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 Elastomers--Tension

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

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

F2083 Specification for Total Knee Prosthesis

Keywords

elastomer; finger; implant; Elastomeric materials/applications--specifications; Flexible surgical implant materials--specifications; Joint prostheses--specifications;

ICS Code

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

DOI: 10.1520/F1781-03R09

ASTM International is a member of CrossRef.

ASTM F1781