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
中国药品生产洁净室（区）的空气洁净度标准
| 洁净度级别 | 尘埃最允许数/平方米 | 微生物最大允许数 | ||
|---|---|---|---|---|
| ≥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最大浓度限值(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 | 35200000 | 8320000 | 293000 | |||
国家标准GB50073-2001
空气过滤器效率规格对照表
常用净化车间洁净度等级
