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ASTM F1781-03(2009)

(Specification)

Standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants

Standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants

ABSTRACT
This specification covers the biocompatibility and other performance requirements, and associated test methods for elastomeric flexible hinge finger total joint implants, used with and without metal grommets in the reconstruction of the metacarpophalangeal (MCP) and proximal interphalangeal (PIP) joints. This specification excludes those implants that do not have an across-the-joint elastomeric linkage, and is limited to implants made from one material in a single one-step molding procedure.
SCOPE
1.1 This specification covers elastomeric flexible hinge finger total joint implants, used with and without metal grommets in the reconstruction of the metacarpophalangeal (MCP) and proximal interphalangeal (PIP) joints.
1.2 This specification excludes those implants that do not have an across-the-joint elastomeric linkage. The specification is limited to implants made from one material in a single one-step molding procedure.
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

General Information

Status
Historical
Publication Date
31-Jan-2009
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

Relations

Replaces
ASTM F1781-03 - Standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants
Effective Date
01-Feb-2009

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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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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:F1781 −03(Reapproved 2009)
Standard Specification for
1
Elastomeric Flexible Hinge Finger Total Joint Implants
This standard is issued under the fixed designation F1781; 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 F981 Practice for Assessment of Compatibility of Biomate-
rials for Surgical Implants with Respect to Effect of
1.1 This specification covers elastomeric flexible hinge
Materials on Muscle and Bone
finger total joint implants, used with and without metal
F983 Practice for Permanent Marking of Orthopaedic Im-
grommets in the reconstruction of the metacarpophalangeal
plant Components
(MCP) and proximal interphalangeal (PIP) joints.
F2083 Specification for Knee Replacement Prosthesis
1.2 This specification excludes those implants that do not
F2042 GuideforSiliconeElastomers,Gels,andFoamsUsed
have an across-the-joint elastomeric linkage. The specification
in Medical Applications Part II—Crosslinking and Fabri-
is limited to implants made from one material in a single
cation
one-step molding procedure.
2.2 Government Standards:
1.3 The values stated in SI units are to be regarded as 21 CFR 820 Good Manufacturing Practices for Medical
3
standard. No other units of measurement are included in this Devices
standard. MIL STD 177A Rubber Products, Terms for Visible De-
3
fects
2. Referenced Documents
2.3 Other Standard:
2
EN 30993-1 Biological Evaluations of Medical Devices Part
2.1 ASTM Standards:
4
1: Guidance on Selection of Tests
D412 Test Methods forVulcanized Rubber andThermoplas-
tic Elastomers—Tension
3. Significance and Use
D624 Test Method for Tear Strength of Conventional Vul-
3.1 The prostheses described in this specification are in-
canized Rubber and Thermoplastic Elastomers
tended for use in the proximal interphalangeal (PIP) and
D813 TestMethodforRubberDeterioration—CrackGrowth
metacarpophalangeal (MCP) joints.
D1052 Test Method for Measuring Rubber Deterioration—
Cut Growth Using Ross Flexing Apparatus
4. Classification
D2240 Test Method for Rubber Property—Durometer Hard-
4.1 Constrained—A constrained joint prosthesis is used for
ness
F67 Specification for Unalloyed Titanium, for Surgical Im- joint replacement and prevents dislocation of the prosthesis in
more than one anatomical plane and consists of either a single,
plant Applications (UNS R50250, UNS R50400, UNS
R50550, UNS R50700) flexible, across-the-joint component, or more than one compo-
nent linked together or affined.
F86 Practice for Surface Preparation and Marking of Metal-
lic Surgical Implants
5. Materials and Manufacture
F601 Practice for Fluorescent Penetrant Inspection of Me-
tallic Surgical Implants
5.1 Proper material selection is necessary, but insufficient to
F748 PracticeforSelectingGenericBiologicalTestMethods ensuresuitablefunctioningofadevice.Alldevicesconforming
for Materials and Devices
to this specification shall be fabricated from materials with
adequate mechanical strength, durability and biocompatibility.
5.2 All elastomeric components shall conform to Guides
1
This specification is under the jurisdiction of ASTM Committee F04 on
F2083andF2042.Testandevaluationparametersthatcouldbe
Medical and Surgical Materials and Devicesand is the direct responsibility of
considered for the elastomeric implant materials are Guides
Subcommittee F04.22 on Arthroplasty.
Current edition approved Feb. 1, 2009. Published March 2009. Originally
approved in 1997. Last previous edition approved in 2003 as F1781 – 03. DOI:
3
10.1520/F1781-03R09. AvailablefromU.S.GovernmentPrintingOfficeSuperintendentofDocuments,
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or 732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401, http://
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM www.access.gpo.gov.
4
Standards volume information, refer to the standard’s Document Summary page on Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
the ASTM website. 4th Floor, New York, NY 10036, Error! Hyperlink reference not valid.>
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F1781−03 (2009)
F2083 and F2042, Practice F748, Test Methods D813, D1052, ing force or motion, or both, anticipated in clinical application
D2240, D412 and D624. Before implants can be manufactured during flexural testing.
from other materials, manufacturers must comply with 5.4.
6.4 Durometer—The hardness of elastomeric components
5.3 Titanium used as a mate
...

