Reference number
ISO 11137:1995
© ISO 2024
ISO 11137:1995
Sterilization of health care products — Requirements for validation and routine control — Radiation sterilization
Edition 1
1995-03
Retirada
Retirada (Edición 1, 1995)

Resumen

Specifies requirements for validation, process control and routine monitoring in the radiation sterilization of health care products. Applies to continuous and batch type gamma irradiators using the radionuclides 60 Co and 137 Cs, and to irradiators using a beam from an electron or x-ray generator. Does not cover facility design, licensing, operator training, factors related to radiation safety, the assessment of the suitability of the product for its intended use.

Informaciones generales

  • Estado
     : Retirada
    Fecha de publicación
     : 1995-03
    Etapa
    : Retirada de la Norma Internacional [95.99]
  • Edición
     : 1
    Número de páginas
     : 61
  • Comité Técnico :
    ISO/TC 198
    ICS :
    11.080.01 
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