■ 中國醫療器械、藥品生產潔凈室（區）的空氣潔凈度標準
潔凈度級別 | 塵埃最允許數/平方米 | 微生物最大允許數 | | ≥0.5um | ≥5um | 浮游菌個/立方米 | 沉降菌個/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 |
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■ 基于≥0.5um粒徑的各國潔凈度等級近似對照表
個/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 | - | - | - | - | - |
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