医疗器械能力验证计划的设计  

Schematic design of medical devices proficiency testing program

作　　者：卢大伟[1] 杨昭鹏[1] 孙雪[1] 

机构地区：[1]中国食品药品检定研究院,北京100050

出　　处：《北京生物医学工程》2017年第3期298-302,共5页Beijing Biomedical Engineering

摘　　要：目的能力验证计划的设计是能力验证项目最为重要的一环,规范可行的设计能够保证能力验证活动达到预期的目的和效果。本文针对能力验证计划设计的各个要素进行分析,从而对设计环节进行规范和指导。方法结合中国食品药品检定研究院2006—2015年组织实施的医疗器械能力验证项目,对能力验证项目设计的团队组成及限定条件、被测量的量值或特征信息、样品稳定性和均匀性检验方法等相关要素逐一进行阐述和分析。结果对能力验证计划设计所涉及的检验及评价方法给出了可行性的建议,并对能力验证计划设计的规范化提供了参考方案。结论此能力验证计划的设计思路及方案对指导能力验证计划的设计具有重要意义。Objective Schematic design is the most important part of proficiency testing program. The feasible design can ensure proficiency testing program to achieve the desired effect. In order to regulate and guide the design of the program,we analyze the various elements of proficiency testing program design. Methods Taking into account of the medical device proficiency testing program during 2006 to 2015 in National Institutes for Food and Drug Control,we described and analyzed the important factors of schematic design,including team composition and qualification,measured value or characteristic information,stability test and homogeneity test. Results Feasible guidance of the test and evaluation methods were provided,and the standardization of the design was also included. Conclusions The schematic design has important practical significance for the testing program.

关 键 词：医疗器械 能力验证 设计 质量管理 实验室间比对 

分 类 号：R318[医药卫生—生物医学工程] TH77[医药卫生—基础医学]