乙醇、01%新潔爾滅消毒效果驗證報告

消毒劑消毒效果驗證報告驗證編號驗證編號：藥業(yè)2023202311報告確定報告確定部門姓名簽名日期起復(fù)草核QCQC審核QCQA批準(zhǔn)Quality目目錄驗證概述·······························1驗證預(yù)備 驗證預(yù)備 1試驗儀器設(shè)備 1試驗用品 1試驗用品 1菌種及菌液 2消毒劑 2菌液計數(shù)菌液計數(shù) 3菌片制備 菌片制備 3菌片菌數(shù)復(fù)核 3載體噴灑消毒殺菌效力試驗·······················4載體噴灑消毒殺菌效力試驗結(jié)果 載體噴灑消毒殺菌效力試驗結(jié)果 4載體噴灑消毒殺菌效力試驗結(jié)論 19人員培訓(xùn)人員培訓(xùn)······························19變更及偏差·····························19驗證結(jié)論驗證結(jié)論······························19驗證概述對75%乙醇、%潔爾滅消毒效果進(jìn)展驗證，驗證中依據(jù)干凈區(qū)不同材質(zhì)選擇規(guī)章外表載體(詳見消毒劑消毒效果驗證方案)，驗證后總結(jié)數(shù)據(jù)形成報告。2.0驗證預(yù)備試驗儀器設(shè)備：〔設(shè)備的檢驗狀況詳見校驗記錄〕設(shè)備型號編號 校驗有效期至生化培育箱〔30~35℃〕BPH-9272S-08-H-11227霉菌培育箱〔20~25℃〕SPX-250S-08-H-11203周密移液器Thermo1000ulYY-08-008生物安全柜BCC-1800IIS-08-H-11128高壓蒸汽滅菌柜3170ELVS-08-H-11224試驗用品批號試驗用品批號來源有效期至無菌塑料吸頭〔ml〕202301北京牛牛基因技術(shù)無菌空平皿〔90mm〕青島金典生化器材酶-1連云港端峰生物科技氯化鈉蛋白胨緩沖液B100912-01自制80的氯化鈉蛋白胨緩沖液B100912-01自制大豆胰蛋白瓊脂〔TSA〕M101110-01自制大豆胰蛋白肉湯〔TSB〕M100912-01自制薩布羅瓊脂〔SDA〕M101110-01自制薩布羅肉湯〔SDB〕M100912-01自制菌種名稱菌種代號菌種名稱菌種代號菌種批號菌液批號金黃色葡萄球菌ATCC6538W101113-Sa-2BNA101114-Sa-3NA101115-Sa-3NA101116-Sa-3ATCC8739W101113-Ec-2BNA101114-Ec-3NA101115-Ec-3NA101116-Ec-3ATCC9027W101113-Pa-2BNA101114-Pa-3NA101115-Pa-3NA101116-Pa-3〔 Staphylococcus〔 Staphylococcusaureus〕大腸埃希菌Escherichiacoi銅綠假單胞菌〔 Pseudomonasaeruginos〕枯草芽孢桿菌Bacillussubtili〕W101113-Bs-2BATCC6633NAW101113-Bs-2C白色念珠菌Candidaalbican〕ATCC10231W101113-Ca-2BNA101113-Ca-3NA101114-Ca-3NA101115-Ca-3黑曲霉AspergillusnigrATCC16404W101109-An-4BW101109-An-4CNA人表皮葡萄球菌(Staphylocococcushominis)NA101114-Sh-3N/AW101113-Sh-2BNA101115-Sh-3NA101116-Sh-3名稱 來源 原始批號 有效期至 配制濃度 配制批號 自制消毒劑效期75%乙醇%潔爾滅

國藥集團(tuán)化學(xué)試劑南昌華鑫醫(yī)藥化工

101115-W-05啟封后一年 75% 101116-W-05101117-W-05101115-W-06100601 % 101116-W-06101117-W-06

