Reference number
ISO 11137-2:2012
ISO 11137-2:2012
Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
Edition 2
2012-03
Retirada
ISO 11137-2:2012
51238
Retirada (Edición 2, 2012)

Resumen

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.

Informaciones generales

  •  : Retirada
     : 2012-03
    : Retirada de la Norma Internacional [95.99]
  •  : 2
     : 70
  • ISO/TC 198
    11.080.01 
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