ISO 14644 Standards were first formed from the US Federal Standard 209E Airborne Particulate Cleanliness Classes in

Cleanrooms A cleanroom or clean room is an engineered space that maintains a very low concentration of airborne particulates. It is well-isolated, well-controlled from contamination, and actively cleansed. Such rooms are commonly needed for scientifi ...

and Clean Zones. The need for a single standard for cleanroom classification and testing was long felt. After

ANSI The American National Standards Institute (ANSI ) is a private nonprofit organization that oversees the development of voluntary consensus standards for products, services, processes, systems, and personnel in the United States. The organiz ...

and

IEST The Institute of Environmental Sciences and Technology (IEST) is a non-profit, technical society where professionals who impact controlled environments connect, gain knowledge, receive advice, and work together to create industry best practices. ...

petitioned to

ISO The International Organization for Standardization (ISO ; ; ) is an independent, non-governmental, international standard development organization composed of representatives from the national standards organizations of member countries. Me ...

for new standards, the first document of ISO 14644 was published in 1999, ISO 14644-1. In 2000, ISO 14644-2 was published, which began the process of

FED-STD-209E FED-STD-209 E ''Airborne Particulate Cleanliness Classes in Cleanrooms and Cleanzones'' was a federal standard concerning classification of air cleanliness, intended for use in environments like cleanrooms. The standard based its classifications on ...

being canceled. On November 29, 2001, the document was canceled and superseded by ISO 14644-1 and ISO 14644-2. ;ISO 14644 is now composed of: *ISO 14644-1: Classification of air cleanliness *ISO/DIS 14644-1.2(2014): Classification of air cleanliness by particle concentration *ISO 14644-2: Specifications for testing and monitoring to prove continued compliance with ISO 14644-1 *ISO/DIS 14644-2.2(2014): Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration *ISO 14644-3: Test Methods *ISO 14644-4: Design, Construction, and Start-up *ISO 14644-5: Operations *ISO 14644-6: Vocabulary *ISO 14644-7: Separative devices (clean air hoods, gloveboxes, isolators and minienvironments *ISO 14644-8:2022(en), Cleanrooms and associated controlled environments — Part 8: Assessment of air cleanliness for chemical concentration (ACC) *ISO 14644-9: Classification of surface particle cleanliness *ISO 14644-10: Classification of Surface Cleanliness by Chemical Concentration *ISO 14644-12: Classification of Air Cleanliness by Nanoscale Particle Concentration *ISO 14644-13:2017 Cleaning of surfaces to achieve defined levels of cleanliness in terms of particle and chemical classifications *ISO 14644-14: Assessment of suitability for use of equipment by airborne particle concentration *ISO 14644-15, Cleanrooms and associated controlled environments — Part 15: Assessment of suitability for use of equipment and materials by airborne chemical concentration *ISO 14644-17, Cleanrooms and associated controlled environments — Part 17: Particle deposition rate applications *ISO 14644-18:2023(en) Cleanrooms and associated controlled environments — Part 18: Assessment of suitability of consumables *ISO/TR 14644-21:2023 Cleanrooms and associated controlled environments - Part 21: Airborne particle sampling techniques

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 Particulate matter (PM) or particulates are microscopic particles of solid or liquid matter suspension (chemistry), suspended in the atmosphere of Earth, air. An ''aerosol'' is a mixture of particulates and air, as opposed to the particulate ...

. 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

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. 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.

Part 3: Test Methods

This part specifies

test method A test method is a method for a test in science or engineering, such as a physical test, chemical test, or statistical test. It is a specified procedure that produces a test result. To ensure accurate and relevant results, a test method should b ...

s for designated classification of airborne particulate cleanliness and for characterizing the performance of

cleanroom A cleanroom or clean room is an engineered space that maintains a very low concentration of airborne particulates. It is well-isolated, well-controlled from contamination, and actively cleansed. Such rooms are commonly needed for scientifi ...

s 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. 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.

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 A supply chain is a complex logistics system that consists of facilities that convert raw materials into finished products and distribute them to end consumers or end customers, while supply chain management deals with the flow of goods in distr ...

, and

designers A designer is a person who plans the form or structure of something before it is made, by preparing drawings or plans. In practice, anyone who creates tangible or intangible objects, products, processes, laws, games, graphics, services, or exper ...

of cleanroom installations. It was submitted as an American National Standard in 2001.

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: *Operational systems that must be in place *Selection and use of appropriate cleanroom garments *

Training Training is teaching, or developing in oneself or others, any skills and knowledge or fitness that relate to specific useful competencies. Training has specific goals of improving one's capability, capacity, productivity and performance. I ...

and monitoring of

personnel Employment is a relationship between two parties regulating the provision of paid labour services. Usually based on a contract, one party, the employer, which might be a corporation, a not-for-profit organization, a co-operative, or any othe ...

and activities *Installation and use of equipment *Requirements for materials used in the cleanroom *Maintaining the cleanroom environment in a clean, usable condition conforming to design standards. 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.

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 The ISO 14698 Standards features two International Standards on biocontamination control for cleanroom A cleanroom or clean room is an engineered space that maintains a very low concentration of airborne particulates. It is well-isolate ...

. In March 2008 this ISO Standard recently became an American National Standard.

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

Part 8: Classification of airborne molecular contamination

This part of ISO 14644 covers the classification of airborne molecular contamination (AMC) in

s and associated controlled environments, in terms of airborne concentrations of specific

chemical substance A chemical substance is a unique form of matter with constant chemical composition and characteristic properties. Chemical substances may take the form of a single element or chemical compounds. If two or more chemical substances can be com ...

s (individual, group or category) and provides a protocol to include

s, analysis and time-weighted factors within the specification for classification. This document became a Standard in 2006. It was developed by the Secretariat of ISO Technical Committee 209, IEST.

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 Annexation, in international law, is the forcible acquisition and assertion of legal title over one state's territory by another state, usually following military occupation of the territory. In current international law, it is generally held to ...

References

External links

*http://www.iest.org *http://www.ansi.org *http://www.iso.org {{ISO standards #14644 Cleanroom technology