臨用制臨用制臨用制臨用制臨用制臨用制菌液計數(shù)：〔菌液計數(shù)詳見原始記錄〕試驗菌試驗菌稀釋級計數(shù)結(jié)果cfu/皿平均值濃菌液菌數(shù)cfu/ml金黃色葡萄球菌10-76574×108大腸埃希菌10-76861×108銅綠假單胞菌10-74332×108枯草芽孢桿菌10-7525654×108白色念珠菌10-63124×107黑曲霉10-53934×106人表皮葡萄球菌10-7717774×108試驗菌稀釋級試驗菌稀釋級計數(shù)結(jié)果cfu/皿平均值濃菌液菌數(shù)cfu/ml試驗菌金黃色試驗菌金黃色葡萄球載體結(jié)果10-5Ca:10-4An:10-3大腸埃希菌銅綠假單胞菌枯草芽孢桿菌白色念株菌黑曲霉人表皮葡萄球軟塑料平均菌片菌數(shù)硬質(zhì)塑料10-5Ca:10-4An:10-3平均菌片菌數(shù)10-5Ca:10-4An:10-3不銹鋼平均菌片菌數(shù)紙張10-5菌菌56582263182365714735512536825763500005250000285000057000002150002950073500005952357343366264434258263267346150000475000038500006550000345000340006450000746542532426737263476741356773646070730000064000004450000600000032500030500700000075533662324267大腸埃大腸埃銅綠假枯草芽白色念希菌單胞菌孢桿菌株菌菌696346662731菌8572584164767202300580000041000006400000295000365007600000644642672838677362465724317354446226706850000540000044000006202300260000345007000000364224421621474235343621164539293946390000038500002900000390000018500018500460000063533446354145575225493025566033600000052500002950000475000032500033000505000062664349293441465231532152285459375125435400000590000037000005100000250000430003450000試驗菌金黃色葡萄球黑曲霉人表皮試驗菌金黃色葡萄球黑曲霉人表皮葡萄球載體結(jié)果Ca:10-4An:10-3平均菌片菌數(shù)10-5Ca:10-4An:10-3玻璃平均菌片菌數(shù)干凈服面料10-5Ca:10-4An:10-3平均菌片菌數(shù)10-5Ca:10-4An:10-3橡膠平均菌片菌數(shù)10-5Ca:10-4An:10-3鋁合金平均菌片菌數(shù)結(jié)論：上述結(jié)果顯示，每個菌片的含菌量均不小于105cfu/片，符合驗證試驗要求。確認(rèn)人/日期： 復(fù)核人/日期：3.0載體噴灑消毒殺菌效力試驗載體噴灑消毒殺菌效力試驗結(jié)果：結(jié)果試驗菌

載體名稱

軟塑料消毒劑消毒劑批號消毒劑消毒劑批號結(jié)果cfu/皿殺滅對數(shù)值陰性比照結(jié)論101115-W-0510符合規(guī)定75%乙醇101116-W-0550符合規(guī)定101117-W-0570符合規(guī)定101115-W-0630符合規(guī)定%潔爾滅101116-W-0660符合規(guī)定101117-W-0610符合規(guī)定101115-W-0530符合規(guī)定75%乙醇101116-W-0560符合規(guī)定101117-W-0510符合規(guī)定101115-W-0650符合規(guī)定%潔爾滅101116-W-0660符合規(guī)定101117-W-0620符合規(guī)定101115-W-0510符合規(guī)定75%乙醇101116-W-0540符合規(guī)定101117-W-0540符合規(guī)定101115-W-0620符合規(guī)定%潔爾滅101116-W-0660符合規(guī)定101117-W-0610符合規(guī)定101115-W-05420符合規(guī)定75%乙醇101116-W-05250符合規(guī)定101117-W-05240符合規(guī)定101115-W-0650符合規(guī)定%潔爾滅101116-W-06150符合規(guī)定101117-W-06160符合規(guī)定101115-W-0530符合規(guī)定75%乙醇101116-W-0560符合規(guī)定101117-W-0510符合規(guī)定大腸埃希菌銅綠假單胞菌枯草芽孢桿菌白色念珠菌消毒劑消毒劑批號結(jié)果cfu/皿殺滅對數(shù)值陰性比照結(jié)論101115-W-0630符合規(guī)定%潔爾滅101116-W-0660符合規(guī)定101117-W-0610符合規(guī)定101115-W-0550符合規(guī)定75%乙醇101116-W-0550符合規(guī)定101117-W-0530符合規(guī)定101115-W-0640符合規(guī)定%潔爾滅101116-W-0650符合規(guī)定101117-W-0620符合規(guī)定101115-W-0530符合規(guī)定75%乙醇101116-W-0560符合規(guī)定101117-W-0510符合規(guī)定101115-W-0650符合規(guī)定%潔爾滅101116-W-0650符合規(guī)定101117-W-0630符合規(guī)定結(jié)果載體名稱結(jié)果載體名稱軟塑料試驗菌黑曲霉人表皮葡萄球菌結(jié)論：上述各次試驗結(jié)果顯示，經(jīng)消毒劑噴灑消毒后，軟塑料載體菌片的殺3，符合標(biāo)準(zhǔn)要求。結(jié)果載體名稱結(jié)果載體名稱試驗菌消毒劑消毒劑批號結(jié)果硬質(zhì)塑料殺滅對 陰性結(jié)論金黃色葡萄球菌cfu/皿數(shù)值比照101115-W-0530符合規(guī)定75%乙醇101116-W-0550符合規(guī)定101117-W-0510符合規(guī)定101115-W-0620符合規(guī)定%潔爾滅101116-W-0630符合規(guī)定101117-W-0650符合規(guī)定結(jié)果試驗菌

