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ASTM F2077-01

(Test Method)

Test Methods For Intervertebral Body Fusion Devices

Test Methods For Intervertebral Body Fusion Devices

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 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.
1.4 This test method does not purport to address expulsion testing of intervertebral body fusion device assemblies. However, since expulsion is a potential clinical failure mode, the user should address the implant's resistance to expulsion.
1.5 Guidelines are established for measuring displacements, determining the yield load or moment, evaluating the stiffness, and strength of the intervertebral body fusion device assemblies.
1.6 Some intervertebral body fusion device assemblies may not be testable in all test configurations.
1.7 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.
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
09-May-2001
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 F2077-00 - Test Methods For Intervertebral Body Fusion Devices
Effective Date
10-May-2001
Replaced By
ASTM F2077-03 - Test Methods For Intervertebral Body Fusion Devices
Effective Date
10-Apr-2003
Referred By
ASTM F2267-22 - Standard Test Method for Measuring Load-Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression
Effective Date
10-May-2001
Referred By
ASTM F2706-18 - Standard Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model
Effective Date
10-May-2001
Referred By
ASTM F2423-11(2020) - Standard Guide for Functional, Kinematic, and Wear Assessment of Total Disc Prostheses
Effective Date
10-May-2001
Referred By
ASTM F3574-22 - Standard Test Methods for Sacroiliac Joint Fusion Devices
Effective Date
10-May-2001
Referred By
ASTM F3292-19 - Standard Practice for Inspection of Spinal Implants Undergoing Testing
Effective Date
10-May-2001
Referred By
ASTM F1717-21 - Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
Effective Date
10-May-2001
Referred By
ASTM F2346-18 - Standard Test Methods for Static and Dynamic Characterization of Spinal Artificial Discs
Effective Date
10-May-2001

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ASTM F2077-01 - Test Methods For Intervertebral Body Fusion DevicesASTM F2077-01 - Test Methods For Intervertebral Body Fusion Devices
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ASTM F2077-01 - Test Methods For Intervertebral Body Fusion Devices
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Standards Content (Sample)

NOTICE: This standard has either been superceded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
Designation: F 2077 – 01
Test Methods For
1
Intervertebral Body Fusion Devices
This standard is issued under the fixed designation F 2077; 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 (e) indicates an editorial change since the last revision or reapproval.
2
1. Scope E 4 Practices for Force Verification of Testing Machines
E 6 Terminology Relating to Methods of Mechanical Test-
1.1 This test method covers the materials and methods for
2
ing
the static and dynamic testing of intervertebral body fusion
E 1823 Terminology Relating to Fatigue and Fracture Test-
device assemblies, spinal implants designed to promote arthro-
2
ing
desis at a given spinal motion segment.
3
F 1582 Terminology Relating to Spinal Implants
1.2 This test method is intended to provide a basis for the
mechanical comparison among past, present, and future non-
3. Terminology
biologic intervertebral body fusion device assemblies. This test
3.1 For definition of terms refer to Terminology E 6,
method allows comparison of intervertebral body fusion device
E 1823, and F 1582.
assemblies with different intended spinal locations and meth-
3.2 Definitions of Terms Specific to This Standard:
ods of application to the intradiscal spaces. This test method is
3.2.1 coordinate system/axes, n—Three orthogonal axes are
intended to enable the user to compare intervertebral body
defined by Terminology F 1582. The center of the coordinate
fusion device assemblies mechanically and does not purport to
system is located at the geometric center of the intervertebral
provide performance standards for intervertebral body fusion
body fusion device assembly. The XY plane is to bisect the
device assemblies.
sagittal plane angle between superior and inferior lines (sur-
1.3 The test method describes static and dynamic tests by
faces) that are intended to simulate the adjacent vertebral end
specifying load types and specific methods of applying these
plates. The positive Z axis is to be directed superiorly. Force
loads. These tests are designed to allow for the comparative
components parallel to the XY plane are shear components of
evaluation of intervertebral body fusion device assemblies.
loading. The compressive axial force is defined to be the
1.4 This test method does not purport to address expulsion
component in the negative Z direction. Torsional load is
testing of intervertebral body fusion device assemblies. How-
defined to be the component of moment parallel to the Z axis.
ever, since expulsion is a potential clinical failure mode, the
3.2.2 fatigue life, n—The number of cycles, N, that the
user should address the implant’s resistance to expulsion.
intervertebral body fusion device assembly can sustain at a
1.5 Guidelines are established for measuring displacements,
particular load or moment before mechanical or functional
determining the yield load or moment, evaluating the stiffness,
failure occurs.
and strength of the intervertebral body fusion device assem-
3.2.3 functional failure, n—Permanent deformation that
blies.
renders the intervertebral body fusion device assembly inef-
1.6 Some intervertebral body fusion device assemblies may
fective or unable to resist load and/or maintain attachment
not be testable in all test configurations.
adequately.
1.7 The values stated in SI units are to be regarded as the
3.2.4 ideal insertion location, n—The implant location with
standard with the exception of angular measurements, which
respect to the simulated inferior and superior vertebral bodies
may be reported in terms of either degrees or radians.
(polyacetal or metal blocks) dictated by the type, design, and
1.8 This standard does not purport to address all of the
manufacturer’s surgical installation instructions.
safety concerns, if any, associated with its use. It is the
3.2.5 intended method of application, n—Intervertebral
responsibility of the user of this standard to establish appro-
body fusion device assemblies may contain different types of
priate safety and health practices and determine the applica-
stabilizing anchors such as threads, spikes, and knurled sur-
bility of regulatory limitations prior to use.
faces. Each type of anchor has an intended method of appli-
2. Referenced Documents cation or attachment to the spine.
3.2.6 intended spinal location, n—The anatomic region of
2.1 ASTM Standards:
the spine intended for the intervertebral body fusion device
assembly. Intervertebral body fusion device assemblies may be
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.
2
Curr
...

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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.  
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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
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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.  
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SCOPE
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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.  
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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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