TWSJD 002-2019 醫(yī)用清洗劑衛(wèi)生要求

ICS11.080.01團(tuán) 體 標(biāo) 準(zhǔn)T/WSJD002-2019醫(yī)用清洗劑衛(wèi)生要求Hygienicrequirementsformedicaldetergents2019-8-22發(fā)布 2019-10-1實(shí)施中國(guó)衛(wèi)生監(jiān)督協(xié)會(huì) 發(fā)布T/WSJD002-2019T/WSJD002-2019PAGEPAGE12前 言本標(biāo)準(zhǔn)由中國(guó)衛(wèi)生監(jiān)督協(xié)會(huì)團(tuán)體標(biāo)準(zhǔn)委員會(huì)提出并歸口。）3M中國(guó)有限公司、醫(yī)用清洗劑衛(wèi)生要求范圍本標(biāo)準(zhǔn)適用于醫(yī)用清洗劑的生產(chǎn)與應(yīng)用。GB/T65開(kāi)槽圓柱頭螺釘GB/T601化學(xué)試劑標(biāo)準(zhǔn)滴定溶液的制備GB/T603化學(xué)試劑試驗(yàn)方法中所用制劑及制品的制備GB/T679化學(xué)試劑乙醇（95%）GB/T700碳素結(jié)構(gòu)鋼GB/T1173鑄造鋁合金GB/T1220不銹鋼棒GB/T2059銅及銅合金帶材GB/T2481.1固結(jié)磨具用磨料粒度組成的檢測(cè)和標(biāo)記GB/T5750.4生活飲用水標(biāo)準(zhǔn)檢驗(yàn)方法感官性狀和物理指標(biāo)GB/T9721GB9985手洗餐具用洗滌劑GB/T15818表面活性劑生物降解度試驗(yàn)方法JB/T7901金屬材料實(shí)驗(yàn)室均勻腐蝕全浸試驗(yàn)方法ISO15883清洗消毒器《消毒技術(shù)規(guī)范》（2002年版）衛(wèi)生部下列術(shù)語(yǔ)和定義適用于本文件。3.1醫(yī)用清洗劑medicaldetergent用于增強(qiáng)水對(duì)醫(yī)療器械、器具及其他相關(guān)物品上污物清洗效果的制劑。3.2酸性用洗劑acid medicaldetergentpH值≤6.5的醫(yī)用清洗劑。3.3neutralmedicaldetergentpH在6.5～7.5間醫(yī)用洗 3.4堿性醫(yī)用清洗劑alkalinemedicaldetergentpH值≥7.5的醫(yī)用清洗劑。3.5含酶醫(yī)用清洗劑enzyme-containingmedicaldetergent加入了酶制劑如蛋白酶、淀粉酶和脂肪酶等，能分解相應(yīng)有機(jī)污染物的醫(yī)用清洗劑。3.6特殊用途的醫(yī)用清洗劑detergentforspecialuse具有專門用途，如抗抑菌、去除生物膜、除垢除銹等作用的醫(yī)用清洗劑。原料求 25≤15μS/cmc）d）（11GB9985中性醫(yī)用清洗劑對(duì)金屬基本無(wú)腐蝕；酸性和堿性醫(yī)用清洗劑宜對(duì)金屬基本無(wú)腐蝕或僅有輕度腐蝕；醫(yī)用清洗劑對(duì)器械的腐蝕程度不宜強(qiáng)于水洗。醫(yī)用清洗劑宜能減少或絡(luò)合水中的金屬離子（如Ca2+和Mg2+），降低水的硬度，減少水垢沉積。醫(yī)用清洗劑宜為低泡型，易于漂洗干凈。在高溫、低溫試驗(yàn)條件下，產(chǎn)品的物理性狀應(yīng)保持原有狀態(tài)不變。1≤10≤20產(chǎn)品應(yīng)注明開(kāi)封后有效期。在標(biāo)識(shí)的開(kāi)封后有效期內(nèi)，有效成分含量下降率應(yīng)≤10%或其清洗效果達(dá)到要求?！?9%ATP≥9995%90605090，ATP9090細(xì)菌菌落總數(shù)限值為100CFU/mL，不得含有致病菌。GB9985。方法見(jiàn)附錄A。GB/T5750.4。穩(wěn)定性-10℃±124h40℃±124h可采用自然存放試驗(yàn)或加速試驗(yàn)測(cè)定有效成分含量穩(wěn)定性：3790d10%可B。C。D。。F。（2002）。GB/T15818（2002）。（2002產(chǎn)品運(yùn)輸時(shí)應(yīng)輕裝輕卸，不得倒置，防壓、防撞、防擠、防止暴曬、雨淋，車輛應(yīng)保持干燥。a)b)c)d)e)產(chǎn)品運(yùn)輸包裝應(yīng)有下列標(biāo)志：AA附 錄 A（規(guī)范性附錄）醫(yī)用清洗劑對(duì)金屬腐蝕性的測(cè)定目的測(cè)定醫(yī)用清洗劑對(duì)各種金屬的腐蝕程度。金屬片：圓形，直徑24.0mm，厚1.0mm，穿一直徑為2.0mm小孔，表面積總值約為9.8cm2（a)碳鋼（規(guī)格見(jiàn)GB/T700）；注：碳鋼易氧化生銹，應(yīng)保存于油中。