ASTM F1541-02(2015)
Standard Specification and Test Methods for External Skeletal Fixation Devices

Standard No.

ASTM F1541-02(2015)

Release Date

2002

Published By

American Society for Testing and Materials (ASTM)

Status

Be replaced

Replace By

ASTM F1541-17

Latest

ASTM F1541-17

Scope

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.

1.1 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—

ASTM F1541-02(2015) Referenced Document

• ASTM A938 Standard Test Method for Torsion Testing of Wire
• ASTM D790 Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials*， 2024-04-20 Update
• ASTM E4 Standard Practices for Force Verification of Testing Machines
• ASTM F1058 Standard Specification for Wrought 40Cobalt-20Chromium-16Iron-15Nickel-7Molybdenum Alloy Wire and Strip for Surgical Implant Applications (UNS R30003 and UNS R30008)
• ASTM F1264 Standard specifications and test methods for intramedullary fixation devices*， 2024-04-20 Update
• ASTM F136 Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401) for Surgical Implant Applications
• ASTM F138 Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)
• ASTM F1472 Standard Specification for Wrought Titanium -6Aluminum -4Vanadium Alloy (UNS R56400) for Surgical Implant Applications
• ASTM F1713 Standard Specification for Wrought Titanium-13Niobium-13Zirconium Alloy for Surgical Implant Applications
• ASTM F366 Standard Specification for Fixation Pins and Wires
• ASTM F543 Standard Specification and Test Methods for Metallic Medical Bone Screws
• ASTM F544 Reference Chart for Pictorial Cortical Bone Screw Classification (Withdrawn 1998)
• ASTM F67 Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700)
• ASTM F90 Standard Specification for Wrought Cobalt-20 Chromium-15 Tungsten-10 Nickel Alloy for Surgical Implant Applications (UNS R30605)

ASTM F1541-02(2015) history

• 2017 ASTM F1541-17 Standard Specification and Test Methods for External Skeletal Fixation Devices
• 2002 ASTM F1541-02(2015) Standard Specification and Test Methods for External Skeletal Fixation Devices
• 2002 ASTM F1541-02(2011)e1 Standard Specification and Test Methods for External Skeletal Fixation Devices
• 2002 ASTM F1541-02(2011) Standard Specification and Test Methods for External Skeletal Fixation Devices
• 2002 ASTM F1541-02(2007)e1 Standard Specification and Test Methods for External Skeletal Fixation Devices
• 2002 ASTM F1541-02(2007) Standard Specification and Test Methods for External Skeletal Fixation Devices
• 2002 ASTM F1541-02 Standard Specification and Test Methods for External Skeletal Fixation Devices
• 2001 ASTM F1541-01 Standard Specification and Test Methods for External Skeletal Fixation Devices
• 2000 ASTM F1541-00 Standard Specification and Test Methods for External Skeletal Fixation Devices
• 1999 ASTM F1541-99 Standard Specification and Test Methods for External Skeletal Fixation Devices