Research on Test Method of Active Medical Device Preset Service Life Evaluation
10.12455/j.issn.1671-7104.240046
- VernacularTitle:有源医疗器械预设使用期限评价试验方法研究
- Author:
Fei HE
1
;
Weiming WANG
Author Information
1. 上海市医疗器械检验研究院,上海市,201318;国家药品监督管理局医用电气设备重点实验室,上海市,201318;国家药品监督管理局呼吸麻醉设备重点实验室,上海市,201318
- Keywords:
active medical device;
preset service life;
accelerated test time;
service life evaluation
- From:
Chinese Journal of Medical Instrumentation
2024;48(5):586-590
- CountryChina
- Language:Chinese
-
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.