b)銅規(guī)格見(jiàn)GB/T2059）；c)鋁GB/T1173）；d)不銹鋼（規(guī)格見(jiàn)GB/T1220）。80m～100m。A.2.3 砂紙12GB/T481天平0.1g120（.1m5℃1h0.1mg200mL72h72h1cm（含600mL消毒液）進(jìn)行。JB/T7901（500mL36%～381000mL1.19）中1min～3min；200g/L5min～30min；1000mL5min～10min1.42）1min；不銹鋼：浸泡于60℃硝酸溶液（66%～68%硝酸100mL加蒸餾水至1000mL）20min?；蚪?0℃150g1000mL）中10min～60min50℃恒溫0.3mgt (A.1)：t 式中：

8760104m-mR= Std

(A.1)8760——一年中的小時(shí)數(shù)（h）；10000——單位換算值；R——腐蝕速率，單位為毫米每年（mm/a）；m——試驗(yàn)前金屬片重量，單位為克（g）；mt——試驗(yàn)后金屬片重量，單位為克（g）；mk——化學(xué)處理去除腐蝕產(chǎn)物樣片失重值，單位為克（g），若試驗(yàn)中未進(jìn)行化學(xué)清除處理者，計(jì)算時(shí)在公式中刪去mk值；S——金屬片的表面積總值，單位為平方厘米（cm2）；t——試驗(yàn)時(shí)間，單位為小時(shí)（h）；d——金屬材料密度，單位為千克每立方米（kg/m3）。腐蝕性分級(jí)標(biāo)準(zhǔn)見(jiàn)表A.1。表A.1 腐蝕分標(biāo)準(zhǔn)腐蝕速率Rmm/a級(jí)別＜0.0100基本無(wú)腐蝕0.0100～＜0.100輕度腐蝕0.100～＜1.00中度腐蝕≥1.00重度腐蝕20℃～25oCBB附 錄 B（）α定義1mL液體酶，于60℃、pH=6.0條件，1h液化1g可溶性淀粉，即為1個(gè)酶活力單位，以U/g(U/mL)表示。原理αα-1,4(KI)22g500mL，20g500mL2.000g0.00lg70mL30mLl00mLB.1.3.4磷酸緩沖液(pH=6.0)：稱取磷酸氫二鈉(Na2HPO4·12H20)45.23g、檸檬酸(C6H807·H2O)8.07g，用水溶解并定容至10OOmL。配好后用pH計(jì)校正。B.1.3.5GB/T9721B.1.3.6：60℃±0.2B.1.3.7B.1.3.8：25mm×200mm吸取液體酶1.00mL，用磷酸緩沖液定容至刻度(將估計(jì)酶活力除以4,即酶活力應(yīng)在3.7U/mL～5.6U/mL范圍內(nèi))，搖勻。通過(guò)四層紗布過(guò)濾，濾液供測(cè)定用。測(cè)定(B.1.3.3)20.0mL60℃±0.2℃5min1.00mL5min。于5.OOmLB.1.3.2)lOmm(AB.1表B.1 吸光與試α-粉濃度照表吸光度A酶濃度cU/mL吸光度A酶濃度cU/mL吸光度A酶濃度cU/mL0.1000.1010.1020.1030.1040.1050.1060.1070.1080.1090.1100.1110.1120.1130.1140.1150.1160.1170.1180.1190.1200.1210.1220.1230.1240.1250.1260.1270.1280.1290.1300.1310.1320.1330.1344.6944.6894.6844.6794.6744.6694.6644.6594.6544.6494.6444.6394.6344.62946244.6194.6144.6094.6044.59945944.5894.58445794.5744.56945644.5594.5544.5494.5444.53945344.5294.5240.1370.1380.1390.1400.1410.1420.1430.1440.1450.1460.1470.1480.1490.1500.1510.1520.1530.1540.1550.1560.1570.1580.1590.1600.1610.1620.1630.1640.1650.1660.1670.1680.1690.1700.1714.5074.5024.4974.4924.4874.4824.4774.4724.4674.4624.4574.4524.4474.4424.4384.4334.4284.4234.4184.4134.4084.4044.3994.3944.3894.3854.3804.3754.3704.3664.3614.3564.3524.3474.3420.1740.1750.1760.1770.1780.1790.1800.1810.1820.1830.1840.1850.1860.1870.1880.1890.1900.1910.1920.1930.1940.1950.1960.1970.1980.1990.2000.2010.2020.2030.2040.2050.2060.2070.2084.3294.3244.3194.3154.3104.3064.3014.2974.2924.2884.2834.2794.2754.2704.2664.2614.2574.2534.2484.2444.2404.2354.2314.2274.2224.2184.2144.2104.2054.2014.1974.1934.1894.1854.181T/WSJD002-2019表T/WSJD002-2019表B.1 