Cleanliness class designations and quantity have changed from
FS209E. Along with the obvious change to metric measure of air volume, ISO
14644-1 adds three additional classes - two cleaner than Class 10 and one
dirtier than Class 100,000.
Table A
Airborne Particulate Cleanliness Classes
|
Number of
Particles per Cubic Meter by Micrometer Size |
||||||
|
CLASS |
0.1µm |
0.2 |
0.3µm |
0.5µm |
1µm |
5µm |
|
ISO-1 |
10 |
2 |
- |
- |
- |
- |
|
ISO-2 |
100 |
24 |
10 |
4 |
- |
- |
|
ISO-3 |
1000 |
237 |
102 |
35 |
8 |
- |
|
ISO-4 |
10,000 |
2370 |
1020 |
352 |
83 |
- |
|
ISO-5 |
100,000 |
23700 |
10200 |
3520 |
832 |
29 |
|
ISO-6 |
1000000 |
237000 |
102000 |
35200 |
8320 |
293 |
|
ISO-7 |
NA |
NA |
NA |
352000 |
83200 |
2930 |
|
ISO-8 |
NA |
NA |
NA |
3520000 |
832000 |
29300 |
|
ISO-9 |
NA |
NA |
NA |
35200000 |
8320000 |
293000 |
Table B compares FED STD 209E to the new ISO
14644-1.
Table B
Airborne Particulate Cleanliness Class Comparison
|
ISO-14644-I |
FED.STD-209E |
|
|
1 |
NA |
NA |
|
2 |
NA |
NA |
|
3 |
1 |
M1.5 |
|
4 |
10 |
M2.5 |
|
5 |
100 |
M3.5 |
|
6 |
1000 |
M4.5 |
|
7 |
10,000 |
M5.5 |
|
8 |
100,000 |
M6.5 |
|
9 |
NA |
NA |
ISO-14644-2
Cleanroom Testing for Compliance
ISO 14644-2 determines the type and frequency of testing required
to conform to the standard. Table C indicates which tests are mandatory and
table E indicates which tests are optional.
Table C
Strategic Testing (Required)
Table 1 Schedule of tests to demonstrate
continuing compliance.
|
Test Parameter |
Class |
Maximum Time Interval |
Test Procedure |
|
Non-Viable
Particle Counting |
ISO1-5 |
6 Months |
ISO-14644-I |
|
Recovery Test |
ISO5-9 |
12 Months |
ISO-14644-I |
|
Pressure
Differential |
All |
12 Months |
ISO-14644-I |
|
Airflow |
All |
12 Months |
ISO-14644-I |
Table
D
Strategic Testing (Required)
Table 2 Schedule of additional optional tests
|
Test Parameter |
Class |
Maximum Time Interval |
Test Procedure |
|
Installed Filter Leakage |
All |
24 Months |
ISO-14644-III |
|
Containment Leakage |
All |
24 Months |
ISO-14644-III |
|
Recovery |
All |
24 Months |
ISO-14644-III |
|
Airflow Visualization |
All |
24 Months |
ISO-14644-III |
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 a primer 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.