[医用电子直线加速器生产风险分析及现场检查要点]。

Q4 Medicine

中国医疗器械杂志 Pub Date : 2024-03-30 DOI:10.12455/j.issn.1671-7104.230405

Yiqiang Yang

{"title":"[医用电子直线加速器生产风险分析及现场检查要点]。","authors":"Yiqiang Yang","doi":"10.12455/j.issn.1671-7104.230405","DOIUrl":null,"url":null,"abstract":"The medical electron linear accelerator（LINAC） has the characteristics of complex system structure, many core components and high precision control requirements, which puts forward higher requirements for product quality control and regulation. This study puts forward the main points of field inspection through the analysis of the technical characteristics and production risk of LINAC, combined with the requirements of the good manufacturing practice of medical devices. It has certain reference significance for quality management personnel and field inspectors.","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"48 2","pages":"212-216"},"PeriodicalIF":0.0000,"publicationDate":"2024-03-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"[Production Risk Analysis and Key Points for Field Inspection of Medical Electron Linear Accelerator].\",\"authors\":\"Yiqiang Yang\",\"doi\":\"10.12455/j.issn.1671-7104.230405\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"The medical electron linear accelerator（LINAC） has the characteristics of complex system structure, many core components and high precision control requirements, which puts forward higher requirements for product quality control and regulation. This study puts forward the main points of field inspection through the analysis of the technical characteristics and production risk of LINAC, combined with the requirements of the good manufacturing practice of medical devices. It has certain reference significance for quality management personnel and field inspectors.\",\"PeriodicalId\":52535,\"journal\":{\"name\":\"中国医疗器械杂志\",\"volume\":\"48 2\",\"pages\":\"212-216\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2024-03-30\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"中国医疗器械杂志\",\"FirstCategoryId\":\"1087\",\"ListUrlMain\":\"https://doi.org/10.12455/j.issn.1671-7104.230405\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q4\",\"JCRName\":\"Medicine\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"中国医疗器械杂志","FirstCategoryId":"1087","ListUrlMain":"https://doi.org/10.12455/j.issn.1671-7104.230405","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"Medicine","Score":null,"Total":0}

引用次数: 0

摘要

医用电子直线加速器（LINAC）具有系统结构复杂、核心部件多、控制精度要求高等特点，对产品质量控制和监管提出了更高的要求。本研究通过分析 LINAC 的技术特点和生产风险，结合医疗器械良好生产规范的要求，提出了现场检验的要点。对质量管理人员和现场检验人员具有一定的参考意义。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

查看原文本刊更多论文

[Production Risk Analysis and Key Points for Field Inspection of Medical Electron Linear Accelerator].

The medical electron linear accelerator（LINAC） has the characteristics of complex system structure, many core components and high precision control requirements, which puts forward higher requirements for product quality control and regulation. This study puts forward the main points of field inspection through the analysis of the technical characteristics and production risk of LINAC, combined with the requirements of the good manufacturing practice of medical devices. It has certain reference significance for quality management personnel and field inspectors.

求助全文

通过发布文献求助，成功后即可免费获取论文全文。去求助

来源期刊

中国医疗器械杂志 Medicine-Medicine (all)

CiteScore

0.40

自引率

0.00%

发文量

8086

期刊介绍： Chinese Journal of Medical Instrumentation mainly reports on the development, progress, research and development, production, clinical application, management, and maintenance of medical devices and biomedical engineering. Its aim is to promote the exchange of information on medical devices and biomedical engineering in China and turn the journal into a high-quality academic journal that leads academic directions and advocates academic debates.