ASTM_F_1903_-_18.pdf

Designation:F190318Standard Practice forTesting for Cellular 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 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 assessment of cellular responsesto wear particles and degradation products from implantedmaterials that may lead to a cascade of biological responsesresulting in damage to adjacent and remote tissues.In order toascertain the role of particles in stimulating such responses,thenature of the responses,and the consequences of the responses,established protocols are needed.This is an emerging,rapidlydeveloping area,and the information gained from standardprotocols is necessary to interpret cellular responses to par-ticles and to determine if these correlate with in vivo responses.Since there are many possible and established ways of deter-mining responses,a single standard protocol is not stated.However,well described protocols are needed to compareresults from different investigators using the same materialsand to compare biological responses for evaluating(ranking)different materials.For laboratories without establishedprotocols,recommendations are given and indicated with anasterisk(*).1.2 Since the purpose of the following test procedures is topredict the response in human tissues,the use of human(preferably macrophage lineage)cells is recommended.However,the use of non-macrophage cell lineage or the use ofcells from non-human and non-primate sources may be accept-able.The source of the cells or the cell line used should bejustified based on the cellular responses under test and/or tissueof interest.Non-human cells should not be used if there isevidence of possible cross-species difference for specific testresults as the results of this in vitro test may not correspond toactual human response.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-priate safety,health,and environmental practices and deter-mine the applicability of regulatory limitations prior to use.1.5 This international standard was developed in accor-dance with internationally recognized principles on standard-ization established in the Decision on Principles for theDevelopment of International Standards,Guides and Recom-mendations issued by the World Trade Organization TechnicalBarriers to Trade(TBT)Committee.2.Referenced Documents2.1 ASTM Standards:2F619 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 Cellular 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 Cellular responses to particles may be evaluated usingmaterials 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 methods(for example,derivedfrom in vitro mechanical testing or retrieved from ex vivoperi-implant tissues either from clinical retrievals or animalmodels)may also be used as long as they have characteristicssimilar to those produced by the implant or device being testedwith appropriate justification.3.3 The purpose of this practice is to assess the response ofcells in direct contact with particles and therefore,this 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.The size range of particles(among other particlecharacteristics)should be clearly defined and stratification of1This 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 Oct.1,2018.Published October 2018.Originallyapproved in 1998.Last previous edition approved in 2010 as F1903 10.DOI:10.1520/F1903-18.2For 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-