Reference number
ISO 11137-2:2006
ISO 11137-2:2006
Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
Edition 1
2006-04
Retirada
ISO 11137-2:2006
33953
Retirada (Edición 1, 2006)

Resumen

ISO 11137-2:2006 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. It also specifies methods of dose auditing in order to demonstrate the continued effectiveness of the sterilization dose.

ISO 11137-2:2006 defines product families for dose establishment and dose auditing.

Informaciones generales

  •  : Retirada
     : 2006-04
     : 2006-07
     : 2006-07
    : Retirada de la Norma Internacional [95.99]
  •  : 1
     : 60
  • ISO/TC 198
    11.080.01 
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