摘要
医疗器械生物学试验是评价其生物安全性的重要环节,良好的试验全程质量管理是保证试验结果真实、完整、可靠的有力保障。该文以医疗器械生物学试验为基础,将我国医疗器械检测机构中广泛采用的ISO/IEC 17025质量体系和GLP相比较,并从GLP的通用原则出发,阐述了参照GLP加强ISO/IEC 17025体系下医疗器械生物学试验质量管理的实施要点,为我国医疗器械检测机构的质量管理提供参考。
Biological tests of medical devices is an important part to evaluate its biological safety.Good quality management of the test is a powerful guarantee to ensure the authenticity,integrity and reliability of the test results.This paper is based on the biological tests of medical devices,compares GLP and ISO/IEC 17025 which is widely used in China medical device testing institutions,describes the implementation of the GLP reference points to strengthen the quality management of biological tests of medical devices under the ISO/IEC 17025 system,to provide reference for quality management of medical device testing institutions.
作者
向健
杨立峰
田胜慧
曹穗兰
颜林
XIANG Jian;YANG Lifeng;TIAN Shenghui;CAO Suilan;YAN Lin(Guangdong Medical Devices Quality Surveillance and Test Institute,Guangzhou,510080)
出处
《中国医疗器械杂志》
2018年第4期282-285,共4页
Chinese Journal of Medical Instrumentation
作者简介
向健,E-mail:465121388@qq.com。
