Historical
ANSI/AAMI/ISO 11137-2:2012
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
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 10û6. This part of ISO 11137 also specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose
CONTENT PROVIDER
Association for the Advancement of Medical Instrumentation [aami]
Association for the Advancement of Medical Instrumentation [aami]