ISO 11137-2:2013
International Standard
Current Edition
·
Approved on
21 May 2013
Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
ISO 11137-2:2013 Files
English
68 Pages
Current Edition
90.6 BHD
ISO 11137-2:2013 Scope
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.
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