ISO 11137-2:2012 PDF
Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
Title (English):
ISO 11137-2:2012
Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
- Document status:
- Withdrawn
- Format:
- Electronic (PDF)
- Number of pages:
- 70
- Publication date:
- March 15, 2012
- Edition:
- ISO IS 11137 edition 2 version 1
- ICS:
- 11.080.01
Description (English):
ISO 11137-2:2011 specifies methods of 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 11137-2:2011 also specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose. ISO 11137-2:2011 defines product families for sterilization dose establishment and sterilization dose audit.
Technical details
- Technical committee
- ISO/TC 198 - Sterilization of health care products
- SKU
- ISO 11137-2:2012
