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Clean Rooms

Clean room particle testing standards are published by ASTM and ISO. ISO standards are included in the package ISO 14644-1 and 14644-2, which include parts 1 and 2 of the cleanrooms and associated control environments package. Other individually available ISO documents cover operations and classification of surface cleanliness by particle concentration and chemical concentration. ASTm standards cover standard test methods and practices for sizing and counting particulate contaminant in and on clean room garments, design and construction of aerospace cleanrooms and contamination controlled areas, counting of particles and fibers from cleanroom wipers using optical and scanning electron microscopy, and witness surfaces for measuring particle deposition in cleanrooms and associated controlled environments.

ISO 14644-1 and ISO 14644-2 - Classification of Air Cleanliness Package

ISO 14644-1 and ISO 14644-2

ISO 14644-1 and ISO 14644-2 - Classification of Air Cleanliness Package provides specifications for air cleanliness in cleanrooms and associated controlled environments. It also prescribes testing methods and procedures to determine the concentration of airborne particles. ISO 14644-1 and ISO 14644-2 - Classification of Air Cleanliness Package includes: ISO 14644-1:2015 ISO 14644-2:2015

ISO 14644-1:2015

Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration

ISO 14644-1:2015 specifies the classification of air cleanliness in terms of concentration of airborne particles in cleanrooms and clean zones; and separative devices as defined in ISO 14644 7. Only particle populations having cumulative distributions based on threshold (lower limit) particle sizes ranging from 0,1 µm to 5 µm are considered for classification purposes. The use of light scattering (discrete) airborne particle counters (LSAPC) is the basis for determination of the concentration of airborne particles, equal to and greater than the specified sizes, at designated sampling locations. ISO 14644-1:2015 does not provide for classification of particle populations that are outside the specified lower threshold particle-size range, 0,1 µm to 5 µm. Concentrations of ultrafine particles (particles smaller than 0,1 µm) will be addressed in a separate standard to specify air cleanliness by nano-scale particles. An M descriptor (see Annex C) may be used to quantify populations of macroparticles (particles larger than 5 µm). ISO 14644-1:2015 cannot be used to characterize the physical, chemical, radiological, viable or other nature of airborne particles.

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ISO 14698-2:2003

Cleanrooms and associated controlled environments - Biocontamination control - Part 2: Evaluation and interpretation of biocontamination data

ISO 14698-2:2003 gives guidance on methods for the evaluation of microbiological data and the estimation of results obtained from sampling for viable particles in risk zones for biocontamination control. It should be used, where appropriate, in conjunction with ISO 14698-1.

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ISO 14644-5:2004

Cleanrooms and associated controlled environments - Part 5: Operations

ISO 14644-5:2004 specifies basic requirements for cleanroom operations. It is intended for those planning to use and operate a cleanroom. Aspects of safety that have no direct bearing on contamination control are not considered in this part of ISO 14644 and national and local safety regulations must be observed. This document considers all classes of cleanrooms used to produce all types of products. Therefore, it is broad in application and does not address specific requirements for individual industries. Methods and programmes for routine monitoring within cleanrooms are not covered in detail in this part of ISO 14644 but reference should be made to ISO 14644-2 and ISO 14644-3 for monitoring particles, and ISO 14698-1 and ISO 14698-2 for monitoring micro-organisms.

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ISO 14644-9:2012

Cleanrooms and associated controlled environments - Part 9: Classification of surface cleanliness by particle concentration

ISO 14644-9:2012 establishes the classification of cleanliness levels on solid surfaces by particle concentration in cleanrooms and associated controlled environment applications. Recommendations on testing and measuring methods, as well as information about surface characteristics are also given ISO 14644-9:2012 applies to all solid surfaces in cleanrooms and associated controlled environments such as walls, ceilings, floors, working environments, tools, equipment and products. The surface particle cleanliness (SPC) classification is limited to particles between 0,05 µm and 500 µm. The following issues are not considered: requirements for the cleanliness and suitability of surfaces for specific processes; procedures for the cleaning of surfaces; material characteristics; references to interactive bonding forces or generation processes that are usually time-dependent and process-dependent; selection and use of statistical methods for classification and testing; other characteristics of particles, such as electrostatic charge, ionic charges, microbiological state, etc.

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ISO 14644-10:2013

Cleanrooms and associated controlled environments - Part 10: Classification of surface cleanliness by chemical concentration

ISO 14644-10:2012 defines the classification system for cleanliness of surfaces in cleanrooms with regard to the presence of chemical compounds or elements (including molecules, ions, atoms and particles). It is applicable to all solid surfaces in cleanrooms and associated controlled environments such as walls, ceilings, floors, working environment, tools, equipment and devices.

