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ASTM F2077-11

(Test Method)

Test Methods For Intervertebral Body Fusion Devices

Test Methods For Intervertebral Body Fusion Devices

SIGNIFICANCE AND USE
Intervertebral body fusion device assemblies 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 outlines materials and methods for the characterization and evaluation of the mechanical performance of different intervertebral body fusion device assemblies so that comparisons can be made between different designs.
This test method is designed to quantify the static and dynamic characteristics of different designs of intervertebral body fusion device assemblies. These tests are conducted in vitro to allow for analysis and comparison of the mechanical performance of intervertebral body fusion device assemblies to specific force modalities.
The forces applied to the intervertebral body fusion assemblies may differ from the complex loading seen in vivo, and therefore, the results from these tests may not directly predict in vivo performance. The results, however, can be used to compare mechanical performance of different intervertebral body fusion device assemblies.
Since the environment may affect the dynamic performance of intervertebral body fusion device assemblies, dynamic testing in a saline environment may be considered. Fatigue tests should first be conducted in air (at ambient temperature) for comparison purposes since the environmental effects could be significant. If a simulated in vivo environment is desired, the investigator should consider testing in a saline environmental bath at 37°C (for example, 0.9-g NaCl per 100-mL water) at a rate of 1 Hz or less. A simulated body fluid, a saline drip or mist, distilled water, or other type of lubrication at 37°C could also be used with adequate justification.
If the devices are known to be temperature and environment dependent, testing should be conducted in physiologic solution as described in 5.4. Devices that require physiologic solution for ...
SCOPE
1.1 This 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.
1.2 This 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.
1.3 The 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.
1.4 These tests are designed to characterize the structural integrity of the device and are not intended to test the bone-implant interface.
1.5 This test method does not address expulsion testing of intervertebral body fusion device assemblies (see 1.4).  
1.6 Guidelines are established for measuring displacements, determining the yield force or moment, evaluating the stiffness, and strength of the intervertebral body fusion device assemblies.
1.7 Some intervertebral body fusion device assemblies may not be testable in all test configurations.
1.8 The 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.
1.9 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the respon...

General Information

Status
Historical
Publication Date
14-Jul-2011
ICS
11.040.20 - Transfusion, infusion and injection equipment
Technical Committee
F04 - Medical and Surgical Materials and Devices
Drafting Committee
F04.25 - Spinal Devices
Current Stage
Ref Project

Relations

Replaces
ASTM F2077-03 - Test Methods For Intervertebral Body Fusion Devices
Effective Date
15-Jul-2011
Replaced By
ASTM F2077-14 - Test Methods For Intervertebral Body Fusion Devices
Effective Date
01-Oct-2014
Referred By
ASTM F2346-18 - Standard Test Methods for Static and Dynamic Characterization of Spinal Artificial Discs
Effective Date
15-Jul-2011
Referred By
ASTM F3574-22 - Standard Test Methods for Sacroiliac Joint Fusion Devices
Effective Date
15-Jul-2011
Referred By
ASTM F2267-22 - Standard Test Method for Measuring Load-Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression
Effective Date
15-Jul-2011
Referred By
ASTM F2423-11(2020) - Standard Guide for Functional, Kinematic, and Wear Assessment of Total Disc Prostheses
Effective Date
15-Jul-2011
Referred By
ASTM F2706-18 - Standard Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model
Effective Date
15-Jul-2011
Referred By
ASTM F1717-21 - Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
Effective Date
15-Jul-2011
Referred By
ASTM F3292-19 - Standard Practice for Inspection of Spinal Implants Undergoing Testing
Effective Date
15-Jul-2011

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Standards Content (Sample)

