YY/T 1507.1-2016 in English

This standard specifies a method for determining the content of titanium (Ti) elements in impurity elements of ultra-high molecular weight polyethylene powder used for surgical implants, using inductively coupled plasma mass spectrometry (ICP-MS). It outlines the applicable scope, the required reagents and materials, the preparation of samples, the analytical procedures, and the calculation methods for test results. The standard provides detailed guidance on the operating conditions of the instrument, the calibration of the equipment, and the quality control measures to ensure the accuracy and reliability of the test results. It is intended for use by relevant laboratories and personnel involved in the testing and analysis of materials used in medical devices to ensure compliance with safety and quality requirements.