續(xù))PAGEPAGE17吸光度A酶濃度cU/mL吸光度A酶濃度cU/mL吸光度A酶濃度cU/mL01350.1360.2110.2120.2130.2140.2150.2160.2170.2180.2190.2200.2210.2220.2230.2240.2250.2260.2270.2280.2290.2300.2310.2320.2330.2340.2350.2360.2370.2380.2390.2400.2410.2420.2430.2440.2450.2460.2474.5184.5134.1684.1644.1604.1564.1524.1484.1444.1404.1364.1324.1284.1244.1204.1164.1124.1084.1054.1014.0974.0934.0894.0854.0824.0784.0744.0704.0674.0634.0594.0564.0524.0484.0454.0414.0374.0344.0300.1720.1730.2500.25102520.2530.2540.2550.2560.2570.2580.2590.2600.26102620.2630.26402650.2660.2670.2680.2690.2700.2710.2720.2730.2740.2750.2760.2770.2780.2790.2800.2810.2820.2830.2840.2850.2864.3384.3334.0194.0164.0124.0094.0054.0023.9983.9953.9913.9883.9843.9813.9783.9743.9713.9683.9643.9613.9583.9543.9513.9483.9443.9413.9383.9353.9323.9283.9253.9223.9193.9163.9133.9223.9193.9153.9120.2090.2100.2890.2900.2910.2920.2930.2940.2950.2960.2970.2980.2990.3000.3010.3020.3030.3040.3050.3060.3070.3080.3090.3100.3110.3120.3130.3140.3150.3160.3170.3180.3190.3200.3210.3220.3230.3240.3254.1764.1723.9033.9003.8973.8943.8913.8883.8853.8813.8783.8753.8723.86938663.8633.8603.8573.8543.8513.8483.8453.8423.8393.8363.8333.8303.8273.8243.8213.8183.8153.8123.8093.8063.8033.8003.7973.794吸光度A酶濃度cU/mL吸光度A酶濃度cU/mL吸光度A酶濃度cU/mL0.2480.2490.3280.3290.3300.3310.3320.3330.3340.3350.3360.3370.3380.3390.34003410.3420.3430.3440.3450.3460.3470.3480.3490.3500.3510.3520.3530.3540.3550.3560.3570.3580.3590.3600.3610.3620.3630.3644.0264.0233.7853.7823.7793.7763.7743.7713.7683.7653.7623.7593.7563.7533.7503.7473.7443.7413.7393.7363.7333.7303.7273.7243.7213.7183.7163.7133.7103.7073.7043.7013.6993.6963.6933.6903.6873.6843.6820.2870.2880.3670.3680.3690.3700.3710.3720.3730.3740.3750.3760.3770.3780.3790.38003810.3820.3830.3840.3850.3860.3870.3880.3890.3900.3910.3920.3930.3940.39503960.3970.3980.3990.4000.4010.402o.4033.9093.9063.6733.6703.6683.6653.6623.