ASTM F2193-02(2007)
(Specification)Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System
Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System
ABSTRACT
These specifications and test methods provide standard specifications that specify material, labeling, and handling requirements for components used in surgical fixation of the spinal skeletal system such as metallic spinal screws, spinal plates, and spinal rods. The specifications and test methods establish (1) common terminology that can be used to describe the size and other physical characteristics of spinal components and performance definitions related to the performance of spinal components, and (2) performance requirements and standard test methods to consistently measure performance-related mechanical characteristics of spinal components. It is not the intention of these specifications and test methods to define levels of performance or case-specific clinical performance for spinal components and to describe or specify specific designs for the individual components. For these specifications and test methods may not be appropriate for all types of spinal surgical fixation systems, the appropriateness of these specifications in view of the particular implant system and its potential application shall be considered. The test methods include static and fatigue bending strength tests. Requirements for marking and packaging are specified as well.
SCOPE
1.1 These specifications and test methods are intended to provide a comprehensive reference for the components of systems used in the surgical fixation of the spinal skeletal system. The document catalogs standard specifications that specify material, labeling, and handling requirements. The specifications and test methods also establish common terminology that can be used to describe the size and other physical characteristics of spinal components and performance definitions related to the performance of spinal components. Additionally, the specifications and test methods establish performance requirements and standard test methods to consistently measure performance-related mechanical characteristics of spinal components.
1.2 These specifications and test methods are a series of standards available for addressing the concerns related to systems used in the surgical fixation of the spinal skeletal system. These specifications and test methods concentrate on the individual components, which are found in many spinal fixation systems. If the user is interested in evaluating the next level in the spinal fixation system chain, the interconnections between individual components and subassemblies (two or more components), the user should consult Guide F 1798. At the highest level in this chain is Test Methods F 1717, which is used to evaluate an entire construct assembled from many components and involves numerous interconnections and several subassemblies.
1.3 It is not the intention of these specifications and test methods to define levels of performance or case-specific clinical performance for spinal components addressed by this document. Insufficient knowledge is available to predict the consequences of using any of these components in individual patients for specific activities of daily living. Furthermore, it is not the intention of this document to describe or specify specific designs for the individual components of systems used in the surgical internal fixation of the spinal skeletal system.
1.4 These specifications and test methods may not be appropriate for all types of spinal surgical fixation systems. The user is cautioned to consider the appropriateness of this document in view of the particular implant system and its potential application.
1.5 This document includes the following specifications and test methods that are used in determining the spinal component's mechanical performance characteristics:
1.5.1 Specification for Metallic Spinal Screws—Annex A1.
1.5.2 Specification for Metallic Spinal Plates—Annex A2.
1.5.3 Specification for Metallic Spinal Rods—Annex A3.
1.5.4 Test Method for Measuring the Static and Fatigue Bending Stren...
General Information
Relations
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:F2193 −02(Reapproved 2007)
Standard Specifications and Test Methods for
Components Used in the Surgical Fixation of the Spinal
Skeletal System
This standard is issued under the fixed designation F2193; 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 1.4 These specifications and test methods may not be
appropriateforalltypesofspinalsurgicalfixationsystems.The
1.1 These specifications and test methods are intended to
user is cautioned to consider the appropriateness of this
provide a comprehensive reference for the components of
document in view of the particular implant system and its
systems used in the surgical fixation of the spinal skeletal
potential application.
system. The document catalogs standard specifications that
specify material, labeling, and handling requirements. The 1.5 This document includes the following specifications and
specifications and test methods also establish common termi- test methods that are used in determining the spinal compo-
nology that can be used to describe the size and other physical nent’s mechanical performance characteristics:
characteristics of spinal components and performance defini- 1.5.1 Specification for Metallic Spinal Screws—Annex A1.
tions related to the performance of spinal components. 1.5.2 Specification for Metallic Spinal Plates—Annex A2.
