ISO 11137-2:2012
Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
Reference number
ISO 11137-2:2012
Edición 2
2012-03
© ISO 2024
Retirada
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

  • Estado
     : Retirada
    Fecha de publicación
     : 2012-03
    Etapa
    : Retirada de la Norma Internacional [95.99]
  • Edición
     : 2
    Número de páginas
     : 70
  • Comité Técnico :
    ISO/TC 198
    ICS :
    11.080.01 
  • RSS actualizaciones

Ciclo de vida

Got a question?

Check out our FAQs

Customer care
+41 22 749 08 88

Opening hours:
Monday to Friday - 09:00-12:00, 14:00-17:00 (UTC+1)

  2. Tienda
  3. Standards catalogue
  4. TC
  5. ISO/TC 198
  6. ISO 11137-2:2012