ISO 14644

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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]

FED-STD-209 EAirborne 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 the measurement of airborne particles.

American National Standards Institute non-profit organization in the United States that develops standards

The American National Standards Institute is a private non-profit organization that oversees the development of voluntary consensus standards for products, services, processes, systems, and personnel in the United States. The organization also coordinates U.S. standards with international standards so that American products can be used worldwide.

The Institute of Environmental Sciences and Technology (IEST) is a non-profit, technical society. It's where professionals who impact controlled environments connect, gain knowledge, receive solid advice, and work together to create industry best practices. The organization uniquely serves environmental test engineers, qualification engineers, cleanroom professionals, those who work in product testing and evaluation, and others who work across a variety of industries, including: acoustics, aerospace, automotive, biotechnology/bioscience, climatics, cleanroom operations/design/equipment/certification, dynamics, filtration, food processing, HVAC design, medical devices, nanotechnology, pharmaceutical, semiconductors/microelectronics, and shock/vibration. Information on ISO 14644 and ISO 14698 standards can be found through this organization.

Contents

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 On November 29, 2001, the document was canceled and superseded by ISO 14644-1 and ISO 14644-2.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

Barrier isolator is a general term that includes two types of devices: isolators and restricted access barriers (RABS). Both are devices that provide a physical and aerodynamic barrier between the external clean room environment and a work process. The isolator design is the more dependable of the two barrier design choices, as it prevents contamination hazards by achieving a more comprehensive separation of the processing environment from the surrounding facility. Nonetheless, both Isolator and RABS designs are contemporary approaches developed over the last 35 years and a great advancement over designs of the 1950s-70s that were far more prone to microbial contamination problems.

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]

Particulates microscopic solid or liquid matter suspended in the Earths atmosphere

Particulates – also known as atmospheric aerosol particles, atmospheric particulate matter, particulate matter (PM), or suspended particulate matter (SPM) – are microscopic solid or liquid matter suspended in the air. The term aerosol commonly refers to the particulate/air mixture, as opposed to the particulate matter alone. Sources of particulate matter can be natural or anthropogenic. They have impacts on climate and precipitation that adversely affect human health, in addition to direct inhalation.

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]

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 definitive procedure that produces a test result. In order to ensure accurate and relevant test results, a test method should be "explicit, unambiguous, and experimentally feasible.", as well as effective and reproducible.

Cleanroom facility designed to maintain extremely low levels of particulates, such as dust, airborne organisms, or vaporized particles

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 a 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.

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]

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:

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]

See also

Related Research Articles

Nephelometer Instrument for measuring the concentration of suspended particulates

A nephelometer is an instrument for measuring the concentration of suspended particulates in a liquid or gas colloid. A nephelometer measures suspended particulates by employing a light beam and a light detector set to one side of the source beam. Particle density is then a function of the light reflected into the detector from the particles. To some extent, how much light reflects for a given density of particles is dependent upon properties of the particles such as their shape, color, and reflectivity. Nephelometers are calibrated to a known particulate, then use environmental factors (k-factors) to compensate lighter or darker colored dusts accordingly. K-factor is determined by the user by running the nephelometer next to an air sampling pump and comparing results. There are a wide variety of research-grade nephelometers on the market as well as open source varieties.

Air ioniser ION is mostly used on air conditioning products. Ioniser is another word for air purifier

An air ioniser is a device that uses high voltage to ionise air molecules. Negative ions, or anions, are particles with one or more extra electron, conferring a net negative charge to the particle. Cations are positive ions missing one or more electrons, resulting in a net positive charge. Some commercial air purifiers are designed to generate negative ions. Another type of air ioniser is the electrostatic discharge (ESD) ioniser used to neutralise static charge. In 2002, in an obituary in The Independent newspaper, Cecil Alfred 'Coppy' Laws was credited with being the inventor of the domestic air ioniser.

A particulate air filter is a device composed of fibrous or porous materials which removes solid particulates such as dust, pollen, mold, and bacteria from the air. Filters containing an adsorbent or catalyst such as charcoal (carbon) may also remove odors and gaseous pollutants such as volatile organic compounds or ozone. Air filters are used in applications where air quality is important, notably in building ventilation systems and in engines.

MIL-STD-498 (Military-Standard-498) was a United States military standard whose purpose was to "establish uniform requirements for software development and documentation." It was released Nov. 8, 1994, and replaced DOD-STD-2167A, DOD-STD-7935A, and DOD-STD-1703. It was meant as an interim standard, to be in effect for about two years until a commercial standard was developed.

ULPA is an acronym for "Ultra Low Particulate Air (filter)" An ULPA filter can remove from the air at least 99.999% of dust, pollen, mold, bacteria and any airborne particles with a size of 100 nanometres (0.1 µm) or larger.

