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]

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 On November 29, 2001, the document was canceled and superseded by ISO 14644-1 and ISO 14644-2.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

ISO 14644-8:2022(en), Cleanrooms and associated controlled environments — Part 8: Assessment of air cleanliness for chemical concentration (ACC)

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]

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

<span class="mw-page-title-main">Cleanroom</span> Dust-free room for research or production

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 scientific research and in industrial production for all nanoscale processes, such as semiconductor manufacturing. A cleanroom is designed to keep everything from dust to airborne organisms or vaporised particles away from it, and so from whatever material is being handled inside it.

<span class="mw-page-title-main">Nephelometer</span> Instrument for measuring the concentration of suspended particulates

A nephelometer or aerosol photometer 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.

<span class="mw-page-title-main">Air ioniser</span> 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 electrons, 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.

<span class="mw-page-title-main">HEPA</span> Efficiency standard of air filters

HEPA filter, also known as high-efficiency particulate absorbing filter and high-efficiency particulate arrestance filter, is an efficiency standard of air filters.

<span class="mw-page-title-main">Respirator</span> Device worn to protect the user from inhaling contaminants

A respirator is a device designed to protect the wearer from inhaling hazardous atmospheres including fumes, vapours, gases and particulate matter such as dusts and airborne pathogens such as viruses. There are two main categories of respirators: the air-purifying respirator, in which respirable air is obtained by filtering a contaminated atmosphere, and the air-supplied respirator, in which an alternate supply of breathable air is delivered. Within each category, different techniques are employed to reduce or eliminate noxious airborne contaminants.

Ultra-low particulate air (ULPA) is a type of air filter. A ULPA filter can remove from the air at least 99.999% of dust, pollen, mold, bacteria and any airborne particles with a minimum particle penetration size of 120 nanometres. A ULPA filter can remove—to a large extent but not 100%—oil smoke, tobacco smoke, rosin smoke, smog, and insecticide dust. It can also remove carbon black to some extent. Some fan filter units incorporate ULPA filters. The EN 1822 and ISO 29463 standards may be used to rate ULPA filters.

A particle counter is used for monitoring and diagnosing particle contamination within specific clean media, including air, water and chemicals. Particle counters are used in a variety of applications in support of clean manufacturing practices, industries include: electronic components and assemblies, pharmaceutical drug products and medical devices, and industrial technologies such as oil and gas.

<span class="mw-page-title-main">Air shower (room)</span>

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 before entering clean environments reduces the number of airborne particulates introduced.

The Air Movement and Control Association International, Inc. (AMCA) is an American trade body that sets standards for Heating, Ventilation and Air Conditioning (HVAC) equipment. It rates fan balance and vibration, aerodynamic performance, air density, speed and efficiency.

First fix and second fix are terms used in the UK and Irish housebuilding and commercial building construction industry.

<span class="mw-page-title-main">Particle size</span> Notion for comparing dimensions of particles in different states of matter

Particle size is a notion introduced for comparing dimensions of solid particles, liquid particles (droplets), or gaseous particles (bubbles). The notion of particle size applies to particles in colloids, in ecology, in granular material, and to particles that form a granular material.

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. 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.

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.

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.

<span class="mw-page-title-main">Contamination control</span> Activities aiming to reduce 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.

Cleanliness suitability describes the suitability of operating materials and ventilation and air conditioning components for use in cleanrooms where the air cleanliness and other parameters are controlled by way of technical regulations. Tests are carried out to determine this.

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.

<span class="mw-page-title-main">Fan filter unit</span>

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.

<span class="mw-page-title-main">Medical gown</span> Type of personal protective equipment worn by medical professionals

Medical gowns are hospital gowns worn by medical professionals as personal protective equipment (PPE) in order to provide a barrier between patient and professional. Whereas patient gowns are flimsy often with exposed backs and arms, PPE gowns, as seen below in the cardiac surgeon photograph, cover most of the exposed skin surfaces of the professional medics.

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 "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.
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