DSF/EN ISO 11137-2/PRA1
Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose – Amendment 1 (ISO 11137-2:2013/DAmd 1:2021)
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| Organization: | DS |
| Status: | active |
| Page Count: | 17 |
| ICS Code (Sterilization and disinfection in general): | 11.080.01 |
scope:
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 dose to achieve a sterility assurance level, SAL, of 10-6. This part of ISO 11137 also specifies methods of dose auditing in order to demonstrate the continued effectiveness of the sterilization dose. This part of ISO 11137 defines product families for dose establishment and dose auditing.
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.
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...
DSF/EN ISO 11137-2/PRA1
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...