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IN F Wuxi 'Lhushi Sterilization Factory
<br />;V1Aq File Numbed S7.l.F/mi ©5 02 Version/revision number 8/1
<br />Original Record or BI Growth Test after sterilization
<br />1;P -17,4 Customer: Suzhou Lengfeng Medical Instruments Co.,Ltd
<br />Product Same*: K{ NADRON NEEDLES
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<br />tt*14H Test Item: BI. Growth Test Record -
<br />0A I-1 J91
<br />ecord0AI=11!11 'rest Date: 2019-2020
<br />WA44 Test Standard: ISO 11737-2:2009
<br />&MR29 Test Equipment:
<br />tL.Atlf ig1ftIM9 Electric Constant temp Incubation Container, MrPTIV- ~, Ultra -Clean -Bench.
<br />*R1ibK,4tAVR Test Record and Result:
<br />1. p 4191tl * Supple Prepared: r4 1 t€1 M1 Make Incubation Medium. Test Liquid
<br />according to standards
<br />2. }ft&ViM Test Method: Ajr#j#M, %H !MUR Direct Inoculation,Viewand Record Everyday
<br />`lJ#TAtzft) f01i�i>;iz BI Growth Test Record Time Table
<br />1'$1�l--Vh# -X Strain: )b11.MA BI Manufacturer: it #liil"11 # 1l Rlc:F7
<br />Bocillus Otrophoeus AICC9372 Hangzhou Future Biotech Co.,Ltd
<br />BI ' Lot \0.:200825 V&*jF Nominal Po ulation:l.7x 106cfu unit
<br />t;' MI Incubation Temperature: 36°C 11ilrrl Culture time: 7days
<br />WiMAA' Strip ho(1-264)
<br />U -lax) 12 3 4
<br />5 1
<br />6 7 8 9 1 10 it 12 13
<br />24 hour - - - -
<br />-
<br />- - - - - - -
<br />48 hour _ -
<br />- - - - - - -
<br />168hour - - - -
<br />- - - - - - - -
<br />(11-264) 14 15 16 17
<br />1 18
<br />19 20 21 22 23 24 25 26
<br />24 hour - - - -
<br />-
<br />- - - - - - - +
<br />48 hour - - - -
<br />-
<br />- - - - - - - +
<br />168hour
<br />24-48 �1�ihrFri i l l e.
<br />M11 Result: (1-250&J''a#C,)EIAt—K, fspdXtlt€ IT (264) &M#24-48
<br />Artor 168 hours inCIN11. ion, The (1-25x)are no bacteria growth. Positive(260bacteria growth well.
<br />Note: represent negative, (+): *4,1R1tt: represent positive
<br />&ffijthjQ Detection conclusion:
<br />i ftf 7�Ct 1 i i C iS011135:2014 1i?t.[iJ'J.z>kiill9 A**int, til #lnf )f T BI (1-25#) )EM.t k.
<br />r�it'tlatt�ial1 143, i�ll4►ltiklr`11t17ca,
<br />All testing Bis no bacteria growth except the positive control growth well. it sho ai4�Stcitit of this Lot
<br />is qualified. For this lot, the placement of BI and to atxha ed on 15011135;20Iir results m,aka that.
<br />Test by: ` '» i VIA Review by: ,j#,t M1 Il!', i i i NH mut
<br />- - i # Cam ny stamp
<br />I'a8,c�,of2
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