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Norm
ISO 11137-2:2013
Issue date: 2013 05 21
Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
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 ...
Valid
Publisher:
International Organization for Standardization
Format:
Digital | 68 Pages
Language:
English
ICS
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.
ISO 11137-2:2013
2013 05 21
Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
Norm
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ISO 11137-2:2012
2012 03 15
Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
Norm
ISO 11137-2:2006/Cor 1:2009
2009 02 10
Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose — Te...
Norm
ISO 11137-2:2006
2006 04 19
Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose (Cor...
Norm
ISO 11137:1995/Amd 1:2001
2001 12 13
Sterilization of health care products — Requirements for validation and routine control — Radiation ...
Norm
ISO 11137:1995/Cor 1:1997
1997 05 22
Sterilization of health care products — Requirements for validation and routine control — Radiation ...
Norm
ISO 11137:1995
1995 03 09
Sterilization of health care products — Requirements for validation and routine control — Radiation ...
Norm
Norm
Issue date :
2022 06 13
Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose — Amendment 1
