1.1 本规范涵盖了用于重建掌指关节（MCP）和近端指间关节（PIP）的弹性柔性铰链手指全关节植入物，该植入物配有或不配有金属套圈。 1.2 本规范不包括没有跨关节弹性连接的植入物。本规范仅限于在一次一步成型过程中由一种材料制成的植入物。 1.3 以国际单位制表示的数值应视为标准值。本标准不包括其他计量单位。 1.4 本国际标准是根据世界贸易组织技术性贸易壁垒（TBT）委员会发布的《关于制定国际标准、指南和建议的原则的决定》中确立的国际公认标准化原则制定的。

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.