ASTM_F_1906_-_98_2003.pdf

Designation:F 1906 98(Reapproved 2003)Standard Practice forEvaluation of Immune Responses In BiocompatibilityTesting Using ELISA Tests,Lymphocyte Proliferation,andCell Migration1This standard is issued under the fixed designation F 1906;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(e)indicates an editorial change since the last revision or reapproval.1.Scope1.1 This practice covers the introduction of a foreign sub-stance into mammalian body that may induce the formation ofan immune response.The immune response may lead toinadvertent tissue damage and be an undesirable event.In thestandard protocols for biocompatibility testing,various studiesin animals are done.These animals or their blood and tissuescould be used to determine if immune responses have occurredand what types have occurred.At the current time,theimmunologic testing in biocompatibility protocols is verylimited.Techniques can be developed in the future which aresimple,reliable,and sensitive.1.2 It is the purpose of this practice to delineate somepossible test methods.It must be remembered that these areprotocols for use in biocompatibility testing,they are notdiagnostic tests for evaluation of human conditions.Diagnostictests for use on humans must go through evaluation at theregulatory agencies.The tests described here are clearlyadaptable for use in humans and can be used for researchpurposes and provide data in clinical trials,but are notnecessarily cleared for diagnostic purposes.This practicepresent selected methods.Other validated methods may beequally applicable.1.3 The values stated in SI units are to be regarded as thestandard.1.4 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:2F 619 Practice for Extraction of Medical PlasticsF 719 Practice for Testing Biomaterials in Rabbits forPrimary Skin IrritationF 720 Practice for Testing Guinea Pigs for Contact Aller-gens:Guinea Pig Maximization TestF 748 Practice for Selecting Generic Biological Test Meth-ods for Materials and DevicesF 763 Practice for Short-Term Screening of Implant Mate-rialsF 981 Practice for Assessment of Compatibility of Bioma-terials for Surgical Implants with Respect to Effect ofMaterials on Muscle and Bone3.Summary of Practice3.1 Immunologic testing is done using specimens fromanimals being tested according to the Practice F 748 matrix forirritation and sensitivity,or for implantation.Blood,organs,ortissues from the animals may be used.Blood or biopsies frompatients in a clinical trial may also be used.Animals(rabbits ormice)are also immunized with various antigens in thispractice.Humans may be immunized with an approved vac-cine.3.2 Immunologic testing is done using materials,knowncomponents of the materials,or extracts prepared according toPractice F 619.These materials,components,or extracts maybe used for in vivo tests or for the in vitro tests.1This 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 Nov.1,2003.Published December 2003.Originallyapproved in 1998.Last previous edition approved in 1998 as F 1906 98.2For 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.1Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959,United States.4.Significance and Use4.1 This practice is to be used to help evaluate the biocom-patibility of materials used in medical devices in terms of theimmune response.4.2 The appropriateness of the methods should be carefullyconsidered since not all materials or applications need to betested by this practice.4.3 The testing suggestions in Practice F 748 and in thematrices of recommended tests issued by regulatory agenciesmay be considered before proceeding with these tests.4.4 These tests require the use of blood.Procedures forobtaining whole blood or serum should follow the recommen-dations of the animal research committee of the institutionresponsible for the animals.In general serum and plasmabehave the same in these tests,but it should be noted whichwas used.4.5 The Testing ProtocolsThese will be divided into thetwo specific areas of humoral immunity and cell mediatedimmunity,and subdivided from there.The tests for the humoralimmune responses will be based on solid phase immunoassaysfor use with enzyme linked immunoassay