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ASTM F1541-02

(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--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 the standard.
1.6 The following safety hazards caveat pertains only to the test method portions (Annex A2-Annex A6):
1.7 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
09-Apr-2002
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 F1541-01 - Standard Specification and Test Methods for External Skeletal Fixation Devices
Effective Date
10-Apr-2002
Replaced By
ASTM F1541-02(2007) - Standard Specification and Test Methods for External Skeletal Fixation Devices
Effective Date
15-Jun-2007

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

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn. Please
contact ASTM International (www.astm.org) for the latest information.
Designation: F 1541 – 02
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
2.1 ASTM Standards:
consequences of the use of any of these devices in individual
2
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
and Reinforced Plastics and Electrical Insulating Materi-
specific designs for ESFDs.
3
als
1.2 This specification describes ESFDs for surgical fixation
4
E4 Practices for Force Verification of Testing Machines
of the skeletal system. It provides basic ESFD geometrical
F67 Specification for Unalloyed Titanium (UNS R50250,
definitions, dimensions, classification, and terminology; mate-
R50400, R50550, R50700) for Surgical Implant Applica-
rial specifications; performance definitions; test methods; and
5
tions
characteristics determined to be important to the in-vivo
F 90 Specification for Wrought Cobalt-20Chromium-
performance of the device.
15Tungsten-10Nickel Alloy for Surgical Implant Applica-
1.3 This specification includes a terminology and classifi-
5
tions (R30605)
cationannexandfivestandardtestmethodannexesasfollows:
F 136 Specification for Wrought Titanium-6Aluminum-
1.3.1 Classification of External Fixators—Annex A1.
4Vanadium ELI (Extra Low Interstitial) Alloy (UNS
1.3.2 Test Method for External Skeletal Fixator
5
R56401) for Surgical Implant Applications
Connectors—Annex A2.
F138 Specification for Wrought 18Chromium-14Nickel-
1.3.3 Test Method for Determining In-Plane Compressive
2.5Molybdenum Stainless Steel Bar and Wire for Surgical
Properties of Circular Ring or Ring Segment Bridge
5
Implants (UNS S31673)
Elements—Annex A3.
5
F366 Specification for Fixation Pins and Wires
1.3.4 Test Method for External Skeletal Fixator Joints—
5
F543 Specification for Metallic Medical Bone Screws
Annex A4.
F544 Reference Chart for Pictorial Cortical Bone Screw
1.3.5 Test Method for External Skeletal Fixator Pin Anchor-
6
Classification
age Elements—Annex A5.
F1058 SpecificationforWroughtCobalt-Chromium-Nickel
1.3.6 Test Method for External Skeletal Fixator
Molybdenum-IronAlloy for Surgical ImplantApplications
Subassemblies—Annex A6.
5
(UNS R30003 and UNS R30008)
1.3.7 Test Method for External Skeletal Fixator/Constructs
F1264 Specification and Test Methods for Intramedullary
Subassemblies—Annex A7.
5
Fixation Devices
1 2
This specification is under the jurisdiction of ASTM Committee F04 on Annual Book of ASTM Standards, Vol 01.03.
3
Medical and Surgical Materials and Devices and is the direct responsibility of Annual Book of ASTM Standards, Vol 08.01.
4
Subcommittee F04.21 on Osteosynthesis. Annual Book of ASTM Standards, Vol 03.01.
5
Current edition approved Apr. 10, 2002. Published June 2002. Originally Annual Book of ASTM Standards, Vol 13.01.
6
published as F1541–94. Last previous edition F1541–010. Discontinued; see 1998 Annual Book of ASTM Standards, Vol 13.01.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1

---------------------- Page: 1 ----------------------
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1.5 The accuracy of the guide depends very much on the representative nature of the oil sample used. Certain oils can have different properties depending on their chemical contents at the moment a sample is taken.  
1.6 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.7 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.

  • Guide
    4 pages
    English language
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  • Guide
    4 pages
    English language
    sale 15% off