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ASTM F2267-04

(Test Method)

Standard Test Method for Measuring Load Induced Subsidence of an Intervertebral Body Fusion Device Under Static Axial Compression

Standard Test Method for Measuring Load Induced Subsidence of an Intervertebral Body Fusion Device Under Static Axial Compression

SIGNIFICANCE AND USE
Intervertebral body fusion devices are generally simple geometric shaped devices, which are often porous or hollow in nature. Their function is to support the anterior column of the spine to facilitate arthrodesis of the motion segment.  
This test method is designed to quantify the subsidence characteristics of different designs of intervertebral body fusion devices since this is a potential clinical failure mode. These tests are conducted in vitro in order to simplify the comparison of simulated vertebral body subsidence induced by the intervertebral body fusion devices.
The static axial compressive loads that will be applied to the intervertebral body fusion devices and test blocks will differ from the complex loading seen in vivo, and therefore, the results from this test method may not be used to directly predict in vivo performance. The results, however, can be used to compare the varying degrees of subsidence between different intervertebral body fusion device designs for a given density of simulated bone.
The location within the simulated vertebral bodies and position of the intervertebral body fusion device with respect to the loading axis will be dependent upon the design and manufacturer’recommendation for implant placement.
SCOPE
1.1 This test method specifies the materials and methods for the axial compressive subsidence testing of non-biologic intervertebral body fusion devices, spinal implants designed to promote arthrodesis at a given spinal motion segment.
1.2 This test method is intended to provide a basis for the mechanical comparison among past, present, and future non-biologic intervertebral body fusion devices. This test method allows comparison of intervertebral body fusion devices with different intended spinal locations and methods of application to the intradiscal spaces. This test method is intended to enable the user to mechanically compare intervertebral body fusion devices and does not purport to provide performance standards for intervertebral body fusion devices.
1.3 This test method describes a static test method by specifying a load type and a specific method of applying this load. This test is designed to allow for the comparative evaluation of intervertebral body fusion devices.
1.4 Guidelines are established for measuring test block deformation and determining the subsidence of intervertebral body fusion devices.
1.5 Units—The values stated in SI units are to be regarded as the standard with the exception of angular measurements, which may be reported in terms of either degrees or radians.
1.6 Since some intervertebral body fusion devices require the use of additional implants for stabilization, the testing of these types of implants may not be in accordance with the manufacturer's recommended usage.
1.7 The use of this standard may involve the operation of potentially hazardous 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 and health practices and determine the applicability of regulatory limitations prior to use.

General Information

Status
Historical
Publication Date
31-Mar-2004
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

Relations

Replaces
ASTM F2267-03 - Standard Test Method for Measuring Load Induced Subsidence of an Intervertebral Body Fusion Device Under Static Axial Compression
Effective Date
01-Apr-2004
Replaced By
ASTM F2267-04(2011) - Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression
Effective Date
01-Dec-2011
Referred By
ASTM F2789-10(2020) - Standard Guide for Mechanical and Functional Characterization of Nucleus Devices
Effective Date
01-Apr-2004
Referred By
ASTM F3292-19 - Standard Practice for Inspection of Spinal Implants Undergoing Testing
Effective Date
01-Apr-2004

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ASTM F2267-04 - Standard Test Method for Measuring Load Induced Subsidence of an Intervertebral Body Fusion Device Under Static Axial CompressionASTM F2267-04 - Standard Test Method for Measuring Load Induced Subsidence of an Intervertebral Body Fusion Device Under Static Axial Compression
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ASTM F2267-04 - Standard Test Method for Measuring Load Induced Subsidence of an Intervertebral Body Fusion Device Under Static Axial Compression
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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:F2267–04
Standard Test Method for
Measuring Load Induced Subsidence of Intervertebral Body
1
Fusion Device Under Static Axial Compression
This standard is issued under the fixed designation F2267; 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 2. Referenced Documents
2
1.1 This test method specifies the materials and methods for 2.1 ASTM Standards:
the axial compressive subsidence testing of non-biologic in- E4 Practices for Force Verification of Testing Machines
tervertebral body fusion devices, spinal implants designed to F1582 Terminology Relating to Spinal Implants
promote arthrodesis at a given spinal motion segment. F1839 Specification for Rigid Polyurethane Foam for Use
1.2 This test method is intended to provide a basis for the as a Standard Material for Testing Orthopaedic Devices
mechanical comparison among past, present, and future non- and Instruments
biologic intervertebral body fusion devices.This test method is F2077 Test Methods For Intervertebral Body Fusion De-
intended to enable the user to mechanically compare interver- vices
tebral body fusion devices and does not purport to provide
3. Terminology
performance standards for intervertebral body fusion devices.
1.3 This test method describes a static test method by 3.1 Allsubsidencetestingterminologyisconsistentwiththe
referenced standards above, unless otherwise stated.
specifying a load type and a specific method of applying this
load.This test method is designed to allow for the comparative 3.2 Definitions:
3.2.1 coordinate system/axes—three orthogonal axes are
evaluation of intervertebral body fusion devices.
1.4 Guidelines are established for measuring test block defined by Terminology F1582 as seen in Fig. 4. The center of
the coordinate system is located at the geometric center of the
deformation and determining the subsidence of intervertebral
body fusion devices. intervertebralbodyfusiondeviceassembly.The X-axisisalong
the longitudinal axis of the implant, with positive X in the
1.5 Units—The values stated in SI units are to be regarded
anterior direction, Y is lateral, and Z is cephalic.
as the standard with the exception of angular measurements,
which may be reported in terms of either degrees or radians. 3.2.2 ideal insertion location—the implant location with
respect to the simulated inferior and superior vertebral bodies
1.6 Since some intervertebral body fusion devices require
the use of additional implants for stabilization, the testing of (polyurethane)dictatedbythetype,design,andmanufacturer’s
surgical installation instructions.
these types of implants may not be in accordance with the
manufacturer’s recommended usage. 3.2.3 intended method of application—intervertebral body
fusion devices may contain different types of stabilizing
1.7 The use of this standard may involve the operation of
potentially hazardous equipment. This standard does not pur- features such as threads, spikes, and knurled surfaces. Each
type of feature has an intended method of application or
port to address all of the safety concerns, if any, associated
with its use. It is the responsibility of the user of this standard attachment to the spine.
3.2.4 intended spinal location—the anatomic region of the
to establish appropriate safety and health practices and
determine the applicability of regulatory limitations prior to spine intended for the intervertebral body fusion device.
Intervertebral body fusion devices may be designed and
use.
developed for specific regions of the spine such as the lumbar,
thoracic, and cervical spine. Also, there potentially exist
1
This test method is under the jurisdiction ofASTM Committee F04 on Medical
and Surgical Materials and Devices and is the direct responsibility of Subcommittee
2
F04.25 on Spinal Devices. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Current edition approved Apr. 1, 2004. Published April 2004. Originally contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
approved in 2003. Last previous edition approved in 2003 as F2267 – 03. DOI: Standards volume information, refer to the standard’s Document Summary page on
10.1520/F2267-04. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1

---------------------- Page: 1 ----------------------
F2267–04
FIG. 1 Intradiscal Height Diagram
FIG. 2 Typical Load-Displacement Curve with 1.5 mm (Thoracic Device) Offset for Polyurethane Foam Test Blocks
different anatomical surgical approaches, which will resul
...

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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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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.

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