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EN 552: validating 25 kGy as a sterilization dose
1SGS Yarsley International Certification Services, Weston-super-Mare, UK.
Medical Device Technology
|June 6, 1996
Abstract:
EN 552 and ISO 11137 present challenges to the historically accepted dose of 25 kGy for sterilizing medical devices. New demands are being made of manufacturers who must now supply experimental evidence to substantiate the effectiveness of 25 kGy. This article explains those demands and provides guidance on meeting them. Some of the shortcomings of the standards and, in particular, the alarming cost issues are examined.