ASTM E2657-16
(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 inter-laboratory 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 and health practices and determine the applicability of regulatory limitations prior to use.
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Designation: E2657 − 16 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.
4
1. Scope 2.2 Government Standard:
29 CFR 1910.1450 Occupational Exposure to Hazardous
1.1 This practice covers quantitative methods for the sam-
Chemicals in Laboratories
pling and determination of bacterial endotoxin concentrations
5
in water miscible metalworking fluids (MWF). 2.3 Other Documents:
Criteria Document for a Recommended Standard: Occupa-
1.2 Users of this practice need to be familiar with the
tional Exposure to Metalworking Fluids, 1998 NIOSH
handling of MWF.
Manual ofAnalytical Methods (NMAM), 4th ed., Eller and
1.3 This practice gives an estimate of the endotoxin con-
Cassinelli, Eds., 1994
centration in the sampled MWF.
1.4 This practice replaces Method E2250. 3. Terminology
1.5 This practice seeks to minimize inter-laboratory varia- 3.1 For definitions of terms relating to this practice, refer to
tion of endotoxin data but does not ensure uniformity of Terminology E1542.
results.
3.2 Definitions of Terms Specific to This Standard:
1.6 This standard does not purport to address all of the
3.2.1 control standard endotoxin (CSE), n—a purified
safety concerns, if any, associated with its use. It is the
preparation of endotoxin based on the USPReference Standard
responsibility of the user of this standard to establish appro-
Endotoxin (RSE); used in laboratories to prepare standard
priate safety and health practices and determine the applica-
solutions.
bility of regulatory limitations prior to use.
3.2.2 endotoxin, n—pyrogenichighmolarmasslipopolysac-
charide (LPS) complex associated with the cell wall of
2. Referenced Documents
gram-negative bacteria.
2
2.1 ASTM Standards:
3.2.2.1 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
3.2.3 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).
Miscible and Straight Oil Metal Removal Fluids
3.2.3.1 Discussion—The current RSE (EC-6) is equivalent
E1542 Terminology Relating to Occupational Health and
to 1ng = 10 EU.
Safety
3.2.4 geometric mean (GM), n—thecentraltendencyofaset
E2250 Method for Determination of Endotoxin Concentra-
of numbers expressed as the nth root of their product.
tion in Water Miscible Metal Working Fluids (Withdrawn
3
2008)
3.2.5 geometric standard deviation (GSD), n—the spread of
data in a set of numbers expressed as a geometric mean.
1
This practice is under the jurisdiction of ASTM Committee E34 on Occupa-
3.2.6 Gram-negative bacteria, n—prokaryotic cells that
tional Health and Safety and is the direct responsibility of Subcommittee E34.50 on
have a complex cell wall structure that stains characteristically
Health and Safety Standards for Metal Working Fluids.
when subjected to the differential Gram staining procedure.
Current edition approved Oct. 1, 2016. Published October 2016. Originally
approved in 2009. Last previous edition approved in 2011 as E2657 - 11. DOI:
10.1520/E2657-16.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
4
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM AvailablefromU.S.GovernmentPrintingOfficeSuperintendentofDocuments,
Standards volume information, refer to the standard’s Document Summary page on 732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401, http://
the ASTM website. www.access.gpo.gov.
3 5
The last approved version of this historical standard is referenced on Available from CDC/NIOSH, 4676 Columbia Pkwy, Cincinnati, OH 45226-
www.astm.org. 1998.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
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E2657 − 16
3.2.7 inhibition/enhancement phenomenon, n—conditions 5. Significance and Use
or artifacts in sample solutions that cause endotoxin concen-
5.1 The determination of endotoxin concentrations in MWF
tration data from LAL assays to be less than or more than the
is a parameter that can be used in decision-making for prudent
concentration of endotoxin actually present in a given aqueous
fluid management
...
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 − 11 E2657 − 16 An American National Standard
Standard Test Method 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
1.1 This test method covers quantitative methods for the sampling and determination of bacterial endotoxin concentrations in
water miscible metalworking fluids (MWF).
1.2 Users of this test method need to be familiar with the handling of MWF.
1.3 This method gives an estimate of the endotoxin concentration in the sampled MWF.
1.4 This method replaces Test Method E2250.
1.5 This test method seeks to minimize inter-laboratory 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 and health practices and determine the applicability of regulatory
limitations prior to use.
2. Referenced Documents
2
2.1 ASTM Standards:
D4840 Guide for Sample Chain-of-Custody Procedures
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
2.2 Government Standard:
29 CFR 1910.1450 Occupational Exposure to Hazardous Chemicals in Laboratories
4
2.3 Other Documents:
Criteria Document for a Recommended Standard: Occupational Exposure to Metalworking Fluids, 1998 NIOSH
Manual of Analytical Methods (NMAM), 4th ed., Eller and Cassinelli, Eds., 1994
3. Terminology
3.1 Definitions of Terms Specific to This Standard:
3.1.1 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.
3.1.2 endotoxin, n—pyrogenic high molar mass lipopolysaccharide (LPS) complex associated with the cell wall of
gram-negative bacteria.
1
This test method 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 Dec. 1, 2011Oct. 1, 2016. Published January 2012October 2016. Originally approved in 2009. Last previous edition approved in 20092011 as
E2657 - 09.E2657 - 11. DOI: 10.1520/E2657-11.10.1520/E2657-16.
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.
4
Available from U.S. Government Printing Office Superintendent of Documents, 732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401, http://
www.access.gpo.gov.
5
Available from CDC/NIOSH, 4676 Columbia Pkwy, Cincinnati, OH 45226-1998.
3.1.2.1 Discussion—
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
E2657 − 16
Though endotoxins are pyrogens, not all pyrogens are endotoxins. Endotoxins are specifically detected through a Limulus
Amoebocyte Lysate (LAL) test.
3.1.3 endotoxin unit (EU), n—a biological potency unit equivalent to the FDA Reference Standard Endotoxin (RSE).
3.1.3.1 Discussion—
The current RSE (EC-6) is equivalent to 1ng = 10 EU.
3.1.4 geometric mean (GM), n—the central tendency of a set of numbers expressed as the nth root of their product.
3.1.5 geometric standard deviation (GSD), n—the spread of data in a set of numbers expressed as a geometric mean.
3.1.6 Gram-negative bacteria, n—prokaryotic cells that have a complex cell wall structure that stains characteristically when
subjected to the differential Gram staining procedure.
3.1.7 inhibition/enhancement phenomenon, n—conditions or artifacts in sample solutions that cause endotoxin concentration
data from LAL assays to be less than or more than the concentration of endotoxin actually present in a given aqueous sample.
3.1.8 Limulus amebocyte lysate (LAL) assay, n—a biological assay dependent on a series of cascading enzyme reactions that
occur when Limulu
...
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