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: F2077 − 11
TestMethods For
1
Intervertebral Body Fusion Devices
This standard is issued under the fixed designation F2077; 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 1.9 This standard does not purport to address all of the
safety concerns, if any, associated with its use. It is the
1.1 This test method covers the materials and methods for
responsibility of the user of this standard to establish appro-
the static and dynamic testing of intervertebral body fusion
priate safety and health practices and determine the applica-
device assemblies, spinal implants designed to promote arthro-
bility of regulatory limitations prior to use.
desis at a given spinal motion segment.
1.2 This test method is intended to provide a basis for the
2. Referenced Documents
mechanical comparison among past, present, and future non-
2
2.1 ASTM Standards:
biologic intervertebral body fusion device assemblies.This test
E4 Practices for Force Verification of Testing Machines
methodallowscomparisonofintervertebralbodyfusiondevice
E6 Terminology Relating to Methods of Mechanical Testing
assemblies with different intended spinal locations and meth-
E1823 TerminologyRelatingtoFatigueandFractureTesting
ods of application to the intradiscal spaces. This test method is
E2309 Practices for Verification of Displacement Measuring
intended to enable the user to compare intervertebral body
Systems and Devices Used in Material Testing Machines
fusion device assemblies mechanically and does not purport to
F1582 Terminology Relating to Spinal Implants
provide performance standards for intervertebral body fusion
device assemblies.
3. Terminology
1.3 The test method describes static and dynamic tests by
3.1 For definition of terms refer to Terminology E6, E1823,
specifying force types and specific methods of applying these
and F1582.
forces. These tests are designed to allow for the comparative
evaluation of intervertebral body fusion device assemblies. 3.2 Definitions of Terms Specific to This Standard:
3.2.1 coordinate system/axes, n—Three orthogonal axes are
1.4 These tests are designed to characterize the structural
defined by Terminology F1582. The center of the coordinate
integrity of the device and are not intended to test the
system is located at the geometric center of the intervertebral
bone-implant interface.
body fusion device assembly. The XY plane is to bisect the
1.5 This test method does not address expulsion testing of
sagittal plane angle between superior and inferior lines (sur-
intervertebral body fusion device assemblies (see 1.4).
faces) that are intended to simulate the adjacent vertebral end
plates. The positive Z axis is to be directed superiorly. Force
1.6 Guidelines are established for measuring displacements,
components parallel to the XY plane are shear components of
determiningtheyieldforceormoment,evaluatingthestiffness,
loading. The compressive axial force is defined to be the
and strength of the intervertebral body fusion device assem-
component in the negative Z direction. Torsional force is
blies.
defined to be the component of moment parallel to the Z axis.
1.7 Some intervertebral body fusion device assemblies may
3.2.2 crack, n—an externally visible physical discontinuity
not be testable in all test configurations.
in the form of a narrow opening that arises from mechanical
1.8 The values stated in SI units are to be regarded as
forces.
standard. No other units of measurement are included in this
3.2.3 fatigue life, n—the number of cycles, N, that the
standard, with the exception of angular measurements, which
intervertebral body fusion device assembly can sustain at a
may be reported in terms of either degrees or radians.
particular force or moment before mechanical or functional
failure occurs.
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 . For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Current edition approved July 15, 2011. Published August 2011. Originally contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
published in 2000. Last previous edition approved in 2003 as F2077 - 03. DOI: Standards volume information, refer to the standard’s Document Summary page on
10.1520/F2077-11. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F2077 − 11
3.2.4 functional failure, n—perman
...

This document is not anASTM standard and is intended only to provide the user of anASTM 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:F2077–03 Designation: F2077 – 11
Test Methods For
1
Intervertebral Body Fusion Devices
This standard is issued under the fixed designation F2077; 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 This 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.
1.2 This 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 load types and specific methods of applying these loads.
These tests are designed to allow for the comparative evaluation of intervertebral body fusion device assemblies.
1.4This test method does not address expulsion testing of intervertebral body fusion device assemblies (see X1.11
1.3 The 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.
1.4 These tests are designed to characterize the structural integrity of the device and are not intended to test the bone-implant
interface.
1.5 This test method does not address expulsion testing of intervertebral body fusion device assemblies (see 1.4).
1.56 Guidelines are established for measuring displacements, determining the yield loadforce or moment, evaluating the
stiffness, and strength of the intervertebral body fusion device assemblies.
1.6Some1.7 Some intervertebral body fusion device assemblies may not be testable in all test configurations.
1.7The1.8 The 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.
1.81.9 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.
2. Referenced Documents
2
2.1 ASTM Standards:
E4 Practices for Force Verification of Testing Machines
E6 Terminology Relating to Methods of Mechanical Testing
E1823 Terminology Relating to Fatigue and Fracture Testing
E2309 Practices for Verification of Displacement Measuring Systems and Devices Used in Material Testing Machines
F1582 Terminology Relating to Spinal Implants
3. Terminology
3.1 For definition of terms refer to Terminology E6, E1823, and F1582.
3.2 Definitions of Terms Specific to This Standard:
3.2.1 coordinatesystem/axes,n—ThreeorthogonalaxesaredefinedbyTerminologyF1582.Thecenterofthecoordinatesystem
is located at the geometric center of the intervertebral body fusion device assembly. The XY plane is to bisect the sagittal plane
angle between superior and inferior lines (surfaces) that are intended to simulate the adjacent vertebral end plates. The positive
1
This test method is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.25 on Spinal Devices .
Current edition approvedApr. 10, 2003. Published May 2003. Originally published in 2000. Last previous edition approved in 2001 as F2077-01. DOI: 10.1520/F2077-03.
Current edition approved July 15, 2011. Published August 2011. Originally published in 2000. Last previous edition approved in 2003 as F2077 - 03. DOI:
10.1520/F2077-11.
2
For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
volume information, refer to the standard’’s Document Summary
...

