Cleanrooms (part 4)

Cleanroom Standards

ISO/TC 209 Standards: ISO 14644-1 (U.S. Title: ANSI/IEST/ISO 14644-1:1999)

ISO 14644-1, Cleanrooms and associated controlled environments--Part 1: Classification of air cleanliness, may be ordered directly through IEST. ISO Standard 14644-1 was the first ISO International Standard prepared by ISO Technical Committee 209 (ISO/TC 209). IEST serves as Secretariat for ISO/TC 209, which developed the document as part of a series of 11 documents to serve the needs of the global contamination control community. 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-209.

Introduction to ISO 14644-1
ISO 14644-1 is one part of a series of documents, being developed as International Standards, concerned with cleanrooms and associated subjects. Many factors besides airborne particulate cleanliness must be considered in the design, specifications, operations and control of cleanrooms and other controlled environments. These are covered in some detail in other parts of the International Standards prepared by ISO/TC 209. Cleanrooms and associated controlled environments provide for the control of airborne particulate contamination to levels appropriate for accomplishing contamination-sensitive activities. Products and processes that benefit from the control of airborne contamination include aerospace, microelectronics, pharmaceuticals, medical devices, healthcare, food, and others. Many factors besides airborne particulate cleanliness must be considered in the design, specification, operation, and control of cleanrooms and other controlled environments. top of page

Scope of ISO 14644-1
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 particles. Furthermore, the only particle populations consideration for classification purposes are those have cumulative distributions based on threshold (lower limit) sizes ranging from 0.1 µm to 5 µm. top of page

The United Kingdom is the convenor for the Working Group that produced ISO 14644-1. Over 1,000 professionals from the 34 nations of ISO/TC 209 have united to create a family of true international standards, governing all aspects of the cleanroom community - from design inception to daily operations. top of page

The Standard
ISO 14644 currently consists of the following parts, under the general title Cleanrooms and associated controlled environments:

Part 1: Classification of air cleanliness
Part 2: Specifications for testing and monitoring to prove continued compliance with ISO 14644-1
Part 3: Test methods
Part 4: Design, construction and start-up
Part 5: Operations
Part 6: Terms and definitions
Part 7: Separative devices (clean air hoods, gloveboxes, isolators and minienvironments)
Part 8: Classification of airborne molecular contamination

ISO 14698 consists of the following parts, under the general title Cleanrooms and associated controlled environments:

Part 1: Biocontamination control – General principles
Part 2: Biocontamination control – Evaluation and interpretation of biocontamination data
Part 3: Biocontamination control – Methodology for measuring the efficiency of processes of cleaning and (or) disinfections of inert surfaces bearing biocontaminated wet soiling or biofilms

Also see: Aspects of clean-rooms that determine their application-specific requirements

Related terms:

wall partition, laminar flow workstation, modular cleanroom, class 100 clean room, laminar flow, cleanroom protocol, clean room specification, cleanroom supplier, class 10000 clean room, class 1000 clean room, 100000 class clean room, clean room supplier, clean room material

Useful links:

Wikipedia definition of Cleanroom and Clean room design

IEST Guides to the cleanroom ISO Standards

IEST Contamination Control Working Groups' Recommended Practices and Standards: topics include Testing Cleanrooms, Unidirectional Flow Clean-Air Devices, HEPA and ULPA Filters, and more.

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