ISO14644-1 | FED STD 209E | CLASS | Number of Par Cubic Meter by Micrometer Size | ISO Class | English | Metric | | 0.1um | 0.2um | 0.3um | 0.5um | 0.5um | 5um | | | | | m3 | m3 | m3 | ft3 | m3 | | 1 | | | ISO1 | | | | | | | 2 | | | ISO2 | | | | | 4 | | 3 | 1 | M1.5 | 1SO3 | | | | | 35 | | 4 | 10 | M2.5 | ISO4 | | | | 10 | 353 | | 5(百级) | 100 | M3.5 | ISO5 | | | | 100 | 3,530 | 29 | 6(千级) | 1,000 | M4.5 | ISO6 | | | | 1000 | 35,300 | 293 | 7(万级) | 10,000 | M5.5 | ISO7 | | | | 10000 | 353,000 | 2,930 | 8(十万级) | 100,000 | M6.5 | ISO8 | | | | 100000 | 3,530,000 | 29,300 | 9 | | | ISO9 | | | | 1000000 | 35,300,000 | 293,000 |
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■ 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/立方米 | 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 |
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