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ASTM F2706-08

(Test Method)

Standard Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model

Standard Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model

SIGNIFICANCE AND USE
Occipital-cervical and occipital-cervical-thoracic spinal implants are generally composed of several components which, when connected together, form either an occipital-cervical spinal implant assembly or an occipital-cervical-thoracic spinal implant assembly. Occipital-cervical and occipital-cervical-thoracic spinal implant assemblies are designed to provide some stability to the spine during the process of arthrodesis. These test methods outline standard materials and methods for the evaluation of different spinal implant assemblies to facilitate comparisons between different designs.
These test methods are used to quantify the static and dynamic mechanical characteristics of different designs of occipital-cervical and occipital-cervical-thoracic spinal implant assemblies. The mechanical tests are conducted in vitro using simplified load schemes and do not attempt to mimic the complex loads of the occipital-cervical and occipital-cervical-thoracic spine.
The loads applied to the spinal implant assemblies in vivo will, in general, differ from the loading configurations used in these test methods. The results obtained here cannot be used directly to predict in vivo performance. The results can be used to compare different component designs in terms of the relative mechanical parameters.
Fatigue testing in a simulated body fluid or saline may cause fretting, corrosion, or lubricate the interconnections and thereby affect the relative performance of tested devices. This test should be initially performed dry (ambient room conditions) for consistency. The effect of the environment may be significant. Repeating all or part of these test methods in simulated body fluid, saline (9 g NaCl per 1000 mL water), a saline drip, water, or a lubricant should be considered. The maximum recommended frequency for this type of cyclic testing should be 5 Hz.
The location of the longitudinal elements is determined by the intended in vivo location of the anchors. The perpendicul...
SCOPE
1.1 These test methods cover the materials and methods for the static and fatigue testing of occipital-cervical and occipital-cervical-thoracic spinal implant assemblies in a vertebrectomy model. The test materials for most combinations of occipital-cervical and occipital-cervical-thoracic spinal implant components can be specific depending on the intended location and intended method of attachment.
1.2 These test methods are intended to provide a basis for the mechanical comparison among past, present, and future occipital-cervical and occipital-cervical-thoracic spinal implant assemblies. They allow comparison of occipital-cervical and occipital-cervical-thoracic spinal implant constructs with different methods of application to the spine. These test methods are not intended to define levels of performance, since sufficient knowledge is not available to predict the consequences of the use of a particular device.
1.3 These test methods set out guidelines for load types and methods of applying loads. Methods for three static load types and two fatigue tests for the comparative evaluation of occipital-cervical and occipital-cervical-thoracic spinal implant assemblies are defined.
1.4 These test methods establish guidelines for measuring displacements, determining the yield load, and evaluating the stiffness and strength of occipital-cervical or occipital-cervical-thoracic spinal implant assemblies.
1.5 It may not be possible to test some occipital-cervical and some occipital-cervical-thoracic spinal constructs in all test configurations.
1.6 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.7 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 reg...

General Information

Status
Historical
Publication Date
31-Jul-2008
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

Replaced By
ASTM F2706-08(2014) - Standard Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model
Effective Date
01-Oct-2014
Referred By
ASTM F3292-19 - Standard Practice for Inspection of Spinal Implants Undergoing Testing
Effective Date
01-Aug-2008