6593.6563.6543.65l3.6483.6453.6433.6403.6373.6343.6323.6293.6263.6233.6213.6183.6153.6123.6103.6073.6043.6023.5993.5963.5943.5913.5883.5853.5833.5803.5773.5750.3260.3270.4060.4070.4080.4090.4100.4110.4120.4130.4140.4150.4160.4170.4180.4190.4200.4210.4220.4230.4240.4250.4260.4270.4280.4290.4300.4310.4320.4330.4340.4350.4360.4370.4380.4390.4400.4410.4423.7913.7883.5673.5643.5593.5563.5543.5513.5483.5463.5433.5413.5383.5353.5333.5303.5283.5253.5223.5203.5173.5153.5123.5093.5073.5043.5023.4993.4973.4943.4923.4893.4873.4843.4823.4793.4773.4743.472吸光度A酶濃度cU/mL吸光度A酶濃度cU/mL吸光度A酶濃度cU/mL0.3650.3660.4450.4460.4470.4480.4490.4500.4510.4520.4530.4540.4550.4560.4570.4580.4590.4600.4610.4620.4630.4640.4650.46604670.4680.4690.4700.4710.4720.4730.4740.4750.4760.4770.4780.4790.4800.4813.6793.6763.4643.4623.4593.4573.4543.4523.4493.4473.4443.4423.4403.4373.4353.4323.4303.4273.4253.4233.4203.4183.4153.4133.4113.4083.40634043.4013.3993.3973.3943.3923.3893.3873.3853.3833.3803.3780.4040.4050.4840.4850.4860.4870.4880.4890.4900.4910.4920.4930.4940.4950.4960.4970.4980.4990.5000.5010.5020.5030.5040.5050.5060.5070.5080.5090.5100.5110.5120.5130.5140.5150.5160.5170.5180.5190.5203.5723.5693.3713.3693.3663.3643.3623.3593.3573.3553.3533.3503.3483.3463.3443.3413.3393.3373.3353.3333.3303.32833263.3243.3213.3193.3173.3153.3133.3113.3083.3063.3043.3023.3003.2983.2953.2933.2910.4430.4440.5230.5240.5250.5260.5270.5280.5290.5300.5310.5320.5330.5340.5350.5360.5370.5380.5390.5400.5410.5420.5430.5440.5450.5460.5470.5480.5490.5500.5510.5520.5530.5540.5550.5560.5570.5580.5593.4693.4673.2853.2833.2803.2783.2763.2743.2723.2703.2683.2663.2643.2623.2603.2583.2553.2533.2513.2493.2473.2453.2433.2413.2393.2373.2353.2333.2313.2293.2273.2253.2233.2213.2193.2173.2153.2133.211吸光度A酶濃度cU/mL吸光度A酶濃度cU/mL吸光度A酶濃度cU/mL0.4820.4830.5620.5630.5640.5650.5660.5670.5680.5690.5700.5710.5720.5730.5740.5750.5760.5770.5780.5790.5800.5810.5820.5830.5840.5850.5860.5870.5880.5890.5900.5910.5920.5930.5940.5950.5960.5970.5983.3763.3733.2053.2043.2023.2003.1983.1963.1943.1923.1903.1883.1863.1843.1833.1813.1793.1773.1753.1733.1713.1693.1683.1663.1643.1623.1603.1583.