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ASTM F51/F51M-20

Standard Test Method for Sizing and Counting Particulate Contaminant In and On Clean Room Garments

1.1 This test method covers the determination of detachable particulate contaminant 5 m or larger, in and on the fabric of clean room garments. 1.2 This test method does not apply to nonporous fabrics such as Tyvek (trademarked) or Gortex (trademarked). It only applies to fabrics that are porous such as cotton or polyester. 1.3 This test method provides not only the traditional optical microscopic analysis but also a size distribution and surface obscuration analysis for particles on a fine-textured membrane filter or in a tape lift sample. It utilizes transmitted illumination to render all particles darker than the background for gray level detection. Particles collected on opaque plates must be transferred to a suitable membrane filter. 1.4 Units The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system are not necessarily exact equivalents; therefore, to ensure conformance with the standard, each system shall be used independently of the other, and values from the two systems shall not be combined. 1.5 This standard may involve hazardous materials, operations, and equipment. This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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ASTM E2217-12(2019)

Standard Practice for Design and Construction of Aerospace Cleanrooms and Contamination Controlled Areas

1.1 The purpose of this practice is to provide design and construction guidelines for contamination controlled facilities used in the assembly and integration of aerospace hardware. The guidelines herein are intended to ensure that the facilities, when used properly, will meet the cleanliness requirements of aerospace hardware and processes. The objective is to limit contamination due to the deposition of particulate and molecular contaminants on flight hardware surfaces. 1.2 One cleanliness classification of a facility is the airborne particle concentrations in accordance with ISO 14644-1 and 14644-2. Airborne particle concentrations in accordance with FED-STD-209E are included for reference. This simple classification is inadequate to describe a facility that will support the assembly and integration of spacecraft. The extended duration of hardware exposure during fabrication and testing, the sensitivity of the hardware to hydrocarbons and other molecular contaminants, and the changing requirements during assembly and integration must be considered in addition to the airborne particle concentrations. 1.3 The guidelines specified herein are intended to provide facilities that will effectively restrict contaminants from entering the facility, limit contamination generated by and within the facility, and continuously remove airborne contaminants generated during normal operations. Some items of support hardware, such as lifting equipment, stands, and shoe cleaners, are addressed since these items are often purchased and installed with the facility and may require accommodation in the design of the facility. 1.4 Active filtration of molecular contaminants (such as hydrocarbons, silicones, and other chemicals) is discussed. Such active filtration of molecular contaminants may be required for the processing of highly sensitive optical devices, especially infrared and cryogenic sensors. Control of microbiological contamination is not included although HEPA (High Efficiency Particulate Air) filtration will provide some control of airborne bacteria, spores, and other viable contaminants that are typically carried on particles of sizes 0.3 m and larger. Control of radioactive contamination and accommodation of very hazardous materials such as propellants, strong acids or caustics, or carcinogens are not addressed. 1.5 No facility will compensate for excessive contamination generated inside the facility. In addition to an effective facility design, the user must also institute a routine maintenance program (see Practice E2042 ) for the facility, and personnel and operational disciplines that limit the transfer of contaminants through entry doors and contaminant generation inside the facility. 1.6 This practice only addresses guidelines for contamination control in facility design. It must be implemented in compliance with all mandatory government and regulatory building and safety codes. References to related cleanroom standards and U.S. building codes and standards may be found in IEST-RP-CC012. 1.7 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.7.1 The values given in parentheses are provided for information only and are not considered standard. 1.8 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.9 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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ASTM E2090-12(2020)

Standard Test Method for Size-Differentiated Counting of Particles and Fibers Released from Cleanroom Wipers Using Optical and Scanning Electron Microscopy

1.1 This test method covers testing all wipers used in cleanrooms and other controlled environments for characteristics related to particulate cleanliness. 1.2 This test method includes the use of computer-based image analysis and counting hardware and software for the counting of densely particle-laden filters (see 7.7 7.9 ). While the use of this equipment is not absolutely necessary, it is strongly recommended to enhance the accuracy, speed, and consistency of counting. 1.3 The values stated in SI units are to be regarded as the standard. 1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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ASTM E2088-06(2021)

Standard Practice for Selecting, Preparing, Exposing, and Analyzing Witness Surfaces for Measuring Particle Deposition in Cleanrooms and Associated Controlled Environments

1.1 This practice is intended to assist in the selection, preparation, exposure, and analysis of witness surfaces for the purpose of characterizing particle deposition rates in cleanrooms and associated controlled environments, particularly for aerospace applications. 1.2 Requirements may be defined in terms of particle size distribution and count, percent area coverage, or product performance criteria such as optical transmission or scatter. Several choices for witness surfaces are provided. 1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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