ASTM E2657-21
(Practice)Standard Practice for Determination of Endotoxin Concentrations in Water-Miscible Metalworking Fluids
Standard Practice for Determination of Endotoxin Concentrations in Water-Miscible Metalworking Fluids
SIGNIFICANCE AND USE
5.1 The determination of endotoxin concentrations in MWF is a parameter that can be used in decision-making for prudent fluid management practices (fluid draining, cleaning, recharging, or biocide dosages).
5.2 This standard provides a practice for analysts who perform quantitative endotoxin analyses of water-miscible MWF.
SCOPE
1.1 This practice covers quantitative methods for the sampling and determination of bacterial endotoxin concentrations in water-miscible metalworking fluids (MWF).
1.2 Users of this practice need to be familiar with the handling of MWF.
1.3 This practice gives an estimate of the endotoxin concentration in the sampled MWF.
1.4 This practice replaces Method E2250.
1.5 This practice seeks to minimize interlaboratory variation of endotoxin data but does not ensure uniformity of results.
1.6 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.
1.7 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.
General Information
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Standards Content (Sample)
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.
Designation: E2657 − 21 An American National Standard
Standard Practice for
Determination of Endotoxin Concentrations in Water-
1
Miscible Metalworking Fluids
This standard is issued under the fixed designation E2657; 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* Miscible and Straight Oil Metal Removal Fluids
E1542 Terminology Relating to Occupational Health and
1.1 This practice covers quantitative methods for the sam-
Safety
pling and determination of bacterial endotoxin concentrations
E2250 Method for Determination of Endotoxin Concentra-
in water-miscible metalworking fluids (MWF).
tion in Water Miscible Metal Working Fluids (Withdrawn
3
1.2 Users of this practice need to be familiar with the
2008)
handling of MWF.
E2523 Terminology for Metalworking Fluids and Opera-
tions
1.3 This practice gives an estimate of the endotoxin con-
4
centration in the sampled MWF.
2.2 Government Standard:
29 CFR 1910.1450 Occupational Exposure to Hazardous
1.4 This practice replaces Method E2250.
Chemicals in Laboratories
1.5 Thispracticeseekstominimizeinterlaboratoryvariation 5
2.3 Other Documents:
of endotoxin data but does not ensure uniformity of results.
NIOSH Criteria Document for a Recommended Standard:
1.6 This standard does not purport to address all of the
Occupational Exposure to Metalworking Fluids, 1998
safety concerns, if any, associated with its use. It is the
NIOSH Manual of Analytical Methods (NMAM), 5th Edi-
responsibility of the user of this standard to establish appro-
tion
priate safety, health, and environmental practices and deter-
3. Terminology
mine the applicability of regulatory limitations prior to use.
1.7 This international standard was developed in accor-
3.1 Definitions:
dance with internationally recognized principles on standard-
3.1.1 For definitions of terms relating to this practice, refer
ization established in the Decision on Principles for the
to Terminologies E1542 and E2523.
Development of International Standards, Guides and Recom-
3.1.2 control standard endotoxin (CSE), n—a purified
mendations issued by the World Trade Organization Technical
preparation of endotoxin based on the USPReference Standard
Barriers to Trade (TBT) Committee.
Endotoxin (RSE); used in laboratories to prepare standard
solutions.
2. Referenced Documents
3.1.3 endotoxin, n—pyrogenichighmolarmasslipopolysac-
2
2.1 ASTM Standards:
charide (LPS) complex associated with the cell wall of
D2881 Classification for Metalworking Fluids and Related
Gram-negative bacteria.
Materials
3.1.3.1 Discussion—Though endotoxins are pyrogens, not
D4840 Guide for Sample Chain-of-Custody Procedures
all pyrogens are endotoxins. Endotoxins are specifically de-
E1488 GuideforStatisticalProcedurestoUseinDeveloping
tected through a Limulus Amoebocyte Lysate (LAL) test.
and Applying Test Methods
3.1.4 endotoxin unit (EU), n—a biological potency unit
E1497 Practice for Selection and Safe Use of Water-
equivalent to the FDA Reference Standard Endotoxin (RSE).
3.1.4.1 Discussion—The current RSE (EC-6) is equivalent
1 to1ng=10EU.
This practice is under the jurisdiction of ASTM Committee E34 on Occupa-
tional Health and Safety and is the direct responsibility of Subcommittee E34.50 on
Health and Safety Standards for Metal Working Fluids.
