ISO develops standards for safety, environmental and industrial goals. ISO 14644 covers cleanrooms and other clean areas, with guidelines for measurement, design, and operation. Many countries have adopted this standard as part of their legal codes. ISO 14644 makes it easier for countries to trade sensitive products. The standard measures both the concentration and type of particles in cleanrooms. ISO has released many other documents as part of this standard to cover advanced or special applications.
The International Organization for Standardization (ISO) develops standards that help countries achieve common safety, environmental and industrial goals. ISO 14644 covers cleanrooms and other clean areas, such as those found in laboratory and precision manufacturing applications. This standard not only sets limits on the amount of pollutants or particulates inside a cleanroom, but also includes guidelines for measurement, design and operation. While ISO 14644 is not a law in and of itself, many countries have adopted this standard as part of their official legal codes. In non-regulated areas, organizations can rely on this standard to help them ensure adequate cleanroom conditions, even if such compliance is not required by law.
An agreed set of cleanroom standards makes it easier for countries to trade products related to healthcare, medicine, and high-end or sensitive products. In 1999, ISO developed ISO 14644-1, which served as the basic method for defining cleanroom conditions. Section two of ISO 14644 was released the following year, with numerous additional sections released over the next decade. These additional sections have been designed to clarify or refine the original ideas and standards set forth in ISO 14644.
The very first version of ISO 14644 was intended simply to define what a cleanroom should be. This publication establishes specific maximum levels of pollution or particulate matter within these spaces. The standard measures both the concentration, or particles per cubic meter, and the type and size of these particles. Some more hazardous materials may be subject to stricter restrictions than less hazardous substances.
Section two of the ISO was created to help organizations measure particulate matter concentrations more accurately. It includes both acceptable testing techniques and how these tests should be performed. This section also covers certification and compliance pathways.
Section four of ISO 14644 covers cleanroom design and construction techniques. Advise users on proper ventilation, as well as materials and layout. Section Five describes how these rooms should be managed to maintain a clean, sterile environment. It covers maintenance and cleaning as well as safe clothing and preventative measures for workers in and around these spaces.
As ISO has received feedback on ISO 14644, it has released many other documents as part of this standard. Section Six simply helps define the terms used in the document to give readers a better understanding. Subsequent sections cover advanced or special applications that have not been addressed in previous releases.
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