T/CSBM 0014-2021 Active

Main Technical Content: 1. General Requirements: 1.1 Instrumentation Equipment: 1.1.1 The test system should be able to set pressure (pressure difference), frequency, test temperature, and cycle count. If other parameters need to be monitored, explain the basis for using this method. 1.1.2 Pressure Control System: A pressure sensing system capable of accurately measuring pressure near the device at the test frequency should be selected. The pressure measurement system must be calibrated and validated (traceable). 1.1.3 Cycle Count System: The instrumentation should include a cycle count system to measure the number of loading cycles of the heart valve during the test. 1.1.4 Temperature Control System: A temperature control and measurement system that has been calibrated and validated should be included to provide a constant test environment temperature for the heart valve. 1.1.5 Displacement Size Measurement Device: The heart valve should be monitored for displacement during the test, and a device capable of monitoring displacement size, such as an optical assisting device or high-speed camera, should be included. 1.2 Data Sources for Set Parameters: 1.2.1 The movement form and actual clinical use environment of the heart valve can be obtained through the following methods, and the basis should be explained if necessary. 1.2.2 According to clinical literature, if clinical literature is referenced, the source should be indicated. 1.2.3 Clinical data requirements include but are not limited to: a) The collected samples should meet statistical significance; b) The sampling period should be greater than 10 cardiac cycles; c) The measurement data source should consider the bias introduced by measurement angles and positions. 1.3 Test Fixtures: 1.3.1 The heart valve should be fixed in a loading fixture similar to the clinical intended use environment. The fixture should be made of materials with elasticity similar to the tissue at