DS/EN ISO 11137-2
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
inactive
| Organization: | DS |
| Publication Date: | 27 April 2012 |
| Status: | inactive |
| Page Count: | 90 |
| ICS Code (Sterilization and disinfection in general): | 11.080.01 |
scope:
ISO 11137-2:2011 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. ISO 11137-2:2011 also specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose. ISO 11137-2:2011 defines product families for sterilization dose establishment and sterilization dose audit.
Document History
April 24, 2023
Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose – Amendment 1 (ISO 11137-2:2013/Amd 1:2022)
This part of ISO 11137 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...
July 6, 2015
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
This part of ISO 11137 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...
June 21, 2013
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
A description is not available for this item.
DS/EN ISO 11137-2
April 27, 2012
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
ISO 11137-2:2011 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...
June 3, 2009
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
This part of ISO 11137 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...
June 14, 2007
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
This part of ISO 11137 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 of health care products – Radiation – Part 2: Establishing the sterilization dose – Amendment 1 (ISO 11137-2:2013/DAmd 1:2021)
This part of ISO 11137 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 of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO/FDIS 11137-2:2013)
A description is not available for this item.
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO/FDIS 11137-2:2011)
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 of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO/DIS 11137-2:2010)
This part of ISO 11137 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...