ISO 11137-2:2013 PDF
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Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
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.
| Edition | 2013 |
|---|---|
| Standard Part No | 2 |
| Published Date | 2013 |
| Published By | International Standardization Organisation |
| Page Count | 68 |
