ASTM F1541-17
(Specification)Standard Specification and Test Methods for External Skeletal Fixation Devices
Standard Specification and Test Methods for External Skeletal Fixation Devices
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.
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.
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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.
Designation:F1541 −17
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 (´) indicates an editorial change since the last revision or reapproval.
1. Scope 1.3.7 Test Method for External Skeletal Fixator/Constructs
Subassemblies—Annex A7.
1.1 This specification provides a characterization of the
design and mechanical function of external skeletal fixation 1.4 A rationale is given in Appendix X1.
devices (ESFDs), test methods for characterization of ESFD
1.5 The values stated in SI units are to be regarded as
mechanical properties, and identifies needs for further devel-
standard. No other units of measurement are included in this
opment of test methods and performance criteria.The ultimate
standard.
goal is to develop a specification, which defines performance
1.6 Multiple test methods are included in this standard.
criteria and methods for measurement of performance-related
However, the user is not necessarily obligated to test using all
mechanicalcharacteristicsofESFDsandtheirfixationtobone.
of the described methods. Instead, the user should only select,
It is not the intention of this specification to define levels of
with justification, test methods that are appropriate for a
performance or case-specific clinical performance of the
particular device design. This may be only a subset of the
devices, as insufficient knowledge is available to predict the
herein described test methods
consequences of the use of any of these devices in individual
patients for specific activities of daily living. Furthermore, it is
1.7 The following safety hazards caveat pertains only to the
not the intention of this specification to describe or specify test method portions (Annex A2 – Annex A6):
specific designs for ESFDs.
1.8 This standard does not purport to address all of the
safety concerns, if any, associated with its use. It is the
1.2 This specification describes ESFDs for surgical fixation
of the skeletal system. It provides basic ESFD geometrical responsibility of the user of this standard to establish appro-
priate safety, health, and environmental practices and deter-
definitions, dimensions, classification, and terminology; mate-
rial specifications; performance definitions; test methods; and mine the applicability of regulatory limitations prior to use.
1.9 This international standard was developed in accor-
characteristics determined to be important to the in-vivo
performance of the device. dance with internationally recognized principles on standard-
ization established in the Decision on Principles for the
1.3 This specification includes a terminology and classifi-
Development of International Standards, Guides and Recom-
cationannexandfivestandardtestmethodannexesasfollows:
mendations issued by the World Trade Organization Technical
1.3.1 Classification of External Fixators—Annex A1.
Barriers to Trade (TBT) Committee.
1.3.2 Test Method for External Skeletal Fixator
Connectors—Annex A2.
2. Referenced Documents
1.3.3 Test Method for Determining In-Plane Compressive
2
2.1 ASTM Standards:
Properties of Circular Ring or Ring Segment Bridge
A938Test Method for Torsion Testing of Wire
Elements—Annex A3.
D790Test Methods for Flexural Properties of Unreinforced
1.3.4 Test Method for External Skeletal Fixator Joints—
and Reinforced Plastics and Electrical Insulating Materi-
Annex A4.
als
1.3.5 Test Method for External Skeletal Fixator Pin Anchor-
E4Practices for Force Verification of Testing Machines
age Elements—Annex A5.
F366Specification for Fixation Pins and Wires
1.3.6 Test Method for External Skeletal Fixator
F543Specification and Test Methods for Metallic Medical
Subassemblies—Annex A6.
Bone Screws
F544Reference Chart for Pictorial Cortical Bone Screw
1
This specification is under the jurisdiction of ASTM Committee F04 on
Medical and Surgical Materials and Devices and is the direct responsibility of
2
Subcommittee F04.21 on Osteosynthesis. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Current edition approved Sept. 1, 2017. Published September 2017. Originally contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
published as F1541 – 94. Last previous edition approved in 2015 as Standards volume information, refer to the standard’s Document Summary page on
F1541–02(2015). DOI: 10.1520/F1541-17. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO B
...
This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: F1541 − 02 (Reapproved 2015) F1541 − 17
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. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
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 safety, health, and healthenvironmental 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
2
2.1 ASTM Standards:
A938 Test Method for Torsion Testing of Wire
1
This specification is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.21 on Osteosynthesis.
Current edition approved Sept. 1, 2015Sept. 1, 2017. Published October 2015September 2017. Originally published as F1541 – 94. Last previous edition approved in
ε1
20112015 as F1541 – 02 (2011)(2015). . DOI: 10.1520/F1541-02R15.10.1520/F1541-17.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
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