ASTM_F_2567_-_06_2010.pdf

Designation:F256706(Reapproved 2010)Standard Practice forTesting for Classical Pathway Complement Activation inSerum by Solid Materials1This standard is issued under the fixed designation F2567;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 vitrofunctional screening for classical pathway complement activat-ing properties of solid materials used in the fabrication ofmedical devices that will contact blood.1.2 This practice is intended to evaluate the acute in vitroclassical pathway complement activating properties of solidmaterials intended for use in contact with blood.For thispractice,“serum”is synonymous with“complement.”1.3 This practice consists of two procedural parts.Proce-dureAdescribes exposure of solid materials to a standard lot ofhuman serum HS,using 0.1 mL serum per 13100 mmdisposable glass test tube.Procedure B describes assaying theexposed serum for significant functional classical pathwaycomplement depletion(decrease in amount of C4)as comparedto control serum samples not exposed to the material.Theendpoint in Procedure B is lysis of sheep red blood cells(RBC)coated with antibody(hemolysin).1.4 This practice does not address the use of plasma as asource 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.Practice F1984 provides guidance for testing solid materials forwhole complement activation in human serum,but does notdiscriminate between the classical or alternative pathway ofactivation.Practice F2065 provides guidance for testing solidmaterials for alternative pathway complement activation inserum.1.6 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.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 limitations prior to use.2.Referenced Documents2.1 ASTM Standards:2F748 Practice for Selecting Generic Biological Test Methodsfor Materials and DevicesF1984 Practice for Testing for Whole Complement Activa-tion in Serum by Solid MaterialsF2065 Practice for Testing for Alternative Pathway Comple-ment Activation in Serum by Solid Materials2.2 Other Document:ISO 10993-4 Biological Evaluation of Medical Devices,Part4:Selection of Tests for Interactions with Blood33.Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 waterdistilled,endotoxin-free.3.2 Abbreviations:3.2.1 Abantibody(hemolysin)3.2.2 BBSbarbital buffered saline3.2.3 BBS-Gbarbital buffered salinegelatin3.2.4 BBS-GM(Ca Buffer)barbital buffered salinegelatinmetals3.2.5 Ccomplement3.2.6 C4the fourth component of complement3.2.7 C4(-)GPSC4-deficient guinea pig serum serumfrom guinea pigs genetically incapable of producing C43.2.8 EDTAethylenediaminetetraacetic acid,disodiumsalt,dihydrate3.2.9 HAGGheat aggregated gamma globulin1This 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 Sept.1,2010.Published November 2010.Originallyapproved in 2006.Last previous edition approved in 2006 as F2567 06.DOI:10.1520/F2567-06R10.2For 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 3.2.10 HShuman serum3.2.11 I“ice”control tube with serum but no material,kept on ice3.2.12 Mtube containing serum plus a test material3.2.13 NMtube containing serum but no material3.2.14 RBCred blood cell(s)4.Summary of Practice4.1 This practice is based on a method published by Gaitheret al,1974(1).44.2 Solid material specimens are exposed to a standard lotof human C(specially-prepared,commercial human serumHS)under defined conditions,in parallel with appropriatecontrols(Procedure A).If the classical complement pathway isactivated by the material,C4 will be depleted from the serum.Exposed serum is then tested for remaining C4 functionalactivity.An appropriate dilution of the HS,which by itself istoo dilute to lyse sensitized sheep R