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ASTM E2312-11

(Practice)

Standard Practice for Tests of Cleanroom Materials

Standard Practice for Tests of Cleanroom Materials

SIGNIFICANCE AND USE
This practice is not intended to advocate or discourage use of any particular test method. It is intended for information only, and to provide a useful guide for further detailed study, test, and evaluation of cleanroom materials and products.
SCOPE
1.1 This practice identifies test methods used to evaluate the properties of various materials and products used in cleanrooms and for cleanroom construction.
1.2 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 and health practices and determine the applicability of regulatory limitations prior to use.

General Information

Status
Historical
Publication Date
31-Dec-2010
ICS
13.040.35 - Cleanrooms and associated controlled environments
Technical Committee
E21 - Space Simulation and Applications of Space Technology
Drafting Committee
E21.05 - Contamination
Current Stage
Ref Project

Relations

Replaces
ASTM E2312-04 - Standard Practice for Tests of Cleanroom Materials
Effective Date
01-Jan-2011
Replaced By
ASTM E2312-11(2019) - Standard Practice for Tests of Cleanroom Materials
Effective Date
01-Jul-2019

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Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: E2312 − 11
Standard Practice for
1
Tests of Cleanroom Materials
This standard is issued under the fixed designation E2312; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope tion in Cleanrooms and Associated Controlled Environ-
ments
1.1 This practice identifies test methods used to evaluate the
E2090 Test Method for Size-Differentiated Counting of
properties of various materials and products used in clean-
Particles and Fibers Released from Cleanroom Wipers
rooms and for cleanroom construction.
Using Optical and Scanning Electron Microscopy
1.2 This standard does not purport to address all of the
E2217 Practice for Design and Construction of Aerospace
safety concerns, if any, associated with its use. It is the
Cleanrooms and Contamination Controlled Areas
responsibility of the user of this standard to establish appro-
F25 Test Method for Sizing and Counting Airborne Particu-
priate safety and health practices and determine the applica-
late Contamination in Cleanrooms and Other Dust-
bility of regulatory limitations prior to use.
Controlled Areas
F51 Test Method for Sizing and Counting Particulate Con-
2. Referenced Documents
taminant In and On Clean Room Garments
2
2.1 ASTM Standards:
F739 Test Method for Permeation of Liquids and Gases
E595 Test Method for Total Mass Loss and Collected Vola-
throughProtectiveClothingMaterialsunderConditionsof
tile Condensable Materials from Outgassing in a Vacuum
Continuous Contact
Environment
3
2.2 IEST Standards:
E1216 Practice for Sampling for Particulate Contamination
IESTRP-CC003 Garment System Considerations for Clean-
by Tape Lift
rooms and Other Controlled Environments
E1234 Practice for Handling, Transporting, and Installing
IEST RP-CC004 Evaluating Wiping Materials Used in
Nonvolatile Residue (NVR) Sample Plates Used in Envi-
Cleanrooms and Other Controlled Environments
ronmentally Controlled Areas for Spacecraft
IEST RP-CC005 Gloves and Finger Cots Used in Clean-
E1235 Test Method for Gravimetric Determination of Non-
rooms and Other Controlled Environments
volatile Residue (NVR) in Environmentally Controlled
IEST RP-CC020 Substrates and Forms for Documentation
Areas for Spacecraft
in Cleanrooms
E1549 Specification for ESD Controlled Garments Required
IEST RP-CC022 Electrostatic Charge in Cleanrooms and
in Cleanrooms and Controlled Environments for Space-
Other Controlled Environments
craft for Non-Hazardous and Hazardous Operations
4
2.3 Others:
E1559 Test Method for Contamination Outgassing Charac-
ANSI/AAMI/ISO 11137 Sterilization of Health Care Prod-
teristics of Spacecraft Materials
ucts Radiation Part 1
E1560 Test Method for Gravimetric Determination of Non-
volatile Residue From Cleanroom Wipers
3. Terminology
E1731 Test Method for Gravimetric Determination of Non-
volatile Residue from Cleanroom Gloves
3.1 Definitions:
E2088 Practice for Selecting, Preparing, Exposing, andAna- 3.1.1 ESD—electrostatic discharge, the transfer of electro-
lyzing Witness Surfaces for Measuring Particle Deposi-
static charge between bodies that have different electric poten-
tial.
1 3.1.2 fiber—particlehavinganaspect(length-to-width)ratio
This practice is under the jurisdiction of ASTM Committee E21 on Space
Simulation andApplications of Space Technology and is the direct responsibility of of 10 or more.
Subcommittee E21.05 on Contamination.
Current edition approved Jan. 1, 2011. Published February 2011. Originally
approved in 2004. Last previous edition approved in 2004 as E2312 – 04. DOI:
3
10.1520/E2312-11. Available from Institute of Environmental Sciences and Technology (IEST),
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or Arlington Place One, 2340 S. Arlington Heights Rd., Suite 100, Arlington Heights,
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM IL 60005-4516, http://www.iest.org.
4
Standards volume information, refer to the standard’s Document Summary page on Available from American National Standards Institute (ANSI), 25 W. 43rd St.,
the ASTM website. 4th Floor, New York, NY 10036, http://www.ansi.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
E2312 − 11
3.1.3 microorganism—living organism of microscopic size properties of various cleanroom materials and products.Where
capable of growth and reproduction. Examples include no test is presently listed it is probable that a test will be
bacteria, yeasts, and molds. required and must be identified or develope
...

