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ASTM F384-12

(Specification)

Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices

Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices

SIGNIFICANCE AND USE
A2.5.1 The test method establishes a uniform cantilever bending fatigue test to characterize and compare the fatigue performance of different angled device designs. This test method may be used to determine the fatigue life of an angled device at either a specific or over a range of maximum bending moment conditions. Additionally, this test method may be alternatively used to estimate the fatigue strength of an angled device for a specified number of fatigue cycles.
A2.5.2 The test method utilizes a simplified angled device cantilever bending load model that may not be exactly representative of the in-situ loading configuration. The user should note that the test results generated by this test method can not be used to directly predict the in-vivo performance of the angled device being tested. The data generated from this test method can be used to conduct relative comparisons of different angled device designs.
A2.5.3 This test method may not be appropriate for all types of implant applications. The user is cautioned to consider the appropriateness of the method in view of the devices being tested and their potential application.
A2.5.4 This test method assumes that the angled device is manufactured from a material that exhibits linear-elastic material behavior; therefore, this test method is not applicable for testing angled devices made from materials that exhibit nonlinear elastic behavior.
A2.5.5 This test method is restricted to the testing of angled devices within the linear-elastic range of the material; therefore, this test method is not applicable for testing angled devices under conditions that would approach or exceed the bending strength of the angled device being tested.
SCOPE
1.1 These specifications and test methods provide a comprehensive reference for angled devices used in the surgical internal fixation of the skeletal system. This standard establishes consistent methods to classify and define the geometric and performance characteristics of angled devices. This standard also presents a catalog of standard specifications that specify material, labeling, and handling requirements, and standard test methods for measuring performance related mechanical characteristics determined to be important to the in vivo performance of angled devices.
1.2 It is not the intention of this standard to define levels of performance or case-specific clinical performance for angled devices, as insufficient knowledge is available to predict the consequences of their use in individual patients for specific activities of daily living. Futhermore, this standard does not describe or specify specific designs for angled devices used in the surgical internal fixation of the skeletal system.
1.3 This standard may not be appropriate for all types of angled devices. The user is cautioned to consider the appropriateness of this standard in view of a particular angled device and its potential application.  
Note 1—This standard is not intended to address intramedullary hip screw nails or other angled devices without a sideplate.
1.4 This standard includes the following test methods used in determining the following angled device mechanical performance characteristics:  
1.4.1 Standard test method for single cycle compression bend testing of metallic angled orthopedic fracture fixation devices (see Annex A1).
1.4.2 Standard test method for determining the bending fatigue properties of metallic angled orthopedic fracture fixation devices (see Annex A2).
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
Note 2—There is currently no ISO standard that is either similar to equivalent to this standard.

General Information

Status
Historical
Publication Date
14-May-2012
ICS
11.040.40 - Implants for surgery, prosthetics and orthotics
Technical Committee
F04 - Medical and Surgical Materials and Devices
Drafting Committee
F04.21 - Osteosynthesis
Current Stage
Ref Project

Relations

Replaces
ASTM F384-06(2011) - Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices
Effective Date
15-May-2012

