ISO 11137-2:2012
International Standard
Historical
·
Approved on
15 March 2012
Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
ISO 11137-2:2012 Files
English
70 Pages
Historical
31.09 OMR
ISO 11137-2:2012 Scope
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.
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