{"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":"<p><p>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.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":null,"pages":null},"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}
引用次数: 0
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.
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