ASTM F1781-03(2009) - 1.2.2009
 
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

D412-16(2021)

Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension

MIL STD 177A

Rubber Products, Terms for Visible Defects

F86-21(2026)

Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants

F2042-18

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

F2038-18

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

F983-24

Standard Practice for Permanent Marking of Orthopaedic Implant Components

F981-23

Standard Practice for Assessment of Muscle and Bone Tissue Responses to Long-Term Implantable Materials Used in Medical Devices

F748-25

Standard Practice for Selecting Biological Test Methods for Materials and Devices

F601-23

Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants

F67-24

Standard Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700)

D624-00(2020)

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

D813-07(2025)

Standard Test Method for Rubber Deterioration—Crack Growth

ISO 10993-1

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

D2240-15(2021)

Standard Test Method for Rubber Property—Durometer Hardness

D1052-09(2026)

Standard Test Method for Measuring Rubber Deterioration—Cut Growth Using Ross Flexing Apparatus

21 CFR 820

Good Manufacturing Practices for Medical Devices