iso 14644

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 C n = 10 N (0.1 / D)2.08

(1)

where C n = 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 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 m

> 0.2 m

> 0.3 m

> 0.5 m

ISO Class 1

10

2

ISO Class 2

100

ISO Class 3

> 1 m

> 5 m

24

10

4

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

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ISO Cleanroom Standards y y y

y y y y y y y y

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 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: y y

y

ISO Establishes 0.1um as the "Standard" Diameter ISO Creates 3 New Cleanliness Classeso 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 ISO 1

10

0.2 um

2

0.3 um

0.5 um

1 um

5 um





ISO 3 ISO 4 ISO 5 ISO 6

1,000

237

102

35

8

10,000

2,370

1,020

352

83

100,000

23,700

10,200

3,520

832

29

1,000,000 237,000 102,000

35,200

8,320

293

ISO 7 ISO 8 ISO 9

352,000

83,200

2,930

3,520,000

832,000

29,300

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

Airborne Particulate Cleanliness Class Comparison

3

1 M1.5

4

10 M2.5

5

100 M3.5

6

1,000 M4.5

7

10,000 M5.5





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.

Test Parameter

Class

Maximum Time

Test

Interval

Procedure

< or = ISO 5

6 Months

> ISO 5

12 Months

Air Pressure Difference

All Classes

12 Months

Airflow

All Classes

12 Months

Particle Count Test

ISO 14644-1 Annex A

ISO 14644-1 Annex B5 ISO 14644-1 Annex B4

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

Maximum

Test

Time Interval

Procedure

Test Parameter

Class

Installed Filter Leakage

All Classes

24 Months

Containment Leakage

All Classes

24 Months

Recovery

All Classes

24 Months

Airflow Visualization

All Classes

24 Months

ISO 14644-3 Annex B6 ISO 14644-3 Annex B4 ISO 14644-3 Annex B13 ISO 14644-3 Annex B7







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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iso 14644

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