ISO 14644

ISO 14644 Standards were first formed from the US Federal Standard 209E Airborne Particulate Cleanliness Classes in Cleanrooms and Clean Zones. The need for a single standard for cleanroom classification and testing was long felt. After ANSI and IEST petitioned to ISO for new standards, the first document of ISO 14644 was published in 1999, ISO 14644-1.[1]

In 2000, ISO 14644-2 was published, which began the process of FED-STD-209E being canceled. On November 29, 2001, the document was canceled and superseded by ISO 14644-1 and ISO 14644-2.[2]

ISO 14644 is now composed of
  • ISO 14644-1: Classification of air cleanliness[3]
  • ISO/DIS 14644-1.2(2014): Classification of air cleanliness by particle concentration[4]
  • ISO 14644-2: Specifications for testing and monitoring to prove continued compliance with ISO 14644-1[3]
  • ISO/DIS 14644-2.2(2014): Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration[5]
  • ISO 14644-3: Test Methods[3]
  • ISO 14644-4: Design, Construction, and Start-up[3]
  • ISO 14644-5: Operations[3]
  • ISO 14644-6: Vocabulary[3]
  • ISO 14644-7: Separative devices (clean air hoods, gloveboxes, isolators and minienvironments[3]
  • ISO 14644-8: Classification of airborne molecular contamination[3]
  • ISO 14644-9: Classification of surface particle cleanliness[3]
  • ISO 14644-10: Classification of Surface Cleanliness by Chemical Concentration
  • ISO 14644-12: Classification of Air Cleanliness by Nanoscale Particle Concentration

Part 1: Classification of air cleanliness

ISO 14644-1 covers the classification of air cleanliness in cleanrooms and associated controlled environments. Classification in accordance with this standard is specified and accomplished exclusively in terms of concentration of airborne particulates.[6] The document was submitted as an American National Standard and has been adopted as ANSI/IEST/ISO 14644-1:1999 in the United States, following the cancellation of FED-STD-209E.[6]

Part 2: Specifications for testing and monitoring to prove continued compliance with ISO 14644-1

Part 2 specifies requirements for periodic testing of a cleanroom or clean zone to prove its continued compliance with ISO 14644-1 for the designated classification of airborne particulate cleanliness. It also specifies requirements for the monitoring of a cleanroom or clean zone (installation) to provide evidence of its continued compliance with ISO 14644-1 for the designated classification of airborne particulate cleanliness.[7] It became an International Standard following the cancellation of FED-STD-209E. In the United States in 2000 it was adopted as ANSI/IEST/ISO 14644-2:2000.[7]

Part 3: Test Methods

This part specifies test methods for designated classification of airborne particulate cleanliness and for characterizing the performance of cleanrooms and clean zones. These test methods are specified in the document for two different types of cleanrooms and clean zones; unidirectional flow and nonunidirectional flow.[8]

The most important objectives of this highly referenced document are to provide an internationally common basis of measurement and evaluation of cleanrooms and, at the same time, not to prevent the introduction of new technologies.[8]

Part 4: Design, construction and start-up

This part specifies requirements for the design and construction of cleanroom and clean air devices, as well as requirements for start-up and qualification, but does not prescribe specific technological nor contractual means to meet the requirements. This document is intended for purchasers, suppliers, and designers of cleanroom installations.[9] It was submitted as an American National Standard in 2001.[9]

Part 5: Operations

ISO 14644-5 provides the basic requirements for operating and maintaining cleanrooms and associated controlled environments. This standard addresses requirements that are basic to the operation of all cleanrooms, regardless of the application. Topics include:[10]

  • Operational systems that must be in place[10]
  • Selection and use of appropriate cleanroom garments[10]
  • Training and monitoring of personnel and activities[10]
  • Installation and use of equipment[10]
  • Requirements for materials used in the cleanroom[10]
  • Maintaining the cleanroom environment in a clean, usable condition conforming to design standards.[10]

This part was published as an International Standard in 2004. The document was submitted as an American National Standard and has been adopted as ANSI/IEST/ISO 14644-5:2004 in the United States.[10]

Part 6: Vocabulary

This part is an important document for any contamination control professional. This document describes all the terms and definitions in ISO 14644 and ISO 14698. In March 2008 this ISO Standard recently became an American National Standard.[11]

Part 7: Separative devices (clean air hoods, gloveboxes, isolators and minienvironments)

This part of ISO 14644 specifies the minimum requirements for the design, construction, installation, testing and approval of separative devices in those respects where they differ from cleanrooms as described in Parts 4 and 5. Separative devices range from open to closed systems.[12]

The limitations are:

  • Application-specific requirements are not addressed.[12]
  • User requirements are as agreed by customer and supplier.[12]
  • Specific processes to be accommodated in the separative device installation are not specified.[12]
  • Fire, safety and other regulatory matters are not considered specifically; the appropriate national and local requirements shall be respected.[12]
  • Full-suits are not within the scope of this standard.[12]

This part was published as an International Standard in 2004. The document was submitted as an American National Standard and has been adopted as ANSI/IEST/ISO 14644-7:2004.[12]

Part 8: Classification of airborne molecular contamination

This part of ISO 14644 covers the classification of airborne molecular contamination (AMC) in cleanrooms and associated controlled environments, in terms of airborne concentrations of specific chemical substances (individual, group or category) and provides a protocol to include test methods, analysis and time-weighted factors within the specification for classification.[13]

This document became a Standard in 2006. It was developed by the Secretariat of ISO Technical Committee 209, IEST.[13]