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1.3 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.  
1.4 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.

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ASTM F2394-07(2022)(Guide)
Standard Guide for Measuring Securement of Balloon-Expandable Vascular Stent Mounted on Delivery System

SIGNIFICANCE AND USE
4.1 The securement of the endovascular stent on the balloon is a critical parameter to ensure that the stent is safely delivered to or from the treatment site.  
4.2 This guide is intended for use by researchers and manufacturers for the development and selection of pre-test treatments, tests, and test endpoints to measure stent securement (displacement distances and dislodgment forces).  
4.3 This guide may be used to investigate which practical combinations of in vitro tests best characterize clinical scenarios.  
4.4 This guide should be used with discretion in choosing securement tests and evaluating results due to the myriad possible combinations of clinical conditions, failure modes, and stent delivery system designs.  
4.5 This guide may be of use for developing a test for meeting Parts 2 and 3 of the requirements of EN 14299, Section 7.3.4.4 on Trackability.  
4.6 This guide may be of use for developing a test to meet section VII-C-8 of CDRH Guidance document.
SCOPE
1.1 This guide provides guidance for the design and development of pre-test treatments, tests, and test endpoints to measure stent securement of pre-mounted, unsheathed, balloon-expandable stent delivery systems. This guide is intended to aid investigators in the design, development, and in vitro characterization of pre-mounted, unsheathed, balloon-expandable stent delivery systems.  
1.2 This guide covers the laboratory determination of the shear force required to displace or dislodge a balloon-expandable endovascular stent mounted on a delivery system. The guide proposes a set of options to consider when testing stent securement. The options cover pre-test treatments, possible stent securement tests, and relevant test endpoints. An example test apparatus is given in 7.1.  
1.3 This guide covers in vitro bench testing characterization only. Measured levels of securement and product design/process differentiation may be particularly influenced by selections of pre-test treatments, securement test type (for example, stent gripping method), and test endpoint. In vivo characteristics may also differ from in vitro results.  
1.4 This guide does not cover all possible pre-test treatments, stent securement tests, or test endpoints. It is intended to provide a starting point from which to select and investigate securement test options.  
1.5 This guide does not specify a method for mounting the stent onto the delivery system.  
1.6 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system are not necessarily exact equivalents; therefore, to ensure conformance with the standard, each system shall be used independently of the other, and values from the two systems shall not be combined.  
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.

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ASTM F2077-22(Test Method)
Standard Test Methods for Intervertebral Body Fusion Devices

SIGNIFICANCE AND USE
5.1 Intervertebral body fusion device assemblies 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 outlines materials and methods for the characterization and evaluation of the mechanical performance of different intervertebral body fusion device assemblies so that comparisons can be made between different designs.  
5.2 This test method is designed to quantify the static and dynamic characteristics of different designs of intervertebral body fusion device assemblies. These tests are conducted in vitro to allow for analysis and comparison of the mechanical performance of intervertebral body fusion device assemblies to specific force modalities.  
5.3 The forces applied to the intervertebral body fusion assemblies may differ from the complex loading seen in vivo, and therefore, the results from these tests may not directly predict in vivo performance. The results, however, can be used to compare mechanical performance of different intervertebral body fusion device assemblies.  
5.4 Since the environment may affect the dynamic performance of intervertebral body fusion device assemblies, dynamic testing in a saline environment may be considered. Fatigue tests should first be conducted in air (at ambient temperature) for comparison purposes since the environmental effects could be significant. If a simulated in vivo environment is desired, the investigator should consider testing in a saline environmental bath at 37 °C (for example, 0.9 g NaCl per 100 mL water) at a rate of 1 Hz or less. A simulated body fluid, a saline drip or mist, distilled water, or other type of lubrication at 37 °C could also be used with adequate justification.  
5.5 If the devices are known to be temperature and environment dependent, testing should be conducted in physiologic solution as described in 5.4. Devices that require...
SCOPE
1.1 This 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.  
1.2 This 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.  
1.3 The 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.  
1.4 These tests are designed to characterize the structural integrity of the device and are not intended to test the bone-implant interface.  
1.5 This test method does not address expulsion testing of intervertebral body fusion device assemblies (see 1.4).  
1.6 Guidelines are established for measuring displacements, determining the yield force or moment, and evaluating the stiffness and strength of the intervertebral body fusion device assemblies.  
1.7 Some intervertebral body fusion device assemblies may not be testable in all test configurations.  
1.8 The 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.  
1.9 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is ...

