International Standard
ISO 11137-1:2006
Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
Reference number
ISO 11137-1:2006
Edición 1
2006-04
International Standard
Vista previa
ISO 11137-1:2006
33952
No disponible en español
Publicado (Edición 1, 2006)
Esta norma se revisó y confirmó por última vez en 2016. Por lo tanto, esta versión es la actual.
Esta norma tiene 2 modificación.

ISO 11137-1:2006

ISO 11137-1:2006
33952
Idioma
Formato
CHF 173
Convertir Franco suizo (CHF) a tu moneda

Resumen

ISO 11137-1:2006 specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices. Although the scope of ISO 11137-1:2006 is limited to medical devices, it specifies requirements and provides guidance that may be applicable to other products and equipment.

ISO 11137-1:2006 covers radiation processes employing irradiators using the radionuclide 60Co or 137Cs, a beam from an electron generator or a beam from an X-ray generator.

ISO 11137-1:2006 does not:

  • specify requirements for development, validation and routine control of a process for inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease;
  • detail specified requirements for designating a medical device as sterile;
  • specify a quality management system for the control of all stages of production of medical devices;
  • specify requirements for occupational safety associated with the design and operation of irradiation facilities;
  • specify requirements for the sterilization of used or reprocessed devices.

Informaciones generales

  •  : Publicado
     : 2006-04
    : Norma Internacional para revisar [90.92]
  •  : 1
     : 37
  • ISO/TC 198
    11.080.01 
  • RSS actualizaciones

 Modificaciones

Las enmiendas se emiten cuando se decide que puede ser necesario agregar nuevo material a un documento de normalización existente. También pueden incluir correcciones editoriales o técnicas que deban aplicarse al documento existente.

Amendment 1

Edición 2013

ISO 11137-1:2006/Amd 1:2013
60165
Idioma
Formato
CHF 18
Convertir Franco suizo (CHF) a tu moneda

Amendment 2

Revision to 4.3.4 and 11.2

Edición 2018

ISO 11137-1:2006/Amd 2:2018
72106
Idioma
Formato
CHF 18
Convertir Franco suizo (CHF) a tu moneda

Ciclo de vida

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