1、Designation:F190310Standard Practice forTesting For Biological Responses to Particles In Vitro1This standard is issued under the fixed designation F1903;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year of last revision.A numb
2、er 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 debris anddegradation products from implanted materials that may lead toa cascade of biological res
3、ponses 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 fro
4、m standard protocols isnecessary to interpret responses and to determine if there iscorrelation with the in vivo responses.Since there are manypossible and established ways of determining responses,asingle standard protocol is not stated.However,well describedprotocols are needed to compare results
5、from different inves-tigators using the same materials and to compare biologicalresponses for evaluating(ranking)different materials.Forlaboratories without established protocols,recommendationsare given and indicated with an asterisk*.1.2 Since the purpose of these studies is to predict theresponse
6、 in humans,the use of human cells would providemuch information.However,in this practice,the use ofnon-human and non-primate cells is described.If the usershould wish to employ cell lines from humans,cell lines areavailable from ATCC and most of the information and recom-mendations will still apply.
7、1.3 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.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-pr
8、iate safety and health practices and determine the applica-bility of regulatory limitations prior to use.2.Referenced Documents2.1 ASTM Standards:2F619 Practice for Extraction of Medical PlasticsF748 Practice for Selecting Generic Biological Test Methodsfor Materials and Devices3.Summary of Practice
9、3.1 Biological responses to particles may be evaluated usingspecimens from animals being tested according to the PracticeF748 matrix for irritation and sensitivity,or for implantation.Blood,organs,or tissues from the animals may be used.3.2 Biological responses to particles may be evaluated usingmat
10、erials or extracts according to Practice F619.These mate-rials or extracts may be used for in vivo tests or for the in vitrotests.Particles generated by other methods may also be used.3.3 The purpose of this practice is to assess the response ofcells in direct contact with particles and,therefore,th
11、is practiceis primarily intended to cover the testing of particles placedinto culture with the cells.This practice should be equallyappropriate for the testing of the response to nanoparticlesplaced in culture,if particles of that size are the particles ofinterest.4.Significance and Use4.1 This prac
12、tice 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 macrophages.The use of nonhuman,nonprimate cells is recommended in thispractice.For laboratories equipped and approved to work withhuman bl
13、ood and tissue,the use of these same protocols wouldbe advantageous for development of understanding of theinteraction of cells and particles.4.2 The appropriateness of the methods should be carefullyconsidered by the user since not all materials or applicationsneed be tested by this practice.1This
14、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 June 1,2010.Published June 2010.Originallyapproved in 1998.Last previous edition appro
15、ved in 2003 as F1903 98(2003).DOI:10.1520/F1903-10.2For 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
16、International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 4.3 Abbreviations:4.3.1 LPSlipopolysaccharide(endotoxin).4.3.2 LALLimulus Amebocyte Lysate.4.3.3 ATCCAmerican Type Culture Collection.4.3.4 FCS(FBS)Fetal Calf Serum.4.3.5 NCSNewborn Calf Serum.4.3.6 PBSPhosphate Buffered Saline.4.3.7 HANKSA balanced salt solution.4.3.8 MMPSMatrix Metallo Proteases.4.3.9 RPMI 1640Specific Growth Medium(Roswell ParkMemorial Institute).4.3.10 HEPESA buffering salt.5.Respo
