ASTM_F_1983_-_14.pdf

Designation:F198314Standard Practice forAssessment of Selected Tissue Effects of AbsorbableBiomaterials for Implant Applications1This standard is issued under the fixed designation F1983;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 provides experimental protocols for bio-logical assays of tissue reactions to absorbable biomaterials forimplant applications.This practice applies only to absorbablematerials with projected clinical applications in which thematerials will reside in bone or soft tissue longer than 30 daysand less than three years.Other standards with designatedimplantation times are available to address shorter time peri-ods.Careful consideration should be given to the appropriate-ness of this practice for slowly degrading materials that willremain for longer than three years.It is anticipated that thetissue response to degrading biomaterials will be different fromthe response to nonabsorbable materials.In many cases,achronic inflammatory response may be observed during thedegradation phase,but the local histology should return tonormal after absorption;therefore,the minimal tissue responseusually equated with“biocompatibility”may require longimplantations.1.2 The time period for implant absorption will vary de-pending on chemical composition implant size,implantlocation,and test subject species;therefore,the implantationtimes for examination of tissue response will be linked to therate of absorption.No single implantation time is indicated inthis practice.1.3 These protocols assess the effects of the material on theanimal tissue in which it is implanted.The experimentalprotocols do not fully assess systemic toxicity,carcinogenicity,teratogenicity,or mutagenicity of the material.Other standardsare available to address these issues.1.4 To maximize use of the animals in the study protocol,alltoxicological findings should be recorded.There are someaspects of systemic toxicity,including effects of degradationproducts on the target organs,that can be addressed with thispractice,and these effects should be documented fully.1.5 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 FluidsF750 Practice for Evaluating Material Extracts by SystemicInjection in the MouseF763 Practice for Short-Term Screening of Implant Materi-alsF981 Practice for Assessment of Compatibility of Biomate-rials for Surgical Implants with Respect to Effect ofMaterials on Muscle and BoneF1408 Practice for Subcutaneous Screening Test for ImplantMaterialsF1903 Practice for Testing For Biological Responses toParticles In VitroF1904 Practice for Testing the Biological Responses toParticles in vivoF1905 Practice For Selecting Tests for Determining thePropensity of Materials to Cause Immunotoxicity(With-drawn 2011)3F1906 Practice for Evaluation of Immune Responses InBiocompatibility Testing Using ELISATests,LymphocyteProliferation,and Cell Migration(Withdrawn 2011)33.Summary of Practice3.1 Under strict aseptic conditions,specimens of the sterilefinal implant form candidate material are implanted into themost relevant anatomical tissue site in small laboratoryanimals,preferably mice,rats,hamsters,or rabbits.1This practice is under the jurisdiction ofASTM CommitteeF04 on Medical andSurgical Materials and Devices and is the direct responsibility of SubcommitteeF04.16 on Biocompatibility Test Methods.Current edition approved Nov.1,2014.Published January 2015.Originallyapproved in 1999.Last previous edition approved in 2008 as F1983 99(2008).DOI:10.1520/F1983-14.2For 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.3The last approved version of this historical standard is referenced onwww.astm.org.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 3.2 The use of larger animals,such as the dog,goat,orsheep may be justified based upon special considerations of theparticular study.Choice of species also should consider theavailability of historical data on biological responses of theseanimals to similar devices to aid in analysis and comparison ofthe data obtained.3.3 All animal studies shall be done in a facility approvedby a nationally recognized organization and in accordance withall appropriat