NEN - NPR-IEC/TR 80001-2-4
Application of risk management for IT-networks incorporating medical devices - Part 2-4: Application guidance - General implementation guidance for healthcare delivery organizations
| Organization: | NEN |
| Publication Date: | 1 December 2012 |
| Status: | active |
| Page Count: | 30 |
| ICS Code (IT applications in health care technology): | 35.240.80 |
| ICS Code (Medical equipment in general): | 11.040.01 |
scope:
This technical report helps a RESPONSIBLE ORGANIZATION 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 as defined in Figure 1 of IEC 80001-1:2010.
Document History