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ASTM F1357-14(2019)

(Specification)

Standard Specification for Articulating Total Wrist Implants

Standard Specification for Articulating Total Wrist Implants

ABSTRACT
This specification covers total wrist implants that provide articulation function through radial carpal components. However, this specification does not include implants with ceramic coated or porous coated surfaces, one-piece elastomeric implants, and those used for custom applications. Implants covered by this specification are of the constrained, partially constrained, or unconstrained joint prosthesis type. The implants shall be manufactured from biocompatible materials made of unalloyed titanium, cobalt-28chromium-6molybdenum alloy, wrought cobalt-20chromium-15tungsten-10nickel alloy, wrought titanium-6aluminum-4vanadium extra low interstitial alloy, wrought 35cobalt-35nickel-20chromium-10molybdenum alloy, wrought cobalt-20nickel-20chromium-3.5molybdenum-3.5tungsten-5iron alloy, cobalt-28chromium-6molybdenum alloy, titanium-6aluminum-4vanadium alloy, or wrought cobalt-28chromium-6molybdenum alloy with dimensions in conformity to the requirements specified. Tests for polymeric creep (cold flow), wear, and range of motion of the device as well as in vitro laboratory testing shall be performed and shall conform to the requirements specified. Per service requirement, metallic implants shall undergo fluorescent penetrant inspection, while cast metallic implants shall undergo radiography.
SCOPE
1.1 This specification describes total wrist implants, including solid ceramic implants, used to provide functioning articulation by employing radial and carpal components.  
1.2 This specification excludes those implants with ceramic-coated or porous-coated surfaces, one-piece elastomeric implants (with or without grommets), and those devices used for custom applications.  
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.4 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.  
1.5 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.

General Information

Status
Historical
Publication Date
14-Nov-2019
ICS
11.040.40 - Implants for surgery, prosthetics and orthotics
Technical Committee
F04 - Medical and Surgical Materials and Devices
Drafting Committee
F04.22 - Arthroplasty
Current Stage
Ref Project

