Codes & Standards - Purchase
ISO 11137-2:2013
Sterilization of health care products -- Radiation -- Part 2: Establishing the sterilization dose
SKU: iso_062442_155146
Published by ISO
Publication Year 2013
3 Edition
68 pages
Product Details
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.