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Wuxi 7,hushi Sterilization factory
<br /> I-i le Number 1,71T,"MI-05-02 I t l� i'St ' Version/revision number 8/1
<br /> Original Record of BI Growth Test after sterilization
<br /> Custcw,er: Suzhou lenal'on13 Medical Innirumonts Co. , Ltd
<br /> Product Njwv: WHO\ \11111.13
<br /> 1-1'Ali Product Lot: INIIi (i•''2SI T (1•'6 035 Oidl (181 O?r' 0114 IIn 1.13 (11117 111118 (111(1, (1111.
<br /> 011'1 111"11 (11''65 01:11117 111;11111 01:5. 012M, 1113(1, II'_1(1:4, ll.;!;! f) {, n;!;4 , (1:'2 71 T 63M. (13031L
<br /> (C{(1"1�1ti Irtwl Ir'It 031111 I1't1•'1j (131'1 It'{I 1T ():{II, (1:i'"' t1'i''i II:4"1 113'':5 11:4''15 (13:'711. (I:S;i11,
<br /> otill 11(110 (Ill' I111'S 1(111' (11 '(1 UI''1' 1 IFI' (1.1"'(51 (41"7t 1 0121( 0.563 (1:,(11, 0.545,'
<br /> I''.ti1i (1"11- 11'�I(1 I! 'I 1 .� 1151`11 Ilii'll Il.i I (Ifillll l 1115(11► ; i (liifl'' Ittd13 o6o.1 Otm (N1(17s 1"418
<br /> .5
<br /> (15(1'11 f Ik.11l (1til l INilS D611 (1151:f 005 117(11 (1511:1 1)-5116, (170911T n710KIS (171' (1713 071.5, 07'0,
<br /> ! 5"( 05"'• 112115, 114;-., 11!1111, (11.111;,'1 i, Il!1(!a, II!)Qi, (111115, (1!115, Ikl(1!I, (111;5; �, (!!11'1'. 1 IIT'" wf! 1, (1!I •11,1, -
<br /> 1005, 1111:)• 1(1115, 141118, 1111!1 111:4!) IIo-I I (111- 1111, 111- 1111; 111'1 11"(1 11"''1I% 112311
<br /> 11:.!IVti Il301"07 1_1:5 I.-li. 1__I I22-1 (.-..., I_:18 I'._..!1 I_'tl
<br /> Test Itvm: 131 Growth Test Ret lrtl
<br /> J l
<br /> 1191 Test Date: 2021
<br /> 4 e Tent Sland;ard: ISO 11737~2:2009
<br /> J R5. Test Eoip;wni :
<br /> �L'WUMI i 'M Electric Constant temp Incubation Container, jw?P'Ej -141 Ultra-Clean-Bench.
<br /> }uIjit:3k!'i¢t3.1 Test Record and Result :
<br /> 1. tJti4ffl,4j Sample Prepared:fir >1criE'llll t°( t' ikKk Make Incubation Medium, Test Liquid
<br /> <u_cording to standards
<br /> 2. tZM,6jk, Test Method: Direct Inoculation,Viewand Record Everyday
<br /> Bl Growth Test Record Time Table
<br /> *kt14W-,Y� Strain: til :larlul'aclurer: bilNtif!l:�h i fiRl�`''J
<br /> Ikwi 1 Ius Of rophoeus ATCC9372 IIanl;zhnu future Biotech C55.,Ltd
<br /> Ill #tt U Lot. W. :200(52:1 _ _ �t iL�i 111 Nominal Population:1.7x 10'cfu/unit
<br /> Mi l't-j21k Incubation Temperature. -jr(1•)til) Culture time: 7davc
<br /> 1'#jl'i titrip \0(1-26#)
<br /> (1 13-) 1 2 a 4 ti 7 9 9 10 11 12 la {
<br /> 48 hour -
<br /> tliRhtntt• -
<br /> t 14 15 16 17 18 19 20 21 22 2:1 24 25 26
<br /> 21 hc;ur - - - - - - - - - - - -
<br /> 18 hour - - - - - - - - - - -
<br /> I68hour - - - - - - - - - -
<br /> M4: Result: (1-20#){L18ila 7EfAIK, 1;I I ftkt PA il- (261x) {LIft-A 24-48 11,llf ii-AA1:k
<br /> ,(('ter 168 hours Incuhation,The(1-25»)are no harterin growth.Positive(26#)hacteria growth well.
<br /> \ote: (-): represent negative, N.- k;j"Plfl.: represent positive
<br /> 0-Whit Detection conclusion:
<br /> i t (1'.Tc"t'1 E ti#fi iSO11135:2014 i4 fi1')x'=J:f( Z1F 15"11, 1,# rl�fl'J` `: Ill ( 1-2a•",) 7E1'ilf,:,
<br /> 1�1t'E��t��`i�tKi!t:t-:E�h7•, i�,1}l�#ll:�r;Tcifir'1;�,Tci#�^�r4, �.----�_
<br /> All testing Bis no bacteria growth except the positive control growth well.It show
<br /> lv4ltatster41iztiti of this Lot
<br /> is qualified.for this lot,the placement of Bland testare-based on ISO 11135:20 results in&6a d that.
<br /> rit, Test by: `�' UK Review by: ��`� Ilf s I I J(JI F jiOrt Dat4;,�'�
<br /> -;J „4i' Comppny st Imps
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