 Cleanroom International Standrad |
Technical Committee 209 of the International Organization for Standardization (ISO) is close to completing its work on new international cleanroom standards which will more than likely displace the current U.S. Federal Standard 209E.
ISO/TC209 has proposed ten (10) documents (see table A) which will make up the cleanroom standards. Many of these documents are at the final voting stage and can be legally used in trade.
| ISO Document | Title |
| ISO-14644-1 | Classification of Air Cleanliness |
| ISO-14644-2 | Cleanroom Testing for Compliance |
| ISO-14644-3 | Biocontamination Control of Surfaces |
| ISO-14644-4 | Cleanroom Design & Construction |
| ISO-14644-5 | Cleanroom Operations |
| ISO-14644-6 | Terms, Definitions & Units |
| ISO-14644-7 | Minienvironments & Isolators |
| ISO-14698-1 | Biocontamination Control General Principles |
| ISO-14698-2 | Evaluation & Interpretation of Biocontamination Data |
| ISO-14698-3 | Biocontamination Control of Surfaces |
ISO-14644-1 Classification of Air Cleanliness
Cleanliness class designations and quantity have changed from FS209E (see table B). 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 B Airborne Particulate Cleanliness Classes |
||||||
| CLASS | Number of Particles per Cubic Meter by Micrometer Size | |||||
| 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 C compares FED STD 209E to the new ISO 14644-1.
| Table C Airborne Particulate Cleanliness Class Comparison |
||
| ISO 14644-1 | FED STD 209E | |
| 1 | ||
| 2 | ||
| 3 | 1 | M1.5 |
| 4 | 10 | M2.5 |
| 5 | 100 | M3.5 |
| 6 | 1,000 | M4.5 |
| 7 | 10,000 | M5.5 |
| 8 | 100,000 | M6.5 |
| 9 | ||
ISO-14644-2 Cleanroom Testing for Compliance
ISO 14644-2 determines the type and frequency of testing required to conform with the standard. Table D indicates which tests are mandatory and table E indicates which tests are optional.
Table DStrategic Testing (Required) |
|||
| Table 1 Schedule of tests to demonstrate continuing compliance | |||
| Test Parameter | Class | Maximum Time Interval | Test Procedure |
| Particle Count Test | <= ISO 5 | 6 Months | ISO 14644-1 Annex A |
| > ISO 5 | 12 Months | ||
| Air Pressure Difference | All Classes | 12 Months | ISO 14644-1 Annex B5 |
| Airflow | All Classes | 12 Months | ISO 14644-1 Annex B4 |
Table EStrategic Testing (Required) |
|||
| Table 2 Schedule of additional optional tests | |||
| Test Parameter | Class | Maximum Time Interval | Test Procedure |
| Installed Filter Leakage | All Classes | 24 Months | ISO 14644-3 Annex B6 |
| Containment Leakage | All Classes | 24 Months | ISO 14644-3 Annex B4 |
| Recovery | All Classes | 24 Months | ISO 14644-3 Annex B13 |
| Airflow Visualization | All Classes | 24 Months | ISO 14644-3 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 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.