Research on medical equipments qualification auditing / 中国医学装备

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.