Part 9: Classification of surface particle cleanliness

This ISO document describes the classification of the particle contamination levels on solid surfaces in cleanrooms and associated controlled environments applications. Recommendations on testing and measuring methods as well as information about surface characteristics are given in informative annexes.[14]

It is currently a Committee Draft and is not yet available as a Standard.[14]

See also

References

  1. ^ "ISO 14644 History". TSS, Inc. 2007-12-03. Archived from the original on 2007-12-30. Retrieved 2008-01-17.
  2. ^ "FED-STD-209E Cancellation". IEST. 2007-12-03. Retrieved 2008-01-17.
  3. ^ a b c d e f g h i "ISO 14644 Standards". IEST. 2007-12-03. Retrieved 2008-01-17.
  4. ^ "ISO 14644-1". IEST. 2014-09-23. Retrieved 2014-09-23.
  5. ^ "ISO 14644-2". IEST. 2014-09-23. Retrieved 2014-09-23.
  6. ^ a b "ISO 14644-1 Scope". IEST. 2007-12-03. Retrieved 2008-01-17.
  7. ^ a b "ISO 14644-2 Scope". IEST. 2007-12-03. Retrieved 2008-01-17.
  8. ^ a b "ISO 14644-3 Scope". IEST. 2007-12-03. Retrieved 2008-01-17.
  9. ^ a b "ISO 14644-4 Scope". IEST. 2007-12-03. Retrieved 2008-01-17.
  10. ^ a b c d e f g h "ISO 14644-5 Scope". IEST. 2007-12-03. Retrieved 2008-01-17.
  11. ^ "ISO 14644-6 Scope". IEST. 2007-12-03. Retrieved 2008-01-17.
  12. ^ a b c d e f g "ISO 14644-7 Scope". IEST. 2007-12-03. Retrieved 2008-01-17.
  13. ^ a b "ISO 14644-8 Scope". IEST. 2007-12-03. Retrieved 2008-01-17.
  14. ^ a b "ISO 14644-9 Scope". IEST. 2007-12-03. Retrieved 2008-01-17.

External links

Cleanroom

A cleanroom or clean room is a facility ordinarily utilized as a part of specialized industrial production or scientific research, including the manufacture of pharmaceutical items and microprocessors. Cleanrooms are designed to maintain extremely low levels of particulates, such as dust, airborne organisms, or vaporized particles. Cleanrooms typically have an cleanliness level quantified by the number of particles per cubic meter at a predetermined molecule measure. The ambient outdoor air in a typical urban area contains 35,000,000 particles for each cubic meter in the size range 0.5 μm and bigger in measurement, equivalent to an ISO 9 cleanroom, while by comparison an ISO 1 cleanroom permits no particles in that size range and just 12 particles for each cubic meter of 0.3 μm and smaller.

Cleanroom suitability

Cleanroom suitability describes the suitability of a machine, operating utility, material, etc. for use in a cleanroom, where air cleanliness and other parameters are controlled by way of technical regulations in accordance with ISO 14644.Cleanroom suitability is a subdomain of cleanliness suitability and primarily describes the particle emission behavior of a machine or operating utility (test piece).

Institute of Environmental Sciences and Technology

The Institute of Environmental Sciences and Technology (IEST) is a non-profit, technical society. Information on ISO 14644 and ISO 14698 standards can be found through this organization.

Founded in 1953, the organization is headquartered in Schaumburg, Illinois. Its members are internationally recognized in the fields of environmental tests; contamination control; product reliability; and aerospace.

Kennedy Space Center

The John F. Kennedy Space Center (KSC, originally known as the NASA Launch Operations Center) is one of ten National Aeronautics and Space Administration field centers. Since December 1968, Kennedy Space Center has been NASA's primary launch center of human spaceflight. Launch operations for the Apollo, Skylab and Space Shuttle programs were carried out from Kennedy Space Center Launch Complex 39 and managed by KSC. Located on the east coast of Florida, KSC is adjacent to Cape Canaveral Air Force Station (CCAFS). The management of the two entities work very closely together, share resources, and even own facilities on each other's property.

Though the first Apollo flights, and all Project Mercury and Project Gemini flights took off from CCAFS, the launches were managed by KSC and its previous organization, the Launch Operations Directorate. Starting with the fourth Gemini mission, the NASA launch control center in Florida (Mercury Control Center, later the Launch Control Center) began handing off control of the vehicle to the Mission Control Center shortly after liftoff; in prior missions it held control throughout the entire mission.Additionally, the center manages launch of robotic and commercial crew missions and researches food production and In-Situ Resource Utilization for off-Earth exploration. Since 2010, the center has worked to become a multi-user spaceport through industry partnerships, even adding a new launch pad (LC-39C) in 2015.

There are about 700 facilities and buildings grouped across the center's 144,000 acres. Among the unique facilities at KSC are the 525 ft tall Vehicle Assembly Building for stacking NASA's largest rockets, the Launch Control Center - which conducts space launches at KSC, the Operations and Checkout Building, which houses the astronauts dormitories and suit-up area, a Space Station factory, and a 3-mile-long Shuttle Landing Facility. There is also a Visitor Complex open to the public on site.

List of International Organization for Standardization standards, 14000-14999

This is a list of published International Organization for Standardization (ISO) standards and other deliverables. For a complete and up-to-date list of all the ISO standards, see the ISO catalogue.The standards are protected by copyright and most of them must be purchased. However, about 300 of the standards produced by ISO and IEC's Joint Technical Committee 1 (JTC1) have been made freely and publicly available.

Particle counter

A particle counter is an instrument that detects and counts physical particles.

ISO standards by standard number
1–9999
10000–19999
20000+

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