Standard

NEK EN IEC 80001-1:2021

Published

Corrigenda and amendments are bought separately.

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Abstract

This document specifies general requirements for ORGANIZATIONS in the application of RISK MANAGEMENT before, during and after the connection of a HEALTH IT SYSTEM within a HEALTH IT INFRASTRUCTURE, by addressing the KEY PROPERTIES of SAFETY, EFFECTIVENESS and SECURITY whilst engaging appropriate stakeholders.

Document information

  • Standard from NEK
  • Published:
  • Edition: 2021-10
  • Version: 1
  • Document type: NAT
  • ICS 11.040.01
  • ICS 35.240.80
  • National Committee NEK/NK62

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