Research on medical equipments qualification auditing
10.3969/J.ISSN.1672-8270.2016.02.038
- VernacularTitle:医疗器械资质审核的要点及方法分析
- Author:
Xiao WANG
;
Jian ZHANG
;
Junxue WANG
- Publication Type:Journal Article
- Keywords:
Medical equipments;
Qualification documents;
Qualification auditing;
Risk management;
Quality control
- From:
China Medical Equipment
2016;(2):120-122
- CountryChina
- Language:Chinese
-
Abstract:
Objective:Based on the laws about medical equipments industry to analyze the basis, key points and methods of medical equipments qualification auditing.Methods: According to the present the qualification documents requirements, medical equipment category were divided into 3 types (categoryⅠ, categoryⅡand categoryⅢ)by risk degree with decreasing order. The qualification and key point of disinfection supplies and each kind of equipment (including in vitro diagnostic reagents) were explained.Results: The main work of medical equipments qualification auditing were confirmed.Conclusion: It is important way to guarantee the safety of clinical diagnosis and treatment through we strengthen the auditing of medical equipments and the qualification documents of suppliers.
