ISO 14698

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.[1]

  • ISO 14698-1, Cleanrooms and associated controlled environments—Biocontamination control, Part 1: General principles and methods
  • ISO 14698-2, Cleanrooms and associated controlled environments—Biocontamination control, Part 2: Evaluation and interpretation of biocontamination data

ISO 14698-1

ISO 14698-1 was first written in 2003. ISO 14698-1 describes the principles and basic methodology for a formal system to assess and control biocontamination, where cleanroom technology is applied, in order that biocontamination in zones at risk can be monitored in a reproducible way and appropriate control measures can be selected. In zones of low or negligible risk this standard may be used as a source of information.[2]

ISO 14698-2

ISO 14698-2 became available to the public in October 2003. ISO 14698-2 gives guidance on basic principles and methodological requirements for all microbiological data evaluation, and the estimation of biocontamination data obtained from sampling for viable particles in zones at risk, as specified by the system selected. This is not intended for testing the performance of microbiological counting techniques of determining viable units.[3]

See also


  1. ^ "History of IEST". IEST. 2007-12-03. Retrieved 2008-01-14.
  2. ^ "ISO 14698-1 Scope". IEST. 2007-12-03. Retrieved 2008-01-14.
  3. ^ "ISO 14698-2 Scope". IEST. 2007-12-03. Retrieved 2008-01-14.

External links

DateTime Report Generated: 19 February 2009 3:59:00 PM (CET)


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.

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.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.

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: Classification of airborne molecular contamination

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

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.

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.

ISO standards by standard number

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