Methods for determining expiration date of in vitro diagnostic medical device and significance for signing expiration date
10.7687/j.issn1003-8868.2017.07.122
- VernacularTitle:体外诊断医用设备使用期限的确方法及其意义
- Author:
Kun WU
1
Author Information
1. 国家食品药品监督管理总局医疗器械技术审评中心
- Keywords:
in vitro diagnostic medical device;
expiration date;
safety;
monitor;
risk management
- From:
Chinese Medical Equipment Journal
2017;38(7):122-124
- CountryChina
- Language:Chinese
-
Abstract:
Objective To explore the common methods for determining the expiration rate of the in vitro diagnostic medical device and the significance for signing the expiration date.Methods The methods for determining the expiration date were analyzed based on the features of the in vitro diagnostic medical device and Regulations for Medical Devices Registration and Management.Results The methods estimated the expiration date effectively,while the expiration date had to be monitored and calibrated in time according to risk management principle.Conclusion The safety and efficiency of the in vitro diagnostic medical device are enhanced by signing the expiration date in the technical manual and label.
