ASTM F1717-21

Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model

SIGNIFICANCE AND USE
5.1 Spinal implants are generally composed of several components which, when connected together, form a spinal implant assembly. Spinal implant assemblies are designed to provide some stability to the spine while arthrodesis takes place. These test methods outline standard materials and methods for the evaluation of different spinal implant assemblies so that comparison between different designs may be facilitated.  
5.2 These test methods are used to quantify the static and dynamic mechanical characteristics of different designs of 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 spine.  
5.3 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.  
5.4 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 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.  
5.5 The location of the longitudinal elements is determined by where the anchors are clinically placed against bony structures. The perpendicular distance to the load direction (block moment arm) between the axis of a hinge pin and the anchor’s attachment points to a UHMWPE block is independent of anchor type. The distance between the anchor’s attachment point to the UHMWPE block an...
SCOPE
1.1 These test methods cover the materials and methods for the static and fatigue testing of spinal implant assemblies in a vertebrectomy model. The test materials for most combinations of spinal implant components can be specific, depending on the intended spinal location and intended method of application to the spine.  
1.2 These test methods are intended to provide a basis for the mechanical comparison among past, present, and future spinal implant assemblies. They allow comparison of spinal implant constructs with different intended spinal locations and 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 one fatigue test are defined for the comparative evaluation of spinal implant assemblies.  
1.4 These test methods establish guidelines for measuring displacements, determining the yield load, and evaluating the stiffness and strength of the spinal implant assembly.  
1.5 Some spinal constructs may not be testable 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.8 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 T...

General Information

• Status: Published
• Publication Date: 31-Mar-2021
• 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

Standards Content (Sample)

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.
Designation: F1717 − 21
Standard Test Methods for
1
Spinal Implant Constructs in a Vertebrectomy Model
This standard is issued under the fixed designation F1717; 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 Development of International Standards, Guides and Recom-
mendations issued by the World Trade Organization Technical
1.1 These test methods cover the materials and methods for
Barriers to Trade (TBT) Committee.
the static and fatigue testing of spinal implant assemblies in a
vertebrectomymodel.Thetestmaterialsformostcombinations
2. Referenced Documents
ofspinalimplantcomponentscanbespecific,dependingonthe
2
intended spinal location and intended method of application to
2.1 ASTM Standards:
the spine. D638Test Method for Tensile Properties of Plastics
E4Practices for Force Verification of Testing Machines
1.2 These test methods are intended to provide a basis for
E6Terminology Relating to Methods of MechanicalTesting
the mechanical comparison among past, present, and future
E177Practice for Use of the Terms Precision and Bias in
spinal implant assemblies. They allow comparison of spinal
ASTM Test Methods
implant constructs with different intended spinal locations and
E691Practice for Conducting an Interlaboratory Study to
methodsofapplicationtothespine.Thesetestmethodsarenot
Determine the Precision of a Test Method
intended to define levels of performance, since sufficient
E739PracticeforStatisticalAnalysisofLinearorLinearized
knowledge is not available to predict the consequences of the
Stress-Life (S-N) and Strain-Life (ε-N) Fatigue Data
use of a particular device.
E1150Definitions of Terms Relating to Fatigue (Withdrawn
1.3 These test methods set out guidelines for load types and 3
1996)
methods of applying loads. Methods for three static load types
F543Specification and Test Methods for Metallic Medical
and one fatigue test are defined for the comparative evaluation
Bone Screws
of spinal implant assemblies.
F1582Terminology Relating to Spinal Implants
1.4 These test methods establish guidelines for measuring F1798Test Method for Evaluating the Static and Fatigue
PropertiesofInterconnectionMechanismsandSubassem-
displacements, determining the yield load, and evaluating the
stiffness and strength of the spinal implant assembly. blies Used in Spinal Arthrodesis Implants
F2077TestMethodsForIntervertebralBodyFusionDevices
1.5 Some spinal constructs may not be testable in all test
configurations.
3. Terminology
1.6 The values stated in SI units are to be regarded as
3.1 Definitions:
standard. No other units of measurement are included in this
3.1.1 For definitions of terms relating to these test methods,
standard.
see Terminology E6, Terminology F1582, and Definitions
1.7 This standard does not purport to address all of the
E1150.
safety concerns, if any, associated with its use. It is the
3.2 Definitions of Terms Specific to This Standard:
responsibility of the user of this standard to establish appro-
3.2.1 active length of the longitudinal element—the straight
priate safety, health, and environmental practices and deter-
line distance between the center of attachment of the superior
mine the applicability of regulatory limitations prior to use.
anchor and the center of attachment of the inferior anchor.
1.8 This international standard was developed in accor-
3.2.2 angular displacement at 2 % offset yield (degrees)—
dance with internationally recognized principles on standard-
the angular displacement of a construct measured via the
ization established in the Decision on Principles for the
1 2
These test methods are under the jurisdiction of ASTM Committee F04 on For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Medical and Surgical Materials and Devices and are the direct responsibility of contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
Subcommittee F04.25 on Spinal Devices. Standards volume information, refer to the standard’s Document Summary page on
Current edition approved April 1, 2021. Published May 2021. Originally the ASTM website.
3
approved in 1996. Last previous edition approved in 2018 as F1717–18. DOI: The last approved version of this historical standard is referenced on
10.1520/F1717-21. www.astm.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F1717 −
...

