ISO 11137-2:2013

ISO 11137-2:2013

June 2013
International standard Current

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 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.

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Main informations

Collections

International ISO standards

Publication date

June 2013

Number of pages

68 p.

Reference

ISO 11137-2:2013

ICS Codes

11.080.01   Sterilization and disinfection in general

Print number

1 - 30/05/2013
Sumary
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 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.

Replaced standards (1)
ISO 11137-2:2012
March 2012
International standard Cancelled
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 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.

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