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ASTM F1541-02(2015)

(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 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
31-Aug-2015
ICS
11.040.40 - Implants for surgery, prosthetics and orthotics
Technical Committee
F04 - Medical and Surgical Materials and Devices
Drafting Committee
F04.21 - Osteosynthesis
Current Stage
Ref Project

Relations

Replaces
ASTM F1541-02(2011)e1 - Standard Specification and Test Methods for External Skeletal Fixation Devices
Effective Date
01-Sep-2015
Replaced By
ASTM F1541-17 - Standard Specification and Test Methods for External Skeletal Fixation Devices
Effective Date
01-Sep-2017

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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:F1541 −02 (Reapproved 2015)
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 The following safety hazards caveat pertains only to the
criteria and methods for measurement of performance-related
test method portions (Annex A2 – Annex A6):
mechanicalcharacteristicsofESFDsandtheirfixationtobone.
It is not the intention of this specification to define levels of 1.7 This standard does not purport to address all of the
safety concerns, if any, associated with its use. It is the
performance or case-specific clinical performance of the
devices, as insufficient knowledge is available to predict the responsibility of the user of this standard to establish appro-
priate safety and health practices and determine the applica-
consequences of the use of any of these devices in individual
patients for specific activities of daily living. Furthermore, it is bility of regulatory limitations prior to use.
not the intention of this specification to describe or specify
specific designs for ESFDs. 2. Referenced Documents
2
2.1 ASTM Standards:
1.2 This specification describes ESFDs for surgical fixation
of the skeletal system. It provides basic ESFD geometrical A938Test Method for Torsion Testing of Wire
D790Test Methods for Flexural Properties of Unreinforced
definitions, dimensions, classification, and terminology; mate-
rial specifications; performance definitions; test methods; and and Reinforced Plastics and Electrical Insulating Materi-
als
characteristics determined to be important to the in-vivo
performance of the device. E4Practices for Force Verification of Testing Machines
F67Specification for Unalloyed Titanium, for Surgical Im-
1.3 This specification includes a terminology and classifi-
plant Applications (UNS R50250, UNS R50400, UNS
cationannexandfivestandardtestmethodannexesasfollows:
R50550, UNS R50700)
1.3.1 Classification of External Fixators—Annex A1.
F90 Specification for Wrought Cobalt-20Chromium-
1.3.2 Test Method for External Skeletal Fixator
15Tungsten-10NickelAlloy for Surgical ImplantApplica-
Connectors—Annex A2.
tions (UNS R30605)
1.3.3 Test Method for Determining In-Plane Compressive
F136 Specification for Wrought Titanium-6Aluminum-
Properties of Circular Ring or Ring Segment Bridge
4VanadiumELI(ExtraLowInterstitial)AlloyforSurgical
Elements—Annex A3.
Implant Applications (UNS R56401)
1.3.4 Test Method for External Skeletal Fixator Joints—
F138 Specification for Wrought 18Chromium-14Nickel-
Annex A4.
2.5MolybdenumStainlessSteelBarandWireforSurgical
1.3.5 Test Method for External Skeletal Fixator Pin Anchor-
Implants (UNS S31673)
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, 2015. Published October 2015. Originally contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
published as F1541–94. Last previous edition approved in 2011 as F1541–02 Standards volume information, refer to the standard’s Document Summary page on
ε1
(2011) . DOI: 10.1520/F1541-02R15. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F1541−02 (2015)
3
Classification (Withdrawn 1998) 6.2.1 The sites of junction between ESFD anchorage ele-
F1058Specification for Wrought 40Cobalt-20Chromium- ments (for example, pins) and bridge e
...

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.
´1
Designation: F1541 − 02 (Reapproved 2011) F1541 − 02 (Reapproved 2015)
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
ε NOTE—Editorial changes were made throughout in July 2012.
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 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.
2. Referenced Documents
2
2.1 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
F67 Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS
R50700)
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 Oct. 1, 2011Sept. 1, 2015. Published October 2011October 2015. Originally published as F1541 – 94. Last previous edition approved in 20072011
ε1
as F1541 – 02 (2007)(2011) . DOI: 10.1520/F1541-02R11E01.10.1520/F1541-02R15.
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

---------------------- Page: 1 ----------------------
F1541 − 02 (2015)
F90 Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applications (UNS
R30605)
F136 Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant
Applications (UNS R56401)
F138 Specificat
...

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1.4 Force control is defined as the mode of control of the test machine that accepts a force level as the set point input and which utilizes a force feedback signal in a control loop to achieve that set point input. For knee simulation, the flexion motion is placed under angular displacement control, internal and external rotation is placed under torque control, and axial load, anterior-posterior shear, and medial-lateral shear are placed under force control.  
1.5 This document establishes kinetic and kinematic test conditions for several activities of daily living, including walking, turning navigational movements, stair climbing, stair descent, and squatting. The kinetic and kinematic test conditions are expressed as reference waveforms used to drive the relevant simulator machine actuators. These waveforms represent motion, as in the case of flexion extension, or kinetic signals representing the forces and moments resulting from body dynamics, gravitation, and the active musculature acting across the knee.  
1.6 This document does not address the assessment or measurement of damage modes, or wear or failure of the prosthetic device.  
1.7 This document is a guide. As defined by ASTM in their “Form and Style for ASTM Standards” book in section C15.2, “A standard guide is a compendium of information or series of options that does not recommend a specific course of action. Guides are intended ...

