Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
Also Known As:
SKU182762545
Published by
International Organization for Standardization
ISO
Publication Date2013-06
Pages CountPages76
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.
Details
| Edition | 3 |
| ICS Codes | 11.080.01 - Sterilization and disinfection in general |
| Language(s) | English |
| File Size | 1.0 MB |
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