Reference number
ISO 14937:2009
International Standard
ISO 14937:2009
Sterilization of health care products — General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
Edition 2
2009-10
Preview
ISO 14937:2009
44954
No disponible en español
Publicado (Edición 2, 2009)
Esta publicación se revisó y confirmó por última vez en 2020. Por lo tanto, esta versión es la actual.

ISO 14937:2009

ISO 14937:2009
44954
Idioma
Formato
CHF 173
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Resumen

ISO 14937:2009 specifies general requirements for the characterization of a sterilizing agent and for the development, validation and routine monitoring and control of a sterilization process for medical devices.

It applies to sterilization processes in which microorganisms are inactivated by physical and/or chemical means and is intended to be applied by process developers, manufacturers of sterilization equipment, manufacturers of medical devices to be sterilized, and organizations responsible for sterilizing medical devices.

ISO 14937:2009 specifies the elements of a Quality Management System which are necessary to assure the appropriate characterization of the sterilizing agent, development, validation and routine monitoring and control of a sterilization process.

Informaciones generales

  •  : Publicado
     : 2009-10
    : Norma Internacional confirmada [90.93]
  •  : 2
     : 37
  • ISO/TC 198
    11.080.01 
  • RSS actualizaciones

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