【国外标准】 Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System

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.AbstractThese 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.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, 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.