1573.1553.1533.1513.1493.1473.1463.1443.1423.1403.1390.5210.5220.6010.6020.6030.6040.6050.6060.6070.6080.6090.6100.6110.6120.6130.6140.6150.6160.6170.6180.6190.6200.6210.6220.6230.6240.6250.6260.6270.6280.6290.6300.6310.6320.6330.6340.6350.6360.6373.2893.2873.1333.1313.1303.1283.1263.1243.1233.1213.1193.1183.1163.1143.1123.1113.1093.1073.1063.1043.1023.1013.0993.0973.0963.0953.0943.0923.0893.0873.0863.0843.0823.0813.0793.0783.0763.0743.0730.5600.5610.6400.6410.6420.6430.6440.6450.6460.6470.6480.6490.6500.6510.6520.6530.6540.6550.6560.6570.6580.6590.6600.6610.6620.6630.6640.6650.6660.6670.6680.6690.6700.6710.6720.6730.6740.6750.6763.2093.2073.06830663.0653.0633.0623.0603.0583.0573.0553.0543.0523.0513.0493.0483.0463.0453.0433.0423.0403.0393.0373.0363.0343.0333.0313.0303.0283.0273.0253.0243.0223.0213.0203.0183.0173.0153.014吸光度A酶濃度cU/mL吸光度A酶濃度cU/mL吸光度A酶濃度cU/mL0.5990.6000.6790.6800.6810.6820.6830.6840.6850.6860.6870.6880.6890.6900.6910.6920.6930.6940.6950.6960.6970.6980.6990.7000.7010.7020.7030.7040.7050.7060.7073.1373.1353.0103.0083.0073.0053.0043.0033.0013.0002.9982.9972.9962.9942.9932.9922.9902.9892.9882.9862.9852.9842.9822.9812.9802.9782.9772.9762.9752.9732.9720.6380.6390.7080.7090.7100.7110.7120.7130.7140.7150.7160.7170.7180.7190.7200.7210.7220.7230.7240.7250.7260.7270.7280.7290.7300.7310.7320.7330.7340.7350.7363.0713.0702.9712.9692.9682.9672.9662.9642.9632.9622.9612.9592.9582.9572.9562.9552.9532.9522.9512.9502.9492.9472.9462.9452.9442.9432.9412.9402.9392.9382.9370.6770.6780.7370.7380.7390.7400.7410.7420.7430.7440.7450.7460.7470.7480.7490.7500.7510.7520.7530.7540.7550.7560.7570.7580.7590.7600.7610.7620.7630.7640.7653.0123.0112.9362.9352.9332.9322.9312.9302.9292.9282.9272.9262.9252.9232.9222.9212.9202.9192.9182.9172.9162.9152.9142.9132.9122.9112.9102.9092.9082.9072.906計(jì)算樣品酶活力，計(jì)算見(jiàn)式(B.1)： Xcn (B.1)式中：X——樣品的酶活力，單位為酶活力單位每克(酶活力單位每毫升)[U/g(U/mL)]；c——測(cè)試酶液的濃度，單位為酶活力單位每毫升(U/mL)；n——樣品的稀釋倍數(shù)。注：所得結(jié)果表示至整數(shù)。T/WSJD002-2019T/WSJD002-2019PAGEPAGE36平行試驗(yàn)相對(duì)誤差不得超過(guò)2%。蛋白酶本方法描述了液體洗滌劑中蛋白酶活性的測(cè)定過(guò)程。4030min10mLpH、（40℃）Alcalase（1.61AU/g－Novozyme））Trizma。