載體名稱cfu/皿數(shù)值cfu/皿數(shù)值比照101115-W-0540符合規(guī)定75%乙醇101116-W-0520符合規(guī)定101117-W-0570符合規(guī)定101115-W-0660符合規(guī)定%潔爾滅101116-W-0680符合規(guī)定101117-W-0660符合規(guī)定101115-W-0530符合規(guī)定75%乙醇101116-W-0540符合規(guī)定101117-W-0520符合規(guī)定101115-W-0660符合規(guī)定%潔爾滅101116-W-0660符合規(guī)定101117-W-0620符合規(guī)定101115-W-05120符合規(guī)定75%乙醇101116-W-05140符合規(guī)定101117-W-0570符合規(guī)定101115-W-06350符合規(guī)定%潔爾滅101116-W-0640符合規(guī)定101117-W-06110符合規(guī)定101115-W-0520符合規(guī)定75%乙醇101116-W-0530符合規(guī)定101117-W-0550符合規(guī)定101115-W-0640符合規(guī)定%潔爾滅101116-W-0620符合規(guī)定101117-W-0670符合規(guī)定101115-W-0560符合規(guī)定75%乙醇101116-W-0510符合規(guī)定101117-W-0530符合規(guī)定

硬質(zhì)塑料結(jié)果 殺滅對 陰性 結(jié)論大腸埃希菌銅綠假單胞菌枯草芽孢桿菌白色念珠菌黑曲霉cfu/皿數(shù)值比照101115-W-0630符合規(guī)定%潔爾滅101116-W-0630符合規(guī)定101117-W-0640符合規(guī)定101115-W-0540符合規(guī)定75%乙醇101116-W-0520符合規(guī)定101117-W-0570符合規(guī)定101115-W-0660符合規(guī)定%潔爾滅101116-W-0610符合規(guī)定101117-W-0630符合規(guī)定結(jié)果載體名稱結(jié)果載體名稱試驗菌消毒劑消毒劑批號結(jié)果硬質(zhì)塑料殺滅對 陰性結(jié)論人表皮葡萄球菌結(jié)論：上述各次試驗結(jié)果顯示，經(jīng)消毒劑噴灑消毒后，硬質(zhì)塑料載體菌片的3，符合標(biāo)準(zhǔn)要求。結(jié)果載體名稱結(jié)果載體名稱不銹鋼試驗菌金黃色葡萄球菌大腸埃希菌消毒劑消毒劑批號結(jié)果cfu/皿殺滅對數(shù)值陰性比照結(jié)論101115-W-0510符合規(guī)定75%乙醇101116-W-0530符合規(guī)定101117-W-0540符合規(guī)定101115-W-0610符合規(guī)定%潔爾滅101116-W-0620符合規(guī)定101117-W-0610符合規(guī)定101115-W-0560符合規(guī)定75%乙醇101116-W-0530符合規(guī)定101117-W-0530符合規(guī)定101115-W-0680符合規(guī)定%潔爾滅101116-W-0630符合規(guī)定101117-W-0650符合規(guī)定結(jié)果試驗菌

