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.
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.
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