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.
Document published on: 2013-06-01 Edition: 3 (Monolingual) ICS: 11.080.01 Status: Published Stage: 60.60 (2013-05-21) TC/SC: ISO/TC 198 Number of Pages: 68
Revises: ISO 11137-2:2012
No corrigenda or amendments available