|
�U W4 114 ir. vv v , i., a wu ,
<br /> 7C4 a s File Number SZLF/STOl-05-02 W,*/4ftA 5 Version/revision number B/1
<br /> Original Record of BI Growth Test after sterilization
<br /> 1 ' -A Customer : Suzhou Lengfeng Medical Instruments Co. , Ltd
<br /> >� au Product Name : KWADRONNEEDLES
<br /> f nu "5 Product Lot : 0101 0114 0120 0219 0225 0302UT 0303 0304 0306 0311UT 0312 031211 0317UT 0320
<br /> 0328 03301JT 0407, 0407B, 0410 0510 0515 0515132 0523 0526 05309 06G610606139 0610 061011 0613 06187 1811 0619
<br /> 0701, 0705, 0709, 070911, 0712, 071713, 0720, 072OB5080130801B, 0802 0811 0815 0820 082211 08221yT 0826 0906UT
<br /> 0909, 0916 0915ATS, 0916MZ, 09157M 0920UT, 0926 0930ATS 09307H 1005 1005B2 1010, 1010111 1010KTS 1010TK
<br /> 1016KTSP 101711 1028, 1108, 1108= 1109 1109139 1113BI 111.51 111139 1120UT 1121 1122 1122TW 1122UT 11235 1127
<br /> 1205 1207 1210 1212t 1215UAt 1219, 12239 122511 1226 1230 1231 01089 0110, 0111s 01159 0117-M 0128 0130 0201
<br /> 0203 0223 0226 0229 0305 0306 0312 0322 0325 0406 0416 0423 0428 0506 0508 0512 0516 0516Y 0520 0521 0522
<br /> 0529, 0530, 0603, 060890612, 0617, 062690627UA, 0701, 0702, 0703, 0706 07079 0710 0718 0719p 0720 0722 07239 0726
<br /> 0730 0807 0810 0817 0818 0901 0902 0904 0906 0906 0914 0915 0916 0917 0921 0923 0926 1006, 1007 1008 1009
<br /> 1010, 1011710121101311017, 1021, 1022, 1023 1024 1030 1104 1109 1111 1112 1113 1116TM7 1120 1121t 1123 1124
<br /> 1130, 1201 , 1204KTS, 1206, 1207, 1208 1210TM, 1211 12159 1218TH 1219TH 1221 1222 1224 12259 1228 1231 FD728
<br /> *?A�JrMi H Test Item : BI Growth Test Record
<br /> & A9 Q M Test Date : 2019 -2020
<br /> i �J71 Test Standard : ISO 11737-2 : 2009
<br /> 1 +i �j (X Test Equipment :
<br /> * PWAXI'M Electric Constant temp Incubation Container, kffi*z41= a UItra-Clean-Bench.
<br /> 4$99i'u3K4 pj Test Record and Result :
<br /> 1 . 4MAP69* Sample Prepared : 4YNUJ ', OMIM AN Make Incubation Medium , Test Liquid
<br /> according to standards
<br /> 2 . *Ag )iM Test Method : A #Mt * H fig, jaJR Direct Inoculation,View and Record Everyday
<br /> tWINTVl * Mflit RUB:R* BI Growth Test Record Time Table
<br /> jA9;ft#A Strain : ViVffMMiff, 5 #VTNfn 1filliall BI Manufacturer : nJil A# PiI �`7
<br /> Bocillus Otrophoeus ATCC9372 Hangzhou Future Biotech Co. , Ltd
<br /> BI 1; Lot N0. : 200825 Nominal Population:1.7x 106cfu/unit
<br /> Incubation Temperature : 36°C X40%f1f7 Culture time : 7days
<br /> M W� Strip No (1-26#)
<br /> 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 /> AA Result : (I-25#) 1t4tprrF)Ef1-* , JSp { RRI& ( 26# ) 3'E*rr24-48iJ*NAfin ;hMlt Ea
<br /> After 168 hours Incubation, The (1-25#) are no bacteria growth. Positive (26#) bacteria growth well.
<br /> Note : (-) : *TP)jJ1 represent negative, (+) ; ;tb/'r% Mit : represent positive
<br /> *Pljffiit Detection conclusion :
<br /> -RiA7ft7a�}nXffipM )V ISO11135 ::52014 {u,7 (fT;j (jY j��'41{��1 , * grmM aX BI ( 1-25# ) )Effijt t- ,
<br /> MIA �S/ J ritt �=U1 �3:.� G¢� > 1JL �� �7N.��l��� PP II� AG TT3e
<br /> All testing Bis no bacteria growth except the positive control growth well. It shRopportDat
<br /> � tet�i, tt of this Lot
<br /> is qualified. For this lot, the placement of Bland to ased on IS011135:2results Ir�tca d that,
<br /> �i9 Test by: i�C ri1 Review by: " #�C , p #(1] l
<br /> me Companystampy � y'
<br />
|