This document is not an ASTM standard and is intended only to provide the user of an ASTM 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: F1717 − 18 F1717 − 21
Standard Test Methods for
1
Spinal Implant Constructs in a Vertebrectomy Model
This standard is issued under the fixed designation F1717; 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
1.1 These test methods cover the materials and methods for the static and fatigue testing of spinal implant assemblies in a
vertebrectomy model. The test materials for most combinations of spinal implant components can be specific, depending on the
intended spinal location and intended method of application to the spine.
1.2 These test methods are intended to provide a basis for the mechanical comparison among past, present, and future spinal
implant assemblies. They allow comparison of spinal implant constructs with different intended spinal locations and 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
one fatigue test are defined for the comparative evaluation of spinal implant assemblies.
1.4 These test methods establish guidelines for measuring displacements, determining the yield load, and evaluating the stiffness
and strength of the spinal implant assembly.
1.5 Some spinal constructs may not be testable 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, health, and environmental practices and determine the applicability of
regulatory limitations prior to use.
1.8 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.
2. Referenced Documents
2
2.1 ASTM Standards:
D638 Test Method for Tensile Properties of Plastics
E4 Practices for Force Verification of Testing Machines
1
These test methods are under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and are the direct responsibility of Subcommittee
F04.25 on Spinal Devices.
Current edition approved June 1, 2018April 1, 2021. Published August 2018May 2021. Originally approved in 1996. Last previous edition approved in 20152018 as
F1717F1717 – 18.–15. DOI: 10.1520/F1717-18.10.1520/F1717-21.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at [e-mail]. 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 ----------------------
F1717 − 21
E6 Terminology Relating to Methods of Mechanical Testing
E177 Practice for Use of the Terms Precision and Bias in ASTM Test Methods
E691 Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
E739 Practice for Statistical Analysis of Linear or Linearized Stress-Life (S-N) and Strain-Life (ε-N) Fatigue Data
3
E1150 Definitions of Terms Relating to Fatigue (Withdrawn 1996)
F543 Specification and Test Methods for Metallic Medical Bone Screws
F1582 Terminology Relating to Spinal Implants
F1798 Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used
in Spinal Arthrodesis Implants
F2077 Test Methods For Intervertebral Body Fusion Devices
3. Terminology
3.1 Definitions:
3.1.1 For definitions of terms relating to these test methods, see Terminology E6, Terminology F1582, and Definitions E1150.
3.2 Definitions of Terms Specific to This Standard:
3.2.1 active length of the longitudinal element—the straight line distance between the center of attachment of the superior anchor
and the center o
...