ASTM_F_1905_-_98_2003.pdf

Designation:F 1905 98(Reapproved 2003)Standard Practice ForSelecting Tests for Determining the Propensity of Materialsto Cause Immunotoxicity1This standard is issued under the fixed designation F 1905;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 foreign materi-als into the body that may have an impact on the immunesystem.One possible effect is that the immune system will bedepressed or certain cell types may be affected.Immunotoxic-ity may be determined with blood and tissue samples from theanimals used in the other biocompatibility test procedures suchas implantation and blood contact test protocols.It is alsopossible to use these techniques with blood samples fromhuman patients in a clinical trial.Any procedures with humansubjects should follow the appropriate rules of the localinstitutional review board and the appropriate regulatory agen-cies.This document may serve as an annex to Practice F 748.1.2 The material may affect the humoral immune response,the cell mediated response,or both.1.3 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 748 Practice for Selecting Generic Biological Test Meth-ods for Materials and Devices3.Terminology3.1 Definitions:3.1.1 antigensthese are substances that stimulate the hostto produce an immune response3.1.2 cell mediated immunity(CMI)some antigens stimu-late the production of lymphocytes that react specifically withthe antigen.These cells do not circulate widely in the host andare generally located at the site of antigen deposition.The useof living lymphocytes is required to test for CMI to an antigen.3.1.3 complementthis is a complex system of circulatingproteins(enzymes,pro-enzymes,and co-factors)found in theblood.This system is usually activated by antigen-antibodyreactions and is a reflection of humoral immunity.However itis apparent that other factors can activate the complementsystem.These include large polysaccharides and various ma-terials and tissues.Activation of complement can affect theimmune system,inflammation,and vascular activity with feverand shock as a consequence of complement activation in thehost.3.1.4 humoral immunitysome antigens stimulate the hostto produce antibodies(immunoglobulins)which are specificfor the antigen and react with the antigen.Antibodies circulatein the blood and tissue fluids.The antibodies produced can bedetected using blood from the host.3.1.5 inflammatory factorsvarious soluble substancesmay be produced by lymphocytes in response to an antigen.This may occur in humoral immune responses or in CMI.These substances may influence the function of other cells andare called cytokines.Many of these act on various white cellsand are called interleukins.They are reflection of antigenicstimulation of the host.4.Summary of Practice4.1 Immunotoxicity 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.In predicting biocom-patibility,tests using animals are recommended even thoughthe material will eventually be used in humans.The use ofhuman material is also feasible in this testing protocol for thoselaboratories having approval for such studies.4.2 Immunologic testing is done using materials or extractsaccording to Practice F 619.These materials or extracts may beused 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 1905 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.5.Significance and Use5.1 This practice is to be used to help assess the biocom-patibility of materials used in medical devices.It is designed totest the immunotoxicity of such materials.5.2 The appropriateness of the methods should be carefullyconsidered by the user since not all materials or applicationsneed be