IEC/TR 80001-2-4:2012
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IEC/TR 80001-2-4:2012
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Abstract

 Preview

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.


General information 

  •  :  Published
     : 2012-11
  •  : 1
     : 18
  •  : ISO/TC 215 Health informatics
  •  :
    11.040.01 Medical equipment in general
    35.240.80 IT applications in health care technology

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