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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.
This abstract is a brief summary of the referenced standard. It is informational only and not an official part of the standard; the full text of the standard itself must be referred to for its use and application. ASTM does not give any warranty express or implied or make any representation that the contents of this abstract are accurate, complete or up to date.
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 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 and health practices and determine the applicability of regulatory limitations prior to use.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
D4020 Specification for Ultra-High-Molecular-Weight Polyethylene Molding and Extrusion Materials
E4 Practices for Force Verification of Testing Machines
E6 Terminology Relating to Methods of Mechanical Testing
E122 Practice for Calculating Sample Size to Estimate, With Specified Precision, the Average for a Characteristic of a Lot or Process
E467 Practice for Verification of Constant Amplitude Dynamic Forces in an Axial Fatigue Testing System
E1823 Terminology Relating to Fatigue and Fracture Testing
E1942 Guide for Evaluating Data Acquisition Systems Used in Cyclic Fatigue and Fracture Mechanics Testing
F67 Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700)
F136 Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401)
F138 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)
F382 Specification and Test Method for Metallic Bone Plates
F543 Specification and Test Methods for Metallic Medical Bone Screws
F565 Practice for Care and Handling of Orthopedic Implants and Instruments
F648 Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
F983 Practice for Permanent Marking of Orthopaedic Implant Components
F1295 Specification for Wrought Titanium-6Aluminum-7Niobium Alloy for Surgical Implant Applications (UNS R56700)
F1314 Specification for Wrought Nitrogen Strengthened 22 Chromium - 13 Nickel - 5 Manganese - 2.5 Molybdenum Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S20910)
F1341 Specification for Unalloyed Titanium Wire UNS R50250, UNS R50400, UNS R50550, UNS R50700, for Surgical Implant Applications
F1472 Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNS R56400)
F1582 Terminology Relating to Spinal Implants
F1717 Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
F1798 Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants
F1839 Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopaedic Devices and Instruments
ISO StandardsISO14630:1997 Non-active Surgical Implants--General Requirements Available from International Organization for Standardization (ISO), 1 rue de Varembe, Case postale 56, CH-1211, Geneva 20, Switzerland.
ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)
UNSPSC Code 42295500(Surgical implants and expanders and extenders and surgical wires and related products)