PD IEC/TR 80001-2-5 is the fifth subpart of the second part of the multiple series standard that focuses on the application of risk management for IT networks incorporating medical devices.
PD IEC/TR 80001-2-5 gives guidance and practical techniques for RESPONSIBLE ORGANIZATIONS, MEDICAL DEVICE manufacturers and providers of other information technology in the application of IEC 80001-1:2010 for the RISK MANAGEMENT of DISTRIBUTED ALARM SYSTEMS. PD IEC/TR 80001-2-5 applies to the transmission of ALARM CONDITIONS between SOURCES, INTEGRATOR and COMMUNICATORS where at least one SOURCE is a MEDICAL DEVICE and at least one communication path utilizes a MEDICAL IT-NETWORK.
PD IEC/TR 80001-2-5 on alarm systems for medical devices is useful for:
ALARM SIGNALS are frequently used to indicate unsatisfactory physiological PATIENT states, unsatisfactory functional states of the MEDICAL DEVICE or other parts of the system to distribute ALARM CONDITIONS or to warn the OPERATOR of HAZARDS to the PATIENT or OPERATOR. The ALARM CONDITIONS that cause these ALARM SIGNALS are often transmitted across the MEDICAL IT-NETWORK, creating a system to distribute ALARM CONDITIONS.
PD IEC/TR 80001-2-5 provides recommendations for the integration, communication of responses and REDIRECTION (to another OPERATOR) of ALARM CONDITIONS from one or more SOURCES to ensure SAFETY and EFFECTIVENESS. PD IEC/TR 80001-2-5 will assist you to know the functions of a MEDICAL IT-NETWORK incorporating SOURCES, an INTEGRATOR and COMMUNICATORS to distribute ALARM CONDITIONS.
Overall, you can use PD IEC/TR 80001-2-5 to be aware of potential or actual HAZARDOUS SITUATION in the premises.
IEC TR 80001-2-5:2014