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ASTM F 2193 : 2014

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System

Available format(s)

Hardcopy , PDF

Superseded date

11-11-2014

Superseded by

ASTM F 2193 : 2018

Language(s)

English

Published date

01-10-2014

€74.48
Excluding VAT

Committee
F 04
DocumentType
Standard
Pages
14
PublisherName
American Society for Testing and Materials
Status
Superseded
SupersededBy
Supersedes

1.1These 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.

1.2These 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.

1.3It 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.

1.4These 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.

1.5This document includes the following specifications and test methods that are used in determining the spinal component's mechanical performance characteristics:

1.5.1Specification for Metallic Spinal Screws—Annex A1.

1.5.2Specification for Metallic Spinal Plates—Annex A2.

1.5.3Specification for Metallic Spinal Rods—Annex A3.

1.5.4Test Method for Measuring the Static and Fatigue Bending Strength of Metallic Spinal Screws—Annex A4.

1.6Unless otherwise indicated, the values stated in SI units shall be regarded as the standard.

1.7This 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.

ASTM F 3292 : 2019 Standard Practice for Inspection of Spinal Implants Undergoing Testing

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