將24.2gTrizma800mL1mol/LpH8.51L25注：不早于測(cè)試前一天配制。50%50g100mL注：保質(zhì)期3個(gè)月，常溫避光保存。1025g250mLB.2.5.40.60.6g10mL50100mLAlcalase0.0161g10mLTris由此可得到活度大約是2.6×10-3AU/g的常備溶液。通過(guò)稱取的Alcalase標(biāo)樣準(zhǔn)確質(zhì)量計(jì)算常備溶液的蛋白酶的活度，至少保留4位有效數(shù)字。）標(biāo)準(zhǔn)溶液1(1.3×10-5AU/mL)：吸取0.05mL常備Alcalase標(biāo)準(zhǔn)溶液至10mL容量瓶中，用Tris標(biāo)準(zhǔn)溶液2(2.6×10-5AU/mL)：吸取0.10mL常備Alcalase標(biāo)準(zhǔn)溶液至10mL容量瓶中，用Tris標(biāo)準(zhǔn)溶液3(5.2×10-5AU/mL)：吸取0.20mL常備Alcalase標(biāo)準(zhǔn)溶液至10mL容量瓶中，用Tris標(biāo)準(zhǔn)溶液4(1.04×10-4AU/mL)：吸取0.40mL常備Alcalase標(biāo)準(zhǔn)溶液至10mL容量瓶中，用Tris標(biāo)準(zhǔn)溶液5(2.08×10-4AU/mL)：吸取0.80mL常備Alcalase標(biāo)準(zhǔn)溶液至10mL容量瓶中，用Tris（）將待分析的樣品的活度稀釋至標(biāo)準(zhǔn)曲線范圍內(nèi)：0.1mL10mL4.9mLTris0.1g10mL4.9mLTris0.05mL10mL4.95mLTris50004010min（1.0mL至20mLB.2.8.4401min30s5mL30min終止反應(yīng)：將5.0mL終止劑按30s的間隔依次加入到每支試管中，渦流攪拌后在室溫下放置10min注：30s間隔的時(shí)間可隨操作熟練程度自行調(diào)整，但要求保證每個(gè)樣品的反應(yīng)時(shí)間精確控制在30min。1.0mLStd2(5.2×10-5AU/mL（15min～20min390nm（AU/mL）vsexcelB.2.9（BR=A稀釋比例5000(B.2)式中：R——蛋白酶活性，單位為酶活力單位每毫升（AU/mL）；A——通過(guò)標(biāo)準(zhǔn)圖譜線形回歸得到的樣品濃度；如果要轉(zhuǎn)換成AU/g除以樣品的密度即可。B.2.9.5對(duì)稱量的樣品，蛋白酶活性計(jì)算見(jiàn)式（B.3）：A稀釋比例5000R= (B.3)W式中：R——（AU/g）；A——W——(g（）定義在40℃條件下,每分鐘水解酪素產(chǎn)生1μg酪氨酸所需的酶量,規(guī)定為一個(gè)酶活力單位。原理（。（）752型分光光度計(jì)、恒溫水浴鍋、試管、濾紙、移液管、秒表、酸度計(jì)、容量瓶、電熱風(fēng)恒溫干燥箱。注：本標(biāo)準(zhǔn)所使用所有的試劑若無(wú)任何說(shuō)明，均為分析純。200LNa2W4·2H210（Na2O4·2H2210h（Li2SO4）50g50mL15min1000mL，12（pH=3.0）甲液：稱取乳酸（80%～90%）10.6g,加蒸餾水溶解并定容至1000mL。乙液：稱取乳酸鈉（70%）16g,加蒸餾水溶解并定容至1000mL。使用液：取甲液8mL,加乙液1mL,搖勻，稀釋一倍，即成0.05mol/L乳酸緩沖溶液。（pH=7.5）（NaH2PO3·2H2O）0.5gpH=10.5)甲液：稱取硼酸鈉19.08g,加水溶解并定容至1000mL。乙液：稱取氫氧化鈉4.0g,加水溶解并定容至1000mL。使用液：取甲液500ml,加乙液400ml,搖勻，用水稀釋至1L。0.4mol/L準(zhǔn)確稱取無(wú)水碳酸鈉42.4g,以蒸餾水溶解定溶至1000mL。0.4mol/L準(zhǔn)確稱取65.4三氯醋酸,以蒸餾水溶解定溶至1000mL。0.5mol/L的NaOH準(zhǔn)確稱取2gNaOH溶解并定至100mL。10.00mg/mL稱取酪素1.000g,用少量的0.5mol/L的氫氧化鈉溶液(若為酸性蛋白酶則用濃乳酸2-3滴)潤(rùn)濕,加入適量的各適宜的緩沖液約80mL,在沸水浴中邊加熱邊攪拌,直至完全溶解,冷卻后,轉(zhuǎn)入100mL容量瓶中,用適宜的緩沖液稀釋至刻度,此溶液在冰箱內(nèi)貯存,有效期為三天。100μg/ml準(zhǔn)確稱取預(yù)先于105℃干燥至恒重的L-酪氨酸0.1000g,用1mol/L的鹽酸60mL溶解后并用0.1mol/L100ml,即為1.00mg/mL吸取1.00mg/mL酪氨酸標(biāo)準(zhǔn)溶液10.00mL,用0.1mol/L鹽酸定容至100mL,即得100.0μg/LL1.000g1mL100LB.2表B.2 L-酪酸準(zhǔn)液制表試管號(hào)012345取100μg/ml酪氨溶液/mL012345蒸餾水/mL1098765酪氨酸實(shí)際濃度/(μg/mL)010203040500.4mol/L5.00mL40±0.220min680nm0管O為（μg9～10范圍內(nèi)40±0.25minB.3.6.2取41mL2mL31mL40℃保溫10min32mL1mL靜置10minB.3.6.6各取1mL濾液分別加0.4mol/L的Na2CO35ml，福林試劑1mL。在40℃顯色20min。680nm處測(cè)OD值。以空白管調(diào)零點(diǎn)。OD（B4X=AK4n (B.4)10式中：X——蛋白酶的活力，單位為酶活力單位每克（U/g）或毫升（mL）；A——樣品平行試驗(yàn)的平均OD值；K——吸光常數(shù)；4——反應(yīng)試劑的總體積，單位為毫升（mL）；10——酶解反應(yīng)時(shí)間，單位為分鐘（min）；n——酶液稀釋總倍數(shù)。脂肪酶定義1mL40℃，pH=7.51μmolU/g原理:RCOOH+NaOH——→RCOONa+H2OPVA1750±50。95%GB/T679)。a）稱取聚乙烯醇(PVA)40g，加水800mL，在沸水浴中加熱、攪拌，直至全部溶解，冷卻后定容至1000mL。以干凈的雙層紗布過(guò)濾，取濾液備用；b）量取4%PVA溶液150mL，加橄欖油50mL，用高速組織搗碎機(jī)處理6min(分2次處理，每次3min,中間休息5min)，即成乳白色PVA乳化液。該溶液要現(xiàn)用現(xiàn)配。該溶液如貯存在冰箱中，有效期為一周。B.4.3.50.025mol/L磷酸緩沖液(pH=7.5)：甲液稱取磷酸二氫鉀(KH2PO4)17.01g500mL；(Na2HPO4·12H2O)44.77g500mL；使用液吸取甲液13mL100mL0.25mol/L0.025mol/LpHc(NOH)0.0molB/T6(Na)=0.5ol/1010g/LGB/T603B.4.4.1：40℃±0.2B.4.4.2高速組織搗碎機(jī)：8000r/min～12000r/min。B.4.4.3pH計(jì)：分度值為0.02pH單位或2mV。：10mL0.05mL吸取液體酶1.00mL，用磷酸緩沖液定容至刻度搖勻、稀釋倍數(shù)參考表B.3，控制酶液濃度，樣品與對(duì)照消耗堿量之差在1mL～2mL范圍內(nèi)。注意，吸取樣品時(shí)，應(yīng)將酶液搖勻后再取。表B.3 酶活估表估測(cè)酶活力U/g稀釋倍數(shù)400060050007506000900測(cè)定用pH=9.22pH100mLA(B95%(B.4.3.3)15.0mL，于40℃±0.2℃水浴A、1.00mL，40℃±0.295%乙醇15.0mL0.05mol/L氫氧化鈉標(biāo)準(zhǔn)溶液滴pH=10.30.05mol/LA(BB.4.3.4)4.00mL和A9540℃±0.2540℃±0.2B9515.0mL滴，用0.05mol/L30s0.05mol/Lcc501n=2000.05153X=BA式中：

BAcn (B.5)X——樣品的酶活力，單位為酶活力單位每克（u/g）；B——（mL）；A——（mL）；c——（mol/L）；0.05——?dú)溲趸c標(biāo)準(zhǔn)溶液濃度換算系數(shù)；50——0.05mol/L氫氧化鈉溶液1.00mL相當(dāng)于脂肪酸50微摩爾(μmol)；1/15——反應(yīng)時(shí)間15min，以1min計(jì)；n——稀釋倍數(shù)；所得的結(jié)果表示至整數(shù)。平行試驗(yàn)相對(duì)誤差不得超過(guò)2%。CC附 錄 C（規(guī)范性附錄）醫(yī)用清洗劑對(duì)血液和細(xì)菌混合物的去除效果測(cè)試方法目的測(cè)定醫(yī)用清洗劑對(duì)有抗熱能力的腸球菌和血液混合污染物的去除效果。腸球菌ATCC6057。新鮮羊血（72h以內(nèi)）。魚精蛋白鹽酸鹽（純度≥99%）。肝素（純度≥99%）。生理鹽水。洗脫液吐溫-800.1蛋白胨1.00.85用蒸餾水配制而成，調(diào)節(jié)pH值在7.0±0.2，經(jīng)121℃壓力蒸汽滅菌后使用。（TPS）胰蛋白胨1.0%。氯化鈉0.85%。用蒸餾水配制而成，調(diào)節(jié)pH值在7.0±0.2，經(jīng)121℃壓力蒸汽滅菌后使用。CSL)酪蛋白胨1.7%。大豆蛋白胨瓊脂0.3%。氯化鈉0.05%。磷酸氫二鉀0.023%。葡萄糖0.025%。用蒸餾水配制而成，調(diào)節(jié)pH為7.3±0.1，經(jīng)121℃壓力蒸汽滅菌后使用。(CSA)酪蛋白胨1.5%。大豆蛋白胨瓊脂0.5%。氯化鈉0.5%。瓊脂1.5%。用蒸餾水配制而成，調(diào)節(jié)pH為7.3±0.1，經(jīng)121℃壓力蒸汽滅菌后使用。開(kāi)槽圓柱頭螺釘M6×20GB/T65有金屬螺蓋的玻璃罐（容積為470mL,可高壓滅菌，并可放入轉(zhuǎn)軸的廣口罐），將罐口覆蓋牛皮紙，加蓋，于121℃壓力蒸汽滅菌后備用。轉(zhuǎn)動(dòng)速度為45r/min～60r/min的滾動(dòng)搖床。ATPATPATPATPATP生物熒光測(cè)試儀。腸球菌經(jīng)增菌培養(yǎng)，分離純化后，將純培養(yǎng)物接種到CSL中，于36℃±1℃培養(yǎng)24h，次日重復(fù)以上操作。第3天，取0.1mL菌液接種于CSA上，在36℃±1℃的條件下培養(yǎng)72h。用生理鹽水洗菌，將細(xì)菌懸浮液放入離心機(jī)內(nèi)，以轉(zhuǎn)速為6000r/min的速度離心10min～15min，棄去上清，用生理鹽水將沉淀物再次混勻。將9.5mL（0.35mL0.15mL（濃度為4mg/mL）20min將經(jīng)脫脂、滅菌處理的不銹鋼螺絲釘完全浸沒(méi)于測(cè)試污染物中至少1min后取出，置于36℃±1℃的條件下干燥5min至血液凝固。在試驗(yàn)開(kāi)始前20min,將盛有300mL按產(chǎn)品說(shuō)明書配制好的待測(cè)醫(yī)用清洗劑的玻璃罐，在水浴中恒溫至40℃（或者為產(chǎn)品說(shuō)明書所規(guī)定的溫度的最低值）。300mL45r/min～60r/min10mLATP101.0mLCSACSAATP同時(shí)用移液槍吸取洗脫液50μL，加入50μL裂解液，震蕩混合，作用30s后加入400μL熒光素酶，進(jìn)行RLU測(cè)定，然后加入10μL標(biāo)準(zhǔn)品溶液，讀取其RLU及ATP含量。10mLC.3.5ATP1mL三次試驗(yàn)結(jié)果，對(duì)細(xì)菌的去除率應(yīng)≥99%，且ATP含量下降率應(yīng)≥99%，可判定為該醫(yī)用清洗劑對(duì)血液和細(xì)菌的混合污染物清洗效果有效。DD附 錄 D（規(guī)范性附錄）醫(yī)用清洗劑對(duì)人工模擬污染物去除效果評(píng)價(jià)方法目的通過(guò)符合ISO15883標(biāo)準(zhǔn)的模擬污染物的去除效果，判定其清洗效果。模擬污染物：蛋白、脂類和多糖的混合物。分析天平感量0.1mg。有金屬螺蓋的玻璃罐（容積為470mL,可高壓滅菌，并可放入轉(zhuǎn)軸的廣口罐），將罐口覆蓋牛皮紙，加蓋，于121℃壓力蒸汽滅菌后備用。轉(zhuǎn)動(dòng)速度為45r/min～60r/min的滾動(dòng)搖床。3片模擬污染物為一組，在干燥器中過(guò)夜后，稱重為m0。每組污染片待天平回零后稱重三次，精確至0.1mg，取其平均值作為試驗(yàn)前重量。稱重時(shí)，應(yīng)用鑷子夾取，勿以手直接接觸樣片。在試驗(yàn)開(kāi)始前20min,將盛有300mL按產(chǎn)品說(shuō)明書配制好的待測(cè)醫(yī)用清洗劑的玻璃罐，在水浴中恒溫至40℃。將3片模擬污染物分別放入3個(gè)盛有300mL待測(cè)醫(yī)用清洗劑玻璃罐中，加蓋。以45r/min～60r/min的轉(zhuǎn)動(dòng)速度旋轉(zhuǎn)洗滌預(yù)定時(shí)間，取下玻璃罐，取出模擬污染物，掛在晾架上，30℃存放2h后，稱重為m1，并目測(cè)其清洗效果。稱量后的污染片，按以下步驟去污：30min；30min；30min；10min；pH30minm2（D.1）：R100% (D.1)m0m2式中：R——人工模擬污染物去除率，%；m0——清洗前模擬污染物質(zhì)量，單位為毫克（mg）；m1——醫(yī)用清洗劑清洗后模擬污染物質(zhì)量，單位為毫克（mg）；m2——洗凈后模擬污染物質(zhì)量，單位為毫克（mg）；每一待測(cè)樣品需準(zhǔn)備三組模擬污染物?！?5%，EE附 錄 E（規(guī)范性附錄）醫(yī)用清洗劑對(duì)脂肪、蛋白質(zhì)和淀粉的去除效果評(píng)價(jià)方法目的醫(yī)用清洗劑對(duì)測(cè)定污染物的去除率。豬油（食品級(jí)）?！?淀粉≥9墻紙糊。載體片聚四氟乙烯片大小為10cm×5cm、每片重量為1.200g±0.010g。天平分析天平感量0.1mg。有金屬螺蓋的玻璃罐（容積為470mL,可高壓滅菌，并可放入轉(zhuǎn)軸的廣口罐），將罐口覆蓋牛皮紙，加蓋，于121℃壓力蒸汽滅菌后備用。轉(zhuǎn)動(dòng)速度為45r/min～60r/min的滾動(dòng)搖床。淀粉污染物：淀粉3ｇ、墻紙糊0.5ｇ，加水至100mL；3ｇ0.5ｇ100mL50℃；45聚四氟乙烯片在使用前，應(yīng)先進(jìn)行脫脂處理。脫脂方法如下：30min；10m