載體名稱

不銹鋼消毒劑消毒劑批號消毒劑消毒劑批號結(jié)果cfu/皿殺滅對數(shù)值陰性比照結(jié)論101115-W-0570符合規(guī)定75%乙醇101116-W-0550符合規(guī)定101117-W-0540符合規(guī)定101115-W-0640符合規(guī)定%潔爾滅101116-W-0630符合規(guī)定101117-W-0620符合規(guī)定101115-W-05340符合規(guī)定75%乙醇101116-W-05230符合規(guī)定101117-W-0510符合規(guī)定101115-W-06150符合規(guī)定%潔爾滅101116-W-06140符合規(guī)定101117-W-0650符合規(guī)定101115-W-0510符合規(guī)定75%乙醇101116-W-0520符合規(guī)定101117-W-0510符合規(guī)定101115-W-0660符合規(guī)定%潔爾滅101116-W-0630符合規(guī)定101117-W-0630符合規(guī)定101115-W-0580符合規(guī)定75%乙醇101116-W-0550符合規(guī)定101117-W-0560符合規(guī)定101115-W-0620符合規(guī)定%潔爾滅101116-W-0650符合規(guī)定101117-W-0640符合規(guī)定101115-W-0560符合規(guī)定75%乙醇101116-W-0530符合規(guī)定101117-W-0530符合規(guī)定枯草芽孢桿菌白色念珠菌黑曲霉人表皮葡萄球菌消毒劑消毒劑批號結(jié)果cfu/皿殺滅對數(shù)值陰性比照結(jié)論101115-W-0680符合規(guī)定%潔爾滅101116-W-0650符合規(guī)定101117-W-0660符合規(guī)定結(jié)果載體名稱結(jié)果載體名稱不銹鋼試驗菌3，符合標(biāo)準(zhǔn)要求。結(jié)果載體名稱結(jié)果載體名稱試驗菌消毒劑消毒劑批號結(jié)果紙張殺滅對陰性結(jié)論金黃色葡萄球菌大腸埃希菌銅綠假單胞菌cfu/皿數(shù)值比照101115-W-0550符合規(guī)定75%乙醇101116-W-0530符合規(guī)定101117-W-0510符合規(guī)定101115-W-0630符合規(guī)定%潔爾滅101116-W-0610符合規(guī)定101117-W-0650符合規(guī)定101115-W-0530符合規(guī)定75%乙醇101116-W-0540符合規(guī)定101117-W-0550符合規(guī)定101115-W-0620符合規(guī)定%潔爾滅101116-W-0630符合規(guī)定101117-W-0650符合規(guī)定101115-W-0520符合規(guī)定75%乙醇101116-W-0550符合規(guī)定101117-W-0540符合規(guī)定101115-W-0660符合規(guī)定%潔爾滅101116-W-0620符合規(guī)定101117-W-0630符合規(guī)定結(jié)果試驗菌

載體名稱cfu/皿數(shù)值cfu/皿數(shù)值比照101115-W-0570符合規(guī)定75%乙醇101116-W-05110符合規(guī)定101117-W-05240符合規(guī)定101115-W-06230符合規(guī)定%潔爾滅101116-W-06450符合規(guī)定101117-W-06210符合規(guī)定101115-W-0530符合規(guī)定75%乙醇101116-W-0510符合規(guī)定101117-W-0550符合規(guī)定101115-W-0630符合規(guī)定%潔爾滅101116-W-0640符合規(guī)定101117-W-0650符合規(guī)定101115-W-0520符合規(guī)定75%乙醇101116-W-0530符合規(guī)定101117-W-0550符合規(guī)定101115-W-0620符合規(guī)定%潔爾滅101116-W-0650符合規(guī)定101117-W-0640符合規(guī)定101115-W-0530符合規(guī)定75%乙醇101116-W-0540符合規(guī)定101117-W-0550符合規(guī)定101115-W-0620符合規(guī)定%潔爾滅101116-W-0630符合規(guī)定101117-W-0650符合規(guī)定

紙張結(jié)果 殺滅對 陰性 結(jié)論枯草芽孢桿菌白色念珠菌黑曲霉人表皮葡萄球菌合格標(biāo)準(zhǔn)：要求各次試驗的殺滅對數(shù)值均≥3，可判定消毒合格。3，符合標(biāo)準(zhǔn)要求。確認(rèn)人/日期： 復(fù)核人/日期：結(jié)果試驗菌

