ASTM_D_7102_-_10.pdf

Designation:D710210Standard Guide forDetermination of Endotoxin on Sterile Medical Gloves1This standard is issued under the fixed designation D7102;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.INTRODUCTIONThis guide is established and designed to determine the qualitative or quantitative presence ofbacterial endotoxin on sterile medical gloves.Bacterial endotoxins are found in the outer membraneof gram negative bacteria and may contaminate gloves during the manufacturing process.Conse-quences of endotoxin introduced into a patient during invasive procedures are dose dependent and mayinclude inflammation,fever,nausea,pain,clot formation,hypoglycemia and reduced profusion of theheart,kidney,and liver as well as endotoxic shock.Endotoxins are not inactivated by routine methodsutilized in the routine sterilization of medical gloves including irradiation(gamma or E-beam),ethylene oxide,or steam.1.Scope1.1 This guide covers a selection of methodologies for thedetermination of bacterial endotoxin on gloves when such adetermination is appropriate.1.2 As bacteria may continue to grow on non-sterile gloves,reportable endotoxin levels are only appropriate for gloveslabeled as sterile.Because most environments contain endo-toxin,once a box of gloves is opened and the gloves aremanipulated,endotoxin levels will increase making it inappro-priate to report endotoxin levels on boxed gloves(ex.exami-nation gloves).This is true even if the box had undergonesterilization prior to distribution.1.3 This guide may also be appropriate for internal qualitycontrol or alert purposes at different stages of manufacturing orduring process change evaluations.1.4 This guide is not applicable to the determination ofpyrogens other than bacterial endotoxins.1.5 The sample preparation method described must be usedregardless of the test method selected.This method does notdescribe laboratory test method validation,analyst qualifica-tion,or reagent confirmation.Product-specific validation isaddressed.1.6 The safe and proper use of medical gloves is beyond thescope of this guide.1.7 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 requirements prior to use.2.Referenced Documents2.1 EN Standard:2EN 455-3:1999 Medical Gloves for Single UsePart 3:Requirements and Testing for Biological Evaluation2.2 ANSI Standard:2ANSI/AAMI ST 72:2002 Bacterial EndotoxinsTest Meth-odologies,Routine Monitoring and Alternatives to BatchTesting3.Terminology3.1 Definitions:3.1.1 bacterial endotoxin test(BET)a method for deter-mining the qualitative or quantitative presence of endotoxin inan aqueous test sample utilizing Limulus amebocyte lysate(LAL)reagent and measuring the resulting proportional reac-tion.3.1.2 batchdefined quantity of intermediate or finishedproduct produced in a defined cycle of manufacture that is saidto be of uniform quality.3.1.3 chromogenic(colorimetric)techniqueBET method-ology that quantifies or detects endotoxin on the basis of ameasured color-producing reaction proportional to the interac-tion of LAL and endotoxin.1This guide is under the jurisdiction of ASTM Committee D11 on Rubber andis the direct responsibility of Subcommittee D11.40 on Consumer Rubber Products.Current edition approved May 1,2010.Published June 2010.Originallyapproved in 2004.Last previous edition approved in 2004 as D7102 04.DOI:10.1520/D7102-10.2Available from American National Standards Institute(ANSI),25 W.43rd St.,4th Floor,New York,NY 10036.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 3.1.4 control standard endotoxin(CSE)purified endotoxinproduct supplied at a known potency and utilized as a standardcontrol in endotoxin testing.3.1.5 devicewith regard to medical gloves,a device isdefined as a pair of gloves when they are packaged in pairs anda single glove when packaged singly.3.1.6 endotoxinhigh molecular weight,heat stable com-plex associated with the cell wall of gram-negative bacteriathat is pyrogenic in humans and specifically interacts with LAL.3.1.7 endotoxin unit(EU)the standard unit of measure forendotoxin activity initially established relative to the activity in0.2 ng of the U.S.Reference Standard Endotoxin(USPstandard reference material).3.1.7.1 DiscussionThe FDAs endotoxin standard and thatof the World Health Organizations International EndotoxinStandard(IU)are sub lots of the same endotoxin preparation,making EU and IU equal.3.1.8 endpoint(gel clot)last positive(coagulated or gelclot)tube in a series of dilutions.3.1.9 enhancementa type of inte