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ASTM F384-12 - Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation DevicesASTM F384-12 - Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices
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12 pages
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Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation:F384 −12
Standard Specifications and Test Methods for
1
Metallic Angled Orthopedic Fracture Fixation Devices
ThisstandardisissuedunderthefixeddesignationF384;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginal
adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.Asuperscript
epsilon (´) indicates an editorial change since the last revision or reapproval.
NOTE 2—There is currently no ISO standard that is either similar to
1. Scope
equivalent to this standard.
1.1 These specifications and test methods provide a com-
prehensive reference for angled devices used in the surgical 2. Referenced Documents
internal fixation of the skeletal system. This standard estab- 2
2.1 ASTM Standards:
lishes consistent methods to classify and define the geometric
E4 Practices for Force Verification of Testing Machines
and performance characteristics of angled devices. This stan-
E8 Test Methods for Tension Testing of Metallic Materials
dard also presents a catalog of standard specifications that
E122 Practice for Calculating Sample Size to Estimate,With
specify material, labeling, and handling requirements, and
Specified Precision, the Average for a Characteristic of a
standard test methods for measuring performance related
Lot or Process
mechanical characteristics determined to be important to the in
F67 Specification for Unalloyed Titanium, for Surgical Im-
vivo performance of angled devices.
plant Applications (UNS R50250, UNS R50400, UNS
1.2 It is not the intention of this standard to define levels of R50550, UNS R50700)
performance or case-specific clinical performance for angled F75 Specification for Cobalt-28 Chromium-6 Molybdenum
devices, as insufficient knowledge is available to predict the Alloy Castings and Casting Alloy for Surgical Implants
(UNS R30075)
consequences of their use in individual patients for specific
activities of daily living. Futhermore, this standard does not F90 Specification for Wrought Cobalt-20Chromium-
15Tungsten-10NickelAlloy for Surgical ImplantApplica-
describe or specify specific designs for angled devices used in
the surgical internal fixation of the skeletal system. tions (UNS R30605)
F136 Specification for Wrought Titanium-6Aluminum-
1.3 This standard may not be appropriate for all types of
4Vanadium ELI (Extra Low Interstitial)Alloy for Surgical
angled devices. The user is cautioned to consider the appro-
Implant Applications (UNS R56401)
priateness of this standard in view of a particular angled device
F138 Specification for Wrought 18Chromium-14Nickel-
and its potential application.
2.5Molybdenum Stainless Steel Bar andWire for Surgical
NOTE 1—This standard is not intended to address intramedullary hip
Implants (UNS S31673)
screw nails or other angled devices without a sideplate.
F139 Specification for Wrought 18Chromium-14Nickel-
1.4 This standard includes the following test methods used
2.5Molybdenum Stainless Steel Sheet and Strip for Sur-
in determining the following angled device mechanical perfor-
gical Implants (UNS S31673)
mance characteristics:
F382 SpecificationandTestMethodforMetallicBonePlates
1.4.1 Standard test method for single cycle compression
F565 PracticeforCareandHandlingofOrthopedicImplants
bend testing of metallic angled orthopedic fracture fixation
and Instruments
devices (see Annex A1).
F620 Specification for TitaniumAlloy Forgings for Surgical
1.4.2 Standard test method for determining the bending
Implants in the Alpha Plus Beta Condition
fatigue properties of metallic angled orthopedic fracture fixa-
F621 Specification for Stainless Steel Forgings for Surgical
tion devices (see Annex A2).
Implants
1.5 The values stated in SI units are to be regarded as
F983 Practice for Permanent Marking of Orthopaedic Im-
standard. No other units of measurement are included in this
plant Components
standard.
F1295 Specification for Wrought Titanium-6Aluminum-
7Niobium Alloy for Surgical Implant Applications (UNS
R56700)
1
These specifications and test methods are under the jurisdiction of ASTM
Committee F04 on Medical and Surgical Materials and Devices and are the direct
2
responsibility of Subcommittee F04.21 on Osteosynthesis. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Current edition approved May 15, 2012. Published June 2012. Originally contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
approved in 1973. Last previous edition approved in 2011 as F384 – 06 (2011). Standards volume information, refer to the standard’s Document Summary page on
DOI: 10.1520/F0384-12. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F384−12
FIG. 1Diagram Illustra
...

