国内外诊断产品标准化体系研究
[Research on the Standardization System of Diagnosis Products at Home and Abroad].
作者信息
Wang Jun, Zhang Hong, Dai Leiying, Wang Huiru, Lu Min
机构信息
Beijing Institute of Medical Device Testing, Beijing, 101111.
出版信息
Zhongguo Yi Liao Qi Xie Za Zhi. 2018 Sep 30;42(5):361-364. doi: 10.3969/j.issn.1671-7104.2018.05.014.
OBJECTIVE
The quality of diagnostic products is closely related to people's health. The standards and standardization system are essential to IVD industry and supervision.
METHODS
Through a study of the standards of ISO, EU, the USA and China, a comparative analysis was carried out.
RESULTS
China's IVD standardization system is different from other organization in terms of standard quantity, type and content. The standardization system has its own characteristics, and conforms to the current industrial characteristics and regulatory needs.
CONCLUSIONS
Some suggestions are put forward to provide references for strengthening supervision of IVD products.
目的
诊断产品质量与人们的健康密切相关。标准及标准化体系对体外诊断医疗器械行业及监管至关重要。
方法
通过研究国际标准化组织（ISO）、欧盟、美国及中国的标准，进行对比分析。
结果
中国体外诊断医疗器械标准化体系在标准数量、类型及内容方面与其他组织不同。该标准化体系有自身特点，符合当前行业特点及监管需求。
结论
提出了一些建议，为加强体外诊断医疗器械产品监管提供参考。
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