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ASTM F1781-03

(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. The inch-pound units given in parentheses are for information only.

General Information

Status
Historical
Publication Date
31-Oct-2003
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 F1781-97 - Standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants
Effective Date
01-Nov-2003
Replaced By
ASTM F1781-03(2009) - Standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants
Effective Date
01-Feb-2009

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ASTM F1781-03 - Standard Specification for Elastomeric Flexible Hinge Finger Total Joint ImplantsASTM F1781-03 - Standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants
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ASTM F1781-03 - Standard Specification for Elastomeric Flexible Hinge Finger Total Joint 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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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: F 1781 – 03
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 (e) indicates an editorial change since the last revision or reapproval.
1. Scope terials for Surgical Implants with Respect to Effect of
Materials on Muscle and Bone
1.1 This specification covers elastomeric flexible hinge
F 983 Practice for Permanent Marking of Orthopaedic Im-
finger total joint implants, used with and without metal
plant Components
grommets in the reconstruction of the metacarpophalangeal
F 2038 Guide for Silicone Elastomers, Gels and Foams
(MCP) and proximal interphalangeal (PIP) joints.
Used in Medical Applications, Part I—Formulations and
1.2 This specification excludes those implants that do not
Uncured Materials
have an across-the-joint elastomeric linkage. The specification
F 2042 Guide for Silicone Elastomers, Gels and Foams
is limited to implants made from one material in a single
Used in Medical Applications, Part II—Crosslinking and
one-step molding procedure.
Fabrication
1.3 The values stated in SI units are to be regarded as
2.2 Government Standards:
standard. The inch-pound units given in parentheses are for
21 CFR Part 820 Good Manufacturing Practices for Medi-
information only.
3
cal Devices
2. Referenced Documents MIL STD 177A Rubber Products, Terms for Visible De-
3
2
fects
2.1 ASTM Standards:
2.3 Other Standard:
D 412 Test Methods for Vulcanized Rubber and Thermo-
EN 30993-1 Biological Evaluations of Medical Devices
plastic Rubbers and Thermoplastic Elastomers—Tension
4
Part 1: Guidance on Selection of Tests
D 624 Test Method for Tear Strength of Conventional
Vulcanized Rubber and Thermoplastic Elastomers
3. Significance and Use
D 813 Test Method for Rubber-Deterioration—Crack
3.1 The prostheses described in this specification are in-
Growth
tended for use in the proximal interphalangeal (PIP) and
D 1052 Test Method for Measuring Rubber Deterioration—
metacarpophalangeal (MCP) joints.
Cut Growth Using Ross Flexing Apparatus
D 2240 Test Method for Rubber Property—Durometer
4. Classification
Hardness
4.1 Constrained—A constrained joint prosthesis is used for
F 67 Specification for Unalloyed Titanium for Surgical
joint replacement and prevents dislocation of the prosthesis in
Implant Applications (UNS R50250, R50400, R50550,
more than one anatomical plane and consists of either a single,
R50700)
flexible, across-the-joint component, or more than one compo-
F 86 Practice for Surface Preparation and Marking of Me-
nent linked together or affixed.
tallic Surgical Implants
F 601 Practice for Fluorescent Penetrant Inspection of Me-
5. Materials and Manufacture
tallic Surgical Implants
5.1 Proper material selection is necessary, but insufficient to
F 748 Practice for Selecting Generic Biological Test Meth-
ensure suitable function of a device.All devices conforming to
ods for Materials and Devices
this specification shall be fabricated from materials with
F 981 Practice for Assessment of Compatibility of Bioma-
adequate mechanical strength, durability and biocompatibility.
5.2 All elastomeric components shall conform to Guides
F 2038 and F 2042. Test and evaluation parameters that could
1
This specification is under the jurisdiction of ASTM Committee F04 on
be considered for the elastomeric implant materials are Guides
Medical and Surgical Material and Devices and is the direct responsibility of
F 2038 and F 2042, Practice F 748, Test Methods D 813,
Subcommittee F04.22 on Arthroplasty.
Current edition approved Nov. 1, 2003. Published December 2003. Originally
approved in 1997. Last previous edition approved in 1997 as F 1781 – 97.
2 3
For referenced ASTM standards, visit the ASTM website, www.astm.org, or Available from Superintendent of Documents, U.S. Government Printing
contactASTM Customer Service at service@astm.org. ForAnnual Book ofASTM Office, Washington, DC 20402.
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.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1

---------------------- Page: 1 ----------------------
F1781–03
D 1052, D 2240, D 412 and D 624. Before implants can be 6.5 The mechanical properties (such as tensile strength,
manufactured from other materials, manufacturers must com- percentage elongation, modulus, and tear strength) of the
ply with 5.4. elastomeric materials used in components shal
...

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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.  
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4.2 This test guide may help characterize the magnitude and location of implant wear as an implant is repetitively moved according to specified load and displacement waveforms.  
4.3 This test guide may also help characterize the functional limitations of a total knee replacement as its motion is guided by these waveforms. These limitations may be observed as impingement, subluxation, or high loading in the soft tissue constraints, whether they are represented physically or virtually.  
4.4 The motions and load conditions in vivo will, in general, differ from the load and motions defined in this guide. The results obtained from this guide cannot be used to directly predict in vivo performance. However, this guide is designed to allow for comparisons in performance of different knee designs, when tested under similar conditions.
SCOPE
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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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SCOPE
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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.

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