This document is not anASTM standard and is intended only to provide the user of anASTM 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:F1781–97 Designation: F 1781 – 03 (Reapproved 2009)
Standard Specification for
1
Elastomeric Flexible Hinge Finger Total Joint Implants
This standard is issued under the fixed designation F 1781; 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 covers elastomeric flexible hinge finger total joint implants, used with and without metal grommets in the
reconstruction of the metacarpophalangeal (MCP) and proximal interphalangeal (PIP) joints.
1.2 This specification excludes those implants that do not have an across-the-joint elastomeric linkage. The specification is
limited to implants made from one material in a single one-step molding procedure.
1.3The values stated in SI units are to be regarded as standard. The inch-pound units given in parentheses are for information
only.
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
2. Referenced Documents
2
2.1 ASTM Standards:
D 412 Test Methods forVulcanized Rubber andThermoplastic Rubbers andThermoplastic Elastomers—TensionTest Methods
for Vulcanized Rubber and Thermoplastic ElastomersTension
D 624 Test Method for Tear Strength of Conventional Vulcanized Rubber and Thermoplastic Elastomers
2
D 813 Test Method for Rubber-Deterioration—Crack Growth Test Method for Rubber DeteriorationCrack Growth
D 1052 Test Method for Measuring Rubber Deterioration—Cut Growth Using Ross Flexing Apparatus
D 2240 Test Method for Rubber Property—Durometer Hardness
F67 Specification for an Unalloyed Titanium for Surgical Implant Application Specification for Unalloyed Titanium, for
Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700)
F86 Practice for Surface Preparation and Marking of Metallic Surgical Implants
3
F 601 Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants
F604Specification for Silicone Elastomers Used in Medical Applications Practice for Fluorescent Penetrant Inspection of
Metallic Surgical Implants
F 748 Practice for Selecting Generic Biological Test Methods for Materials and Devices
F 981 Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on
Muscle and Bone
3
F 983 Practice for Permanent Marking of Orthopaedic Implant Components Practice for Permanent Marking of Orthopaedic
Implant Components
F 2083 Specification for Total Knee Prosthesis
F 2042 Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part IICrosslinking and Fabrication
2.2 Government Standards:
3
21CFR Part CFR 820 Good Manufacturing Practices for Medical Devices
3
MIL STD 177A Rubber Products, Terms for Visible Defects
2.3 Other Standard:
1
This specification is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Material and Devices and is the direct responsibility of Subcommittee
F04.22 on Arthroplasty.
Current edition approved February 10, 1997. Published June 1997.
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 Feb. 1, 2009. Published March 2009. Originally approved in 1997. Last previous edition approved in 2003 as F 1781 – 03.
2
Annual Book of ASTM Standards, Vol 09.01.
2
ForreferencedASTMstandards,visittheASTMwebsite,www.astm.org,orcontactASTMCustomerServiceatservice@astm.org.ForAnnualBookofASTMStandards
volume information, refer to the standard’s Document Summary page on the ASTM website.
3
Annual Book of ASTM Standards, Vol 13.01.
3
Available from U.S. Government Printing Office Superintendent of Documents, 732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401, http://
www.access.gpo.gov.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1

---------------------- Page: 1 ----------------------
F 1781 – 03 (2009)
4
EN 30993-1 Biological Evaluations of Medical Devices Part 1: Guidance on Selection of Tests
3. Significance and Use
3.1 The prostheses described in this specification are intended for use in the proximal interphalangeal (PIP) and metacarpopha-
langeal (MCP) joints.
4. Classification
4.1 Constrained—Aconstrained j
...

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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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