ASTM_F_2502_-_11.pdf

Designation:F250211Standard Specification and Test Methods forAbsorbable Plates and Screws for Internal FixationImplants1This standard is issued under the fixed designation F2502;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 specification and test methods cover the mechani-cal characterization of plates and screws for orthopedic internalfixation.Covered devices are fabricated from one or morehydrolytically degradable polymer(from this point on referredto as“absorbable”)resins or resin composites.1.2 This specification establishes a common terminology todescribe the size and other physical characteristics of absorb-able implants and performance definitions related to theperformance of absorbable devices.1.3 This specification establishes standard test methods toconsistently measure performance-related mechanical charac-teristics of absorbable devices when tested under definedconditions of pretreatment,temperature,humidity,and testingmachine speed.1.4 This specification may not be appropriate for all absorb-able devices,especially those that possess limited hydrolyticsusceptibility and degrade in vivo primarily through enzymaticaction.The user is cautioned to consider the appropriateness ofthe standard in view of the particular absorbable device and itspotential application.1.5 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.1.6 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:2D790 Test Methods for Flexural Properties of Unreinforcedand Reinforced Plastics and Electrical Insulating Materi-alsE4 Practices for Force Verification of Testing MachinesE6 Terminology Relating to Methods of Mechanical TestingE122 Practice for Calculating Sample Size to Estimate,WithSpecified Precision,the Average for a Characteristic of aLot or ProcessE1823 Terminology Relating to Fatigue and Fracture TestingF116 Specification for Medical Screwdriver BitsF382 Specification and Test Method for Metallic Bone PlatesF543 Specification and Test Methods for Metallic MedicalBone ScrewsF565 Practice for Care and Handling of Orthopedic Implantsand InstrumentsF1088 Specification for Beta-Tricalcium Phosphate for Sur-gical ImplantationF1185 Specification for Composition of Hydroxylapatite forSurgical ImplantsF1635 Test Method forin vitro Degradation Testing of Hy-drolytically Degradable Polymer Resins and FabricatedForms for Surgical ImplantsF1839 Specification for Rigid Polyurethane Foam for Use asa Standard Material for Testing Orthopaedic Devices andInstrumentsF1925 Specification for Semi-Crystalline Poly(lactide)Poly-mer and Copolymer Resins for Surgical Implants2.2 ISO Standards:3ISO 13781 Poly(L-Lactide)Resins and Fabricated Formsfor Surgical ImplantsIn Vitro Degradation Testing1This specification and test methods is under the jurisdiction of ASTMCommittee F04 on Medical and Surgical Materials and Devices and is the directresponsibility of Subcommittee F04.21 on Osteosynthesis.Current edition approved June 1,2011.Published July 2011.Originally approvedin 2005.Last previous edition approved in 2009 as F2502 05(2009)1.DOI:10.1520/F2502-11.2For 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.3Available from American National Standards Institute(ANSI),25 W.43rd St.,4th Floor,New York,NY 10036,http:/www.ansi.org.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 ISO 14630Non-Active Surgical ImplantsGeneral Re-quirementsISO 15814 CopolymersandBlendsBasedonPolylactideIn Vitro Degradation Testing3.Terminology3.1 Definitions:3.1.1 Unless otherwise defined in this specification,theterminology related to mechanical testing that is used in thesetest methods will be in accordance with the definitions ofTerminologies E6 and E1823,and Specifications F382 andF543.3.2 General Definitions:3.2.1 absorbable,adjin the body,referring to an initiallydistinct foreign material or substance that either directly orthrough intended degradation can pass through or be assimi-lated by cells and/or tissue.NOTE1See Appendix X1.5 for a discussion regarding the usage of“absorbable”and other related terms.3.2.2 absorbable compositean absorbable polymer resinor construct incorporating a particulate and/or fibrous bioactiveand/or absorbable filler