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    ASTM F1781 - 15

    Standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants

    Active Standard ASTM F1781 | Developed by Subcommittee: F04.22

    Book of Standards Volume: 13.01

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    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.

    This abstract is a brief summary of the referenced standard. It is informational only and not an official part of the standard; the full text of the standard itself must be referred to for its use and application. ASTM does not give any warranty express or implied or make any representation that the contents of this abstract are accurate, complete or up to date.

    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.

    1.3 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 (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.

    ASTM Standards

    D412 Test Methods for Vulcanized Rubber and Thermoplastic ElastomersTension

    D624 Test Method for Tear Strength of Conventional Vulcanized Rubber and Thermoplastic Elastomers

    D813 Test Method for Rubber Deterioration--Crack Growth

    D1052 Test Method for Measuring Rubber Deterioration--Cut Growth Using Ross Flexing Apparatus

    D2240 Test Method for Rubber Property--Durometer Hardness

    F67 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

    F601 Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants

    F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices

    F981 Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone

    F983 Practice for Permanent Marking of Orthopaedic Implant Components

    F2038 Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part I--Formulations and Uncured Materials

    F2042 Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II--Crosslinking and Fabrication

    Government Standards

    21 CFR 820 Good Manufacturing Practices for Medical Devices

    MIL STD 177A Rubber Products, Terms for Visible Defects

    ISO Standard

    ISO 10993-1 Biological Evaluations of Medical Devices -- Part 1: Evaluation and testing within a risk management process

    ICS Code

    ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)

    UNSPSC Code

    UNSPSC Code 42322004(Finger joint implant)

    Referencing This Standard
    Link Here
    Link to Active (This link will always route to the current Active version of the standard.)

    DOI: 10.1520/F1781-15

    Citation Format

    ASTM F1781-15, Standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants, ASTM International, West Conshohocken, PA, 2015, www.astm.org

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