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ASTM F2624-07

(Test Method)

Standard Test Method for Static, Dynamic, and Wear Assessment of Extra-Discal Spinal Motion Preserving Implants

Standard Test Method for Static, Dynamic, and Wear Assessment of Extra-Discal Spinal Motion Preserving Implants

ABSTRACT
This test method deals with static, dynamic, and wear testing of extra-discal motion preserving implants. These implants are intended to augment spinal stability without significant tissue removal while allowing motion of the functional spinal unit(s). Wear is assessed using a weight loss method and a dimensional analysis for determining wear of components used in extra-discal spinal motion preserving procedures, using testing medium as defined in this test method. This test method is not intended to address facet arthroplasty devices and any potential failure mode as it relates to the fixation of the device to its bony interfaces; and does not prescribe methods for assessing the mechanical characteristics of the device in translation. The static test includes the static flexion test, static extension test, static torsion test, static lateral bending test, and fatigue tests. Wear test includes flexion/extension wear assessment, rotational wear assessment, and bending wear assessment. The apparatus which shall be used includes implant components and spinal testing apparatus. The calculation and interpretation of wear results are also elaborated.
SIGNIFICANCE AND USE
This test method is designed to quantify the static, dynamic, and wear characteristics of different designs of extra-discal motion preserving implants using testing medium (see 6.1) for simulating the physiologic environment at 37°C. Wear is assessed using a weight loss method in addition to dimensional analyses. Weight loss is determined after subjecting the implants to dynamic profiles specified in this test method. This information will allow the manufacturer or end user of the product to understand how the specific device in question performs under the test conditions prescribed in this test method.
This test method is intended to be applicable for extra-discal motion preserving implants. These implants augment the motion/load bearing characteristics between adjacent vertebral bodies, and thereby fully or partially support and transmit motion by means of an articulating joint or by use of compliant materials. Ceramics, metals, or polymers, or combinations thereof are used in implant design, and it is the goal of this test method to enable a comparison of the static, dynamic, and wear properties generated by these devices, regardless of material and type of device.
SCOPE
1.1 This test method is intended to provide test methods for the static, dynamic, and wear testing of extra-discal motion preserving implants. These implants are intended to augment spinal stability without significant tissue removal while allowing motion of the functional spinal unit(s).
1.2 Wear is assessed using a weight loss method and a dimensional analysis for determining wear of components used in extra-discal spinal motion preserving procedures, using testing medium as defined in this test method (6.1).
1.3 This test method is not intended to address any potential failure mode as it relates to the fixation of the device to its bony interfaces.
1.4 It is the intent of this test method to enable comparison of motion preserving, extra-discal implants with regard to kinematic, functional, and wear characteristics when tested under the specified conditions. It must be recognized, however, that there are many possible variations in the in vivo conditions. A single laboratory simulation with a fixed set of parameters may not be universally representative.
1.5 This test method is not intended to address facet arthroplasty devices.
1.6 This test method prescribes the use of pure angular rotations for assessing the mechanical characteristics of extra-discal motion preserving implants. This test method does not, however, prescribe methods for assessing the mechanical characteristics of the device in translation (for example, anterior/posterior translation), though this type of linear motion may be clinically relevant.
1.7 In order that the data be reproducib...

General Information

Status
Historical
Publication Date
14-Dec-2007
ICS
11.040.40 - Implants for surgery, prosthetics and orthotics
Technical Committee
F04 - Medical and Surgical Materials and Devices
Drafting Committee
F04.25 - Spinal Devices
Current Stage
Ref Project

