■ 美国联邦标准（USA Federal Standard）209E（1992年） | 洁净度级别 | 粒 径 (um) | | 0.1 | 0.2 | 0.3 | 0.5 | 5.0 | | 1 | 35.0 | 7.50 | 3.00 | 1.00 | NA | | 10 | 350 | 75.0 | 30.0 | 10.0 | NA | | 100 | NA | 750 | 300 | 100 | NA | | 1000 | NA | NA | NA | 1000 | 7.0 | | 10000 | NA | NA | NA | 10000 | 70.3 | | 100000 | NA | NA | NA | 100000 | 700 |
单位：尘埃数量个/ft3 ■ 中国药品生产洁净室（区）的空气洁净度标准 | 洁净度级别 | 尘埃*允许数/平方米 | 微生物*大允许数 | | ≥0.5um | ≥5um | 浮游菌个/立方米 | 沉降菌个/皿.30min | | 100 | 3500 | 0 | 5 | 1 | | 10000 | 350,000 | 2,000 | 100 | 3 | | 100000 | 3,500,000 | 20,000 | 500 | 10 | | 300000 | 10,500,000 | 61,800 | NA | 15 |
国家1999年8月1日发布实施
■ 基于≥0.5um粒径的各国洁净度等级近似对照表
| 个/M3≥0.5um | ISO
14644-1(1999) | US
209E(1992) | US
209D(1988) | EEC
GGMP(1989) | FRANCE
AFNOR(1981) | GERMANY
VDI 2083(1990) | JAPAN
JAOA(1989) | | 1 | - | - | - | - | - | - | - | | 3.5 | 2 | - | - | - | - | 0 | 2 | | 10.0 | - | M1 | - | - | - | - | - | | 35.3 | 3 | M1.5 | 1 | - | - | 1 | 3 | | 100 | - | M2 | - | - | - | - | - | | 353 | 4 | M2.5 | 10 | - | - | 2 | 4 | | 1,000 | - | M3 | - | - | - | - | - | | 3,530 | 5 | M3.5 | 100 | A+B | 4,000 | 3 | 5 | | 10,000 | - | M4 | - | - | - | - | - | | 35,300 | 6 | M4.5 | 1,000 | 1,000 | - | 4 | 6 | | 100,000 | - | M5 | - | - | - | - | - | | 353,000 | 7 | M5.5 | 10,000 | C | 400,000 | 5 | 7 | | 1,000,000 | - | M6 | - | - | - | - | - | | 3,530,000 | 8 | M6.5 | 100,000 | D | 4,000,000 | 6 | 8 | | 10,000,000 | - | 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*大浓度限值(pc/m3) | | 0.1um | 0.2um | 0.3um | 0.5um | 1um | 5um | | 1 | 10 | 2 | | | | | | 2 | 100 | 24 | 10 | 4 | | | | 3 | 1000 | 237 | 102 | 35 | 8 | | | 4 | 10000 | 2370 | 1020 | 352 | 83 | | | 5 | 100000 | 23700 | 10200 | 3520 | 832 | 29 | | 6 | 1000000 | 237000 | 102000 | 35200 | 8320 | 293 | | 7 | | | | 352000 | 83200 | 2930 | | 8 | | | | 3520000 | 832000 | 29300 | | 9 | | | | | 8320000 | 293000 |
国家标准GB50073-2001 |
