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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.
1.1 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. This 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.
1.4 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 (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
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 DeteriorationCrack Growth
D1052 Test Method for Measuring Rubber DeteriorationCut Growth Using Ross Flexing Apparatus
D2240 Test Method for Rubber PropertyDurometer 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 Insertion into Bone
F983 Practice for Permanent Marking of Orthopaedic Implant Components
F2038 Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part IFormulations and Uncured Materials
F2042 Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part IICrosslinking and Fabrication
F2503 Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
F2943 Guide for Presentation of End User Labeling Information for Musculoskeletal Implants
Government Standards21 CFR 820 21 CFR 888.6 Degree of Constraint MIL STD 177A Rubber Products, Terms for Visible Defects
ISO StandardISO 10993-1 Biological Evaluation of Medical DevicesPart 1: Evaluation and testing within a risk management process
ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)
UNSPSC Code 42322004(Finger joint implant)
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ASTM F1781-21, Standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants, ASTM International, West Conshohocken, PA, 2021, www.astm.orgBack to Top