ASTM F1781-21 + Redline

ASTM F1781-21 + Redline

Standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants

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Details

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.


Rationale:

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.

Additional Info

Author American Society for Testing and Materials (ASTM International)
Committee F04.22 - Committee F04 on Medical and Surgical Materials and Devices
Published by ASTM
Document type Standard
Theme ,Implants for surgery, prothetics and orthotics
ICS 11.040.40 : Implants for surgery, prosthetics and orthotics
Number of pages 6
Replace ASTM F1781-15 + Redline
Set ASTM Volume 13.01 - Multi-User - Single-Site Online
Document history ,,,
Keyword F1781

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