Biomed Instrum Technol. 2020 Jun 1;54(s1):53-63. doi: 10.2345/0899-8205-54.s3.53.
ABSTRACT
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.”
PMID:34169973 | DOI:10.2345/0899-8205-54.s3.53
