输注器具铅镉含量能力验证  

Proficiency testing program lead and cadmium content in infusion apparatus

作　　者：卢大伟[1] 陈鸿波[1] 孙雪[1] 杨昭鹏[1] LU Dawei;CHEN Hongbo;SUN Xue;YANG Zhaopeng(National Institutes for Food and Drug Control, Beijing 102629)

机构地区：[1]中国食品药品检定研究院,北京102629

出　　处：《北京生物医学工程》2018年第3期311-314,共4页Beijing Biomedical Engineering

摘　　要：目的通过输注器具铅镉含量能力验证计划评价医疗器械检验机构,为提高实验室检测能力提供指导。方法依据CNAS-CL03:2010《能力验证提供者认可准则》策划并实施本次能力验证。采用模拟输注器具溶出液作为样品,根据随机原则发放给参加者,要求参加者按照作业指导书规定的步骤采用原子吸收分光光度法测定样品中铅镉含量。通过计算专家实验室公仪值获得指定值,计算上一轮次结果的散度作为能力评定标准差。结果全国共有30个省的58家实验室参加,其中39家结果满意,18家不满意,1家退出。通过结果分析参加者应在3个方面提高检验能力,一是设备核心部分加强维护保养,二是按照SOP进行试验操作,三是加强环境监控避免干扰。结论客观准确地评价了全国医疗器械检验机构铅镉含量项目的检验能力,发现并分析了问题,为实验室提高检验能力提供指导。Objective The content of lead cadmium in infusion apparatus is an important test item. This paper aims to improve the laboratory ＇s ability through the proficiency testing program of lead and cadmium content in Infusion apparatus. Methods According to CNAS-CL03： 2010 Accreditation Criteria for Proficiency Testing Providers,we made lead and cadmium solution as proficiency samples,and provided to every labs who had participated this proficiency testing. The expert laboratory value was the assigned value. The result of last turn was the standard deviation for proficiency. Results A total of 58 laboratories from 30 provinces nationwide participated in this proficiency testing program,including 39 laboratories with satisfactory results,and 18 laboratories unsatisfactory. Three problems were found,first was strengthen instrument maintenance, the second was conduct test operation according to SOP, the third was strengthen environmental control.Conclusions In this paper,the ability of labs in lead and cadmium content experiment is evaluated,and problems are found. This paper can guide the labs to improve the ability of lead and cadmium content in Infusion apparatus.

关 键 词：医疗器械 能力验证 质量管理 实验室间比对 

分 类 号：R318.04[医药卫生—生物医学工程]