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    ASTM F1541 - 17

    Standard Specification and Test Methods for External Skeletal Fixation Devices

    Active Standard ASTM F1541 | Developed by Subcommittee: F04.21

    Book of Standards Volume: 13.01

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    Significance and Use

    A1.4 Significance and Use

    A1.4.1 The purpose of this classification is to establish a consistent terminology system by means of which these ESFD configurations can be classified. It is anticipated that a companion testing standard using this classification system will subsequently be developed.

    1. Scope

    1.1 This specification provides a characterization of the design and mechanical function of external skeletal fixation devices (ESFDs), test methods for characterization of ESFD mechanical properties, and identifies needs for further development of test methods and performance criteria. The ultimate goal is to develop a specification, which defines performance criteria and methods for measurement of performance-related mechanical characteristics of ESFDs and their fixation to bone. It is not the intention of this specification to define levels of performance or case-specific clinical performance of the devices, as insufficient knowledge is available to predict the consequences of the use of any of these devices in individual patients for specific activities of daily living. Furthermore, it is not the intention of this specification to describe or specify specific designs for ESFDs.

    1.2 This specification describes ESFDs for surgical fixation of the skeletal system. It provides basic ESFD geometrical definitions, dimensions, classification, and terminology; material specifications; performance definitions; test methods; and characteristics determined to be important to the in-vivo performance of the device.

    1.3 This specification includes a terminology and classification annex and five standard test method annexes as follows:

    1.3.1 Classification of External Fixators—Annex A1.

    1.3.2 Test Method for External Skeletal Fixator Connectors—Annex A2.

    1.3.3 Test Method for Determining In-Plane Compressive Properties of Circular Ring or Ring Segment Bridge Elements—Annex A3.

    1.3.4 Test Method for External Skeletal Fixator Joints—Annex A4.

    1.3.5 Test Method for External Skeletal Fixator Pin Anchorage Elements—Annex A5.

    1.3.6 Test Method for External Skeletal Fixator Subassemblies—Annex A6.

    1.3.7 Test Method for External Skeletal Fixator/Constructs Subassemblies—Annex A7.

    1.4 A rationale is given in Appendix X1.

    1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

    1.6 Multiple test methods are included in this standard. However, the user is not necessarily obligated to test using all of the described methods. Instead, the user should only select, with justification, test methods that are appropriate for a particular device design. This may be only a subset of the herein described test methods

    1.7 The following safety hazards caveat pertains only to the test method portions (Annex A2 – Annex A6):

    1.8 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.

    1.9 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.

    2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.

    ASTM Standards

    A938 Test Method for Torsion Testing of Wire

    D790 Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials

    E4 Practices for Force Verification of Testing Machines

    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

    F366 Specification for Fixation Pins and Wires

    F543 Specification and Test Methods for Metallic Medical Bone Screws

    F1264 Specification and Test Methods for Intramedullary Fixation Devices

    F2503 Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment

    ICS Code

    ICS Number Code 11.040.40 (Implants for surgery, prosthetics and orthotics)

    Referencing This Standard
    Link Here
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    DOI: 10.1520/F1541-17

    Citation Format

    ASTM F1541-17, Standard Specification and Test Methods for External Skeletal Fixation Devices, ASTM International, West Conshohocken, PA, 2017, www.astm.org

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