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ASTM F2706-08 - Standard Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy ModelASTM F2706-08 - Standard Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model
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ASTM F2706-08 - Standard Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model
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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: F2706 − 08
StandardTest Methods for
Occipital-Cervical and Occipital-Cervical-Thoracic Spinal
1
Implant Constructs in a Vertebrectomy Model
This standard is issued under the fixed designation F2706; 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 (´) indicates an editorial change since the last revision or reapproval.
1. Scope priate safety and health practices and determine the applica-
bility of regulatory limitations prior to use.
1.1 These test methods cover the materials and methods for
thestaticandfatiguetestingofoccipital-cervicalandoccipital-
2. Referenced Documents
cervical-thoracic spinal implant assemblies in a vertebrectomy
2
model. The test materials for most combinations of occipital-
2.1 ASTM Standards:
cervical and occipital-cervical-thoracic spinal implant compo-
E4Practices for Force Verification of Testing Machines
nents can be specific depending on the intended location and
E6Terminology Relating to Methods of Mechanical Testing
intended method of attachment.
E739PracticeforStatisticalAnalysisofLinearorLinearized
Stress-Life (S-N) and Strain-Life (´-N) Fatigue Data
1.2 These test methods are intended to provide a basis for
the mechanical comparison among past, present, and future E1823TerminologyRelatingtoFatigueandFractureTesting
F1582Terminology Relating to Spinal Implants
occipital-cervical and occipital-cervical-thoracic spinal im-
plant assemblies. They allow comparison of occipital-cervical F1717Test Methods for Spinal Implant Constructs in a
Vertebrectomy Model
and occipital-cervical-thoracic spinal implant constructs with
different methods of application to the spine. These test F2077TestMethodsForIntervertebralBodyFusionDevices
methodsarenotintendedtodefinelevelsofperformance,since
sufficient knowledge is not available to predict the conse- 3. Terminology
quences of the use of a particular device.
3.1 Definitions—For definitions of terms relating to these
1.3 These test methods set out guidelines for load types and
test methods, see Terminologies E6, F1582, and E1823.
methods of applying loads. Methods for three static load types
3.2 Definitions of Terms Specific to This Standard:
and two fatigue tests for the comparative evaluation of
3.2.1 active length of the longitudinal element, n—the
occipital-cervical and occipital-cervical-thoracic spinal im-
straight line distance between the centers of rotation of the test
plant assemblies are defined.
blocks.
1.4 These test methods establish guidelines for measuring
3.2.2 block moment arm, n—the perpendicular to the ap-
displacements, determining the yield load, and evaluating the
pliedloadbetweentheinsertionpointofananchorandtheaxis
stiffnessandstrengthofoccipital-cervicaloroccipital-cervical-
of the hinge pin.
thoracic spinal implant assemblies.
1.5 Itmaynotbepossibletotestsomeoccipital-cervicaland 3.2.3 compressive or tensile bending stiffness (N/mm),
some occipital-cervical-thoracic spinal constructs in all test n—the compressive or tensile bending yield force divided by
configurations. elastic displacement (see the initial slope of line BC in Fig. 1).
1.6 The values stated in SI units are to be regarded as
3.2.4 compressive or tensile bending ultimate load (N),
standard. No other units of measurement are included in this
n—the maximum compressive or tensile force in the X-Z plane
standard.
applied to an occipital-cervical or occipital-cervical-thoracic
spinalimplantassembly(seetheforceatPointEinFig.1).The
1.7 This standard does not purport to address all of the
ultimate load should be a function of the device and not of the
safety concerns, if any, associated with its use. It is the
load cell or testing machine.
responsibility of the user of this standard to establish appro-
1
These test methods are under the jurisdiction of ASTM Committee F04 on
2
Medical and Surgical Materials and Devices and are the direct responsibility of For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Subcommittee F04.25 on Spinal Devices. contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Current edition approved Aug. 1, 2008. Published September 2008. DOI: Standards volume information, refer to the standard’s Document Summary page on
10.1520/F2706-08. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F2706 − 08
FIG. 1 Typical Load Displacement Curve or Torque Angulation Curve
3.2.5 compressive or tensile bending yield load (N), n—the occipital-cervical-thoracic spinal implant assembly ineffective
compressive or tensile bending f
...

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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.  
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4.1 The purpose of this test guide is to provide load profile information on how one could test a total knee replacement in order to evaluate in vitro its function and wear during several types of knee motions as described in 4.2 and 4.3.  
4.2 This test guide may help characterize the magnitude and location of implant wear as an implant is repetitively moved according to specified load and displacement waveforms.  
4.3 This test guide may also help characterize the functional limitations of a total knee replacement as its motion is guided by these waveforms. These limitations may be observed as impingement, subluxation, or high loading in the soft tissue constraints, whether they are represented physically or virtually.  
4.4 The motions and load conditions in vivo will, in general, differ from the load and motions defined in this guide. The results obtained from this guide cannot be used to directly predict in vivo performance. However, this guide is designed to allow for comparisons in performance of different knee designs, when tested under similar conditions.
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1.1 Motion path, load history, and loading modalities all contribute to the wear, degradation, and damage of implanted prosthetics. Simulating a variety of functional activities promises more realistic testing for wear and damage mode evaluation. Such activities are often called activities of daily living (ADLs). ADLs identified in the literature include walking, stair ascent and descent, sit-to-stand, stand-to-sit, squatting, kneeling, cross-legged sitting, into bath, out of bath, turning, and cutting motions (1-7).2 Activities other than walking gait often involve an extended range of motion and higher imposed loading conditions, which have the ability to cause damage and modes of failure other than normal wear (8-10).  
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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.

  • Guide
    8 pages
    English language
    sale 15% off
  • Guide
    8 pages
    English language
    sale 15% off