Radiation Process Control: Product Dose vs. Process Dose

Autor:	Emily Craven, John R. Logar
Rok vydání:	2021
Předmět:	Computer Networks and Communications Computer science Process (engineering) Control (management) Biomedical Engineering Process control Radiation process Statistical analysis Road map Product (category theory) Reference Standards Sterility assurance level Reliability engineering
Zdroj:	Biomedical instrumentationtechnology. 54(s1)
ISSN:	0899-8205
Popis:	The requirements for the irradiation of healthcare products have been well established and implemented across the globe for several decades. The ISO 11137 series of standards gives the user the road map for designing a radiation process that will routinely deliver the required sterility assurance level so that product consistently meets specifications. The latest addition to the ISO 11137 series of standards should provide much-needed guidance around establishing a highly reproducible process based on a statistical analysis of the validated state of control. Most industries refer to this as "process control."
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=doi_dedup___::dce10aea15ff94ebba71a1d8b8c0b66a https://pubmed.ncbi.nlm.nih.gov/34169973 Zobrazit plný text záznamu