国内外体外诊断产品标准体系研究

Research on the Standardization System of In Vitro Diagnosis Products at Home and Abroad

摘要: 目的体外诊断产品质量与人民健康息息相关,完善的体外诊断产品标准体系,对促进行业规范、服务政府监管具有重要的作用。方法调研国际、欧盟、美国等标准化组织及其标准,与我国体外诊断标准进行比较分析。结果我国体外诊断标准体系在标准数量、标准类型和标准内容方面与国际有所不同,具有自身特点,并符合我国现阶段产业特点和监管需求。结论提出进一步完善我国体外诊断产品标准体系建设的建议,为加强体外诊断产品监管提供参考。

Abstract: Objective The quality of in vitro diagnostic products is closely related to people's health. The standards and standardization system are essential to IVD industry and supervision.Methods Through a study of the standards of ISO, EU, the USA and China, a comparative analysis was carried out.Results China's IVD standardization system is different from other organization in terms of standard quantity, type and content. The standardization system has its own characteristics, and conforms to the current industrial characteristics and regulatory needs.Conclusion Some suggestions are put forward to provide references for strengthening supervision of IVD products.