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ASTM
ASTM F3047M-23(Guide)
Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-Hard Articulations

SIGNIFICANCE AND USE
5.1 The current hip simulator wear test standards (ISO 14242-1 or ISO 14242-3) stipulate only one load waveform and one set of articulation motions. There is a need for more versatile and rigorous wear test regimes, but the knowledge of what represents realistic high demand wear test features is limited. More research is clearly needed before a standard that defines what a representative high demand wear test should include can be written. The objective of this guide is to advise researchers on the possible high demand wear test features that should be included in evaluation of hard-on-hard articulations.  
5.2 This guide makes suggestions of what high demand test features may need to be added to an overall high demand wear test regime. The features described here are not meant to be all inclusive. Based on current knowledge they appear to be relevant to adverse conditions that can occur in clinical use.  
5.3 All the test features, both conventional and high demand, could have interactive effects on the wear of the components.
SCOPE
1.1 The objective of this guide is to advise researchers on the possible high demand wear test features that should be included in evaluation of hard-on-hard articulations. This guide makes suggestions for high demand test features that may need to be added to an overall wear test regime. Device articulating components manufactured from other metallic alloys, ceramics, or with coated or elementally modified surfaces without significant clinical use could possibly be evaluated with this guide. However, such materials may include risks and failure mechanisms that are not addressed in this guide.  
1.2 Hard-on-hard hip bearing systems include metal-on-metal (for example, Specifications F75, F799, and F1537; ISO 5832-4, ISO 5832-12), ceramic-on-ceramic (for example, ISO 6474-1, ISO 6474-2, ISO 13356), ceramic-on-metal, or any other bearing systems where both the head and cup components have high surface hardness. An argument has been made that the hard-on-hard THR articulation may be better for younger, more active patients. These younger patients may be more physically fit and expect to be able to perform more energetic activities. Consequently, new designs of hard-on-hard THR articulations may have some implantations subjected to more demanding and longer wear performance requirements.  
1.3 Total Hip Replacement (THR) with metal-on-metal articulations have been used clinically for more than 50 years (1, 2).2 Early designs had mixed clinical results. Eventually they were eclipsed by THR systems using metal-on-polyethylene articulations. In the 1990s the metal-on-metal articulation again became popular with more modern designs (3), including surface replacement.  
1.4 In the 1970s the first ceramic-on-ceramic THR articulations were used. In general, the early results were not satisfactory (4, 5). Improvement in alumina, and new designs in the 1990s improved the results for ceramic-on-ceramic articulations (6).  
1.5 The values stated in SI units are to be regarded as the standard.  
1.6 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.  
1.7 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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ASTM
ASTM F543-23(Specification)
Standard Specification and Test Methods for Metallic Medical Bone Screws

ABSTRACT
This specification provides requirements for materials, finish and marking, care and handling, and the acceptable dimensions and tolerances for metallic bone screws that are implanted into bone. There are a large variety of medical bone screws currently in use, the following type of screws are used: type HA - spherical undersurface of head, shallow, asymmetrical buttress thread, and deep screw head, type HB - spherical undersurface of head, deep, asymmetrical buttress thread, and shallow screw head, type HC - conical undersurface of head, symmetrical thread, and type HD - conical undersurface of head, symmetrical thread. The torsional strength, breaking angle, axial pullout strength, insertion torque, self-tapping force, and removal torque shall be tested to meet the requirements prescribed.
SIGNIFICANCE AND USE
A1.1 Significance and Use
A1.1.1 This test method is used to measure the torsional yield strength, maximum torque, and breaking angle of the bone screw under standard conditions. The results obtained in this test method are not intended to predict the torque encountered while inserting or removing a bone screw in human or animal bone. This test method is intended only to measure the uniformity of the product tested or to compare the mechanical properties of different, yet similarly sized, products.
SCOPE
1.1 This specification provides requirements for materials, finish and marking, care and handling, and the acceptable dimensions and tolerances for metallic bone screws that are implanted into bone. The dimensions and tolerances in this specification are applicable only to metallic bone screws described in this specification.  
1.2 This specification provides performance considerations and standard test methods for measuring mechanical properties in torsion of metallic bone screws that are implanted into bone. These test methods may also be applicable to other screws besides those whose dimensions and tolerances are specified here. The following annexes are included:  
1.2.1 Annex A1—Test Method for Determining the Torsional Properties of Metallic Bone Screws.  
1.2.2 Annex A2—Test Method for Driving Torque of Medical Bone Screws.  
1.2.3 Annex A3—Test Method for Determining the Axial Pullout Load of Medical Bone Screws.  
1.2.4 Annex A4—Test Method for Determining the Self-Tapping Performance of Self-Tapping Medical Bone Screws.  
1.2.5 Annex A5—Specifications for Type HA and Type HB Metallic Bone Screws.  
1.2.6 Annex A6—Specifications for Type HC and Type HD Metallic Bone Screws.  
1.2.7 Annex A7—Specifications for Metallic Bone Screw Drive Connections.  
1.3 This specification is based, in part, upon ISO 5835, ISO 6475, and ISO 9268.  
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.5 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 only be a subset of the herein described test methods.  
1.6 This standard may involve the use of hazardous materials, operations, and equipment. 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.  
1.7 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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