This document is not anASTM standard and is intended only to provide the user of anASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation:F384–06 (Reapproved 2011) Designation: F384 – 12
Standard Specifications and Test Methods for
1
Metallic Angled Orthopedic Fracture Fixation Devices
ThisstandardisissuedunderthefixeddesignationF384;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginal
adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.Asuperscript
epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope
1.1 These specifications and test methods provide a comprehensive reference for angled devices used in the surgical internal
fixation of the skeletal system. This standard establishes consistent methods to classify and define the geometric and performance
characteristics of angled devices. This standard also presents a catalog of standard specifications that specify material, labeling,
and handling requirements, and standard test methods for measuring performance related mechanical characteristics determined
to be important to the in vivo performance of angled devices.
1.2 It is not the intention of this standard to define levels of performance ofor case-specific clinical performance for angled
devices, as insufficient knowledge is available to predict the consequences of their use in individual patients for specific activities
of daily living. Futhermore, this standard does not describe or specify specific designs for angled devices used in the surgical
internal fixation of the skeletal system.
1.3 This standard may not be appropriate for all types of angled devices. The user is cautioned to consider the appropriateness
of this standard in view of a particular angled device and its potential application.
NOTE 1—This standard is not intended to address intramedullary hip screw nails or other angled devices without a sideplate.
1.4 This standard includes the following test methods used in determining the following angled device mechanical performance
characteristics:
1.4.1 Standardtestmethodforsinglecyclecompressionbendtestingofmetallicangledorthopedicfracturefixationdevices(see
Annex A1).
1.4.2 Standardtestmethodfordeterminingthebendingfatiguepropertiesofmetallicangledorthopedicfracturefixationdevices
(see Annex A2).
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
NOTE 2—There is currently no ISO standard that is either similar to equivalent to this standard.
2. Referenced Documents
2
2.1 ASTM Standards:
E4 Practices for Force Verification of Testing Machines
E8 Test Methods for Tension Testing of Metallic Materials
E122 Practice for Calculating Sample Size to Estimate, With Specified Precision, the Average for a Characteristic of a Lot or
Process
F67 Specification for UnalloyedTitanium, for Surgical ImplantApplications (UNS R50250, UNS R50400, UNS R50550, UNS
R50700)
F75 Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS
R30075)
F90 Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applications (UNS
R30605)
F136 Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant
Applications (UNS R56401)
1
ThesespecificationsandtestmethodsareunderthejurisdictionofASTMCommitteeF04onMedicalandSurgicalMaterialsandDevicesandarethedirectresponsibility
of Subcommittee F04.21 on Osteosynthesis.
´1
Current edition approved June 1, 2011. Published July 2011. Originally approved in 1973. Last previous edition approved in 2006 as F384–06 . DOI:
10.1520/F0384-06R11.
Current edition approved May 15, 2012. Published June 2012. Originally approved in 1973. Last previous edition approved in 2011 as F384 – 06 (2011). DOI:
10.1520/F0384-12.
2
For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1

---------------------- Page: 1 ----------------------
F384 – 12
F138 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants
(UNS S31673)
F139 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Sheet and Strip for Surgical Implants
(UNS S31673)
F382 Specification and Test Method for Metallic Bone Plates F543Specification and T
...

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1.3 Function simulation is defined as the reproduction of loads and motions that might be encountered in activities of daily living, but it does not necessarily cover every possible type of loading. Functional simulation differs from typical wear testing in that it attempts to exercise the prosthetic device through a variety of loading and motion conditions such as might be encountered in situ in the human body in order to reveal various damage modes and damage mechanisms that might be encountered throughout the life of the prosthetic device.  
1.4 Force control is defined as the mode of control of the test machine that accepts a force level as the set point input and which utilizes a force feedback signal in a control loop to achieve that set point input. For knee simulation, the flexion motion is placed under angular displacement control, internal and external rotation is placed under torque control, and axial load, anterior-posterior shear, and medial-lateral shear are placed under force control.  
1.5 This document establishes kinetic and kinematic test conditions for several activities of daily living, including walking, turning navigational movements, stair climbing, stair descent, and squatting. The kinetic and kinematic test conditions are expressed as reference waveforms used to drive the relevant simulator machine actuators. These waveforms represent motion, as in the case of flexion extension, or kinetic signals representing the forces and moments resulting from body dynamics, gravitation, and the active musculature acting across the knee.  
1.6 This document does not address the assessment or measurement of damage modes, or wear or failure of the prosthetic device.  
1.7 This document is a guide. As defined by ASTM in their “Form and Style for ASTM Standards” book in section C15.2, “A standard guide is a compendium of information or series of options that does not recommend a specific course of action. Guides are intended ...

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ASTM
ASTM F3047M-23(Guide)
Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-Hard Articulations

