ASTM E2657-11

Standard Test Method for Determination of Endotoxin Concentrations in Water-Miscible Metalworking Fluids

SIGNIFICANCE AND USE
The determination of endotoxin concentrations in metalworking fluids is a parameter that can be used in decision-making for prudent fluid management practices (fluid draining, cleaning, recharging or biocide dosages).
This standard provides a test method for analysts who perform quantitative endotoxin analyses of water-miscible metalworking fluids.
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.

General Information

• Status: Historical
• Publication Date: 30-Nov-2011
• ICS: 07.100.99 - Other standards related to microbiology
• ICS: 75.100 - Lubricants, industrial oils and related products
• Technical Committee: E34 - Occupational Health and Safety
• Drafting Committee: E34.50 - Health and Safety Standards for Metal Working Fluids

Relations

• Replaces: ASTM E2657-09 - Standard Test Method for Determination of Endotoxin Concentrations in Water-Miscible Metalworking Fluids
• Effective Date: 01-Dec-2011
• Referred By: ASTM E2523-13(2018) - Standard Terminology for Metalworking Fluids and Operations
• Effective Date: 01-Dec-2011
• Referred By: ASTM E2889-12(2017) - Standard Practice for Control of Respiratory Hazards in the Metal Removal Fluid Environment
• Effective Date: 01-Dec-2011
• Referred By: ASTM F86-21 - Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants
• Effective Date: 01-Dec-2011
• Referred By: ASTM E2275-19 - Standard Practice for Evaluating Water-Miscible Metalworking Fluid Bioresistance and Antimicrobial Pesticide Performance
• Effective Date: 01-Dec-2011
• Referred By: ASTM E2148-21 - Standard Guide for Using Documents Related to Metalworking or Metal Removal Fluid Health and Safety
• Effective Date: 01-Dec-2011

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: E2657 − 11 AnAmerican National Standard
Standard Test Method 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 2.3 Other Documents:
Criteria Document for a Recommended Standard: Occupa-
1.1 This test method covers quantitative methods for the
tional Exposure to Metalworking Fluids, 1998 NIOSH
sampling and determination of bacterial endotoxin concentra-
Manual ofAnalytical Methods (NMAM), 4th ed., Eller and
tions in water miscible metalworking fluids (MWF).
Cassinelli, Eds., 1994
1.2 Users of this test method need to be familiar with the
handling of MWF. 3. Terminology
1.3 This method gives an estimate of the endotoxin concen- 3.1 Definitions of Terms Specific to This Standard:
tration in the sampled MWF. 3.1.1 control standard endotoxin (CSE), n—a purified
preparation of endotoxin based on the USPReference Standard
1.4 This method replaces Test Method E2250.
Endotoxin (RSE); used in laboratories to prepare standard
1.5 This test method seeks to minimize inter-laboratory
solutions.
variation of endotoxin data but does not ensure uniformity of
3.1.2 endotoxin, n—pyrogenichighmolarmasslipopolysac-
results.
charide (LPS) complex associated with the cell wall of
1.6 This standard does not purport to address all of the
gram-negative bacteria.
safety concerns, if any, associated with its use. It is the
3.1.2.1 Discussion—Though endotoxins are pyrogens, not
responsibility of the user of this standard to establish appro-
all pyrogens are endotoxins. Endotoxins are specifically de-
priate safety and health practices and determine the applica-
tected through a Limulus Amoebocyte Lysate (LAL) test.
bility of regulatory limitations prior to use.
3.1.3 endotoxin unit (EU), n—a biological potency unit
equivalent to the FDA Reference Standard Endotoxin (RSE).
2. Referenced Documents
3.1.3.1 Discussion—The current RSE (EC-6) is equivalent
2
2.1 ASTM Standards:
to 1ng = 10 EU.
D4840 Guide for Sample Chain-of-Custody Procedures
3.1.4 geometric mean (GM), n—thecentraltendencyofaset
E1497 Practice for Selection and Safe Use of Water-
of numbers expressed as the nth root of their product.
Miscible and Straight Oil Metal Removal Fluids
3.1.5 geometric standard deviation (GSD), n—the spread of
E1542 Terminology Relating to Occupational Health and
data in a set of numbers expressed as a geometric mean.
Safety
3
3.1.6 Gram-negative bacteria, n—prokaryotic cells that
2.2 Government Standard:
have a complex cell wall structure that stains characteristically
29 CFR 1910.1450 Occupational Exposure to Hazardous
when subjected to the differential Gram staining procedure.
Chemicals in Laboratories
3.1.7 inhibition/enhancement phenomenon, n—conditions
or artifacts in sample solutions that cause endotoxin concen-
1
This test method is under the jurisdiction of ASTM Committee E34 on tration data from LAL assays to be less than or more than the
Occupational Health and Safety and is the direct responsibility of Subcommittee
concentration of endotoxin actually present in a given aqueous
E34.50 on Health and Safety Standards for Metal Working Fluids.
sample.
Current edition approved Dec. 1, 2011. Published January 2012. Originally
approved in 2009. Last previous edition approved in 2009 as E2657 - 09. DOI:
3.1.8 Limulus amebocyte lysate (LAL) assay, n—a biologi-
10.1520/E2657-11.
cal assay dependent on a series of cascading enzyme reactions
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
that occur when Limulus blood cell (amebocyte) lysate com-
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
Standards volume information, refer to the standard’s Document Summary page on bines with endotoxin.
the ASTM website.
3
AvailablefromU.S.GovernmentPrintingOfficeSuperintendentofDocuments,
4
732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401, http:// Available from CDC/NIOSH, 4676 Columbia Pkwy, Cincinnati, OH 45226-
www.access.gpo.gov. 1998.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

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E2657 − 11
3.1.9 metalworking fluid (MWF), n—any fluid used for the 6. Interferences
purpose of cooling or treating metal surfaces during metal
6.1 Data from samples analyzed by LALmethodologies are
removal, metal forming or surface protection or preservation.
prone to variations due to batch differences in lysate
comp
...

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.
An American National Standard Designation: E2657 – 11
Designation:E2657–09
Standard Test Method 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 test method gives an estimate of the endotoxin concentration in the sampled MWF.
1.4 This test 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: D2881Classification for Metal Working Fluids and Related Materials
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:
29CFR1910.1450Occupational Exposure to Hazardous Chemicals in Laboratories
29CFR1910.1000Air Contaminants
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-
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—a lipopolysaccharide derived from the outer membrane of Gram-negative bacteria. —pyrogenic high molar
mass lipopolysaccharide (LPS) complex associated with the cell wall of gram-negative bacteria.
3.1.2.1 Discussion—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.
1
This test method is under the jurisdiction ofASTM 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 May 1, 2009. Published June 2009. DOI: 10.1520/E2657-09.
Current edition approved Dec. 1, 2011. Published January 2012. Originally approved in 2009. Last previous edition approved in 2009 as E2657 - 09. DOI:
10.1520/E2657-11.
2
For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at [e-mail]. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
3
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.
4
Available from CDC/NIOSH, 4676 Columbia Pkwy, Cincinnati, OH 45226-1998.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1

---------------------- Page: 1 ----------------------
E2657–11
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 bacteriaGram-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
...