1、Designation:F38417Standard Specifications and Test Methods forMetallic Angled Orthopedic Fracture Fixation Devices1This standard is issued under the fixed designation F384;the number immediately following the designation indicates the year of originaladoption or,in the case of revision,the year of l
2、ast revision.Anumber in parentheses indicates the year of last reapproval.Asuperscriptepsilon()indicates an editorial change since the last revision or reapproval.1.Scope1.1 These specifications and test methods provide a com-prehensive reference for angled devices used in the surgicalinternal fixat
3、ion of the skeletal system.This standard estab-lishes consistent methods to classify and define the geometricand performance characteristics of angled devices.This stan-dard also presents a catalog of standard specifications thatspecify material,labeling,and handling requirements,andstandard test me
4、thods for measuring performance relatedmechanical characteristics determined to be important to the invivo performance of angled devices.1.2 It is not the intention of this standard to define levels ofperformance or case-specific clinical performance for angleddevices,as insufficient knowledge is av
5、ailable to predict theconsequences of their use in individual patients for specificactivities of daily living.Futhermore,this standard does notdescribe or specify specific designs for angled devices used inthe surgical internal fixation of the skeletal system.1.3 This standard may not be appropriate
6、 for all types ofangled devices.The user is cautioned to consider the appro-priateness of this standard in view of a particular angled deviceand its potential application.NOTE1This standard is not intended to address intramedullary hipscrew nails or other angled devices without a sideplate.1.4 This
7、standard includes the following test methods usedin determining the following angled device mechanical perfor-mance characteristics:1.4.1 Standard test method for single cycle compressionbend testing of metallic angled orthopedic fracture fixationdevices(see Annex A1).1.4.2 Standard test method for
8、determining the bendingfatigue properties of metallic angled orthopedic fracture fixa-tion devices(see Annex A2).1.5 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.NOTE2There is currently no ISO standard that is either similar t
9、oequivalent to this standard.1.6 Multiple test methods are included in this standard.However,the user is not necessarily obligated to test using allof the described methods.Instead,the user should only select,with justification,test methods that are appropriate for aparticular device design.This may
10、 be only a subset of theherein described test methods.1.7 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
11、 by the World Trade Organization TechnicalBarriers to Trade(TBT)Committee.2.Referenced Documents2.1 ASTM Standards:2E4 Practices for Force Verification of Testing MachinesE8 Test Methods for Tension Testing of Metallic MaterialsE122 Practice for Calculating Sample Size to Estimate,WithSpecified Prec
12、ision,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)F90 S
13、pecificationforWroughtCobalt-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-
14、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)1These specifications and test methods are under the jurisdiction of ASTMCommittee F04 on Medi
15、cal and Surgical Materials and Devices and are the directresponsibility of Subcommittee F04.21 on Osteosynthesis.Current edition approved Feb.1,2017.Published March 2017.Originallyapproved in 1973.Last previous edition approved in 2012 as F384 12.DOI:10.1520/F0384-17.2For referenced ASTM standards,v
16、isit 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 StatesThis international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for theDevelopment of Internat
