Xiang Jian, Yang Lifeng, Tian Shenghui, Cao Suilan, Yan Lin
Guangdong Medical Devices Quality Surveillance and Test Institute, Guangzhou, 510080.
Zhongguo Yi Liao Qi Xie Za Zhi. 2018 Jul 30;42(4):282-285. doi: 10.3969/j.issn.1671-7104.2018.04.015.
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.
