Standard

NS-EN ISO 14937:2009

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Omfang

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.

Dokumentinformasjon

  • Standard fra SN
  • Publisert:
  • Utgave: 2009-10
  • Versjon: 1
  • Varetype: NAT
  • ICS 11.080.01
  • National Committee CEN/TC 204

Referanser i lov

EU lov: 90/385/EEC, 93/42/EEC, 98/79/EC

Produktrelasjon

Produkt livssyklus