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REDLINE ASTM F1357-14(2019) - Standard Specification for Articulating Total Wrist ImplantsREDLINE ASTM F1357-14(2019) - Standard Specification for Articulating Total Wrist Implants
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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: F1357 − 14 (Reapproved 2019)
Standard Specification for
1
Articulating Total Wrist Implants
This standard is issued under the fixed designation F1357; 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 F90 Specification for Wrought Cobalt-20Chromium-
15Tungsten-10Nickel Alloy for Surgical Implant Applica-
1.1 This specification describes total wrist implants, includ-
tions (UNS R30605)
ing solid ceramic implants, used to provide functioning articu-
F136 Specification for Wrought Titanium-6Aluminum-
lation by employing radial and carpal components.
4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical
1.2 This specification excludes those implants with ceramic-
Implant Applications (UNS R56401)
coated or porous-coated surfaces, one-piece elastomeric im-
F562 Specification for Wrought 35Cobalt-35Nickel-
plants (with or without grommets), and those devices used for
20Chromium-10Molybdenum Alloy for Surgical Implant
custom applications.
Applications (UNS R30035)
1.3 The values stated in SI units are to be regarded as
F563 Specification for Wrought Cobalt-20Nickel-
standard. No other units of measurement are included in this
20Chromium-3.5Molybdenum-3.5Tungsten-5Iron Alloy
standard.
for Surgical Implant Applications (UNS R30563) (With-
3
1.4 This standard does not purport to address all of the
drawn 2005)
safety concerns, if any, associated with its use. It is the
F601 Practice for Fluorescent Penetrant Inspection of Me-
responsibility of the user of this standard to establish appro-
tallic Surgical Implants
priate safety, health, and environmental practices and deter-
F603 Specification for High-Purity Dense Aluminum Oxide
mine the applicability of regulatory limitations prior to use.
for Medical Application
1.5 This international standard was developed in accor-
F629 Practice for Radiography of Cast Metallic Surgical
dance with internationally recognized principles on standard-
Implants
ization established in the Decision on Principles for the
F648 Specification for Ultra-High-Molecular-Weight Poly-
Development of International Standards, Guides and Recom-
ethylene Powder and Fabricated Form for Surgical Im-
mendations issued by the World Trade Organization Technical
plants
Barriers to Trade (TBT) Committee.
F746 Test Method for Pitting or Crevice Corrosion of
Metallic Surgical Implant Materials
2. Referenced Documents
F748 Practice for Selecting Generic Biological Test Methods
2
2.1 ASTM Standards:
for Materials and Devices
F67 Specification for Unalloyed Titanium, for Surgical Im-
F799 Specification for Cobalt-28 Chromium-6 Molybdenum
plant Applications (UNS R50250, UNS R50400, UNS
Alloy Forgings for Surgical Implants (UNS R31537,
R50550, UNS R50700)
R31538, R31539)
F75 Specification for Cobalt-28 Chromium-6 Molybdenum
F981 Practice for Assessment of Compatibility of Biomate-
Alloy Castings and Casting Alloy for Surgical Implants
rials for Surgical Implants with Respect to Effect of
(UNS R30075)
Materials on Muscle and Insertion into Bone
F86 Practice for Surface Preparation and Marking of Metal-
F983 Practice for Permanent Marking of Orthopaedic Im-
lic Surgical Implants
plant Components
F1108 Specification for Titanium-6Aluminum-4Vanadium
1 Alloy Castings for Surgical Implants (UNS R56406)
This specification is under the jurisdiction of ASTM Committee F04 on
Medical and Surgical Materials and Devices and is the direct responsibility of F1537 Specification for Wrought Cobalt-28Chromium-
Subcommittee F04.22 on Arthroplasty.
6Molybdenum Alloys for Surgical Implants (UNS
Current edition approved Nov. 15, 2019. Published December 2019. Originally
R31537, UNS R31538, and UNS R31539)
approved in 1991. Last previous edition approved in 2014 as F1357–14. DOI:
10.1520/F1357-14R19.
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
3
Standards volume information, refer to the standard’s Document Summary page on The last approved version of this historical standard is referenced on www.ast-
the ASTM website. m.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F1357 − 14 (2019)
2.2 ANSI/ASME Standard: shall be determined to exhibit corrosion resistance equal to or
ANSI/ASME B46.1 Surface Texture (Surface Roughness, better than one of the materials listed in 5.2 when tested in
4
Waviness, and Lay) accordance with Test Method F746.
3. Terminology 6. Performance Re
...

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: F1357 − 14 F1357 − 14 (Reapproved 2019)
Standard Specification for
1
Articulating Total Wrist Implants
This standard is issued under the fixed designation F1357; 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 describes total wrist implants, including solid ceramic implants, used to provide functioning articulation
by employing radial and carpal components.
1.2 This specification excludes those implants with ceramic-coated or porous-coated surfaces, one-piece elastomeric implants
(with or without grommets), and those devices used for custom applications.
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.4 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.
1.5 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:
F67 Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS
R50700)
F75 Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS
R30075)
F86 Practice for Surface Preparation and Marking of Metallic Surgical Implants
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)
F562 Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications
(UNS R30035)
F563 Specification for Wrought Cobalt-20Nickel-20Chromium-3.5Molybdenum-3.5Tungsten-5Iron Alloy for Surgical Implant
3
Applications (UNS R30563) (Withdrawn 2005)
F601 Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants
F603 Specification for High-Purity Dense Aluminum Oxide for Medical Application
F629 Practice for Radiography of Cast Metallic Surgical Implants
F648 Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
F746 Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials
F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices
F799 Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538,
R31539)
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
F04.22 on Arthroplasty.
Current edition approved Nov. 15, 2014Nov. 15, 2019. Published January 2015December 2019. Originally approved in 1991. Last previous edition approved in 20092014
as F1357 –09.–14. DOI: 10.1520/F1357-14.10.1520/F1357-14R19.
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.
3
The last approved version of this historical standard is referenced on www.astm.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F1357 − 14 (2019)
F981 Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on
Muscle and Insertion into Bone
F983 Practice for Permanent Marking of Orthopaedic Implant Components
F1108 Specification for Titanium-6Aluminum-4Vanadium Alloy Castings for Surgical Implants (UNS R56406)
F1537 Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS
R31538, and UNS R
...

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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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