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The ISO cleanroom classification standard is specified by ISO 14644-1, which aims to classify cleanrooms of different levels according to the concentration of particulate matter in the air.
According to the air cleanliness standard in the cleanroom, cleanrooms are divided into multiple levels, from ISO Class 1 to ISO Class 9. The lower the level number, the lower the concentration of particulate matter allowed in the air and the higher the cleanliness requirement.
ISO 14644 is a series of international standards developed by the International Organization for Standardization (ISO) that outlines the requirements for cleanrooms and controlled environments. The purpose of these standards is to ensure that the cleanliness of air in these environments is controlled to minimize contamination, thus protecting product quality and safety in various industries.
ISO 14644-1 Clean Room Standards
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% |
| ISO 2 | 0.305-0.508(70-100) | 370-700 | 80-100% |
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.
