1湖南纯臻净化工程无尘车间等级标准无尘车间洁净度等级标准 ISO14644 根据悬浮粒子浓度这个唯一指标来划分洁净室(区)及相关受控环境中空气无尘车间洁净度的等级,并且仅考虑粒径限值(低限)0.1um~0.5um 范围内累计分布的粒子群。根据粒子径,可以划分为常规粒子(0.1um~0.5um)、超微粒子(<0.1um)和宏粒子(>5.0um)。空气洁净度等级(N)大于或等于所标粒径的粒子最大浓度限值(个/每立方米空气粒子)0.1um0.2um0.3um0.5um1.0um5.0umISOClass1102ISOClass210024104ISOClass31,000237102358ISOClass410,0002,3701,02035283ISOClass5100,00023,70010,2003,52083229ISOClass61,000,000237,000102,00035,2008,320293ISOClass7352,00083,2002,930ISOClass83,520,000832,00029,300ISOClass935,200,0008,320,000293,000注:由于涉及测量过程的不确定性,故要求用不超过三个有效的浓度数字来确定等级水平空气无尘车间洁净度分级标准:ISO14644-1(国际标准)空气无尘车间洁净度分级标准:GB/T16292-1996(中国标准)粒径、数值无尘车间洁净度级别尘埃最大允许数/立方米微生物做大允许数≥0.5um≥5.0um游浮菌/立方米沉降菌/皿100 级3,500051,000 级35,0002005010,000 级350,0002,000100100,000 级3,500,00020,0005000300,000 级10,500,00060,00052湖南纯臻净化工程美国联邦标准(USAFederalStandard)空气中微粒的洁净等级对照空气微粒洁净等级(每立方米,每立方英尺)微粒的最大浓度限值ISO14644-1FEDSTD209ECLASSNumberofParCubicMeterbyMicrometerSizeISOClassEnglishMetric0.1um0.2um0.3um0.5um0.5um5umm3m3m3ft3m31ISO11022ISO21002610431M1.5 1SO31,00026510635410M2.5 ISO410,0002,6501,060103535(百级)100M3.5 ISO5100,00026,50010,6001003,530296(千级)1,000M4.5 ISO61,000,000265,000106,000100035,3002937(万级)10,000M5.5 ISO710000353,0002,9308(十万级)100,000M6.5 ISO81000003,530,00029,3009ISO9100000035,300,000293,000中国药品生产洁净室(区)的空气无尘车间洁净度标准尘埃最允许数/立方米微生物最大允许数无尘车间洁净度级别≥0.5um≥5um浮游菌个/立方米沉降菌个/皿.30min100350005110000350,0002,00010031000003,500,00020,0005001030000010,500,00061,800NA15国家药品监督管理局 1999 年 8 月 1 日发布实施基于≥0.5um 粒径的各国无尘车间洁净度等级近似对照表个/M3≥0.5umISO14644-1(1999)...