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ASTM F1541-02(2007)

(Specification)

Standard Specification and Test Methods for External Skeletal Fixation Devices

Standard Specification and Test Methods for External Skeletal Fixation Devices

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.
1.3.2 Test Method for External Skeletal Fixator Connectors.
1.3.3 Test Method for Determining In-Plane Compressive Properties of Circular Ring or Ring Segment Bridge Elements.
1.3.4 Test Method for External Skeletal Fixator Joints.
1.3.5 Test Method for External Skeletal Fixator Pin Anchorage Elements.
1.3.6 Test Method for External Skeletal Fixator Subassemblies.
1.3.7 Test Method for External Skeletal Fixator/Constructs Subassemblies.
1.4 A rationale is given in Appendix X1.
1.5 The values stated in SI units are to be regarded as the standard.
1.6 The following safety hazards caveat pertains only to the test method portions (Annex A2 - Annex A6):
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.

General Information

Status
Historical
Publication Date
14-Jun-2007
ICS
11.120.20 - Wound dressings and compresses
Technical Committee
F04 - Medical and Surgical Materials and Devices
Drafting Committee
F04.21 - Osteosynthesis
Current Stage
Ref Project

Relations

Replaces
ASTM F1541-02 - Standard Specification and Test Methods for External Skeletal Fixation Devices
Effective Date
15-Jun-2007
Replaced By
ASTM F1541-02(2007)e1 - Standard Specification and Test Methods for External Skeletal Fixation Devices
Effective Date
15-Jun-2007

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ASTM F1541-02(2007) - Standard Specification and Test Methods for External Skeletal Fixation DevicesASTM F1541-02(2007) - Standard Specification and Test Methods for External Skeletal Fixation Devices
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ASTM F1541-02(2007) - Standard Specification and Test Methods for External Skeletal Fixation Devices
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Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: F 1541 – 02 (Reapproved 2007)
Standard Specification and Test Methods for
1
External Skeletal Fixation Devices
This standard is issued under the fixed designation F1541; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.A
superscript epsilon (e) indicates an editorial change since the last revision or reapproval.
1. Scope 1.4 A rationale is given in Appendix X1.
1.5 The values stated in SI units are to be regarded as the
1.1 This specification provides a characterization of the
standard.
design and mechanical function of external skeletal fixation
1.6 The following safety hazards caveat pertains only to the
devices (ESFDs), test methods for characterization of ESFD
test method portions (Annex A2-Annex A6):
mechanical properties, and identifies needs for further devel-
1.7 This standard does not purport to address all of the
opment of test methods and performance criteria.The ultimate
safety concerns, if any, associated with its use. It is the
goal is to develop a specification, which defines performance
responsibility of the user of this standard to establish appro-
criteria and methods for measurement of performance-related
priate safety and health practices and determine the applica-
mechanicalcharacteristicsofESFDsandtheirfixationtobone.
bility of regulatory limitations prior to use.
It is not the intention of this specification to define levels of
performance or case-specific clinical performance of the de-
2. Referenced Documents
vices, as insufficient knowledge is available to predict the
2
2.1 ASTM Standards:
consequences of the use of any of these devices in individual
A938 Test Method for Torsion Testing of Wire
patients for specific activities of daily living. Furthermore, it is
D790 TestMethodsforFlexuralPropertiesofUnreinforced
not the intention of this specification to describe or specify
andReinforcedPlasticsandElectricalInsulatingMaterials
specific designs for ESFDs.
E4 Practices for Force Verification of Testing Machines
1.2 This specification describes ESFDs for surgical fixation
F67 Specification for Unalloyed Titanium, for Surgical
of the skeletal system. It provides basic ESFD geometrical
Implant Applications (UNS R50250, UNS R50400, UNS
definitions, dimensions, classification, and terminology; mate-
R50550, UNS R50700)
rial specifications; performance definitions; test methods; and
F 90 Specification for Wrought Cobalt-20Chromium-
characteristics determined to be important to the in-vivo
15Tungsten-10Nickel Alloy for Surgical Implant Applica-
performance of the device.
tions (UNS R30605)
1.3 This specification includes a terminology and classifi-
F 136 Specification for Wrought Titanium-6Aluminum-
cationannexandfivestandardtestmethodannexesasfollows:
4Vanadium ELI (Extra Low Interstitial)Alloy for Surgical
1.3.1 Classification of External Fixators—Annex A1.
Implant Applications (UNS R56401)
1.3.2 Test Method for External Skeletal Fixator
F138 Specification for Wrought 18Chromium-14Nickel-
Connectors—Annex A2.
2.5Molybdenum Stainless Steel Bar and Wire for Surgical
1.3.3 Test Method for Determining In-Plane Compressive
Implants (UNS S31673)
Properties of Circular Ring or Ring Segment Bridge
F366 Specification for Fixation Pins and Wires
Elements—Annex A3.
F543 Specification and Test Methods for Metallic Medical
1.3.4 Test Method for External Skeletal Fixator Joints—
Bone Screws
Annex A4.
F544 Reference Chart for Pictorial Cortical Bone Screw
1.3.5 Test Method for External Skeletal Fixator Pin Anchor-
3
Classification
age Elements—Annex A5.
F1058 Specification for Wrought 40Cobalt-20Chromium-
1.3.6 Test Method for External Skeletal Fixator
16Iron-15Nickel-7Molybdenum Alloy Wire and Strip for
Subassemblies—Annex A6.
Surgical Implant Applications (UNS R30003 and UNS
1.3.7 Test Method for External Skeletal Fixator/Constructs
R30008)
Subassemblies—Annex A7.
1 2
This specification is under the jurisdiction of ASTM Committee F04 on For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Medical and Surgical Materials and Devices and is the direct responsibility of
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Subcommittee F04.21 on Osteosynthesis. Standards volume information, refer to the standard’s Document Summary page on
Current edition approved June 15, 2007. Published June 2007. Originally the ASTM website.
3
published as F1541–94. Last previous edition approved in 2002 as F1541–02. Withdrawn.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1

---------------------- Page: 1 ----------------------
F 1541 – 02 (2007)
F1264 Specification and Test Methods for Intramedullary adequacy of t
...

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