SIGNIFICANCE AND USE
5.1 The current hip simulator wear test standards (ISO 14242-1 or ISO 14242-3) stipulate only one load waveform and one set of articulation motions. There is a need for more versatile and rigorous wear test regimes, but the knowledge of what represents realistic high demand wear test features is limited. More research is clearly needed before a standard that defines what a representative high demand wear test should include can be written. The objective of this guide is to advise researchers on the possible high demand wear test features that should be included in evaluation of hard-on-hard articulations.  
5.2 This guide makes suggestions of what high demand test features may need to be added to an overall high demand wear test regime. The features described here are not meant to be all inclusive. Based on current knowledge they appear to be relevant to adverse conditions that can occur in clinical use.  
5.3 All the test features, both conventional and high demand, could have interactive effects on the wear of the components.
SCOPE
1.1 The objective of this guide is to advise researchers on the possible high demand wear test features that should be included in evaluation of hard-on-hard articulations. This guide makes suggestions for high demand test features that may need to be added to an overall wear test regime. Device articulating components manufactured from other metallic alloys, ceramics, or with coated or elementally modified surfaces without significant clinical use could possibly be evaluated with this guide. However, such materials may include risks and failure mechanisms that are not addressed in this guide.  
1.2 Hard-on-hard hip bearing systems include metal-on-metal (for example, Specifications F75, F799, and F1537; ISO 5832-4, ISO 5832-12), ceramic-on-ceramic (for example, ISO 6474-1, ISO 6474-2, ISO 13356), ceramic-on-metal, or any other bearing systems where both the head and cup components have high surface hardness. An argument has been made that the hard-on-hard THR articulation may be better for younger, more active patients. These younger patients may be more physically fit and expect to be able to perform more energetic activities. Consequently, new designs of hard-on-hard THR articulations may have some implantations subjected to more demanding and longer wear performance requirements.  
1.3 Total Hip Replacement (THR) with metal-on-metal articulations have been used clinically for more than 50 years (1, 2).2 Early designs had mixed clinical results. Eventually they were eclipsed by THR systems using metal-on-polyethylene articulations. In the 1990s the metal-on-metal articulation again became popular with more modern designs (3), including surface replacement.  
1.4 In the 1970s the first ceramic-on-ceramic THR articulations were used. In general, the early results were not satisfactory (4, 5). Improvement in alumina, and new designs in the 1990s improved the results for ceramic-on-ceramic articulations (6).  
1.5 The values stated in SI units are to be regarded as the standard.  
1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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ASTM
ASTM F543-23(Specification)
Standard Specification and Test Methods for Metallic Medical Bone Screws

ABSTRACT
This specification provides requirements for materials, finish and marking, care and handling, and the acceptable dimensions and tolerances for metallic bone screws that are implanted into bone. There are a large variety of medical bone screws currently in use, the following type of screws are used: type HA - spherical undersurface of head, shallow, asymmetrical buttress thread, and deep screw head, type HB - spherical undersurface of head, deep, asymmetrical buttress thread, and shallow screw head, type HC - conical undersurface of head, symmetrical thread, and type HD - conical undersurface of head, symmetrical thread. The torsional strength, breaking angle, axial pullout strength, insertion torque, self-tapping force, and removal torque shall be tested to meet the requirements prescribed.
SIGNIFICANCE AND USE
A1.1 Significance and Use
A1.1.1 This test method is used to measure the torsional yield strength, maximum torque, and breaking angle of the bone screw under standard conditions. The results obtained in this test method are not intended to predict the torque encountered while inserting or removing a bone screw in human or animal bone. This test method is intended only to measure the uniformity of the product tested or to compare the mechanical properties of different, yet similarly sized, products.
SCOPE
1.1 This specification provides requirements for materials, finish and marking, care and handling, and the acceptable dimensions and tolerances for metallic bone screws that are implanted into bone. The dimensions and tolerances in this specification are applicable only to metallic bone screws described in this specification.  
1.2 This specification provides performance considerations and standard test methods for measuring mechanical properties in torsion of metallic bone screws that are implanted into bone. These test methods may also be applicable to other screws besides those whose dimensions and tolerances are specified here. The following annexes are included:  
1.2.1 Annex A1—Test Method for Determining the Torsional Properties of Metallic Bone Screws.  
1.2.2 Annex A2—Test Method for Driving Torque of Medical Bone Screws.  
1.2.3 Annex A3—Test Method for Determining the Axial Pullout Load of Medical Bone Screws.  
1.2.4 Annex A4—Test Method for Determining the Self-Tapping Performance of Self-Tapping Medical Bone Screws.  
1.2.5 Annex A5—Specifications for Type HA and Type HB Metallic Bone Screws.  
1.2.6 Annex A6—Specifications for Type HC and Type HD Metallic Bone Screws.  
1.2.7 Annex A7—Specifications for Metallic Bone Screw Drive Connections.  
1.3 This specification is based, in part, upon ISO 5835, ISO 6475, and ISO 9268.  
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.5 Multiple test methods are included in this standard. However, the user is not necessarily obligated to test using all of the described methods. Instead, the user should only select, with justification, test methods that are appropriate for a particular device design. This may only be a subset of the herein described test methods.  
1.6 This standard may involve the use of hazardous materials, operations, and equipment. This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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