載體名稱cfu/皿數(shù)值cfu/皿數(shù)值比照101115-W-0530符合規(guī)定75%乙醇101116-W-0510符合規(guī)定101117-W-0540符合規(guī)定101115-W-0650符合規(guī)定%潔爾滅101116-W-0620符合規(guī)定101117-W-0610符合規(guī)定101115-W-0530符合規(guī)定75%乙醇101116-W-0530符合規(guī)定101117-W-0530符合規(guī)定101115-W-0640符合規(guī)定%潔爾滅101116-W-0660符合規(guī)定101117-W-0630符合規(guī)定101115-W-0540符合規(guī)定75%乙醇101116-W-0560符合規(guī)定101117-W-0550符合規(guī)定101115-W-0620符合規(guī)定%潔爾滅101116-W-0650符合規(guī)定101117-W-0640符合規(guī)定101115-W-05460符合規(guī)定75%乙醇101116-W-05310符合規(guī)定101117-W-05230符合規(guī)定101115-W-06150符合規(guī)定%潔爾滅101116-W-06420符合規(guī)定101117-W-06410符合規(guī)定101115-W-0550符合規(guī)定75%乙醇101116-W-0520符合規(guī)定101117-W-0510符合規(guī)定

玻璃結(jié)果 殺滅對 陰性 結(jié)論金黃色葡萄球菌大腸埃希菌銅綠假單胞菌枯草芽孢桿菌白色念珠菌cfu/皿數(shù)值比照101115-W-0630符合規(guī)定%潔爾滅101116-W-0630符合規(guī)定101117-W-0630符合規(guī)定101115-W-0540符合規(guī)定75%乙醇101116-W-0560符合規(guī)定101117-W-0530符合規(guī)定101115-W-0640符合規(guī)定%潔爾滅101116-W-0660符合規(guī)定101117-W-0650符合規(guī)定101115-W-0530符合規(guī)定75%乙醇101116-W-0530符合規(guī)定101117-W-0530符合規(guī)定101115-W-0640符合規(guī)定%潔爾滅101116-W-0660符合規(guī)定101117-W-0630符合規(guī)定結(jié)果載體名稱結(jié)果載體名稱試驗菌消毒劑消毒劑批號結(jié)果玻璃殺滅對陰性結(jié)論黑曲霉人表皮葡萄球菌結(jié)論：上述各次試驗結(jié)果顯示，經(jīng)消毒劑噴灑消毒后玻璃載體菌片的殺滅對數(shù)值均大于3，符合標(biāo)準(zhǔn)要求。結(jié)果試驗菌結(jié)果試驗菌金黃色葡萄球菌載體名稱消毒劑消毒劑批號結(jié)果cfu/皿干凈服面料殺滅對數(shù)值陰性比照結(jié)論101115-W-0550符合規(guī)定75%乙醇101116-W-0540符合規(guī)定101117-W-0510符合規(guī)定101115-W-0640符合規(guī)定%潔爾滅101116-W-0610符合規(guī)定101117-W-0650符合規(guī)定載體名稱消毒劑消毒劑批號載體名稱消毒劑消毒劑批號結(jié)果cfu/皿干凈服面料殺滅對數(shù)值陰性比照結(jié)論101115-W-0560符合規(guī)定75%乙醇101116-W-0520符合規(guī)定101117-W-0550符合規(guī)定101115-W-0640符合規(guī)定%潔爾滅101116-W-0630符合規(guī)定101117-W-0620符合規(guī)定101115-W-0550符合規(guī)定75%乙醇101116-W-0530符合規(guī)定101117-W-0520符合規(guī)定101115-W-0620符合規(guī)定%潔爾滅101116-W-0660符合規(guī)定101117-W-0630符合規(guī)定101115-W-05410符合規(guī)定75%乙醇101116-W-05340符合規(guī)定101117-W-05230符合規(guī)定101115-W-06250符合規(guī)定%潔爾滅101116-W-06160符合規(guī)定101117-W-06180符合規(guī)定101115-W-0540符合規(guī)定75%乙醇101116-W-0510符合規(guī)定101117-W-0550符合規(guī)定101115-W-0660符合規(guī)定%潔爾滅101116-W-0620符合規(guī)定101117-W-0650符合規(guī)定101115-W-0540符合規(guī)定75%乙醇101116-W-0530符合規(guī)定101117-W-0520符合規(guī)定大腸埃希菌銅綠假單胞菌枯草芽孢桿菌白色念珠菌黑曲霉載體名稱消毒劑消毒劑批號結(jié)果cfu/皿干凈服面料殺滅對數(shù)值陰性比照結(jié)論101115-W-0650符合規(guī)定%潔爾滅101116-W-0630符合規(guī)定101117-W-0620符合規(guī)定101115-W-0560符合規(guī)定75%乙醇101116-W-0530符合規(guī)定101117-W-0520符合規(guī)定101115-W-0650符合規(guī)定%潔爾滅101116-W-0630符合規(guī)定101117-W-0620符合規(guī)定結(jié)果試驗菌結(jié)果試驗菌人表皮葡萄球菌3，符合標(biāo)準(zhǔn)要求。結(jié)果載體名稱結(jié)果載體名稱試驗菌消毒劑消毒劑批號結(jié)果橡膠殺滅對陰性結(jié)論金黃色葡萄球菌大腸埃希菌cfu/皿數(shù)值比照101115-W-0530符合規(guī)定75%乙醇101116-W-0530符合規(guī)定101117-W-0530符合規(guī)定101115-W-0640符合規(guī)定%潔爾滅101116-W-0620符合規(guī)定101117-W-0650符合規(guī)定101115-W-0560符合規(guī)定75%乙醇101116-W-0570符合規(guī)定101117-W-0550符合規(guī)定101115-W-0650符合規(guī)定%潔爾滅101116-W-0630符合規(guī)定101117-W-0620符合規(guī)定結(jié)果試驗菌