Additionally, the specifications and test methods establish 1.5.3 Specification for Metallic Spinal Rods—Annex A3.
performance requirements and standard test methods to con- 1.5.4 Test Method for Measuring the Static and Fatigue
sistently measure performance-related mechanical characteris- Bending Strength of Metallic Spinal Screws—Annex A4.
tics of spinal components.
1.6 Unless otherwise indicated, the values stated in SI units
1.2 Thesespecificationsandtestmethodsarepartofaseries shall be regarded as the standard.
of standards addressing systems used in the surgical fixation of
1.7 This standard may involve hazardous materials,
the spinal skeletal system. These specifications and test meth-
operations, and equipment. This standard does not purport to
odsconcentrateontheindividualcomponents,whicharefound
address all of the safety concerns, if any, associated with its
in many spinal fixation systems. If the user is interested in
use. It is the responsibility of the user of this standard to
evaluatingthenextlevelinthespinalfixationsystemchain,the
establish appropriate safety and health practices and deter-
interconnections between individual components and subas-
mine the applicability of regulatory limitations prior to use.
semblies (two or more components), the user should consult
Guide F1798.At the highest level in this chain isTest Methods
2. Referenced Documents
F1717, which is used to evaluate an entire construct assembled 2
2.1 ASTM Standards: General
from many components and involves numerous interconnec-
E4 Practices for Force Verification of Testing Machines
tions and several subassemblies.
E6 Terminology Relating to Methods of Mechanical Testing
1.3 It is not the intention of these specifications and test E122 Practice for Calculating Sample Size to Estimate,With
methods to define levels of performance or case-specific Specified Precision, the Average for a Characteristic of a
clinical performance for spinal components addressed by this Lot or Process
document. Insufficient knowledge to predict the consequences E467 Practice for Verification of Constant Amplitude Dy-
of using any of these components in individual patients for namic Forces in an Axial Fatigue Testing System
specific activities of daily living is available. Furthermore, it is E1823 TerminologyRelatingtoFatigueandFractureTesting
not the intention of this document to describe or specify E1942 Guide for Evaluating DataAcquisition Systems Used
specific designs for the individual components of systems used in Cyclic Fatigue and Fracture Mechanics Testing
in the surgical internal fixation of the spinal skeletal system. F382 SpecificationandTestMethodforMetallicBonePlates
F543 Specification and Test Methods for Metallic Medical
Bone Screws
These specifications and test methods are 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. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Current edition approved Nov. 15, 2007. Published November 2007. Originally contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
approved in 2002. Last previous edition approved in 2002 as F2193 – 02. DOI: Standards volume information, refer to the standard’s Document Summary page on
10.1520/F2193-02R07. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F2193−02 (2007)
F565 Practice for Care and Handling of Orthopedic Implants usedinthisdocumentwillbeinaccordancewiththedefinitions
and Instruments of Terminology E6, Terminology E1823, Specification F382,
F983 Practice for Permanent Marking of Orthopaedic Im- Terminology F1582, Test Methods F1717, and Guide F1798.
plant Components
3.3 Terminology—General:
F1582 Terminology Relating to Spinal Implants
3.3.1 expansion head screw, n—threaded anchor that is
F1717 Test Methods for Spinal Implant Constructs in a
designed so that the head can be elastically deformed, through
Vertebrectomy Model
mechanicalmeans,toestablishaninterconnectionwithanother
F1798 Test Method for Evaluating the Static and Fatigue
spinal construct element.
Properties of Interconnection Mechanisms and Subassem-
3.3.2 locking screw, n—threaded anchor that is rigidly
blies Used in Spinal Arthrodesis Implants
connected to the longitudinal element of the spinal construct.
F1839 Specification for Rigid Polyurethane Foam for Use as
3.3.3 self-locking screw, n—threaded anchor design that
a Standard Material for Testing Orthopaedic Devices and
undergoes a deformation process at the end of the insertion
Instruments
process which results in the screw’s locking to the mating
2.2 ASTM Standards: Materials
spinal construct element.
