ISO 11137-2:2006
Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
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Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
ISO 11137-2:2006 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. It also specifies methods of dose auditing in order to demonstrate the continued effectiveness of the sterilization dose.
ISO 11137-2:2006 defines product families for dose establishment and dose auditing.
| Edition | 2006 |
|---|---|
| Standard Part No | 2 |
| Published Date | 2006 |
| Published By | International Standardization Organisation |
| Page Count | 60 |