This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation:E2312–04 Designation:E2312–11
Standard Practice for
1
Tests of Cleanroom Materials
This standard is issued under the fixed designation E2312; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope
1.1 This practice identifies test methods used to evaluate the properties of various materials and products used in cleanrooms
and for cleanroom construction.
1.2 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 and health practices and determine the applicability of regulatory
limitations prior to use.
2. Referenced Documents
2
2.1 ASTM Standards:
E595 Test Method for Total Mass Loss and Collected Volatile Condensable Materials from Outgassing in a Vacuum
Environment
E1216 Practice for Sampling for Particulate Contamination by Tape Lift
E1234 Practice for Handling, Transporting, and Installing Nonvolatile Residue (NVR) Sample Plates Used in Environmentally
Controlled Areas for Spacecraft
E1235 Test Method for Gravimetric Determination of Nonvolatile Residue (NVR) in Environmentally Controlled Areas for
Spacecraft
E1549 Specification for ESD Controlled Garments Required in Cleanrooms and Controlled Environments for Spacecraft for
Non-Hazardous and Hazardous Operations
E1559 Test Method for Contamination Outgassing Characteristics of Spacecraft Materials
E1560 Test Method for Gravimetric Determination of Nonvolatile Residue From Cleanroom Wipers
E1731 Test Method for Gravimetric Determination of Nonvolatile Residue from Cleanroom Gloves
E2088 Practice for Selecting, Preparing, Exposing, and Analyzing Witness Surfaces for Measuring Particle Deposition in
Cleanrooms and Associated Controlled Environments
E2090 Test Method for Size-Differentiated Counting of Particles and Fibers Released from Cleanroom Wipers Using Optical
and Scanning Electron Microscopy
E2217 Practice for Design and Construction of Aerospace Cleanrooms and Contamination Controlled Areas
F25 Test Method for Sizing and CountingAirborne Particulate Contamination in Cleanrooms and Other Dust-ControlledAreas
F51 Test Method for Sizing and Counting Particulate Contaminant In and On Clean Room Garments
F739 Test Method for Permeation of Liquids and Gases through Protective Clothing Materials under Conditions of Continuous
Contact
3
2.2 IEST Standards:
IEST RP-CC003 Garment System Considerations for Cleanrooms and Other Controlled Environments
IESTRP-CC004EvaluatingWipingMaterialsUsedinCleanrooms EvaluatingWipingMaterialsUsedinCleanroomsandOther
Controlled Environments
IEST RP-CC005 Gloves and Finger Cots Used in Cleanrooms and Other Controlled Environments
IEST RP-CC020 Substrates and Forms for Documentation in Cleanrooms
1
This practice is under the jurisdiction of ASTM Committee E21 on Space Simulation and the Applications of Space Technology and is the direct responsibility of
Subcommittee E21.05 on Contamination.
Current edition approved Apr. 1, 2004. Published April 2004. DOI: 10.1520/E2312-04.
Current edition approved Jan. 1, 2011. Published February 2011. Originally approved in 2004. Last previous edition approved in 2004 as E2312 – 04. DOI:
10.1520/E2312-11.
2
For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
3
Available from Institute of Environmental Sciences and Technology (IEST), 5005 Newport Dr., Suite 506, Rolling Meadows, IL 60008-3841.
3
Available from Institute of Environmental Sciences and Technology (IEST), Arlington Place One, 2340 S. Arlington Heights Rd., Suite 100, Arlington Heights, IL
60005-4516, http://www.iest.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1

---------------------- Page: 1 ----------------------
E2312–11
IEST RP-CC022 Electrostatic Charge in Cleanrooms and Other Controlled Environments
4
2.3 Others:
ANSI/AAMI/ISO 11137 Sterilization of Health Care Products Radiation Part 1
3. Terminology
3.1 Definitions:
3.1.1 ESD—electrostatic discharge, the transfer of electrostatic charge between bodies that have different electric
...

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SCOPE
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1.2 An understanding of microbiology and microbiological techniques is essential. Knowledge in the following areas is recommended: microorganisms, antimicrobial products (disinfectants, sporicides, and decontamination agents), the chemistry of disinfection, mechanism of activity of disinfectants on cells, application procedures, cleanroom surfaces, and environmental conditions within a cleanroom. This information is available in several published texts listed in the bibliography.  
1.3 The theoretical basis for disinfectant activity is not addressed in this guide. An understanding of the effect of disinfectant concentration on microbial reduction (concentration exponent) and kinetics is desirable in determining the use-dilution of different disinfectants and in using dilution to neutralize a disinfectant for efficacy testing. USP chapter  provides further information on this topic.  
1.4 This guide is written for the cleanroom environment, although many of the principles outlined in this standard are applicable to manufacturing and processing environments outside of the cleanroom.  
1.5 Evaluation of disinfectants for biofilm control is outside the scope of this document.  
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