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ASTM F 2077 : 2018

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Test Methods For Intervertebral Body Fusion Devices
Available format(s)

Hardcopy , PDF

Superseded date

07-18-2022

Language(s)

English

Published date

08-22-2018

1.1This test method covers the materials and methods for the static and dynamic testing of intervertebral body fusion device assemblies, spinal implants designed to promote arthrodesis at a given spinal motion segment.1.2This test method is intended to provide a basis for the mechanical comparison among past, present, and future nonbiologic intervertebral body fusion device assemblies. This test method allows comparison of intervertebral body fusion device assemblies with different intended spinal locations and methods of application to the intradiscal spaces. This test method is intended to enable the user to compare intervertebral body fusion device assemblies mechanically and does not purport to provide performance standards for intervertebral body fusion device assemblies.1.3The test method describes static and dynamic tests by specifying force types and specific methods of applying these forces. These tests are designed to allow for the comparative evaluation of intervertebral body fusion device assemblies. 1.4These tests are designed to characterize the structural integrity of the device and are not intended to test the bone-implant interface.1.5This test method does not address expulsion testing of intervertebral body fusion device assemblies (see1.4).1.6Guidelines are established for measuring displacements, determining the yield force or moment, evaluating the stiffness, and strength of the intervertebral body fusion device assemblies.1.7Some intervertebral body fusion device assemblies may not be testable in all test configurations.1.8The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard, with the exception of angular measurements, which may be reported in terms of either degrees or radians.1.9This 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.1.10This 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.

1.1This test method covers the materials and methods for the static and dynamic testing of intervertebral body fusion device assemblies, spinal implants designed to promote arthrodesis at a given spinal motion segment.

1.2This test method is intended to provide a basis for the mechanical comparison among past, present, and future nonbiologic intervertebral body fusion device assemblies. This test method allows comparison of intervertebral body fusion device assemblies with different intended spinal locations and methods of application to the intradiscal spaces. This test method is intended to enable the user to compare intervertebral body fusion device assemblies mechanically and does not purport to provide performance standards for intervertebral body fusion device assemblies.

1.3The test method describes static and dynamic tests by specifying force types and specific methods of applying these forces. These tests are designed to allow for the comparative evaluation of intervertebral body fusion device assemblies.

1.4These tests are designed to characterize the structural integrity of the device and are not intended to test the bone-implant interface.

1.5This test method does not address expulsion testing of intervertebral body fusion device assemblies (see 1.4).

1.6Guidelines are established for measuring displacements, determining the yield force or moment, evaluating the stiffness, and strength of the intervertebral body fusion device assemblies.

1.7Some intervertebral body fusion device assemblies may not be testable in all test configurations.

1.8The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard, with the exception of angular measurements, which may be reported in terms of either degrees or radians.

1.9This 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.

1.10This 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.

Committee
F 04
DocumentType
Test Method
Pages
11
PublisherName
American Society for Testing and Materials
Status
Superseded
SupersededBy
Supersedes

ASTM F 2423 : 2011 : R2016 Standard Guide for Functional, Kinematic, and Wear Assessment of Total Disc Prostheses
ASTM F 1717 : 2018 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
ASTM F 3292 : 2019 Standard Practice for Inspection of Spinal Implants Undergoing Testing
ASTM F 2346 : 2018 Standard Test Methods for Static and Dynamic Characterization of Spinal Artificial Discs
ASTM F 3574 : 2022 Standard Test Methods for Sacroiliac Joint Fusion Devices
ASTM F 2267 : 2004 : R2018 Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression
ASTM F 2423 : 2011 : R2020 Standard Guide for Functional, Kinematic, and Wear Assessment of Total Disc Prostheses
ASTM F 1717 : 2021 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model

ASTM F 1582 : 1998 : R2016 Standard Terminology Relating to Spinal Implants
ASTM E 177 : 1990 : REV A : R1996 Standard Practice for Use of the Terms Precision and Bias in ASTM Test Methods
ASTM E 1823 : 2012 : REV : EDT 0 Standard Terminology Relating to Fatigue and Fracture Testing
ASTM E 1823 : 2007 : REV A Standard Terminology Relating to Fatigue and Fracture Testing
ASTM E 1823 : 2009 : REV A Standard Terminology Relating to Fatigue and Fracture Testing
ASTM F 1582 : 1998 : R2003 Standard Terminology Relating to Spinal Implants
ASTM E 6 : 2002 Standard Terminology Relating to Methods of Mechanical Testing
ASTM E 691 : 2020 Standard Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
ASTM E 691 : 2019 : EDT 1 Standard Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
ASTM E 1823 : 2005 : REV A : EDT 1 Standard Terminology Relating to Fatigue and Fracture Testing
ASTM E 1823 : 2010 : REV A Standard Terminology Relating to Fatigue and Fracture Testing
ASTM E 1823 : 2021 Standard Terminology Relating to Fatigue and Fracture Testing
ASTM E 1823 : 2009 : REV B Standard Terminology Relating to Fatigue and Fracture Testing
ASTM E 1823 : 2012 : REV D Standard Terminology Relating to Fatigue and Fracture Testing
ASTM E 691 : 2022 Standard Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
ASTM E 1823 : 2012 : REV B Standard Terminology Relating to Fatigue and Fracture Testing
ASTM E 691 : 2009 Standard Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
ASTM E 6 : 2015 : EDT 3 Standard Terminology Relating to Methods of Mechanical Testing
ASTM E 4 : 2021 Standard Practices for Force Calibration and Verification of Testing Machines
ASTM E 691 : 2021 Standard Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
ASTM F 1582 : 1998 : R2011 Standard Terminology Relating to Spinal Implants
ASTM E 1823 : 1996 : R2002 Standard Terminology Relating to Fatigue and Fracture Testing
ASTM E 1823 : 1996 : EDT 1 Standard Terminology Relating to Fatigue and Fracture Testing
ASTM E 1823 : 2012 : REV A Standard Terminology Relating to Fatigue and Fracture Testing
ASTM E 2309 : 2005 Standard Practices for Verification of Displacement Measuring Systems and Devices Used in Material Testing Machines
ASTM E 1823 : 2007 Standard Terminology Relating to Fatigue and Fracture Testing
ASTM E 6 : 2015 : EDT 4 : REDLINE Standard Terminology Relating to Methods of Mechanical Testing
ASTM E 1823 : 2013 Standard Terminology Relating to Fatigue and Fracture Testing
ASTM E 1823 : 2012 : REV C Standard Terminology Relating to Fatigue and Fracture Testing
ASTM E 1823 : 2020 : REV B Standard Terminology Relating to Fatigue and Fracture Testing
ASTM E 1823 : 2005 : REV A Standard Terminology Relating to Fatigue and Fracture Testing
ASTM F 1582 : 1998 Standard Terminology Relating to Spinal Implants
ASTM E 1823 : 2011 Standard Terminology Relating to Fatigue and Fracture Testing

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