ASTM F1781-97

Standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants

STANDARD published on 1.1.1997

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The information about the standard:

Designation standards: ASTM F1781-97
Note: WITHDRAWN
Publication date standards: 1.1.1997
SKU: NS-51502
The number of pages: 5
Approximate weight : 15 g (0.03 lbs)
Country: American technical standard
Category: Technical standards ASTM

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Annotation of standard text ASTM F1781-97 :

Keywords:

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

Additional information

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

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	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
F983-86(2018)	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
F748-16	Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
F601-23	Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants
F67-13(2017)	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(2019)	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(2019)	Standard Test Method for Measuring Rubber Deterioration´Cut Growth Using Ross Flexing Apparatus
21 CFR 820	Good Manufacturing Practices for Medical Devices

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