PD IEC/TR 80001-2-4:2012
Current
The latest, up-to-date edition.
Application of risk management for IT-networks incorporating medical devices Application guidance. General implementation guidance for healthcare delivery organizations
Hardcopy , PDF
English
29-11-2012
| Committee |
CH/62/1
|
| DocumentType |
Standard
|
| Pages |
28
|
| PublisherName |
British Standards Institution
|
| Status |
Current
|
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.
| 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 |
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