ASTM_F_1984_-_99_2013.pdf

Designation:F198499(Reapproved 2013)Standard Practice forTesting for Whole Complement Activation in Serum by SolidMaterials1This standard is issued under the fixed designation F1984;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 provides a protocol for rapid,in vitroscreening for whole complement activating properties of solidmaterials used in the fabrication of medical devices that willcontact blood.1.2 This practice is intended to evaluate the acute in vitrowhole complement activating properties of solid materialsintended for use in contact with blood.For this practice,thewords“serum”and“complement”are used interchangeably(most biological supply houses use these words synonymouslyin reference to serum used as a source of complement).1.3 This practice consists of two procedural parts.Proce-dureAdescribes exposure of solid materials to a standard lot ofhuman serum,using a 0.1-mL serum/13 x 100-mm disposabletest tube.Cellulose acetate powders and fibers are used asexamples of test materials.Procedure B describes assaying theexposed serum for significant functional whole complementdepletion as compared to control samples.1.4 This practice does not address function,elaboration,ordepletion of individual complement components,nor does itaddress the use of plasma as a source of complement.1.5 This practice is one of several developed for theassessment of the biocompatibility of materials.Practice F748may provide guidance for the selection of appropriate methodsfor testing materials for other aspects of biocompatibility.1.6 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.2.Referenced Documents2.1 ASTM Standards:2F748 Practice for Selecting Generic Biological Test Methodsfor Materials and Devices2.2 ISO Document:ISO 10993-4:Biological Evaluation of Medical Devices,Part 4:Selection of Tests for Interactions with Blood33.Terminology3.1 Abbreviations:3.1.1 Abantibody(hemolysin).3.1.2 BBSbarbital buffered saline.3.1.3 BBS-Gbarbital buffered salinegelatin.3.1.4 BBS-GMbarbital buffered salinegelatin metals.3.1.5 Ccomplement.3.1.6 EDTAethylenediaminetetraacetic acid,disodiumsalt:dihydrate.3.1.7 HShuman serum.3.1.8 PVDFpolyvinylidene fluoride.3.1.9 RBCred blood cell(s).4.Summary of Practice4.1 Solid material specimens are exposed to contact with astandard lot of complement under defined conditions(Proce-dureA).Exposed serum then is tested for significant functionalcomplement depletion compared to controls under identicalconditions(Procedure B).5.Significance and Use5.1 Inappropriate activation of complement by blood-contacting medical devices may have serious acute or chroniceffects on the host.This practice is useful as a simple,inexpensive screening method for determining functionalwhole complement activation by solid materials in vitro.5.2 This practice is composed of two parts.In Part A(Section 11),human serum is exposed to a solid material.Complement may be depleted by the classical or alternativepathways.In principle,nonspecific binding of certain comple-ment components also may occur.The alternative pathway can1This practice is under the jurisdiction ofASTM Committee F04 on Medical andSurgical Materials and Devices and is the direct responsibility of SubcommitteeF04.16 on Biocompatibility Test Methods.Current edition approved Dec.1,2013.Published February 2014.Originallyapproved in 1999.Last previous edition approved in 2008 as F1984 99(2008).DOI:10.1520/F1984-99R13.2For 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.3Available from American National Standards Institute(ANSI),25 W.43rd St.,4th Floor,New York,NY 10036,http:/www.ansi.org.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 deplete later acting components common to both pathways,that is components other than C1,C4,and C3(1).4In Part B(Section 12),complement activity remaining in the serum afterexposure to the test material is assayed by classical pathway-mediated lysis of sensitized RBC.5.3 Assessment of in vitro whole complement activation,asdescribed here,provides one method for predicting potentialcomplement activation by medical materials intended forclinical application in humans when the material contacts theblood.Other test methods for complement activation areavailable,including assays for specific complement compo-nents and their split products(see X1.3 and X1.4).5.4 This in vitro test method is suitable for adoption inspecifications and standards for screening solid materi