ISO 14644 Cleanliness Classes

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.