3
Current edition approved Nov. 1, 2021. Published December 2021. Originally The last approved version of this historical standard is referenced on
approved in 2009. Last previous edition approved in 2016 as E2657 – 16. DOI: www.astm.org.
4
10.1520/E2657-21. AvailablefromU.S.GovernmentPrintingOfficeSuperintendentofDocuments,
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or 732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401, http://
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM www.access.gpo.gov.
5
Standards volume information, refer to the standard’s Document Summary page on Available from CDC/NIOSH, 4676 Columbia Pkwy, Cincinnati, OH 45226-
the ASTM website. 1998.
*A Summary of Changes section appears at the end of this standard
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
E2657 − 21
3.1.5 Gram-negative bacteria, n—prokaryotic cells that 4.4 If data indicate interferences are present, MWF super-
have a complex cell wall structure that stains char
...
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: E2657 − 16 E2657 − 21 An American National Standard
Standard Practice for
Determination of Endotoxin Concentrations in Water-
1
Miscible Metalworking Fluids
This standard is issued under the fixed designation E2657; 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 Scope*
1.1 This practice covers quantitative methods for the sampling and determination of bacterial endotoxin concentrations in water
miscible water-miscible metalworking fluids (MWF).
1.2 Users of this practice need to be familiar with the handling of MWF.
1.3 This practice gives an estimate of the endotoxin concentration in the sampled MWF.
1.4 This practice replaces Method E2250.
1.5 This practice seeks to minimize inter-laboratoryinterlaboratory variation of endotoxin data but does not ensure uniformity of
results.
1.6 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 safety, health, and healthenvironmental practices and determine the
applicability of regulatory limitations prior to use.
1.7 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.
2. Referenced Documents
2
2.1 ASTM Standards:
D2881 Classification for Metalworking Fluids and Related Materials
D4840 Guide for Sample Chain-of-Custody Procedures
E1488 Guide for Statistical Procedures to Use in Developing and Applying Test Methods
E1497 Practice for Selection and Safe Use of Water-Miscible and Straight Oil Metal Removal Fluids
E1542 Terminology Relating to Occupational Health and Safety
3
E2250 Method for Determination of Endotoxin Concentration in Water Miscible Metal Working Fluids (Withdrawn 2008)
E2523 Terminology for Metalworking Fluids and Operations
1
This practice is under the jurisdiction of ASTM Committee E34 on Occupational Health and Safety and is the direct responsibility of Subcommittee E34.50 on Health
and Safety Standards for Metal Working Fluids.
Current edition approved Oct. 1, 2016Nov. 1, 2021. Published October 2016December 2021. Originally approved in 2009. Last previous edition approved in 20112016
as E2657 - 11.E2657 – 16. DOI: 10.1520/E2657-16.10.1520/E2657-21.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM 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
The last approved version of this historical standard is referenced on www.astm.org.
*A Summary of Changes section appears at the end of this standard
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
E2657 − 21
4
2.2 Government Standard:
29 CFR 1910.1450 Occupational Exposure to Hazardous Chemicals in Laboratories
5
2.3 Other Documents:
NIOSH Criteria Document for a Recommended Standard: Occupational Exposure to Metalworking Fluids, 1998 NIOSH
NIOSH Manual of Analytical Methods (NMAM), 4th ed., Eller and Cassinelli, Eds., 19945th Edition
3. Terminology
3.1 For definitions of terms relating to this practice, refer to Terminology E1542.
3.1 Definitions of Terms Specific to This Standard:Definitions:
3.1.1 For definitions of terms relating to this practice, refer to Terminologies E1542 and E2523.
3.1.2 control standard endotoxin (CSE), n—a purified preparation of endotoxin based on the USP Reference Standard Endotoxin
(RSE); used in laboratories to prepare standard solutions.
3.1.3 endotoxin, n—pyrogenic high molar mass lipopolysaccharide (LPS) complex associated with the cell wall of gram-
negativeGram-negative bacteria.
3.1.3.1 Discussion—
Though endotoxins are pyrogens, not all pyrogens are endotoxins. Endotoxins are specifically detected through a Limulus
Amoebocyte Lysate (LAL) test.
3.1.4 endotoxin unit (EU), n—a biological potency unit equivalent to the FDA Reference Standard Endotoxin (RSE).
3.1.4.1 Discussion—
The current RSE (EC-6) is equ
...
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