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ARCA RB PH 9 LAB ARK OOH A SER T 6 MECH “CAIZ) v= “CAL13) 23GB/T 18279.2—2015/1SO/TS 11135-2:2008 RAZ FHCHAMAMAEDSAAM ARE TB RET ERASE TEAR u fn "1 n=10 n=i8 | nae 4=0 | m=20 FRA HSK REESE Be 12) HR 2 My, REM): 10+18 eee BES SESE yA sh BERN y, 0.2, JD I eB PAS SIR AT eR 2) HEU BEN TAY po fis Xe £19) =14X0.21= 2.94 3X 0.17 =3.91 ws = 340,227.48 eyGB/T 18279.2—2015/1S0/TS 11135-2.2008 Bs =55X0.2. ps=65X0=0 PE BIE AE He OE ST fe ps Bo prt pat ps tpt ps tps = 2.943.917 48+9,0-411,0+0=34,33 HH D fF {ED 3 4 a aaa rig EM No= ah EHH, x10") Dac=D+2/V 2.302 6 577 2a.) 5) HERE D AYES CD) AY 95.6 BEA TAY OY FM RAE TS ERR) 4 fi RRM: [es- 10)? x4 ot 2,991 a+ [40-19 x8 oS St 5.207 9 aIxTE mix20 a= 0.254 | G0~28)*x12 6.118 7] + [60 40)* x16 PONS. = 3,368 4] [cc0—s00* x20 FF | inex a=0.25% 18,180 8=4.545 2 2.302 6 T 0.577 22-FInd X10) 2008" 0.577 22-F11-513. =4,545 2X (0.190 45)? 4.545 20,362 7 =0.164 9 Dai=D+2/V =6.54+2-/0,164 9 =6.54+2%0.406 1= 7.35 vast] =4.545 2 ( 4.3.3 RB3}0H ti —4E A Stumbo Murphy Cochran ji: (SMCP) Stumbo Murphy Cochran 2&7 JH SAAB2> FH PE W648 th ABR at D fA. 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Fi FA YT He ABBE a) BRERA: Db) PPR Z fe AY ML Be Se CBR PAR BR A Fl Sh) AL FE ©) AEE MBA RRs RR MAR ACE WHE MI TEP 0 AL.GB/T 18279.2—2015/1SO/TS 11135-2;2008 Sex C1] GB/T 16886.7 BEF aR MAI 7 St AZ eK (2] GB 18281.1 BATRA AAR 1 aS SI [3] GB/T 19972 BEIT ORR th Aydt ay HE A BOR RH A [4] GB/T 19974 BEYPORMIEI SIR HRB AH DB A I WT PRR O03 BOR [5] ISO 15883-1 Washer-disinfectors—Part 1; General requirements, terms and definitions and tests, [6] ISO 15883-2 Washer-disinfectors—Part 2; requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, ustensils, glassware,ete, [7] ISO 15883-4 Washer-disinfectors—Part 4 Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes [8] ISO/TS 15883-5 Washer-disinfectors—Part 5; Test soils and methods for demonstrating cleaning efficacy [9] AAMITIRIS Ethylene oxide sterilization equipment, process considerations and pertinent calcu- lations [10] AAMI TIR28;2001 Product adoption and process equivalency for ethylene oxide sterilization [11] ANSI/AAMI ST41,1999 Ethylene oxide sterilization in health care facilities: Safety and effectiveness [12] AS/NZS 4187 2003 Cleaning disinfecting and sterilizing reusable medical and surgical in- struments and equipment,and maintenance of associated environments in health care facilities [13] EN 1422,1997 Sterilizers for medical purpose~Ethylene oxide steri and test methods [14] GILLIS, J.and SCHMIDT, W.C., Scanning electron microscopy of spores on inoculated product surfaces, Medical Device and diagnostic Industry .5(6) .pp.46-49 1983. (15] HOLCOMB,R.G.and PFLUG,LJ.,The Spearman-Karber method of analyzing quantal as~ say microbial destruction data,In:Pflug I.J.yed.Selected Papers on the Microbiology and Engineering of Sterilization Processes, Sth ed., Minneapol 100, 1988. [16] MOSLEY, G.A., Estimating the effects of EtO BIER-Vessel Operating Precision on D- value Calculations, Medical Device & Diagnostic Industry, April 2002, [17] MOSLEY,G.A.and GILLIS, J.R., Factors Affecting Tailing in Ethylene Oxide Sterlization— Part 1,When Tailing is an Artifact and Scientific Deficiencies in ISO 11135 and EN 550,PDA Journal of Pharmaceutical Science and Technology,58, (2) pp.81-95,2004, [18] MOSLEY, G.A., GILLIS, J.R.and KRUSHEFSKI, G., Evaluating the formulae for inte- grated lethality in ethylene oxide sterilization using six different endospore forming strains of bacteria, ers~Requirements Environmental Sterilization Laboratory, pp. 83- and comparisons of integrated lethality for ethylene oxide and steam systems,PDA J Pharm Sci Tech- nol.59(1) pp.64-86 ,2008. [19] MOSLEY,G.A. ,GILLIS,J.R.and WHITBOURNE,J.E. , Formulae for Calculations of In- tegrated Lethality for EtO Sterilization Processes, Refining the Concepts and Exploring the Applica~ 29GB/T 18279,.2—2015/1SO/TS 11135- 2008 tions, Pharm. Tech.26 ,(10) pp.114-134,,2002. [20] PFLUG,1J., Microbiology and Engineering of Sterilization Processes, Minneapolis, Envi~ ronmental Sterilization Services,11th ed. ,Minneapolis,2003. [21] RODRIGUEZ, A.C., YOUNG, B. ,CAULK,K.,ZELEWSKI,].,DWASNICA,S.and AGU- IRRE,S. Calculating Accumulated Lethality and Survivorship in EtO Sterilization Processes,M D & D 1,September 2001. [22] WEST,K.L. Ethylene oxide sterilization: A study of resistance relationships, In; Steriliza~ tion of Medical Products. Gaughran E, and Kereluk K., eds., Johnson & Johnson, New Brunswick «ND, 1977, [23] SHINTANI et al. Comparison of D10-value accuracy by the limited Spearman-Karber pro- cedure(LSKP) , the Stumbo-Murphy-Cochran procedure(SMCP) sand the survival-curve method(EN) + Biomed. Instrum, Technol.29(2) »pp.113-24, 1995. [24] STUMBO,C.R.,MURPHY,].Rand COCHRAN, J.,Nature of Thermal Death Time Curves for P.A.3679 and Clostridium Botulinum, Food Technology »4pp.321-326 1950. 30IM T 18279. 2-2015 eA RO oe i ETRE ARR RACH ‘$8 2 B5}.GB 18279.1 IE GB/T 18279.2—2015/1SO/TS 11135-2:2008 hag Me AR A AG TS HR AO ML PE 2 55100029) AL CNBR = Mb HH 16 B-C100045) Fait www.spe.net.cn MH (010068533533 AFepAy,(010)51780238 ‘Bea BSF MB .Co10)68523946 a AE AE LT EN SHER EEM FPA 8B0X1230 1/16 ANH 2.29 FR 62 FE 2016 4F 1 AS—AK 2016 AF 1 AB — AN 16%: 195066 + 1-51388 SEH 93.00 TE MADRE HARRAH OR BREA BRB 3248 BAH. (010)68510107 -2015/ISO/TS 11135-2 : 2008 GB/T 18279. 2: