TWSJD 002-2019 医用清洗剂卫生要求

ICS11.080.01团 体 标 准T/WSJD002-2019医用清洗剂卫生要求Hygienicrequirementsformedicaldetergents2019-8-22发布 2019-10-1实施中国卫生监督协会 发布T/WSJD002-2019T/WSJD002-2019PAGEPAGE12前 言本标准由中国卫生监督协会团体标准委员会提出并归口。）3M中国有限公司、医用清洗剂卫生要求范围本标准适用于医用清洗剂的生产与应用。GB/T65开槽圆柱头螺钉GB/T601化学试剂标准滴定溶液的制备GB/T603化学试剂试验方法中所用制剂及制品的制备GB/T679化学试剂乙醇（95%）GB/T700碳素结构钢GB/T1173铸造铝合金GB/T1220不锈钢棒GB/T2059铜及铜合金带材GB/T2481.1固结磨具用磨料粒度组成的检测和标记GB/T5750.4生活饮用水标准检验方法感官性状和物理指标GB/T9721GB9985手洗餐具用洗涤剂GB/T15818表面活性剂生物降解度试验方法JB/T7901金属材料实验室均匀腐蚀全浸试验方法ISO15883清洗消毒器《消毒技术规范》（2002年版）卫生部下列术语和定义适用于本文件。3.1医用清洗剂medicaldetergent用于增强水对医疗器械、器具及其他相关物品上污物清洗效果的制剂。3.2酸性用洗剂acid medicaldetergentpH值≤6.5的医用清洗剂。3.3neutralmedicaldetergentpH在6.5～7.5间医用洗 3.4碱性医用清洗剂alkalinemedicaldetergentpH值≥7.5的医用清洗剂。3.5含酶医用清洗剂enzyme-containingmedicaldetergent加入了酶制剂如蛋白酶、淀粉酶和脂肪酶等，能分解相应有机污染物的医用清洗剂。3.6特殊用途的医用清洗剂detergentforspecialuse具有专门用途，如抗抑菌、去除生物膜、除垢除锈等作用的医用清洗剂。原料求 25≤15μS/cmc）d）（11GB9985中性医用清洗剂对金属基本无腐蚀；酸性和碱性医用清洗剂宜对金属基本无腐蚀或仅有轻度腐蚀；医用清洗剂对器械的腐蚀程度不宜强于水洗。医用清洗剂宜能减少或络合水中的金属离子（如Ca2+和Mg2+），降低水的硬度，减少水垢沉积。医用清洗剂宜为低泡型，易于漂洗干净。在高温、低温试验条件下，产品的物理性状应保持原有状态不变。1≤10≤20产品应注明开封后有效期。在标识的开封后有效期内，有效成分含量下降率应≤10%或其清洗效果达到要求。≥99%ATP≥9995%90605090，ATP9090细菌菌落总数限值为100CFU/mL，不得含有致病菌。GB9985。方法见附录A。GB/T5750.4。稳定性-10℃±124h40℃±124h可采用自然存放试验或加速试验测定有效成分含量稳定性：3790d10%可B。C。D。。F。（2002）。GB/T15818（2002）。（2002产品运输时应轻装轻卸，不得倒置，防压、防撞、防挤、防止暴晒、雨淋，车辆应保持干燥。a)b)c)d)e)产品运输包装应有下列标志：AA附 录 A（规范性附录）医用清洗剂对金属腐蚀性的测定目的测定医用清洗剂对各种金属的腐蚀程度。金属片：圆形，直径24.0mm，厚1.0mm，穿一直径为2.0mm小孔，表面积总值约为9.8cm2（a)碳钢（规格见GB/T700）；注：碳钢易氧化生锈，应保存于油中。b)铜规格见GB/T2059）；c)铝GB/T1173）；d)不锈钢（规格见GB/T1220）。80m～100m。A.2.3 砂纸12GB/T481天平0.1g120（.1m5℃1h0.1mg200mL72h72h1cm（含600mL消毒液）进行。JB/T7901（500mL36%～381000mL1.19）中1min～3min；200g/L5min～30min；1000mL5min～10min1.42）1min；不锈钢：浸泡于60℃硝酸溶液（66%～68%硝酸100mL加蒸馏水至1000mL）20min。或浸于70℃150g1000mL）中10min～60min50℃恒温0.3mgt (A.1)：t 式中：

8760104m-mR= Std

(A.1)8760——一年中的小时数（h）；10000——单位换算值；R——腐蚀速率，单位为毫米每年（mm/a）；m——试验前金属片重量，单位为克（g）；mt——试验后金属片重量，单位为克（g）；mk——化学处理去除腐蚀产物样片失重值，单位为克（g），若试验中未进行化学清除处理者，计算时在公式中删去mk值；S——金属片的表面积总值，单位为平方厘米（cm2）；t——试验时间，单位为小时（h）；d——金属材料密度，单位为千克每立方米（kg/m3）。腐蚀性分级标准见表A.1。表A.1 腐蚀分标准腐蚀速率Rmm/a级别＜0.0100基本无腐蚀0.0100～＜0.100轻度腐蚀0.100～＜1.00中度腐蚀≥1.00重度腐蚀20℃～25oCBB附 录 B（）α定义1mL液体酶，于60℃、pH=6.0条件，1h液化1g可溶性淀粉，即为1个酶活力单位，以U/g(U/mL)表示。原理αα-1,4(KI)22g500mL，20g500mL2.000g0.00lg70mL30mLl00mLB.1.3.4磷酸缓冲液(pH=6.0)：称取磷酸氢二钠(Na2HPO4·12H20)45.23g、柠檬酸(C6H807·H2O)8.07g，用水溶解并定容至10OOmL。配好后用pH计校正。B.1.3.5GB/T9721B.1.3.6：60℃±0.2B.1.3.7B.1.3.8：25mm×200mm吸取液体酶1.00mL，用磷酸缓冲液定容至刻度(将估计酶活力除以4,即酶活力应在3.7U/mL～5.6U/mL范围内)，摇匀。通过四层纱布过滤，滤液供测定用。测定(B.1.3.3)20.0mL60℃±0.2℃5min1.00mL5min。于5.OOmLB.1.3.2)lOmm(AB.1表B.1 吸光与试α-粉浓度照表吸光度A酶浓度cU/mL吸光度A酶浓度cU/mL吸光度A酶浓度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 续)PAGEPAGE17吸光度A酶浓度cU/mL吸光度A酶浓度cU/mL吸光度A酶浓度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酶浓度cU/mL吸光度A酶浓度cU/mL吸光度A酶浓度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酶浓度cU/mL吸光度A酶浓度cU/mL吸光度A酶浓度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酶浓度cU/mL吸光度A酶浓度cU/mL吸光度A酶浓度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酶浓度cU/mL吸光度A酶浓度cU/mL吸光度A酶浓度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计算样品酶活力，计算见式(B.1)： Xcn (B.1)式中：X——样品的酶活力，单位为酶活力单位每克(酶活力单位每毫升)[U/g(U/mL)]；c——测试酶液的浓度，单位为酶活力单位每毫升(U/mL)；n——样品的稀释倍数。注：所得结果表示至整数。T/WSJD002-2019T/WSJD002-2019PAGEPAGE36平行试验相对误差不得超过2%。蛋白酶本方法描述了液体洗涤剂中蛋白酶活性的测定过程。4030min10mLpH、（40℃）Alcalase（1.61AU/g－Novozyme））Trizma。将24.2gTrizma800mL1mol/LpH8.51L25注：不早于测试前一天配制。50%50g100mL注：保质期3个月，常温避光保存。1025g250mLB.2.5.40.60.6g10mL50100mLAlcalase0.0161g10mLTris由此可得到活度大约是2.6×10-3AU/g的常备溶液。通过称取的Alcalase标样准确质量计算常备溶液的蛋白酶的活度，至少保留4位有效数字。）标准溶液1(1.3×10-5AU/mL)：吸取0.05mL常备Alcalase标准溶液至10mL容量瓶中，用Tris标准溶液2(2.6×10-5AU/mL)：吸取0.10mL常备Alcalase标准溶液至10mL容量瓶中，用Tris标准溶液3(5.2×10-5AU/mL)：吸取0.20mL常备Alcalase标准溶液至10mL容量瓶中，用Tris标准溶液4(1.04×10-4AU/mL)：吸取0.40mL常备Alcalase标准溶液至10mL容量瓶中，用Tris标准溶液5(2.08×10-4AU/mL)：吸取0.80mL常备Alcalase标准溶液至10mL容量瓶中，用Tris（）将待分析的样品的活度稀释至标准曲线范围内：0.1mL10mL4.9mLTris0.1g10mL4.9mLTris0.05mL10mL4.95mLTris50004010min（1.0mL至20mLB.2.8.4401min30s5mL30min终止反应：将5.0mL终止剂按30s的间隔依次加入到每支试管中，涡流搅拌后在室温下放置10min注：30s间隔的时间可随操作熟练程度自行调整，但要求保证每个样品的反应时间精确控制在30min。1.0mLStd2(5.2×10-5AU/mL（15min～20min390nm（AU/mL）vsexcelB.2.9（BR=A稀释比例5000(B.2)式中：R——蛋白酶活性，单位为酶活力单位每毫升（AU/mL）；A——通过标准图谱线形回归得到的样品浓度；如果要转换成AU/g除以样品的密度即可。B.2.9.5对称量的样品，蛋白酶活性计算见式（B.3）：A稀释比例5000R= (B.3)W式中：R——（AU/g）；A——W——(g（）定义在40℃条件下,每分钟水解酪素产生1μg酪氨酸所需的酶量,规定为一个酶活力单位。原理（。（）752型分光光度计、恒温水浴锅、试管、滤纸、移液管、秒表、酸度计、容量瓶、电热风恒温干燥箱。注：本标准所使用所有的试剂若无任何说明，均为分析纯。200LNa2W4·2H210（Na2O4·2H2210h（Li2SO4）50g50mL15min1000mL，12（pH=3.0）甲液：称取乳酸（80%～90%）10.6g,加蒸馏水溶解并定容至1000mL。乙液：称取乳酸钠（70%）16g,加蒸馏水溶解并定容至1000mL。使用液：取甲液8mL,加乙液1mL,摇匀，稀释一倍，即成0.05mol/L乳酸缓冲溶液。（pH=7.5）（NaH2PO3·2H2O）0.5gpH=10.5)甲液：称取硼酸钠19.08g,加水溶解并定容至1000mL。乙液：称取氢氧化钠4.0g,加水溶解并定容至1000mL。使用液：取甲液500ml,加乙液400ml,摇匀，用水稀释至1L。0.4mol/L准确称取无水碳酸钠42.4g,以蒸馏水溶解定溶至1000mL。0.4mol/L准确称取65.4三氯醋酸,以蒸馏水溶解定溶至1000mL。0.5mol/L的NaOH准确称取2gNaOH溶解并定至100mL。10.00mg/mL称取酪素1.000g,用少量的0.5mol/L的氢氧化钠溶液(若为酸性蛋白酶则用浓乳酸2-3滴)润湿,加入适量的各适宜的缓冲液约80mL,在沸水浴中边加热边搅拌,直至完全溶解,冷却后,转入100mL容量瓶中,用适宜的缓冲液稀释至刻度,此溶液在冰箱内贮存,有效期为三天。100μg/ml准确称取预先于105℃干燥至恒重的L-酪氨酸0.1000g,用1mol/L的盐酸60mL溶解后并用0.1mol/L100ml,即为1.00mg/mL吸取1.00mg/mL酪氨酸标准溶液10.00mL,用0.1mol/L盐酸定容至100mL,即得100.0μg/LL1.000g1mL100LB.2表B.2 L-酪酸准液制表试管号012345取100μg/ml酪氨溶液/mL012345蒸馏水/mL1098765酪氨酸实际浓度/(μg/mL)010203040500.4mol/L5.00mL40±0.220min680nm0管O为（μg9～10范围内40±0.25minB.3.6.2取41mL2mL31mL40℃保温10min32mL1mL静置10minB.3.6.6各取1mL滤液分别加0.4mol/L的Na2CO35ml，福林试剂1mL。在40℃显色20min。680nm处测OD值。以空白管调零点。OD（B4X=AK4n (B.4)10式中：X——蛋白酶的活力，单位为酶活力单位每克（U/g）或毫升（mL）；A——样品平行试验的平均OD值；K——吸光常数；4——反应试剂的总体积，单位为毫升（mL）；10——酶解反应时间，单位为分钟（min）；n——酶液稀释总倍数。脂肪酶定义1mL40℃，pH=7.51μmolU/g原理:RCOOH+NaOH——→RCOONa+H2OPVA1750±50。95%GB/T679)。a）称取聚乙烯醇(PVA)40g，加水800mL，在沸水浴中加热、搅拌，直至全部溶解，冷却后定容至1000mL。以干净的双层纱布过滤，取滤液备用；b）量取4%PVA溶液150mL，加橄榄油50mL，用高速组织捣碎机处理6min(分2次处理，每次3min,中间休息5min)，即成乳白色PVA乳化液。该溶液要现用现配。该溶液如贮存在冰箱中，有效期为一周。B.4.3.50.025mol/L磷酸缓冲液(pH=7.5)：甲液称取磷酸二氢钾(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高速组织捣碎机：8000r/min～12000r/min。B.4.4.3pH计：分度值为0.02pH单位或2mV。：10mL0.05mL吸取液体酶1.00mL，用磷酸缓冲液定容至刻度摇匀、稀释倍数参考表B.3，控制酶液浓度，样品与对照消耗碱量之差在1mL～2mL范围内。注意，吸取样品时，应将酶液摇匀后再取。表B.3 酶活估表估测酶活力U/g稀释倍数400060050007506000900测定用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氢氧化钠标准溶液滴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——样品的酶活力，单位为酶活力单位每克（u/g）；B——（mL）；A——（mL）；c——（mol/L）；0.05——氢氧化钠标准溶液浓度换算系数；50——0.05mol/L氢氧化钠溶液1.00mL相当于脂肪酸50微摩尔(μmol)；1/15——反应时间15min，以1min计；n——稀释倍数；所得的结果表示至整数。平行试验相对误差不得超过2%。CC附 录 C（规范性附录）医用清洗剂对血液和细菌混合物的去除效果测试方法目的测定医用清洗剂对有抗热能力的肠球菌和血液混合污染物的去除效果。肠球菌ATCC6057。新鲜羊血（72h以内）。鱼精蛋白盐酸盐（纯度≥99%）。肝素（纯度≥99%）。生理盐水。洗脱液吐温-800.1蛋白胨1.00.85用蒸馏水配制而成，调节pH值在7.0±0.2，经121℃压力蒸汽灭菌后使用。（TPS）胰蛋白胨1.0%。氯化钠0.85%。用蒸馏水配制而成，调节pH值在7.0±0.2，经121℃压力蒸汽灭菌后使用。CSL)酪蛋白胨1.7%。大豆蛋白胨琼脂0.3%。氯化钠0.05%。磷酸氢二钾0.023%。葡萄糖0.025%。用蒸馏水配制而成，调节pH为7.3±0.1，经121℃压力蒸汽灭菌后使用。(CSA)酪蛋白胨1.5%。大豆蛋白胨琼脂0.5%。氯化钠0.5%。琼脂1.5%。用蒸馏水配制而成，调节pH为7.3±0.1，经121℃压力蒸汽灭菌后使用。开槽圆柱头螺钉M6×20GB/T65有金属螺盖的玻璃罐（容积为470mL,可高压灭菌，并可放入转轴的广口罐），将罐口覆盖牛皮纸，加盖，于121℃压力蒸汽灭菌后备用。转动速度为45r/min～60r/min的滚动摇床。ATPATPATPATPATP生物荧光测试仪。肠球菌经增菌培养，分离纯化后，将纯培养物接种到CSL中，于36℃±1℃培养24h，次日重复以上操作。第3天，取0.1mL菌液接种于CSA上，在36℃±1℃的条件下培养72h。用生理盐水洗菌，将细菌悬浮液放入离心机内，以转速为6000r/min的速度离心10min～15min，弃去上清，用生理盐水将沉淀物再次混匀。将9.5mL（0.35mL0.15mL（浓度为4mg/mL）20min将经脱脂、灭菌处理的不锈钢螺丝钉完全浸没于测试污染物中至少1min后取出，置于36℃±1℃的条件下干燥5min至血液凝固。在试验开始前20min,将盛有300mL按产品说明书配制好的待测医用清洗剂的玻璃罐，在水浴中恒温至40℃（或者为产品说明书所规定的温度的最低值）。300mL45r/min～60r/min10mLATP101.0mLCSACSAATP同时用移液枪吸取洗脱液50μL，加入50μL裂解液，震荡混合，作用30s后加入400μL荧光素酶，进行RLU测定，然后加入10μL标准品溶液，读取其RLU及ATP含量。10mLC.3.5ATP1mL三次试验结果，对细菌的去除率应≥99%，且ATP含量下降率应≥99%，可判定为该医用清洗剂对血液和细菌的混合污染物清洗效果有效。DD附 录 D（规范性附录）医用清洗剂对人工模拟污染物去除效果评价方法目的通过符合ISO15883标准的模拟污染物的去除效果，判定其清洗效果。模拟污染物：蛋白、脂类和多糖的混合物。分析天平感量0.1mg。有金属螺盖的玻璃罐（容积为470mL,可高压灭菌，并可放入转轴的广口罐），将罐口覆盖牛皮纸，加盖，于121℃压力蒸汽灭菌后备用。转动速度为45r/min～60r/min的滚动摇床。3片模拟污染物为一组，在干燥器中过夜后，称重为m0。每组污染片待天平回零后称重三次，精确至0.1mg，取其平均值作为试验前重量。称重时，应用镊子夹取，勿以手直接接触样片。在试验开始前20min,将盛有300mL按产品说明书配制好的待测医用清洗剂的玻璃罐，在水浴中恒温至40℃。将3片模拟污染物分别放入3个盛有300mL待测医用清洗剂玻璃罐中，加盖。以45r/min～60r/min的转动速度旋转洗涤预定时间，取下玻璃罐，取出模拟污染物，挂在晾架上，30℃存放2h后，称重为m1，并目测其清洗效果。称量后的污染片，按以下步骤去污：30min；30min；30min；10min；pH30minm2（D.1）：R100% (D.1)m0m2式中：R——人工模拟污染物去除率，%；m0——清洗前模拟污染物质量，单位为毫克（mg）；m1——医用清洗剂清洗后模拟污染物质量，单位为毫克（mg）；m2——洗净后模拟污染物质量，单位为毫克（mg）；每一待测样品需准备三组模拟污染物。≥95%，EE附 录 E（规范性附录）医用清洗剂对脂肪、蛋白质和淀粉的去除效果评价方法目的医用清洗剂对测定污染物的去除率。猪油（食品级）。≥9淀粉≥9墙纸糊。载体片聚四氟乙烯片大小为10cm×5cm、每片重量为1.200g±0.010g。天平分析天平感量0.1mg。有金属螺盖的玻璃罐（容积为470mL,可高压灭菌，并可放入转轴的广口罐），将罐口覆盖牛皮纸，加盖，于121℃压力蒸汽灭菌后备用。转动速度为45r/min～60r/min的滚动摇床。淀粉污染物：淀粉3ｇ、墙纸糊0.5ｇ，加水至100mL；3ｇ0.5ｇ100mL50℃；45聚四氟乙烯片在使用前，应先进行脱脂处理。脱脂方法如下：30min；10m