{"title":"从伽玛射线到x射线辐射灭菌过程的变化。","authors":"Christiane Beerlage, Bjoern Wiese, Annemie Rehor Kausch, Milorad Arsenijevic","doi":"10.2345/0899-8205-55.s3.78","DOIUrl":null,"url":null,"abstract":"<p><p>The terminal sterilization of sterile orthopedic implants is a key process that, in addition to providing sterility, changes the material properties of the product and packaging. These changes might be observed during functionality testing and/or biological evaluation. We are establishing an additional sterilization process that appears promising from both a technical and business perspective. Our project aims to add X-ray sterilization to the established gamma sterilization for metallic hip and shoulder implants. To limit complexity, we started with a narrow product range. The main steps of our project journey are described here. Given that X-ray sterilization remains relatively new in terms of understanding the changes that might occur for product materials and functionality compared with changes observed following gamma radiation processing, this article highlights key steps in the change from gamma ray to X-ray sterilization.</p>","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":null,"pages":null},"PeriodicalIF":0.0000,"publicationDate":"2021-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8655705/pdf/i0899-8205-55-s3-78.pdf","citationCount":"3","resultStr":"{\"title\":\"Change in Radiation Sterilization Process from Gamma Ray to X-ray.\",\"authors\":\"Christiane Beerlage, Bjoern Wiese, Annemie Rehor Kausch, Milorad Arsenijevic\",\"doi\":\"10.2345/0899-8205-55.s3.78\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>The terminal sterilization of sterile orthopedic implants is a key process that, in addition to providing sterility, changes the material properties of the product and packaging. These changes might be observed during functionality testing and/or biological evaluation. We are establishing an additional sterilization process that appears promising from both a technical and business perspective. Our project aims to add X-ray sterilization to the established gamma sterilization for metallic hip and shoulder implants. To limit complexity, we started with a narrow product range. The main steps of our project journey are described here. Given that X-ray sterilization remains relatively new in terms of understanding the changes that might occur for product materials and functionality compared with changes observed following gamma radiation processing, this article highlights key steps in the change from gamma ray to X-ray sterilization.</p>\",\"PeriodicalId\":35656,\"journal\":{\"name\":\"Biomedical Instrumentation and Technology\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2021-03-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8655705/pdf/i0899-8205-55-s3-78.pdf\",\"citationCount\":\"3\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Biomedical Instrumentation and Technology\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.2345/0899-8205-55.s3.78\",\"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":"Biomedical Instrumentation and Technology","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.2345/0899-8205-55.s3.78","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"Medicine","Score":null,"Total":0}
Change in Radiation Sterilization Process from Gamma Ray to X-ray.
The terminal sterilization of sterile orthopedic implants is a key process that, in addition to providing sterility, changes the material properties of the product and packaging. These changes might be observed during functionality testing and/or biological evaluation. We are establishing an additional sterilization process that appears promising from both a technical and business perspective. Our project aims to add X-ray sterilization to the established gamma sterilization for metallic hip and shoulder implants. To limit complexity, we started with a narrow product range. The main steps of our project journey are described here. Given that X-ray sterilization remains relatively new in terms of understanding the changes that might occur for product materials and functionality compared with changes observed following gamma radiation processing, this article highlights key steps in the change from gamma ray to X-ray sterilization.
期刊介绍:
AAMI publishes Biomedical Instrumentation & Technology (BI&T) a bi-monthly peer-reviewed journal dedicated to the developers, managers, and users of medical instrumentation and technology.