Clean operating room cleanliness level standard description
grade | Maximum average concentration of settled (floating) bacteria | Maximum surface contamination density | Air cleanliness level | ||
Operating room area | Surrounding area | Operating room area | Surrounding area | ||
I | 0.2 pieces/30min φ 90m (5 pieces/m3) | 0.4 pieces/30min φ 90mL (10 pieces/m3) | 5pcs/cm | Level 100 | Level 1000 |
II | 0.75 pieces/30min φ 90m (25 pieces/m3) | 1.5 pieces/30min φ 90 mm (50 pieces/m3) | 25pcs/cm | Level 1000 | Level 10000 |
III | 2 pieces/30min φ 90m (75 pieces/m3) | 4 pieces/30min φ 90 mm (150 pieces/m3) | 25pcs/cm | Level 10000 | Level 100000 |
IV | 5 pieces/30min, φ90 (175 pieces/m3) | 25pcs/cm2 | Level 300000 |
Other clean room grade standards for reference:
《Good Manufacturing Practice for Pharmaceuticals 》(revised in 1992)
Purification level | Number of live particles/cubic meter | Number of viable microorganisms/cubic meter | |
≥0.5um | ≥5um | ||
Level 1000 | ≤3,500 | 0 | ≤5 |
Level 10000 | ≤350,000 | ≤2,000 | ≤100 |
Level 100000 | ≤3,500,000 | ≤20,000 | ≤500 |
US Federal Standard 209E Cleanliness Standard Description:
Level Name | Level Limit | ||||||||||
0.1um | 0.2um | 0.3um | 0.5um | 5um | |||||||
Dust holding unit | Dust holding unit | Dust holding unit | Dust holding unit | Dust holding unit | |||||||
International units | Imperial Units | m3 | Ft3 | m3 | Ft3 | m3 | Ft3 | m3 | t3 | m3 | Ft3 |
M1.0 | 1 | 350 | 9.91 | 75.7 | 2.14 | 30.9 | 0.875 | 10 | 0.283 | ||
M1.5 | 1240 | 35.0 | 265.0 | 7.5 | 106 | 3 | 35.3 | 2.83 | |||
M2.0 | 10 | 3500 | 99.1 | 757 | 21.4 | 309 | 8.75 | 100 | 28.3 | ||
M2.5 | 12400 | 350.0 | 2650 | 75 | 1060 | 30 | 353 | 100 | |||
M3.0 | 100 | 35000 | 991.0 | 7570 | 214 | 3090 | 87.5 | 1000 | 283 | ||
M3.5 | 26500 | 750 | 10600 | 300 | 3530 | 1000 | |||||
M4.0 | 1000 | 75700 | 2140 | 30900 | 875 | 10000 | 2830 | ||||
M4.5 | 35300 | 10000 | 247 | 7 | |||||||
M5.0 | 10000 | 100000 | 28300 | 618 | 17.5 | ||||||
M5.5 | 353000 | 100000 | 2470 | 70 | |||||||
M6.0 | 100000 | 1000000 | 283000 | 6180 | 175 | ||||||
M6.5 | 3530000 | 100000 | 24700 | 700 | |||||||
M7.0 | 1000000 | 10000000 | 283000 | 61800 | 1750 |