YY/T 1430-2016 in English

本标准规定了通过小型盘状试样测定超高分子量聚乙烯力学性能的小冲孔试验方法。
本标准适用于：表征经柱塞挤出或模压成型后超高分子量聚乙烯（UHMWPE）外科手术材料的性能、评价辐射交联并灭菌后的同种工艺制造的植入物、对由人体回收（从体内取出）的相应植入物进行测试。

Scope

This standard determines the mechanical properties of ultra-high molecular weight polyethylene (UHMWPE) by conducting a small punch test on a small disk-shaped sample (thickness 0.5 mm, diameter 6.4 mm). This standard is suitable for characterizing the performance of UHMWPE surgical materials after plunger extrusion or molding. It is also suitable for evaluating implants made by the same process after radiation cross-linking and sterilization. It is also suitable for the evaluation of implants recycled from the human body ( removed from the body) for testing. The parameters of the small punch test, namely peak load, ultimate displacement, ultimate load and failure work, can provide a measure of the yield strength, ultimate strength, ductility and toughness of UHMWPE under multi-axial loading conditions. Since the mechanical properties of UHMWPE are different under uniaxial and multiaxial loading conditions, the small punch test supplements the mechanical testing technology of the uniaxial tensile test of medical grade UHMWPE in GB/T 19701.2. In addition to being a research tool for implant removal analysis, the small punch test can also be used in laboratory screening tests to evaluate new UH-MWPE materials, such as those irradiated by gamma or electron beam. This test method is also applicable to the performance characterization of UHMWPE materials before/after accelerated aging (such as ASTM F2003), and can specify the mechanical property degradation levels of different UHMWPE samples after oxidative aging. The small punch test can be used with other polymers, including polymethylmethacrylate (PMMA) bone cement, polyacetal, and high-density polyethylene (HDPE). However, polymer small punch testing of other non-UHMWPE materials is outside the scope of this standard test method. International units (SI) are used in this standard. This standard does not attempt to address all safety issues covered, even those relevant to its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and to clarify the applicability of regulatory limitations prior to application.