{"title":"Refining the qualification process for medical materials.","authors":"T W Brodhagen","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>This article examines the history of the use of silicone elastomers in medical devices and explains the importance of understanding a material's physical and chemical properties. Related issues of biocompatibility testing, materials biodurability, process controls, regulation, cost, FDA master files, and expedited approval also are addressed.</p>","PeriodicalId":80065,"journal":{"name":"Medical design and material","volume":"1 1","pages":"26-31"},"PeriodicalIF":0.0,"publicationDate":"1991-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21019950","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}