CSA - ISO 11137-2:16
Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
active, Most Current
| Organization: | CSA |
| Publication Date: | 1 January 2016 |
| Status: | active |
| Page Count: | 91 |
| ICS Code (Sterilization and disinfection in general): | 11.080.01 |
scope:
This part of ISO 11137 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. This part of ISO 11137 also specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose.
This part of ISO 11137 defines product families for sterilization dose establishment and sterilization dose audit.
Document History
ISO 11137-2:16
January 1, 2016
Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
This part of ISO 11137 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...
January 1, 2016
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
This part of ISO 11137 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...