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DV 11f l-rV'tt.*fl' NIF Wu,ti %hushi Steri l i at' l- --
<br />ton nctory
<br />�Ct'� jt Pile Number S7,l.F/ST01_OSOZ /,{� /A&9- Version/revision number
<br />-Tc itrd l�fi#�T�fiiEl�a#��i��
<br />IWWTRWIc 14R1(a7iE!JA* BI Growth Test Record Time Table
<br />Original Record of Ill Growth Test after sterilization
<br />BI #f -
<br />Customer:_ Suzhou Lengfeng Medical Instruments Co ltd
<br />MIMI
<br />►{`,i', Product Name: KWADRON \I:I?Ul,l-'
<br />1'6", n R - Product Lot : f►(Mi. 0 "'til T, 0211 0'3�, fl',0, Ox 1. Oxy' WS I I () 1431 0107 0104 o 110
<br />01 I I
<br />0119 0120 O1'26 01266 0126131 0 2 01 'x 01 i0 p"0'i a°"'' 02 "i 02'"r, 02271T 0'101 O30tIT
<br />030'p T1, 0306, 031. 031(A T. 03121T, X113, 0311-41, 0,116. 03'''' 03123 0:v-1-1, (1'3" . 0"i 'f, O i ',1 1
<br />f►1 iO�
<br />O.i,il, 0332, 0i01, t}1px 0113 (}tt 0.116QUA nl'>u r ►t''^ 0-120A. tit T. ctt'x ►,,i n ctl
<br />>,1,
<br />().5W. 0-507, (fl (► 0.51.'_1 :1 051 hl T 0-52 0:521 Will. WOWS, S Ot42W13WWI 0605 0(-07 (Niftli
<br />(IfdM,l
<br />01104111 0110 111111 W,17 (Hi1801;23 W21-1 071)1 0703 (17(16 07(0.11T O7 OK ti 071' 0713"071.5,
<br />07"0
<br />07'.1_1, 07 15, 0807. 08 15 01A1 0'10''1 A (0.103(005.1(Yto(; 05101 (X1(0.) 09111 1 V1191A. W22, (MA 222111„`
<br />1007 101.5 1016 101(3 1019) 1030 11W 1109t 1111 111,5 HIM. 11111. 120 I I"''M/ I1 :31 1
<br />11 4
<br />II2%Ts, 1130, 1207, 1215 1216; 1221 1"-2•1 1225 1228 1229 12'11
<br />168hour
<br />OMNH Test Item: BI Growth Test Record
<br />Result: (1 GIft)($NTT (264) (:i MA 2:1-48
<br />After 168 hours lncubation, The(I--25tt)are no bacteria growth. Posit ivc(269)bucteria growth well.
<br />#xX H 11E1 Test Date: 2021
<br />(-): t%1:IsIlrE represent negative, 0): t1P*Rltl:: represent positive
<br />$ J%F i% Test Standard: ISO 11737-2:2009
<br />Test Equipment:
<br />*1AN MfMM Electric Constant temp Incubation Container, jrp-l:f�f; Ultra -Clean -Bench.
<br />Test. Record and Result:
<br />I. PkiANS;AA Sample Prepared: # ;4$11*1111M iieill( Make Incubation Medium, Test Liquid
<br />according to standards
<br />1°ffl;6iL Test Method: AM41#&, *qXWEA Direct Inoculation,View and Record Eve ryday
<br />*Mfr iQ Detection conclusion:
<br />i%#tl?x7E1#d(ilili # 150111:15:2014 BI (1-254) VWL-K,
<br />i� 1 f �' �•11!i�'ii.'1111'� �L K I�: �>•. 1� 19) �#Ii; fk 7� lei r�,5i, 7F til n �ti4 • ..-
<br />All testing Bis no bacteria growth except the positive control growth well. It sho �attet'x1i t of this Lot
<br />Is qualified. For this lot, the placement of BI and to R
<br />d on IS0111351.20 T results t) a d that.
<br />4`f i1M Test by: '1 ,1 f# Review by: iii S'. F1101 IRort pat
<br />Ila Cam . ny stamp
<br />_'__. Page2of2
<br />IWWTRWIc 14R1(a7iE!JA* BI Growth Test Record Time Table
<br />i}"�l iJ11'i' Strain:1t�, k"lr9rriil '. �ll' f'i 11011-A BI Manufacturer: RM&1#04W [ .-)
<br />Bocillus Otrophoeus ATCC9372 flangzhou Future Biotech Co.,Ltd
<br />BI #f -
<br />Lot NO. :200825 4fMR Nominal Population:1.7x 10"cfu/unit
<br />MIMI
<br />Incubation Temperature: 36°C JllnlPtn Culture time: 7days
<br />4i 4; Strip No(1-2613)
<br />(1-134)
<br />1 2 3 4 5 6 7 8 9 10 11 12 13
<br />24 hour
<br />- - - - - - - - - - - - -
<br />48 hour
<br />- - - - - - - - - - - - -
<br />168hour
<br />- - - - - - - - - - - - -
<br />(11-26#)
<br />14 15 16 17 18 19 20 21 22 23 24 25 26
<br />24 hour
<br />- - - - - - - - - - - -
<br />48 hour
<br />- - - - - - - - - - -
<br />168hour
<br />Result: (1 GIft)($NTT (264) (:i MA 2:1-48
<br />After 168 hours lncubation, The(I--25tt)are no bacteria growth. Posit ivc(269)bucteria growth well.
<br />r1 Note:
<br />(-): t%1:IsIlrE represent negative, 0): t1P*Rltl:: represent positive
<br />*Mfr iQ Detection conclusion:
<br />i%#tl?x7E1#d(ilili # 150111:15:2014 BI (1-254) VWL-K,
<br />i� 1 f �' �•11!i�'ii.'1111'� �L K I�: �>•. 1� 19) �#Ii; fk 7� lei r�,5i, 7F til n �ti4 • ..-
<br />All testing Bis no bacteria growth except the positive control growth well. It sho �attet'x1i t of this Lot
<br />Is qualified. For this lot, the placement of BI and to R
<br />d on IS0111351.20 T results t) a d that.
<br />4`f i1M Test by: '1 ,1 f# Review by: iii S'. F1101 IRort pat
<br />Ila Cam . ny stamp
<br />_'__. Page2of2
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