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ASTM F2624-07 - Standard Test Method for Static, Dynamic, and Wear Assessment of Extra-Discal Spinal Motion Preserving ImplantsASTM F2624-07 - Standard Test Method for Static, Dynamic, and Wear Assessment of Extra-Discal Spinal Motion Preserving Implants
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ASTM F2624-07 - Standard Test Method for Static, Dynamic, and Wear Assessment of Extra-Discal Spinal Motion Preserving Implants
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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: F2624 − 07
StandardTest Method for
Static, Dynamic, and Wear Assessment of Extra-Discal
1
Spinal Motion Preserving Implants
This standard is issued under the fixed designation F2624; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope 1.8 Without a substantial clinical retrieval history of spinal,
motionpreservingextra-discalimplants,actualloadingprofiles
1.1 This test method is intended to provide test methods for
and patterns cannot be delineated at the time of the writing of
the static, dynamic, and wear testing of extra-discal motion
this test method. It therefore follows that the motion profiles
preserving implants. These implants are intended to augment
specified by this test method do not necessarily accurately
spinal stability without significant tissue removal while allow-
reproduce those occurring in vivo. Rather this method provides
ing motion of the functional spinal unit(s).
useful boundary/endpoint conditions for evaluating implant
1.2 Wear is assessed using a weight loss method and a
designs in a functional manner.
dimensionalanalysisfordeterminingwearofcomponentsused
1.9 This test method is not intended to be a performance
in extra-discal spinal motion preserving procedures, using
standard. It is the responsibility of the user of this test method
testing medium as defined in this test method (6.1).
to characterize the safety and effectiveness of the device under
1.3 This test method is not intended to address any potential
evaluation.
failuremodeasitrelatestothefixationofthedevicetoitsbony
1.10 The values stated in SI units are to be regarded as the
interfaces.
standard. The values given in parentheses are for information
1.4 It is the intent of this test method to enable comparison
only.
of motion preserving, extra-discal implants with regard to
1.11 The values stated in SI units are to be regarded as the
kinematic, functional, and wear characteristics when tested
standard with the exception of angular measurements, which
under the specified conditions. It must be recognized, however,
may be reported in either degrees or radians.
that there are many possible variations in the in vivo condi-
tions. A single laboratory simulation with a fixed set of 1.12 This standard does not purport to address all of the
parameters may not be universally representative. safety concerns, if any, associated with its use. It is the
responsibility of the user of this standard to establish appro-
1.5 This test method is not intended to address facet
priate safety and health practices and determine the applica-
arthroplasty devices.
bility of regulatory limitations prior to use.
1.6 This test method prescribes the use of pure angular
rotations for assessing the mechanical characteristics of extra-
2. Referenced Documents
discal motion preserving implants. This test method does not,
2
2.1 ASTM Standards:
however, prescribe methods for assessing the mechanical
F561 Practice for Retrieval and Analysis of Medical
characteristics of the device in translation (for example,
Devices, and Associated Tissues and Fluids
anterior/posteriortranslation),thoughthistypeoflinearmotion
F1714 Guide for GravimetricWearAssessment of Prosthetic
may be clinically relevant.
Hip Designs in Simulator Devices
1.7 In order that the data be reproducible and comparable
F1717 Test Methods for Spinal Implant Constructs in a
within and between laboratories, it is essential that uniform
Vertebrectomy Model
procedures are established. This test method is intended to
F1877 Practice for Characterization of Particles
facilitate uniform testing methods and data reporting for
F2003 Practice for Accelerated Aging of Ultra-High Mo-
extra-discal motion preserving implants.
lecular Weight Polyethylene after Gamma Irradiation in
Air
1
This test method is under the jurisdiction ofASTM Committee F04 on Medical
2
and Surgical Materials and Devices and is the direct responsibility of Subcommittee For referenced ASTM standards, visit the ASTM website, www.astm.org, or
F04.25 on Spinal Devices. contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Current edition approved Dec. 15, 2007. Published March 2008. DOI: 10.1520/ Standards volume information, refer to the standard’s Document Summary page on
F2624-07. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F2624 − 07
F2423 Guide for Functional, Kinematic, and Wear Assess- 3.2.10 kinematic profile—the relative motion between adja-
m
...

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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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Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-Hard Articulations

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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.  
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.
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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.  
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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