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ASTM F384-06

(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

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 of 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 ).
1.4.2 Standard test method for determining the bending fatigue properties of metallic angled orthopedic fracture fixation devices (see ).
1.5 Unless otherwise indicated, the values stated in SI units shall be regarded as the standard.Note 2
There is currently no ISO standard that is either similar to equivalent to this standard.
1.6 This test method describes methods for bending fatigue testing in order to determine intrinsic structural properties of metallic angled devices. The test method may be used to determine the fatigue life at a specific or over a range of maximum bending moment levels or to estimate the fatigue strength for a specified number of fatigue cycles of an angled device.
1.7 This test method is intended to provide a means to mechanically characterize different angled device designs. This test method does not define angled device performance levels since these characteristics are driven by patient-specific clinical requirements.
1.8 UnitsThe values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
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 and health practices and to determine the applicability of regulatory limitations prior to use.Note 3
Currently, there is no ISO standard that is similar, or equivalent, to this test method.

General Information

Status
Historical
Publication Date
14-Jan-2006
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 F384-00 - Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices
Effective Date
15-Jan-2006
Replaced By
ASTM F384-06e1 - Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices
Effective Date
15-Jan-2006

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ASTM F384-06 - Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation DevicesASTM F384-06 - Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices
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ASTM F384-06 - Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices
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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: F 384 – 06
Standard Specifications and Test Methods for
1
Metallic Angled Orthopedic Fracture Fixation Devices
This standard is issued under the fixed designation F384; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.A
superscript epsilon (e) 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,
specify material, labeling, and handling requirements, and
With a Specified Tolerable Error, the Average for a
standard test methods for measuring performance related
Characteristic of a Lot or Process
mechanicalcharacteristicsdeterminedtobeimportanttothe in
F67 Specification for Unalloyed Titanium, for Surgical
vivo performance of angled devices.
Implant Applications (UNS R50250, UNS R50400, UNS
1.2 It is not the intention of this standard to define levels of
R50550, UNS R50700),
performance of case-specific clinical performance for angled
F75 SpecificationforCobalt-28Chromium-6Molybdenum
devices, as insufficient knowledge is available to predict the
Alloy Castings and Casting Alloy for Surgical Implants
consequences of their use in individual patients for specific
(UNS R30075)
activities of daily living. Futhermore, this standard does not
F90 Specification for Wrought Cobalt-20Chromium-
describe or specify specific designs for angled devices used in
15Tungsten-10Nickel Alloy for Surgical Implant Applica-
the surgical internal fixation of the skeletal system.
tions (UNS R30605)
1.3 This standard may not be appropriate for all types of
F136 Specification for Wrought Titanium-6Aluminum-
angled devices. The user is cautioned to consider the appro-
4Vanadium ELI (Extra Low Interstitial)Alloy for Surgical
priatenessofthisstandardinviewofaparticularangleddevice
Implant Applications (UNS R56401)
and its potential application.
F138 Specification for Wrought 18Chromium-14Nickel-
NOTE 1—This standard is not intended to address intramedullary hip 2.5Molybdenum Stainless Steel Bar and Wire for Surgical
screw nails or other angled devices without a sideplate.
Implants (UNS S31673)
F139 Specification for Wrought 18Chromium-14Nickel-
1.4 This standard includes the following test methods used
2.5Molybdenum Stainless Steel Sheet and Strip for Surgi-
in determining the following angled device mechanical perfor-
cal Implants (UNS S31673)
mance characteristics:
F382 Specification and Test Method for Metallic Bone
1.4.1 Standard test method for single cycle compression
Plates
bend testing of metallic angled orthopedic fracture fixation
F543 Specification and Test Methods for Metallic Medical
devices (see Annex A1).
Bone Screws
1.4.2 Standard test method for determining the bending
F565 Practice for Care and Handling of Orthopedic Im-
fatigue properties of metallic angled orthopedic fracture fixa-
plants and Instruments
tion devices (see Annex A2).
F620 Specification for Alpha Plus Beta Titanium Alloy
1.5 Unless otherwise indicated, the values stated in SI units
Forgings for Surgical Implants
shall be regarded as the standard.
1
These specifications and test methods are under the jurisdiction of ASTM
2
Committee F04 on Medical and Surgical Materials and Devices and are the direct For referenced ASTM standards, visit the ASTM website, www.astm.org, or
responsibility of Subcommittee F04.21 on Osteosynthesis. contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Current edition approved Jan. 15, 2006. Published February 2006. Originally Standards volume information, refer to the standard’s Document Summary page on
approved in 1973. Last previous edition approved in 2000 as F384–00. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1

---------------------- Page: 1 ----------------------
F384–06
FIG. 1 Diagram Illustrating Compression Hip Screw Angled Devices
F621 SpecificationforStainlessSteelForgingsforSurgical
Implants
F983 Practice for Permanent Marking of Orthopaedic Im-
plant Components
F1295 Specification for Wrought Titanium-6Aluminum-
...

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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.  
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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.

  • Technical specification
    22 pages
    English language
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  • Technical specification
    22 pages
    English language
    sale 15% off