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1、洁净室(区)空气洁净级别表洁净度级别尘粒最大允许数/立方米≥0.5μm尘粒数≥5μm尘粒数微生物最大允许数浮游菌/立方米沉降菌/皿100级3,50005110,000级350,0002,0001003100,000级3,500,00020,00050010300,000级10,500,00060,000100015ISO14644-1(国际标准)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(空气粒子数个/立方米)0.1um0.2um0.3um0.5um1.0um5.0umISOClass1102ISOC
2、lass210024104ISOClass31,000237102358ISOClass410,0002,3701,02035283ISOClass5100,00023,70010,2003,52083229ISOClass61,000,000237,000102,00035,2008,320293ISOClass7352,00083,2002,930ISOClass83,520,000832,00029,300ISOClass935,200,0008,320,000293,000注:由于涉及测量过程的不确定性,故
3、要求用不超过三个有效的浓度数字来确定等级水平各国洁净度等级近似对照表个/M≥0.5umISO14644-1US209E(1992)US209D(1988)EECcGMP(1989)FRANCEAFNOR(1981)GERMANYVDI2083(1990)JAPANJAOA(1989)1-------3.52----0210.0-M1-----35.33M1.51--13100-M2-----3534M2.510--241,000-M3-----3,5305M3.5100A+B4,0003510,000-M4----
4、-35,3006M4.51,0001,000-46100,000-M5-----353,0007M5.510,000C400,000571,000,000-M6-----3,530,0008M6.5100,000D4,000,0006810,000,000-M7-----洁净室及洁净区空气中悬浮粒子洁净度等级空气洁净度等级(N)大于或等于表中粒径的最大浓度限值(pc/m³)0.1um0.2um0.3um0.5um1um5um1102210024104310002371023584(十级)10000237010203
5、52835(百级)10000023700102003520832296(千级)10000002370001020003520083202937(万级)3520008320029308(十万级)3520000832000293009(一百万级)352000008320000293000