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ASTM
ASTM ISO/ASTM51939-17(2022)(Practice)
Standard Practice for Blood Irradiation Dosimetry

SIGNIFICANCE AND USE
4.1 Blood and blood components are irradiated to predetermined absorbed doses to inactivate viable lymphocytes to help prevent transfusion-induced graft-versus-host disease (GVHD) in certain immunocompromised patients and those receiving related-donor products (1, 2).9  
4.2 The assurance that blood and blood components have been properly irradiated is of crucial importance for patient health. This shall be demonstrated by means of accurate absorbed-dose measurements on the product, or in simulated product.  
4.3 Blood and blood components are usually irradiated using gamma radiation from 137Cs or 60Co sources, or X-radiation from X-ray units.  
4.4 Blood irradiation specifications include a lower limit of absorbed dose, and may include an upper limit or central target dose. For a given application, any of these values may be prescribed by regulations that have been established on the basis of available scientific data (see 2.6).  
4.5 For each blood irradiator, an absorbed-dose rate at a reference position within the canister is measured as part of irradiator acceptance testing using a reference-standard dosimetry system. That reference-standard measurement is used to establish operating parameters so as to deliver specified dose to blood and blood components.  
4.6 Absorbed-dose measurements are performed within the blood or blood-equivalent volume for determining the absorbed-dose distribution. Such measurements are often performed using simulated product (for example, polystyrene is considered blood equivalent for 137Cs photon energies).  
4.7 Dosimetry is part of a measurement management system that is applied to ensure that the radiation process meets predetermined specifications (see ISO/ASTM Practice 52628).  
4.8 Blood and blood components are usually irradiated in chilled or frozen condition. Care should be taken, therefore, to ensure that the dosimeters and radiation-sensitive indicators can be used under such temperature conditions.  
4.9 Proper ...
SCOPE
1.1 This practice outlines the irradiator installation qualification program and the dosimetric procedures to be followed during operational qualification and performance qualification of the irradiator. Procedures for the routine radiation processing of blood product (blood and blood components) are also given. If followed, these procedures will help ensure that blood product exposed to gamma radiation or X-radiation (bremsstrahlung) will receive absorbed doses with a specified range.  
1.2 This practice covers dosimetry for the irradiation of blood product for self-contained irradiators (free-standing irradiators) utilizing radionuclides such as 137Cs and  60Co, or X-radiation (bremsstrahlung). The absorbed dose range for blood irradiation is typically 15 Gy to 50 Gy.  
1.3 The photon energy range of X-radiation used for blood irradiation is typically from 40 keV to 300 keV.  
1.4 This practice also covers the use of radiation-sensitive indicators for the visual and qualitative indication that the product has been irradiated (see ISO/ASTM Guide 51539).  
1.5 This document is one of a set of standards that provides recommendations for properly implementing dosimetry in radiation processing and describes a means of achieving compliance with the requirements of ISO/ASTM Practice 52628 for dosimetry performed for blood irradiation. It is intended to be read in conjunction with ISO/ASTM Practice 52628.  
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 ...

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ASTM A908-03(2019)(Specification)
Standard Specification for Stainless Steel Needle Tubing

ABSTRACT
The specification covers austenitic, stainless steel, needle tubing in hard-drawn tempers for industrial application. An electric furnace or other similar primary melting process with or without degassing or refining may be used. Needle tubing shall be made by the seamless or welded and drawn process and shall be furnished in the hard-drawn temper condition. Tension tests shall be made to meet the required tensile requirements.
SCOPE
1.1 This specification covers austenitic, stainless steel, needle tubing in hard-drawn tempers for industrial applications.  
1.2 In general, needle tubing describes small-diameter tubing with outside diameters (ODs) in the range of 0.008 to 0.203 in. (0.2 to 5.2 mm) with nominal wall thicknesses in the range of 0.002 to 0.015 in. (0.05 to 0.4 mm). Needle tubing gages are normally 6 through 33.  
1.3 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard.  
1.4 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.

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