ISO 14644-14, “Cleanrooms and associated controlled environments — Part 14: Assessment of suitability for use of equipment by airborne particle concentration,” has just been issued. This new cleanroom standard helps you determine if a particular piece of equipment is suitable for use in your cleanroom environment. It’s a methodology for defining the level of particle contamination that is acceptable in a cleanroom. Then the equipment is tested to see if the particulate emissions from the equipment falls within the required range.
What industries use cleanrooms and the ISO 14644 series of standards? You’ll find contamination control to be essential in aerospace, microelectronics, optics, nuclear and life sciences (like pharmaceuticals, medical devices, food and healthcare).
What kind of equipment does the ISO 14644-14 address? It covers equipment like machinery, measuring equipment, process equipment, components and tools. And it covers particle size ranges from 0.1 μm to equal to or larger than 5 μm. These are the sizes from ISO 14644-1.
Are some items not covered by the new ISO 14644-14? Yes, here is a list from the standard itself:
- biocontamination assessment
- decontamination agents and techniques
- cleanability of equipment and materials
- equipment design and material selection
- other physical properties of materials (like electrostatic or themal properties)
- equipment optimization
- statistical methods for your testing
- local safety regulations
If you are operating cleanroom environments and want a protocol for the inclusion of equipment in your controlled environments, this is the standard for you. You can purchase a copy in either paper format or for pdf download from Document Center Inc. at www.document-center.com. We are an authorized distributor of the ISO standards, so you can purchase from us with confidence. Here is a direct link to the order page for ISO 14644-14 for your convenience.
Do you have additional standards requirements or questions? Just get in touch with our staff. We’ve been working with standards since 1982 and have the knowledge to assist you with many of your questions. And we have a wide range of products and services all designed to maximize your compliance investments. You can reach us by phone (650-591-7600) or email (info@document-center.com). Remember — We’re your Standards Experts!