摘要
目的:体外诊断系统给疾病正确诊断和治疗提供重要的信息,与生命健康息息相关,因此对体外诊断系统产品质量的监管必不可少,标准是监管的重要依据,完善的标准体系建设对科学管理体外诊断系统具有重要的意义。本文介绍了体外诊断系统标准现状,分析了体系化管理的必要性,提出了体系建设的建议。
Objective： in vitro diagnostic system can offer the significant information for the diagnoses and treatment of diseases.It is closely related to our life health. It is essential to supervise the product quality of in vitro diagnostic system which on the basis of standard. Perfecting the construction of standardization system is relevant to the scientific management of in vitro diagnostic system. In this paper, the status quo of in vitro diagnostic system standardization is introduced. As well as the necessity of systematism management is analyzed. There are also some suggestions about the construction of this system.
出处
《医疗装备》
2009年第7期12-16,共5页
Medical Equipment
关键词
体外诊断
标准体系
in vitro diagnosis
standardization system
