T/CSBM 0016-2021 Active

Main Technical Content: **Technical Requirements:** 1. **Method Principle**: Test the nickel ion release from the device over time. Obtain the nickel ion release amount at different extraction times. The test will involve multiple extraction cycles of the same device. First, place the device in a suitable container filled with test solution and extract at a temperature range of (37 ± 1) °C. After reaching the specified time, remove all extracted solution and replace it with new solution to continue the extraction process, repeating this until all set extraction time points are completed. The nickel ion concentration in the test solution can be determined using a graphite furnace atomic absorption spectrometer (AAS), inductively coupled plasma emission spectrometer (ICP-OES), or inductively coupled plasma mass spectrometer (ICP-MS), or other appropriate analytical methods. The unit of nickel release at corresponding set time points is μg/cm2·day. All extracted solutions at all time points should be tested for nickel ion concentration as soon as possible. 2. **Reagents**: 2.1 **General Requirements**: Analytical-grade reagents, distilled water/deionized water, or water of equivalent purity should be used in the analysis. The use of other reagents should be justified. 2.2 **Diluted Nitric Acid**: Transfer 15 mL of nitric acid into a 500 mL beaker pre-filled with 100 mL of deionized water, stir and cool to room temperature. Transfer the solution into a 250 mL volumetric flask, dilute to the mark with deionized water, and mix well. 3. **Instrumentation**: 3.1 **Analytical Spectrometers**: The sensitivity of the analytical instrument should be μg/L or higher. Recommended instruments include a graphite furnace atomic absorption spectrometer (AAS), inductively coupled plasma emission spectrometer (ICP-OES), or inductively coupled plasma mass spectrometer (ICP-MS), or other appropriate analytical methods. 3.2 **Sterilization Method**: Use a high-tempe