摘要
基于体外诊断试剂注册体系核查实践,系统分析校准品量值溯源的共性问题与风险。研究发现,企业在溯源过程中存在溯源研究资料不完整、溯源资料不一致及溯源资源缺失等核心问题,其根源与现行ISO 17511/GB/T 21415版标准中“测量程序完整性”“基质效应评估”等要求存在执行差距。结合国内GB/T 21415修订动态(2023年启动,拟替代2008版并衔接ISO 2020版),提出从规程文件细化、不确定度全要素分析、基质互换性验证三方面强化溯源控制,为提升校准品量值可靠性及注册申报合规性提供实践参考。
This paper is based on the verification practices of the in vitro diagnostic reagent registration system,systematically analyzing common issues and risks associated with traceability of calibrator values.The study found that companies face core problems such as incomplete traceability research documentation,inconsistent traceability data,and missing traceability resources during the traceability process.These issues stem from discrepancies in the implementation of requirements like“measurement procedure completeness”and“matrix effect assessment”in the current ISO 17511/GB/T 21415 standards.In light of the domestic GB/T 21415 revision dynamics(launched in 2023,intended to replace the 2008 version and align with the ISO 2020 version),this paper proposes strengthening traceability control through three aspects:refining procedural documents,conducting comprehensive uncertainty analysis,and verifying matrix interchangeability.This provides practical references for enhancing the reliability of calibrator values and compliance with registration applications.
作者
谢静
楚霜
刘永章
XIE Jing;CHU Shuang;LIU Yong-zhang(Shanghai Medical Device Cosmetics Evaluation and Verification Center,Shanghai 200010)
出处
《中国医疗器械信息》
2025年第15期5-8,共4页
China Medical Device Information
基金
2022年度中华人民共和国科学技术部项目(课题名称:全自动高通量液相悬浮芯片系统的研制,课题编号:2022YFC2406603)。
关键词
体外诊断试剂
校准品
量值溯源
体系核查
in vitro diagnostic reagents
calibrator
traceability
system inspection
