ASTM_E_2657_-_16.pdf

Designation:E265716An American National StandardStandard Practice forDetermination of Endotoxin Concentrations in Water-Miscible Metalworking Fluids1This standard is issued under the fixed designation E2657;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year of last revision.A number in parentheses indicates the year of last reapproval.Asuperscript epsilon()indicates an editorial change since the last revision or reapproval.1.Scope1.1 This practice covers quantitative methods for the sam-pling and determination of bacterial endotoxin concentrationsin water miscible metalworking fluids(MWF).1.2 Users of this practice need to be familiar with thehandling of MWF.1.3 This practice gives an estimate of the endotoxin con-centration in the sampled MWF.1.4 This practice replaces Method E2250.1.5 This practice seeks to minimize inter-laboratory varia-tion of endotoxin data but does not ensure uniformity ofresults.1.6 This standard does not purport to address all of thesafety concerns,if any,associated with its use.It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.2.Referenced Documents2.1 ASTM Standards:2D4840 Guide for Sample Chain-of-Custody ProceduresE1488 Guide for Statistical Procedures to Use in Developingand Applying Test MethodsE1497 Practice for Selection and Safe Use of Water-Miscible and Straight Oil Metal Removal FluidsE1542 Terminology Relating to Occupational Health andSafetyE2250 Method for Determination of Endotoxin Concentra-tion in Water Miscible Metal Working Fluids(Withdrawn2008)32.2 Government Standard:429 CFR 1910.1450 Occupational Exposure to HazardousChemicals in Laboratories2.3 Other Documents:5Criteria Document for a Recommended Standard:Occupa-tional Exposure to Metalworking Fluids,1998 NIOSHManual of Analytical Methods(NMAM),4th ed.,Eller andCassinelli,Eds.,19943.Terminology3.1 For definitions of terms relating to this practice,refer toTerminology E1542.3.2 Definitions of Terms Specific to This Standard:3.2.1 control standard endotoxin(CSE),na purifiedpreparation of endotoxin based on the USP Reference StandardEndotoxin(RSE);used in laboratories to prepare standardsolutions.3.2.2 endotoxin,npyrogenic high molar mass lipopolysac-charide(LPS)complex associated with the cell wall ofgram-negative bacteria.3.2.2.1 DiscussionThough endotoxins are pyrogens,notall pyrogens are endotoxins.Endotoxins are specifically de-tected through a Limulus Amoebocyte Lysate(LAL)test.3.2.3 endotoxin unit(EU),na biological potency unitequivalent to the FDA Reference Standard Endotoxin(RSE).3.2.3.1 DiscussionThe current RSE(EC-6)is equivalentto 1ng=10 EU.3.2.4 geometric mean(GM),nthe central tendency of a setof numbers expressed as the nth root of their product.3.2.5 geometric standard deviation(GSD),nthe spread ofdata in a set of numbers expressed as a geometric mean.3.2.6 Gram-negative bacteria,nprokaryotic cells thathave a complex cell wall structure that stains characteristicallywhen subjected to the differential Gram staining procedure.1This practice is under the jurisdiction of ASTM Committee E34 on Occupa-tional Health and Safety and is the direct responsibility of Subcommittee E34.50 onHealth and Safety Standards for Metal Working Fluids.Current edition approved Oct.1,2016.Published October 2016.Originallyapproved in 2009.Last previous edition approved in 2011 as E2657-11.DOI:10.1520/E2657-16.2For referenced ASTM standards,visit the ASTM website,www.astm.org,orcontact ASTM Customer Service at serviceastm.org.For Annual Book of ASTMStandards volume information,refer to the standards Document Summary page onthe ASTM website.3The last approved version of this historical standard is referenced onwww.astm.org.4Available 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.5Available 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 States1 3.2.7 inhibition/enhancement phenomenon,nconditionsor artifacts in sample solutions that cause endotoxin concen-tration data from LAL assays to be less than or more than theconcentration of endotoxin actually present in a given aqueoussample.3.2.8 Limulus amebocyte lysate(LAL)assay,na biologi-cal assay dependent on a series of cascading enzyme reactionsthat occur when Limulus blood cell(amebocyte)lysate com-bines with endotoxin.3.2.9 metalworking fluid(MWF),nany fluid used for thepurpose of cooling or treating metal surfaces during metalremoval,metal forming or surface protection or preservation.3.2.10 metal removal fluid(MRF),nany fluid in thesubclass of metalworking fluids used to cut,or otherwise takeaway material or piece of stock.3.2.10.1 DiscussionMetal removal fluids inclu