D4020 Specification for Ultra-High-Molecular-Weight Poly-
ethylene Molding and Extrusion Materials
3.3.4 shaft screw, n—threaded anchor having an unthreaded
F67 Specification for Unalloyed Titanium, for Surgical Im-
shank equal to its thread diameter.
plant Applications (UNS R50250, UNS R50400, UNS
3.4 Terminology—Geometric:
R50550, UNS R50700)
3.4.1 rod diameter (mm), n—length in mm of a chord
F136 Specification for Wrought Titanium-6Aluminum-
passing through the center of the rod’s cross-section.
4Vanadium ELI (Extra Low Interstitial)Alloy for Surgical
3.4.2 rod length (mm), n—overall dimension measured in
Implant Applications (UNS R56401)
mm between the ends of a given rod.
F138 Specification for Wrought 18Chromium-14Nickel-
2.5Molybdenum Stainless Steel Bar and Wire for Surgical
3.5 Terminology—Mechanical/Structural:
Implants (UNS S31673)
3.5.1 0.2 % offset displacement (mm), n—permanent dis-
F648 Specification for Ultra-High-Molecular-Weight Poly-
placement equal to 0.002 times the test gage section length for
ethylene Powder and Fabricated Form for Surgical Im-
the specific test, in mm.The test gage section length is equal to
plants
the bending moment arm for spinal screw tests. The test gage
F1295 Specification for Wrought Titanium-6Aluminum-
section length is equal to the center span distance for spinal
7Niobium Alloy for Surgical Implant Applications (UNS
plate and rod tests where the loading rollers are directly
R56700)
contactingthetestspecimen(Fig.A2.1andFig.A3.1).Thetest
F1314 Specification for Wrought Nitrogen Strengthened 22
gage section length is equal to the unsupported distance
Chromium–13 Nickel–5 Manganese–2.5 Molybdenum
betweentheendsoftheextensionsegmentsforspinalplateand
Stainless Steel Alloy Bar and Wire for Surgical Implants
rod tests where extension segments are used to load the test
(UNS S20910)
sample (Fig. A2.2). (distance 0B in Fig. A4.1).
F1341 Specification for Unalloyed Titanium Wire UNS
3.5.2 axial pull-out load (N), n—tensile force in N required
R50250, UNS R50400, UNS R50550, UNS R50700, for
to fail or remove a screw from a material into which the screw
Surgical Implant Applications (Withdrawn 2006)
has been inserted when tested in accordance with Specification
F1472 Specification for Wrought Titanium-6Aluminum-
and Test Methods F543, Annex A3.
4VanadiumAlloy for Surgical ImplantApplications (UNS
3.5.3 bending fatigue runout moment (N·m), n—value in
R56400)
N-m of the maximum moment that can be applied to a spinal
2.3 ISO Standards:
component where all of the tested samples have experienced
ISO 14630:1997 Non-active Surgical Implants—General
4 2 500 000 loading cycles without a failure at a specific R-ratio.
Requirements
3.5.4 bending moment arm, L (mm), n—distance in mm
3. Terminology between the point where the test sample is gripped (typically
the axis of the longitudinal element) and the line-of-action for
3.1 Unless otherwise defined in these specifications and test
the applied force prior to any deformation of of the assembly.
methods, the terminology used in this document that is related
(See dimension L of Fig. A4.2).
to spinal implants will be in accordance with the definitions of
Specification F382, Specification F543, and Terminology 3.5.5 bending stiffness, S (N/mm), n—slope in N/mm of the
initial linear elastic portion of the load versus total displace-
F1582.
ment curve (slope of line 0m in Fig. A4.1).
3.2 Unless otherwise defined in these specifications and test
3.5.6 bending ultimate moment (N·m), n—maximum bend-
methods, the terminology related to mechanical testing that is
ing moment in N-m that can be applied to a test sample. This
would correspond to the bending moment at Point E in Fig.
The last approved version of this historical standard is referenced on
A4.1.
www.astm.org.
