ASTM_F_382_-_14.pdf

Designation:F38214Standard Specification and Test Method forMetallic Bone Plates1This standard is issued under the fixed designation F382;the number immediately following the designation indicates the year of originaladoption or,in the case of revision,the year of last revision.Anumber in parentheses indicates the year of last reapproval.Asuperscriptepsilon()indicates an editorial change since the last revision or reapproval.1.Scope1.1 This specification and test method is intended to providea comprehensive reference for bone plates used in the surgicalinternal fixation of the skeletal system.The standard estab-lishes consistent methods to classify and define the geometricand performance characteristics of bone plates.The standardalso presents a catalog of standard specifications that specifymaterial;labeling and handling requirements;and standard testmethods for measuring performance related mechanical char-acteristics determined to be important to the in vivo perfor-mance of bone plates.1.2 It is not the intention of the standard to define levels ofperformance or case-specific clinical performance for boneplates,as insufficient knowledge is available to predict theconsequences or their use in individual patients for specificactivities of daily living.Futhermore,it is not the intention ofthe standard to describe or specify specific designs for boneplates used in the surgical internal fixation of the skeletalsystem.1.3 This document may not be appropriate for all types ofbone plates.The user is cautioned to consider the appropriate-ness of the standard in view of a particular bone plate and itspotential application.1.4 This document includes the following test methods usedin determining the following bone plate mechanical perfor-mance characteristics:1.4.1 Standard Test Method for Single Cycle Bend Testingof Metallic Bone PlatesAnnex A1,and1.4.2 Standard Test Method for Determining the BendingFatigue Properties Of Metallic Bone PlatesAnnex A2.1.5 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.1.6 Multiple test methods are included in this standard.However,it must be noted that the user is not obligated to testusing all of the described methods.Instead,the user shouldonly select test methods that are appropriate for a particulardevice design.In most instances,only a subset of the hereindescribed test methods will be required.1.7 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:2E122 Practice for Calculating Sample Size to Estimate,WithSpecified Precision,the Average for a Characteristic of aLot or ProcessF67 Specification for Unalloyed Titanium,for Surgical Im-plant Applications(UNS R50250,UNS R50400,UNSR50550,UNS R50700)F75 Specification for Cobalt-28 Chromium-6 MolybdenumAlloy Castings and Casting Alloy for Surgical Implants(UNS R30075)F86 Practice for Surface Preparation and Marking of Metal-lic Surgical ImplantsF90 SpecificationforWroughtCobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applica-tions(UNS R30605)F136 Specification for Wrought Titanium-6Aluminum-4Vanadium ELI(Extra Low Interstitial)Alloy for SurgicalImplant Applications(UNS R56401)F138 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for SurgicalImplants(UNS S31673)F139 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Sheet and Strip for Sur-gical Implants(UNS S31673)F543 Specification and Test Methods for Metallic MedicalBone ScrewsF565 Practice for Care and Handling of Orthopedic Implantsand Instruments1This specification and test method is under the jurisdiction of ASTM Commit-tee F04 on Medical and Surgical Materials and Devices and is the directresponsibility of Subcommittee F04.21 on Osteosynthesis.Current edition approved Nov.1,2014.Published January 2014.Originallyapproved in 1973.Last previous edition approved in 2008 as F382 99(2008)1.DOI:10.1520/F0382-14.2For 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 F620 Specification for Titanium Alloy Forgings for SurgicalImplants in the Alpha Plus Beta ConditionF621 Specification for Stainless Steel Forgings for SurgicalImplantsF983 Practice for Permanent Marking of Orthopaedic Im-plant ComponentsF1295 Specification for Wrought Titanium-6Aluminum-7Niobium Alloy for Surgical Implant Applications(UNSR56700)F1314 Specification for Wrought Nitrogen Strengthened 22Chromium13 Nickel5 Mangan