US Federal Standard 209E_第4页

Federal Standard 209E was a United States standard that specified the cleanliness levels of cleanrooms and controlled environments. It was primarily used in industries where the control of particulate contamination is critical, such as semiconductor manufacturing, pharmaceuticals, and aerospace.

In 2001, Federal Standard 209E was superseded by ISO 14644, which provides a more comprehensive and internationally recognized framework for cleanroom classification and testing. ISO standards offer a more global approach to cleanroom cleanliness, aligning with international practices.

While Federal Standard 209E is no longer the primary standard in use, its legacy continues in the cleanroom industry, and understanding this standard can still be beneficial for those familiar with historical practices in cleanliness and contamination control.

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US Federal Standard 209E

Airborne Particulate Cleanliness Classes
CLASS	Number of Particles per Cubic Meter by Micrometer Size
	0.1 micron	0.2micron	0.3micron	0.5micron	1 micron	5 microns
IS01	10	2
ISO2	100	24	10	4
IS03	1,000	237	102	35	8
IS04	10,000	2,370	1,020	352	83
IS05	100,000	23,700	10,200	3,520	832	29
IS06	1,000,000	237,000	102,000	35,200	8,320	293
IS07				352,000	83,200	2,930
IS08				3,520,000	832,000	29,300
IS09				35,200,000	8,320,000	293,000

AirborneParticulate Cleanliness Class Comparison
ISO14644-1	FEDERALSTANDARD209E
ISO Class	English	Metric
ISO 1
ISO 2
ISO 3	1	M1.5
ISO 4	10	M2.5
ISO 5	100	M3.5
IS0 6	1,000	M4.5
ISO 7	10,000	M5.5
ISO 8	100,000	M6.5
ISO 9

Energy Efficient Low Operating Cost Cleanroom Airflow Design
FS Cleanroom Class	ISO Equivalent Class	Air Change Rate
1	ISO3	370-530
10	ISO 4	300-530
100	ISO 5	230-480
1,000	IS0 6	150-230
10,000	IS0 7	70-90
100,000	ISO 8	5-48

Federal and lSO Airflow Velocity Standards
Class ISO 146144-1 (FSD 209E)	Average Airflow Velocity m/s(ft/min)	Air Changes Per Hour	Ceiling Coverage
ISO8(Class 100,000)	0.005-0.041(1-8)	5-48	5-15%
ISO 7(Class 10,000)	0.051-0.076(10-15)	70-90	15-20%
ISO 6(Class 1,000)	0.127-0.203(25-30)	150-230	25-30%
ISO 5(Class 100)	0.203-0.306(30-80)	230-480	35-70%
ISO 4(Class 10)	0.254-0.457(50-90)	300-530	50-90%
ISO 3(Class 1)	0.305-0.457(70-90)	370-530	70-100%
IS01-2	0.305-0.508(70-100)	370-700	80-100%

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US Federal Standard 209E Video Introduction

FAQ

what is clean room classification?
It follows standards set by organizations such as the ISO (International Organization for Standardization). The classifications, such as ISO 1 to ISO 9, denote the maximum allowable particle count per cubic meter of air for specific particle sizes (e.g., 0.5 micrometers). Higher classifications (e.g., ISO 1) indicate cleaner environments with fewer particles,
What are the cleanroom classifications?
ISO 14644-2:ISO 1、ISO 2、ISO 3、ISO 4、ISO 5、ISO 6、ISO 7、ISO 8、ISO 9
FS 209E: Class 1,Class 10,Class 100,Class 1000,Class 1000,Class 10000,
What is the FDA classification of clean rooms?
Class A clean area: The level of airborne suspended particles is ISO 5, with ≥5.0μm suspended particles as the limit.
Class B clean area: The class of airborne suspended particles is ISO 6, which includes both ≥0.5μm and ≥5.0μm suspended particles.
Class C clean area: Airborne particles are classified as ISO 7 for static and dynamic conditions respectively.
Class D clean area: The airborne particulate level is ISO 8 for static conditions.
What is a Class 7 or 8 clean room?
ISO Class 7 clean room: Permissible dust particle count (0.5μm): not more than 352,000 particles per cubic meter.
ISO Class 8 clean room: Permissible dust particle count (0.5μm): not more than 3,520,000 particles per cubic meter.
What is class 1000 clean room?
A Class 1000 clean room, as defined by the Federal Standard 209E (FS209E), In a Class 1000 clean room, the environment is controlled to maintain an acceptable level of airborne particles, For particles of size 0.5 micrometers (μm)1,000 particles per cubic foot(approximately 35,300 particles per cubic meter).
what is a class 10 clean room?
A Class 10 clean room, as defined by the Federal Standard 209E (FS209E), For particles of size 0.5 micrometers (μm).10 particles per cubic foot (approximately 353 particles per cubic meter).
What are the lSO 6 standards?
Key Specifications for ISO 6 Clean Rooms:
For particles of 0.5 micrometers (μm) in size: 1,000,000 particles per cubic meter (approximately 35,300 particles per cubic foot).
For particles of 5.0 micrometers (μm) in size: 29,300 particles per cubic meter (approximately 1,000 particles per cubic foot).
ISO 6 defines a clean room environment with specific limits on airborne particulate contamination, providing guidance for industries that require controlled environments but do not need the stricter cleanliness levels of ISO 5 or higher classifications.
What is lSO 14644 clean room classification?
ISO 14644 is an international standard that provides guidelines for cleanrooms and controlled environments. It includes a series of standards that define the classification of air cleanliness according to the concentration of airborne particulate contamination.
The classifications range from ISO Class 1 (the cleanest) to ISO Class 9 (the least clean).
What is GMP Class A and B cleanroom environments??
Class A: 3520 suspended particles greater than or equal to 0.5 microns and 20 suspended particles greater than or equal to 5.0 microns per cubic meter in a static environment. The requirements for dynamic environments are the same as for static.
Class B (Class B): per cubic meter, static environment, close to Class A, suspended particles greater than or equal to 0.5 microns are allowed 3520, and suspended particles greater than or equal to 5.0 microns are allowed 29. In a dynamic environment, 352,000 suspended particles greater than or equal to 0.5 microns and 2900 suspended particles greater than or equal to 5.0 microns are allowed.
What is lSO 14644 clean room classification?
ISO (International Organization for Standardization) and GMP (Good Manufacturing Practice) are both important frameworks that establish standards for cleanrooms, but they serve different purposes and focus on different aspects of cleanroom management and operation.