有源医疗器械预设使用期限评价试验方法研究

      Research on Test Method of Active Medical Device Preset Service Life Evaluation

      • 摘要: 有源医疗器械在申请注册时,需提交产品使用期限的研究验证资料。该研究主要提出了如何通过可靠性试验的方法来验证和评价有源医疗器械预设的使用期限。首先介绍了产品使用期限的定义,然后阐述了如何进行试验样本量、试验应力类型及量级、常规试验时间、加速试验时间的确定,以及如何根据试验结果来评价有源医疗器械的使用期限。最后通过无创呼吸机使用期限评价实例进行说明。该研究提供了通过试验法验证评价有源医疗器械预设使用期限的整个闭环过程,为企业、监管机构等提供了科学合理、切实可行的较全面的试验评价方法,具有广泛的推广意义,有助于企业、检测机构等开展相关研究验证工作。

         

        Abstract: When applying for registration of an active medical device, it is necessary to submit research and verification data regarding the device's service life. This study primarily proposes how to verify and evaluate the preset service life of active medical devices through reliability testing. Initially, the definition of the product's service life is introduced. Subsequently, the determination of the test sample size, the type and magnitude of the test stress, the conventional test duration, the accelerated test duration, and the evaluation of the service life of the active medical device based on the test results are elucidated. Finally, an example of evaluating the service life of a non-invasive ventilator is provided for further illustration. This study offers a comprehensive closed-loop process for verifying and evaluating the preset service life of active medical devices using the test method, providing a scientific, reasonable, practical, and exhaustive test evaluation approach for enterprises and regulatory agencies. This has broad significance for universal dissemination and aids enterprises and testing institutions in conducting pertinent research and verification tasks.

         

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