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Standard

IEC/TR 80001-2-4:2012

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Abstract

IEC/TR 80001-2-4:2012(E), which is a technical report, provides guidance to help a healthcare delivery organization fulfilling its obligations as a responsible organization in the application of IEC 80001-1. A healthcare delivery organization includes hospitals, doctors' offices, community care homes and clinics. Specifically, this guide helps the healthcare delivery organization assess the impact of IEC 80001-1 on the organization and establish a series of business as usual processes to manage RISK in the creation, maintenance and upkeep of its medical IT-networks. This technical report will be useful to those responsible for establishing an IEC 80001-1 compliant risk management framework within a healthcare delivery organization that is expecting to establish one or more medical IT-networks. It provides help through the key decisions and steps required to establish a risk management framework, before the organization embarks on a detailed risk assessment of an individual instance of a medical IT-network. The steps are supported by a series of decision points to steer the responsible organization through the process of understanding the medical IT-network context and identifying any organizational changes required to execute the responsibilities of top management.

Document information

  • Standard from IEC
  • Published:
  • Withdrawn:
  • Edition: 1
  • Document type: TR
  • Pages
  • Publisher IEC
  • Distributor IEC
  • ICS 35.240.80
  • ICS 11.040.01
  • ISO TC ISO/TC 215

Product Relations

  • Joinded work item: IEC/SC62A