ASTM-F2193 Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System

ASTM-F2193 - 2018A EDITION - CURRENT
Show Complete Document History

Document Center Inc. is an authorized dealer of ASTM standards.
The following bibliographic material is provided to assist you with your purchasing decision:


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.

ORDER

Price:

$52.00        

Changes from the previous issue

A redline edition is available for this document, with all changes visible. Ask Document Center Inc. for more information.

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, 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.

Keywords

bend testing–plate; bend testing–rod; bend testing–screw; bend testing–surgical implants; fatigue test–plate; fatigue test–rod; fatigue test–screw; fatigue test–surgical implants; orthopedic medical device–plate; orthopedic medical device–rod; orthopedic medical device–screw; orthopedic spinal devices; performance; spinal arthrodesis; surgical devices; terminology; test methods–surgical implants;; ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)

To find similar documents by ASTM Volume:

13.01 (Medical and Surgical Materials and Devices)

To find similar documents by classification:

11.040.40 (Implants for surgery, prosthetics and orthotics Including pacemakers Ophthalmic implants, see 11.040.70)

This document comes with our free Notification Service, good for the life of the document.

This document is available in either Paper or PDF format.

Document Number

ASTM-F2193-18a

Revision Level

2018A EDITION

Status

Current

Modification Type

Revision

Publication Date

April 1, 2018

Document Type

Specification

Page Count

15 pages

Committee Number

F04.25