| 陈宇婷,陆珠儿,陈丹丹,李博.医疗器械监管中致癌性试验研究进展[J].中国药事,2023,(5):574-582 |
| 医疗器械监管中致癌性试验研究进展 |
| Research Progress in Carcinogenicity Test of Medical Device Supervision |
| 投稿时间：2022-02-12 |
| DOI：10.16153/j.1002-7777.2023.05.011 |
| 中文关键词: 医疗器械 致癌性试验 模型 医用材料 金属 |
| 英文关键词: medical device carcinogenicity test model medical materials metal |
| 基金项目:国家自然科学基金(编号 32130059) |
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| 摘要点击次数: 890 |
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| 中文摘要: |
| 目的：为完善我国医疗器械监管，提高医疗器械致癌性方面的研究水平提供一定参考。方法：通过查阅相关文献，介绍医疗器械的定义分类以及致癌性试验的有关模型，并且对现有医用材料致癌性试验进行论述。结果与结论：医疗器械监管中的致癌性试验是在对试验动物进行浸提液或植入物暴露试验后测定其致癌潜能的试验，根据试验结果初步估计产生不良影响的剂量指标，为建立人体暴露的安全标准提供参考依据。当前我国医疗器械相关的规范性文件有所欠缺，提高国产医疗器械的检测技术和相关标准，实现医疗器械风险性评价有助于完善监管体系，加快相关医疗器械产品进入市场。 |
| 英文摘要: |
| Objective: To provide certain reference for improving the medical device regulation and research level of medical device carcinogenicity. Methods: This review briefl y introduces the defi nition and classifi cation of medical devices and the relevant models of the carcinogenicity test, and discusses the carcinogenicity test of existing medical materials. Results and Conclusion: The carcinogenicity test of medical device supervision is to determine the carcinogenic potential of experimental animals after exposure tests to extracts or implants, to preliminarily estimate the dose index of adverse reactions according to the test results, and to provide a reference for establishing the safety standard of human exposure. At present, there is a lack of normative documents related to medical devices in our country. Improving the testing technology and related standards of domestic medical devices and realizing the risk assessment of medical devices will help improve the regulatory system and speed up the entry of related medical device products into the market. |
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