3.5.7 bending yield moment (N·m), n— bending moment in
Available from International Organization for Standardization (ISO), 1 rue de
Varembe, Case postale 56, CH-1211, Geneva 20, Switzerland. N-m necessary to produce a 0.2 % offset displacement in the
F2193−02 (2007)
spinal component. If the specimen fractures before the test the user with information that may be used to predict the
reaches the 0.2 % offset displacement point, the bending yield mechanical performance of different design variations of simi-
moment shall be defined as the bending moment at fracture lar (function and indication) spinal construct components.
(point D in Fig. A4.1).
5. Requirements
3.5.8 exposed length (mm), n—linear distance measured in
mm between the surface of the test block that the screw is 5.1 The following spinal components shall conform to the
embedded in during the test and the location where the screw requirements of the listed standard specification:
is anchored (typically the axis of the longitudinal element) in 5.1.1 Screws—Standard Specification for Metallic Spinal
the test fixture (see Fig. A4.2). Screws (see Annex A1).
5.1.2 Plates—Standard Specification for Metallic Spinal
3.5.9 gross failure, n—permanent displacement resulting
Plates (see Annex A2).
from fracture or plastic deformation in excess of the yield
5.1.3 Rods—Standard Specification for Metallic Spinal
displacement that renders the spinal component ineffective in
Rods (see Annex A3).
fulfilling its intended function.
3.5.10 insertion depth (mm), n—linear advancement in mm
6. Marking, Packaging, Labeling, and Handling
of the screw into the test block measured relative to its seated
6.1 Mark spinal components using the methods specified in
position at the test block’s surface prior to testing.
Practice F983.
3.5.11 median bending fatigue moment at N cycles (N·m),
6.2 Markings on spinal components shall identify the manu-
n—value in N-m of the maximum moment that can be applied
facturer or distributor. When size permits, the following
to a spinal component for which 50 % of the test specimens of
information should be legibly marked on the spinal component
a given sample can be expected to survive N loading cycles at
(items listed in order of preference):
a specific R-ratio.
6.2.1 Manufacturer’s name or logo,
3.5.12 permanent displacement (mm), n—totaldisplacement
6.2.2 Materialand,whenapplicable,theASTMdesignation,
in mm remaining after the applied load has been removed from
6.2.3 Catalog number,
the test specimen.
6.2.4 Manufacturing lot number, and
3.5.13 torsion yield moment (N·m), n— applied torque in
6.2.5 If the component is manufactured according to an
N-m at which the screw reaches its proportional limit when
ASTM specification, the ASTM designation.
tested in accordance with Specification and Test Methods
6.3 Packaging shall be adequate to protect the spinal com-
F543, Annex A1. The value is determined by using an offset
ponent during shipment.
method with a 2° angular offset.
6.4 Package labeling for spinal components shall include
3.5.14 total displacement (mm), n—distance in mm, in the
the following information:
direction of the applied load, which the load application point
6.4.1 Manufacturer and product name,
hasmovedrelativetothezeroloadinterceptoftheinitiallinear
6.4.2 Catalog number,
segment of the load versus displacement curve (point 0 in Fig.
6.4.3 Lot or serial number,
A4.1).
6.4.4 Material and, when applicable, theASTM designation
3.5.15 yield displacement (mm), n—total displacement in
for the material, and
mm associated with the bending yield strength (distance 0A in
6.4.5 The sterility condition of the packaged spinal compo-
Fig. A4.1).
nent.
4. Significance and Use
6.5 Spinal components shall be cared for and handled
according to the requirements specified in Practice F565.
4.1 Spinal implant constructs are typically a compilation of
several components. Screws, plates, and rods are integral
7. Materials
components of many spinal implant constructs. These compo-
nents are designed to transfer load between the bone and the 7.1 The manufacturer is responsible for ensuring that mate-
longitudinal or transverse element, or both. These specifica- rials used to manufacture spinal components are suitable for
tions and test methods identify specifications for such compo- implanting into the body. Material suitability can be verified
nents and define standard equivalent test methods that can be with the methods described in ISO 14630.
used when evaluating different related component designs.
7.2 The manufacturer should also
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.