Cleanroom Classification Table (ISO / FED STD / GMP)

Cleanroom Level	ISO 14644-1			FED STD 209E	EU GMP Grade (In Operation)	Particle Count Standard (≧0.5µm)
Ultra Clean	ISO Class 1			-	-	≦10 particles/m3
Very Clean	ISO Class 2			-	-	≦100 particles/m3
Superior Grade	ISO Class 3			Class 1	-	≦1,000 particles/m3
High Grade	ISO Class 4			Class 10	Grade A	≦10,000 particles/m3
Medium Grade	ISO Class 5			Class 100	Grade B	≦100,000 particles/m3
Common Grade	ISO Class 6			Class 1,000	Grade C	≦1,000,000 particles/m3
Basic Grade	ISO Class 7			Class 10,000	Grade D	-
Minimum Grade	ISO Class 8			Class 100,000	-	-

※Particle Size and Typical Applications
Particle Size Description / Application Example
≥0.5μm Standard for semiconductor and optical assembly
≥0.3μm Higher-grade control for medical and pharmaceutical
≥5μm Common threshold for GMP pharmaceutical regulations

※Notes
ISO 14644-1: The current international standard used widely across industries such as semiconductor, optics, pharmaceuticals, and medical devices.
FED STD 209E: An outdated U.S. federal standard that has been replaced by ISO but is still referenced in some legacy systems or documents.
EU GMP Grades: Used in pharmaceutical cleanrooms, with grades A to D defined by operational state (in operation or at rest). The table shows "in operation" levels.