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A PROCESS OF ASCERTAINING RELIABILITY AND DETERMINING SAFE SERVICE LIFE OF HIGH RISK MEDICAL IMPLANTS LIKE ARTIFICIAL HEART VALVES USING AN ACCELERATED DURABILITY TESTING APPARATUS
A PROCESS OF ASCERTAINING RELIABILITY AND DETERMINING SAFE SERVICE LIFE OF HIGH RISK MEDICAL IMPLANTS LIKE ARTIFICIAL HEART VALVES USING AN ACCELERATED DURABILITY TESTING APPARATUS
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机译：使用加速的耐用性测试设备来确保像人工心脏瓣膜一样的高风险医疗植入物的可靠性并确定其服务寿命
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摘要
A physical process to determine and demonstrate the reliability of high risk implants by designing, setting and validation of accelerated durability testing system. Specifically, the invention relates to the safe service life estimation of the tilting disc heart valves or similar components using accelerated durability test system. The process comprising the steps of testing a first set of test valves for 400 million cycles at a cycling rate of 700 cycles per minutes, removing the valves from the acrylic test chamber periodically, cleaning the said valves by ultrasonic cleaning and degreasing the said valves and then dried, measuring the weight loss due to wear, wherein the process is repeated for every 40 million cycles till 400 million cycles and at the end of it the valves are removed from the test chamber and weighed when a second set of similar test valves are tested at a cycling rate of 175 cycles per minute, wherein the accelerated factor is determined by performing accelerated tests at minimum two higher stress levels of 700 cycles/minute and 175 cycles/minute to obtain a model from high stress level acceleration data to be used to estimate the wear at normal use conditions when the safe service life of each valve is determined based on the model developed from the test data generated by the said apparatus. Fig. 6.
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