ISO 11137-2:2013 specifies methods for determining the minimum dose needed to achieve a specified requirement for sterility and methods to substantiate the use of 25 kGy or 15 kGy as the sterilization dose to achieve a sterility assurance level, SAL, of 10−6. ISO 11137-2:2013 also specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose.
ISO 11137-2:2013 defines product families for sterilization dose establishment and sterilization dose audit.
Status: PublishedPublication date: 2013-06
Edition: 3Number of pages: 68
Technical Committee: ISO/TC 198 Sterilization of health care products
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Stage: 90.93 (Confirmed)
Corrigenda / AmendmentsPublished