載體名稱cfu/皿數(shù)值cfu/皿數(shù)值比照101115-W-0560符合規(guī)定75%乙醇101116-W-0550符合規(guī)定101117-W-0530符合規(guī)定101115-W-0630符合規(guī)定%潔爾滅101116-W-0620符合規(guī)定101117-W-0640符合規(guī)定101115-W-05130符合規(guī)定75%乙醇101116-W-05220符合規(guī)定101117-W-05140符合規(guī)定101115-W-06110符合規(guī)定%潔爾滅101116-W-06310符合規(guī)定101117-W-06240符合規(guī)定101115-W-0540符合規(guī)定75%乙醇101116-W-0520符合規(guī)定101117-W-0550符合規(guī)定101115-W-0660符合規(guī)定%潔爾滅101116-W-0670符合規(guī)定101117-W-0650符合規(guī)定101115-W-0550符合規(guī)定75%乙醇101116-W-0530符合規(guī)定101117-W-0520符合規(guī)定101115-W-0660符合規(guī)定%潔爾滅101116-W-0650符合規(guī)定101117-W-0630符合規(guī)定101115-W-0560符合規(guī)定75%乙醇101116-W-0530符合規(guī)定101117-W-0520符合規(guī)定

橡膠結(jié)果 殺滅對 陰性 結(jié)論銅綠假單胞菌枯草芽孢桿菌白色念珠菌黑曲霉人表皮葡萄球菌cfu/皿數(shù)值比照101115-W-0660符合規(guī)定%潔爾滅101116-W-0650符合規(guī)定101117-W-0630符合規(guī)定結(jié)果載體名稱結(jié)果載體名稱試驗菌消毒劑消毒劑批號結(jié)果橡膠殺滅對陰性結(jié)論結(jié)論：上述各次試驗結(jié)果顯示，經(jīng)消毒劑噴灑消毒后，橡膠載體的殺滅對數(shù)值均大于3，符合標(biāo)準(zhǔn)要求。結(jié)果載體名稱結(jié)果載體名稱鋁合金試驗菌金黃色葡萄球菌大腸埃希菌銅綠假單胞菌消毒劑消毒劑批號結(jié)果cfu/皿殺滅對數(shù)值陰性比照結(jié)論101115-W-0520符合規(guī)定75%乙醇101116-W-0510符合規(guī)定101117-W-0540符合規(guī)定101115-W-0660符合規(guī)定%潔爾滅101116-W-0630符合規(guī)定101117-W-0640符合規(guī)定101115-W-0560符合規(guī)定75%乙醇101116-W-0560符合規(guī)定101117-W-0540符合規(guī)定101115-W-0620符合規(guī)定%潔爾滅101116-W-0610符合規(guī)定101117-W-0640符合規(guī)定101115-W-0520符合規(guī)定75%