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
- ADD TO ALERT |
- PDF |
Association for the Advancement of Medical Instrumentation [aami]