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.<\/p>\n
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.<\/p>\n
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.<\/p>\n
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.<\/p>\n
1.5 This document includes the following specifications and test methods that are used in determining the spinal component’s mechanical performance characteristics:<\/p>\n
1.5.1 Specification for Metallic Spinal ScrewsAnnex A1.<\/p>\n
1.5.2 Specification for Metallic Spinal PlatesAnnex A2.<\/p>\n
1.5.3 Specification for Metallic Spinal RodsAnnex A3.<\/p>\n
1.5.4 Test Method for Measuring the Static and Fatigue Bending Strength of Metallic Spinal ScrewsAnnex A4.<\/p>\n
1.6 Unless otherwise indicated, the values stated in SI units shall be regarded as the standard.<\/p>\n
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.<\/i><\/p>\n
| PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
|---|---|---|---|---|---|---|---|
| 1<\/td>\n | Scope Referenced Documents <\/td>\n<\/tr>\n | ||||||
| 2<\/td>\n | Terminology <\/td>\n<\/tr>\n | ||||||
| 3<\/td>\n | Significance and Use Requirements Marking, Packaging, Labeling, and Handling Materials <\/td>\n<\/tr>\n | ||||||
| 4<\/td>\n | Keywords A1. SPECIFICATION FOR METALLIC SPINAL SCREWS A1.1 Scope A1.2 Classification A1.3 Marking, Packaging, Labeling, and Handling A1.4 Materials A1.5 General Requirements, Performance Considerations, and Test Methods <\/td>\n<\/tr>\n | ||||||
| 5<\/td>\n | A2. SPECIFICATION FOR METALLIC SPINAL PLATES A2.1 Scope A2.2 Classification A2.3 Marking, Packaging, Labeling, and Handling A2.4 Materials A2.5 Performance Considerations and Test Methods TABLE A2.1 <\/td>\n<\/tr>\n | ||||||
| 6<\/td>\n | A3. SPECIFICATION FOR METALLIC SPINAL RODS A3.1 Scope A3.2 Classification A3.3 Marking, Packaging, Labeling, and Handling A3.4 Materials A3.5 Performance Considerations and Test Methods FIG. A2.1 FIG. A2.2 <\/td>\n<\/tr>\n | ||||||
| 7<\/td>\n | A4. TEST METHOD FOR MEASURING THE STATIC AND FATIGUE BENDING STRENGTH OF METALLIC SPINAL SCREWS A4.1 Scope FIG. A3.1 <\/td>\n<\/tr>\n | ||||||
| 8<\/td>\n | A4.2 Summary of Method A4.3 Significance and Use A4.4 Apparatus A4.5 Sampling <\/td>\n<\/tr>\n | ||||||
| 9<\/td>\n | A4.6 Preparation of Apparatus FIG. A4.1 FIG. A4.2 <\/td>\n<\/tr>\n | ||||||
| 10<\/td>\n | A4.7 Procedure A4.8 Calculation and Interpretation of Results <\/td>\n<\/tr>\n | ||||||
| 11<\/td>\n | A4.9 Report A4.10 Precision and Bias X1. RATIONALE FOR THE OVERALL SPECIFICATION X1.1 X1.2 <\/td>\n<\/tr>\n | ||||||
| 12<\/td>\n | X1.3 X1.4 X1.5 X1.6 X2. ANNEX A1 RATIONALE X2.1 X2.2 X2.3 X2.4 X2.5 X2.6 <\/td>\n<\/tr>\n | ||||||
| 13<\/td>\n | X3. RATIONALE FOR ANNEX A2 X3.1 X3.2 X3.3 X3.4 X4. RATIONALE FOR ANNEX A3 X4.1 X4.2 X4.3 X4.4 X5. RATIONALE FOR ANNEX A4 X5.1 X5.2 REFERENCES <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" F2193-02 Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System<\/b><\/p>\n |