Application of risk management for IT-networks incorporating medical devices Application guidance. General implementation guidance for healthcare delivery organizations

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

29-11-2012

Publisher

British Standards Institution

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.

Committee	CH/62/1
DocumentType	Standard
Pages	28
PublisherName	British Standards Institution
Status	Current

Standards	Relationship
IEC TR 80001-2-4:2012	Identical

IEC 80001-1:2010	Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities
IEC TR 80001-2-1:2012	Application of risk management for IT-networks incorporating medical devices - Part 2-1: Step by step risk management of medical IT-networks - Practical applications and examples