Reference number
ISO 11137:1995
ISO 11137:1995
Sterilization of health care products — Requirements for validation and routine control — Radiation sterilization
Edition 1
1995-03
Retirada
ISO 11137:1995
19156
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

  •  : Retirada
     : 1995-03
    : Retirada de la Norma Internacional [95.99]
  •  : 1
     : 61
  • ISO/TC 198
    11.080.01 
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