首页|新版本标准下的医疗器械遗传毒性试验变化分析

新版本标准下的医疗器械遗传毒性试验变化分析

Modifications to Medical Device Genetic Toxicity Testing Under the New Version Standard

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遗传毒性检验是医疗器械检验中保证安全性的重要组成部分.GB/T 16883.3-2019新版本的发布,对医疗器械的遗传毒性检测提出了更具体的要求.并且随着YY/T 0870一系列行标的更新,对实验内容也进行了调整.本文将着重介绍标准更新后对于医疗器械遗传毒性检验的影响,以期为医疗器械产品具体的遗传毒性检测提供参考.
A crucial component of safety assurance in the assessment of medical devices is the genetic toxicity test.More detailed guidelines for the identification of genetic toxicity in medical devices have been released with the introduction of GB/T 16883.3-2019.Additionally,the substance of the experiment has various requirements,as does YY/T 0870,a sequence of line mark updates.In order to provide guidance for particular genetic toxicity testing of medical devices,this study will concentrate on the effects of new standards on genetic toxicity testing of medical devices.

medical devicesgenetic toxicitystandard update

王蕊、韩倩倩、史建峰

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中国食品药品检定研究院 (北京 102629)

医疗器械 遗传毒性 标准更新

国家重点研发计划

2022YFC2409805

2024

中国医疗器械信息
中国医疗器械行业协会

中国医疗器械信息

影响因子:0.375
ISSN:1006-6586
年,卷(期):2024.30(13)
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