Influence Factor and Evaluation Discuss of IVD Medical Equipment Service Life.
10.3969/j.issn.1671-7104.2021.05.018
- Author:
Pengtao MOU
1
;
Ke ZHANG
1
;
Shuo JIANG
1
Author Information
1. Medical Electrical Equipment Inspection Department, Shandong Province Quality Inspection Center for Medical Devices, Ji'nan, 250101.
- Publication Type:Journal Article
- Keywords:
IVD medical equipment;
evaluation;
influence factor;
service life
- From:
Chinese Journal of Medical Instrumentation
2021;45(5):555-558
- CountryChina
- Language:Chinese
-
Abstract:
In order to help the IVD medical equipment manufacturers to establish the service life of products scientifically, we analyze the main factors that may affect the service life of IVD medical equipment in accordance with the guiding principles for technical review of active medical devices issued by the center of medical device evaluation of NMPA, and focuse on an evaluation method of accelerated fatigue test, in order to standardize and guide the IVD medical equipment manufacturers to evaluate and formulate the product service life scientifically.
