Standard

NEK EN ISO 14971:2012

Tilbaketrukket

Merknad: Denne standarden har en ny utgave: NEK EN ISO 14971:2019

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Omfang

ISO 14971:2007 specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.The requirements of ISO 14971:2007 are applicable to all stages of the life-cycle of a medical device.

Dokumentinformasjon

  • Standard fra NEK
  • Publisert:
  • Tilbaketrukket:
  • Utgave: 2012-07
  • Versjon: 1
  • Varetype: NAT
  • Products.Specs.pages
  • ICS 11.040.01
  • National Committee CEN/CLC/JTC 3

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