ASTM_F_1904_-_14.pdf

Designation:F190414Standard Practice forTesting the Biological Responses to Particles in vivo1This standard is issued under the fixed designation F1904;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 covers the production of wear particles anddegradation products from implanted materials that may lead toa cascade of biological responses resulting in damage toadjacent and remote tissues.In order to ascertain the role ofparticles in stimulating such responses,the nature of theresponses,and the consequences of the responses,establishedprotocols are needed.This is an emerging,rapidly developingarea and the information gained from standard protocols isnecessary to interpret responses.Some of the procedures listedhere may,on further testing,not prove to be predictive ofclinical responses to particulate debris.However,only the useof standard protocols will establish which are useful tech-niques.Since there are many possible and established ways ofdetermining responses,a single standard protocol is not stated.However,this recommended practice indicates which neces-sary information should be supplied with test results.Forlaboratories without established protocols,recommendationsare given and indicated with an asterisk(*).1.2 This standard is not designed to provide a comprehen-sive assessment of the systemic toxicity,carcinogenicity,teratogenicity,or mutagenicity of the material.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:2F561 Practice for Retrieval and Analysis of MedicalDevices,and Associated Tissues and FluidsF619 Practice for Extraction of Medical PlasticsF748 Practice for Selecting Generic Biological Test Methodsfor Materials and DevicesF1877 Practice for Characterization of Particles3.Summary of Practice3.1 Biological responses to particles testing may be doneusing specimens from animals being tested in accordance withthe Practice F748 matrix for irritation and sensitivity,or forimplantation.If particles were implanted during the testingprocedures or generated during the experimental time period,the response to those particles may form a part of the overallinvestigation of response to particles.Blood,organs,or tissuesfrom the animals may be used.3.2 Biological responses to particles may be tested using theactual particulate materials or extracts in accordance withPractice F619.The increased surface area of small particlesmay enhance the amount of extracted substances but,since theresponse to particles may be related to the physical size,shapeand composition,the use of only extracts will not completelyaddress the question of the impact of particle formation on thetissue response and actual implantation or other testing ofparticles should be included as a part of the characterization oftissue response when particle generation is likely during actualusage.These materials or extracts may be used in in vivo testsor for the in vitro tests.Particles generated by other methodsmay also be used.The method of generation shall be described.4.Significance and Use4.1 This practice is to be used to help assess the biocom-patibility of materials used in medical devices.It is designed totest the effect of particles from the materials on the host tissues.4.2 The appropriateness of the methods should be carefullyconsidered by the user since not all materials or applicationsneed to be tested by this practice.The validity of these studiesin predicting the human response is not known at this time andstudies such as those described here are needed.4.3 Abbreviations Used:4.3.1 CDCluster differentiation.4.3.2 DNADeoxyribonucleic acid.4.3.3 EDSEnergy dispersive X-ray spectroscopy.4.3.4 EUEndotoxin unit.4.3.5 HLAHuman leukocyte antigens.4.3.6 LALLimulus amebocyte lysate.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 March 1,2014.Published May 2014.Originallyapproved in 1998.Last previous edition approved in 2008 as F1904 98(2008).DOI:10.1520/F1904-14.2For 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.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 4.3.7 LPSLipopolysaccharide(endotoxin).4