte�ert DatM �
<br />Corn ar tam
<br />
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