Clean room maintained virtually free of contaminants, such as dust or bacteria, are used in laboratory work and

in the production of precision parts for electronic or aerospace equipment.

In the clean room standard ISO 14644-1 "Classification of Air Cleanliness" the classes are based on the
formula

Cn = 10N (0.1 / D)2.08            (1)

where

Cn = maximum permitted number of particles per cubic meter equal to or greater than the specified particle
size, rounded to whole number

N = is the ISO class number, which must be a multiple of 0.1 and be 9 or less

D = is the particle size in micrometers

Maximum Number of Particles in Air

(particles in each cubic meter equal to or greater than the specified size)

ISO
Class Particle size

> 0.1 μm > 0.2 μm > 0.3 μm > 0.5 μm > 1 μm > 5 μm

ISO Class 1 10 2

4
ISO Class 2 100 24 10

ISO Class 3 1000 237 102 35 8

ISO Class 4 10,000 2,370 1,020 352 83
ISO Class 5 100,000 23,700 10,200 3,520 832 29
ISO Class 6 1,000,000 237,000 102,000 35,200 8,320 293
ISO Class 7 352,000 83,200 2930
ISO Class 8 3,520,000 832,000 29,300
ISO Class 9 35,200,000 8,320,000 293,000
ISO Cleanroom Standards

 ISO-14644-1 Classification of Air Cleanliness

 ISO-14644-2 Cleanroom Testing for Compliance
 ISO-14644-3 Methods for Evaluating & Measuring Cleanrooms & Associated
Controlled Environment
 ISO-14644-4 Cleanroom Design & Construction
 ISO-14644-5 Cleanroom Operations
 ISO-14644-6 Terms, Definitions & Units
 ISO-14644-7 Enhanced Clean Devices
 ISO-14644-8 Molecular Contamination
 ISO-14698-1 Biocontamination: Control General Principles
 ISO-14698-2 Biocontamination: Evaluation & Interpretation of Data
 ISO-14698-3 Biocontamination: Methodology for Measuring Efficiency of
Cleaning Inert Surfaces
Sterile Environment Technologies practices proper procedures to Decontaminate your
Cleanroom, Data Center, and other critical environments.

ISO 14644 Standards can be found through IEST, the Secretariat of ISO/TC209.

Data Centers
What is Federal Standard 209e for Data Centers?
The outmoded (replaced by ISO 14644) benchmark for optimum and safe operating levels is compared to
Federal Standard 209e for Data Centers at 100,000 particles at .5 microns per cubic foot of air space. Optimum
levels for temperature should normally be 70 to 72 degrees Fahrenheit, with humidity levels at 50%.

Please note: equipment manufacturers have varying optimum operating levels.

Notice:
Federal Standard 209E has been replaced with ISO Standard 14644. The first subsection in ISO 14644 (ISO
STND. 14644-1) has some unique changes from the old Federal Standard - however they are very similar. This
standard is now in effect for critical environments (Cleanrooms, Data Centers, etc.) worldwide. Some companies
have been successful with the federal Standard 209E, and may not have switched over yet. It is important for
these companies to know the main differences are easy to implement and may not be a costly change.
The main differences between Federal Standard 209E and ISO 14644-1 (Testing Standards) are:

 ISO Establishes 0.1um as the "Standard" Diameter

 ISO Creates 3 New Cleanliness Classes-
o 2 "Cleaner" classes (ISO class 1 and ISO class 2) than Federal Standard 209E
o 1 "Dirtier" Class (ISO Class 9) which is allows more particulate than Fed Standard 209E class
100,000
 Allows for discarding of "Outliers" - Federal Standard 209E did not.

International Standards for Cleanrooms and Critical Environments

International Cleanroom Standards:
ISO/TC209 has proposed ten (10) documents which will make up the cleanroom standards. These documents
are in their final voting stages and can be legally used in trade. The tables and sections below outline the first
seven of these documents in order.

ISO-14644-1 Classification of Air Cleanliness

Cleanliness class designations and quantity have changed from FS209E (see Table 1). Along with the obvious
change to metric measure of air volume, ISO 14644-1 adds three additional classes.

(Table 1) Airborne Particulate Cleanliness Classes (same as table above)

Number of Particles per Cubic Meter by Micrometer Size
 Class
 0.1 um  0.2 um 0.3 um  0.5 um  1 um  5 um 

 ISO 1 10  2         

 ISO 2 100  24  10  4     

 ISO 3 1,000  237   102 35  8   

  ISO 4 10,000  2,370  1,020  352   83  

 ISO 5 100,000  23,700  10,200  3,520   832 29 

 ISO 6 1,000,000  237,000  102,000  35,200   8,320 293 

 ISO 7       352,000  83,200  2,930 

 ISO 8       3,520,000  832,000  29,300 

 ISO 9       35,200,000  8,320,000  293,000 

(Table 2) Comparing FED STD 209E to the new ISO 14644-1.

 ISO 14644-1  FED STD 209E
1    

2   

3 1   M1.5

4 10   M2.5
Airborne Particulate
Cleanliness Class 5 100   M3.5
Comparison
6 1,000   M4.5

7 10,000   M5.5

8 100,000   M6.5

9   

ISO-14644-2 Cleanroom Testing for Compliance

This document determines the type and frequency of testing required to conform with the standard.

Strategic Testing: (Table 1) Schedule of Tests to Demonstrate Continuing

Compliance.
Maximum Time Test
 Test Parameter Class
Interval Procedure
 < or = ISO 5 6 Months ISO 14644-1
 Particle Count Test
Annex A
 > ISO 5 12 Months

 ISO 14644-1
 Air Pressure Difference All Classes 12 Months
Annex B5

ISO 14644-1
 Airflow All Classes 12 Months
Annex B4

Strategic Testing: (Table 2) Schedule of Additional Optional Tests.

Maximum
 Test Parameter Class Test Procedure
Time Interval

 ISO 14644-3
 Installed Filter Leakage  All Classes  24 Months
Annex B6

 ISO 14644-3
 Containment Leakage  All Classes  24 Months
Annex B4

 ISO 14644-3
 Recovery All Classes 24 Months
Annex B13

ISO 14644-3
Airflow Visualization All Classes 24 Months
Annex B7

ISO-14644-4 Cleanroom Design & Construction

This document will be a primer on the design and construction of cleanrooms. It will cover all aspects of the
process from design development to startup and commissioning.

ISO-14644-5 Cleanroom Operations

This document will be an introduction on cleanroom operation. It will cover all aspects of the operation of a
cleanroom including entry and exit procedures for equipment and personnel, education and training, cleanroom
apparel, and facility issues such as maintenance, housekeeping, monitoring, system failure, etc.

ISO-14644-6 Terms, Definitions & Units

This document will provide a consistent reference for all terms, definitions and units discussed across all ISO
cleanroom standards.

ISO-14644-7 Minienvironments & Isolators

This document will focus on specialized stand-alone clean spaces including their design, construction, and
operations.
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