MIL-STD-810

MIL-STD-810, Environmental Engineering Considerations and Laboratory Tests, is a United States Military Standard that emphasizes tailoring an equipment's environmental design and test limits to the conditions that it will experience throughout its service life, and establishing chamber test methods that replicate the effects of environments on the equipment rather than imitating the environments themselves. Although prepared specifically for military applications, the standard is often used for commercial products as well.

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

Air shower (room)

Air showers are specialized enclosed antechambers which are incorporated as entryways of cleanrooms and other controlled environments to reduce particle contamination. Air showers utilize high-pressure, HEPA- or ULPA-filtered air to remove dust, fibrous lint and other contaminants from personnel or object surfaces. The forceful "cleansing" of surfaces prior to entering clean environments reduces the number of airborne particulates introduced.

The ISO 14698 Standards features two International Standards on biocontamination control for cleanrooms. IEST, the Secretariat and Administrator of ISO Technical Committee 209, helped develop this series of ISO 14698 Standards.

IEST-STD-CC1246D, published in 2002,is the latest revision of MIL-STD-1246D. This all came about in 1997, the Army Missile Command commissioned the Institute of Environmental Sciences and Technology (IEST) to revise and adopt MIL-STD-1246 as an industry standard as its usefulness had expanded far beyond military applications, and U.S. policy was requiring agencies to convert government standards to nongovernmental standards where practical.

Contamination control activities aiming to control the existence, growth and proliferation of contamination

Contamination control is the generic term for all activities aiming to control the existence, growth and proliferation of contamination in certain areas. Contamination control may refer to the atmosphere as well as to surfaces, to particulate matter as well as to microbes and to contamination prevention as well as to decontamination.

'ANSI/ISEA 110-2003, the American National Standard for Air-Purifying Respiratory Protective Smoke Escape Devices was established to define test criteria and approval methods for fire/smoke escape hoods published by the American National Standards Institute (ANSI). ANSI/ISEA 110 provides design guidance to Respiratory Protective Smoke Escape Devices (RPED) manufacturers in the form of a detailed set of performance requirements and testing procedures. Key sections of the standard cover certification, labeling, design, performance, conditioning and testing requirements.

Acceptance sampling uses statistical sampling to determine whether to accept or reject a production lot of material. It has been a common quality control technique used in industry. It is usually done as products leaves the factory, or in some cases even within the factory. Most often a producer supplies a consumer a number of items and a decision to accept or reject the items is made by determining the number of defective items in a sample from the lot. The lot is accepted if the number of defects falls below where the acceptance number or otherwise the lot is rejected.

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.

Fan filter unit

A fan filter unit (FFU) is a type of motorized air filtering equipment. It is used to supply purified air to cleanrooms, laboratories, medical facilities or microenvironments by removing harmful airborne particles from recirculating air. The units are installed within the system's ceiling or floor grid. Large cleanrooms require a proportionally large number of FFUs, which in some cases may range from several hundred to several thousand. Units often contain their own pre-filter, HEPA filter and internally controllable fan air distribution.

The Open Smart Grid Protocol (OSGP) is a family of specifications published by the European Telecommunications Standards Institute (ETSI) used in conjunction with the ISO/IEC 14908 control networking standard for smart grid applications. OSGP is optimized to provide reliable and efficient delivery of command and control information for smart meters, direct load control modules, solar panels, gateways, and other smart grid devices. With over 5 million OSGP based smart meters and devices deployed worldwide it is one of the most widely used smart meter and smart grid device networking standards.

ISO/IEC JTC 1/SC 37 Biometrics is a standardization subcommittee in the Joint Technical Committee ISO/IEC JTC 1 of the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC), which develops and facilitates standards within the field of biometrics. The international secretariat of ISO/IEC JTC 1/SC 37 is the American National Standards Institute (ANSI), located in the United States.

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. 1 2 3 4 5 6 7 8 9 "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. 1 2 "ISO 14644-1 Scope". IEST. 2007-12-03. Retrieved 2008-01-17.
  7. 1 2 "ISO 14644-2 Scope". IEST. 2007-12-03. Retrieved 2008-01-17.
  8. 1 2 "ISO 14644-3 Scope". IEST. 2007-12-03. Retrieved 2008-01-17.
  9. 1 2 "ISO 14644-4 Scope". IEST. 2007-12-03. Retrieved 2008-01-17.
  10. 1 2 3 4 5 6 7 8 "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. 1 2 3 4 5 6 7 "ISO 14644-7 Scope". IEST. 2007-12-03. Retrieved 2008-01-17.
  13. 1 2 "ISO 14644-8 Scope". IEST. 2007-12-03. Retrieved 2008-01-17.
  14. "ISO 14644-9 Scope". IEST. 2007-12-03. Retrieved 2008-01-17.