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ISO 11137-2

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose

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Organization: ISO
Publication Date: 1 June 2013
Status: active
Page Count: 76
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
June 1, 2013
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...
March 15, 2012
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...
February 15, 2009
Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose TECHNICAL CORRIGENDUM 1
A description is not available for this item.
April 15, 2006
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...

References

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