ASTM F2193-18
(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.
SIGNIFICANCE AND USE
4.1 Spinal implant constructs are typically a compilation of several components. Screws, plates, and rods are integral components of many spinal implant constructs. These components are designed to transfer load between the bone and the longitudinal or transverse element, or both. These specifications and test methods identify specifications for such components and define standard equivalent test methods that can be used when evaluating different related component designs.
4.2 Since the loading of spinal components in-vivo may differ from the loading configurations addressed in these specifications and test methods, the results obtained from this document may not predict in-vivo performance of either the components or the construct as a whole. Such tests can, however, be used to compare different component designs in terms of relevant mechanical performance characteristics.
4.3 The performance-related mechanical characteristics determined by these specifications and test methods will supply the user with information that may be used to predict the mechanical performance of different design variations of similar (function and indication) spinal construct components.
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 part of a series of standards addressing 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 F1798. At the highest level in this chain is Test Methods F1717, 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 th...
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Designation:F2193 −18
Standard Specifications and Test Methods for
Components Used in the Surgical Fixation of the Spinal
1
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, health, and environmental prac-
interconnections between individual components and subas-
tices and determine the applicability of regulatory limitations
semblies (two or more components), the user should consult
prior to use.
Guide F1798.At the highest level in this chain isTest Methods
1.8 This international standard was developed in accor-
F1717, which is used to evaluate an entire construct assembled
dance with internationally recognized principles on standard-
from many components and involves numerous interconnec-
ization established in the Decision on Principles for the
tions and several subassemblies.
Development of International Standards, Guides and Recom-
mendations issued by the World Trade Organization Technical
1.3 It is not the intention of these specifications and test
Barriers to Trade (TBT) Committee.
methods to define levels of performance or case-specific
clinical performance for spinal components addressed by this
2. Referenced Documents
document. Insufficient knowledge to predict the consequences
2
of using any of these components in individual patients for
2.1 ASTM Standards: General
specific activities of daily living is available. Furthermore, it is
E4 Practices for Force Verification of Testing Machines
not the intention of this document to describe or specify
E6 Terminology Relating to Methods of Mechanical Testing
specific designs for the individual components of systems used
E122 Practice for Calculating Sample Size to Estimate,With
in the surgical internal fixation of the spinal skeletal system.
Specified Precision, the Average for a Characteristic of a
Lot or Process
1
These specifications and test methods are under the jurisdiction of ASTM
Committee F04 on Medical and Surgical Materials and Devices and are the direct
2
responsibility of Subcommittee F04.25 on Spinal Devices. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Current edition approved Feb. 1, 2018. Published March 2018. Originally contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
approved in 2002. Last previous edition approved in 2014 as F2193 – 14. DOI: Standards volume information, refer to the standard’s Document
...
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: F2193 − 14 F2193 − 18
Standard Specifications and Test Methods for
Components Used in the Surgical Fixation of the Spinal
1
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
1.1 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 part of a series of standards addressing 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
F1798. At the highest level in this chain is Test Methods F1717, 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 to predict the consequences of using any
of these components in individual patients for specific activities of daily living is available. 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 Strength of Metallic Spinal Screws—Annex A4.
1.6 Unless otherwise indicated, the values stated in SI units shall be regarded as the standard.
1.7 This standard may involve hazardous materials, operations, and equipment. 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 safety, health, and healthenvironmental 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.
1
These specifications and test methods are under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and isare the direct
responsibility of Subcommittee F04.25 on Spinal Devices.
Current edition approved Oct. 1, 2014Feb. 1, 2018. Published November 2014March 2018. Originally approved in 2002. Last previous edition approved in 20072014 as
F2193 – 02 (2007).F2193 – 14. DOI: 10.1520/F2193-14.10.1520/F2193-18.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. Unite
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