T/CSBM 0011-2021 Active

Main Technical Content: 1. Samples and Reagents 1.1 Samples 1.1.1 Requirements: 1.1.1.1 The test samples should be fully processed and representative of the final product preparation process, including the same processing methods, process parameters, processing direction, and post-processing. The same structure should include the same surface quality and structure. 1.1.1.2 The test samples and the final product should undergo the same manufacturing, post-processing, cleaning, and sterilization processes. 1.1.1.3 If the finished device is suitable for ion dissolution testing, it should be used directly as the test sample. 1.1.2 Blank Control Setup A blank control group, i.e., an extraction medium without test materials, should be prepared. During extraction, it should be placed in the same container (or equipment) as the test materials and subjected to the same extraction conditions. 1.1.3 Test Samples Test samples can be implant products (e.g., bone screws, bone plates, implants, dental arch wires, etc.), or standard parts prepared under the same process conditions (when the implant size and extraction method are not easily matched). The principle is that under the set extraction conditions (e.g., in a specific dissolution device), they should be able to be stably fixed in the container or specific clamps without any extraction-induced visible random displacement. The sampling mass and added extraction medium ratio should comply with the relevant provisions of GB/T 16886.12. Note 1: The container can be a general container such as a centrifuge tube, or a special fixture customized for fixing medical devices according to specific needs. Note 2: Specialized equipment for evaluating the dissolution and release performance of medical device implant products is now available. If applicable, such equipment should be used for evaluating ion dissolution performance and the necessary working conditions should be clearly specified. 1.2 Reagents 1.2