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Clean operating room cleanliness level standard description

2024-10-20 Visits:

Clean operating room cleanliness level standard description

gradeMaximum average concentration of settled (floating) bacteriaMaximum surface contamination densityAir cleanliness level
Operating room areaSurrounding areaOperating room areaSurrounding area
I0.2 pieces/30min φ 90m (5 pieces/m3)0.4 pieces/30min φ 90mL (10 pieces/m3)5pcs/cmLevel 100Level 1000
II0.75 pieces/30min φ 90m (25 pieces/m3)1.5 pieces/30min φ 90 mm (50 pieces/m3)25pcs/cmLevel 1000Level 10000
III2 pieces/30min φ 90m (75 pieces/m3)4 pieces/30min φ 90 mm (150 pieces/m3)25pcs/cmLevel 10000Level 100000
IV5 pieces/30min, φ90  (175 pieces/m3)25pcs/cm2Level 300000


Other clean room grade standards for reference:

《Good Manufacturing Practice for Pharmaceuticals 》(revised in 1992)

Purification levelNumber of live particles/cubic meterNumber of viable microorganisms/cubic meter
≥0.5um≥5um
Level 1000≤3,5000≤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

0.5um5um
Dust holding unitDust holding unitDust holding unitDust holding unitDust holding unit

International units

Imperial

Units

m3Ft3m3Ft3m3Ft3m3t3m3Ft3

M1.0

1

350

9.91

75.7

2.14

30.9

0.87510

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

10035000991.0

7570

214

3090

87.5

1000

283



M3.5




26500

750

10600

300

3530

1000



M4.0

1000

75700214030900875

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

2830006180175

M6.5








3530000

100000

24700700
M7.01000000





10000000283000618001750


ISO/DIS 14644-1 Classification of clean rooms and clean areas according to the concentration of suspended particles in the air

iso-cleanrooms.jpg

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