PD IEC/TR 80001-2-3:2012

What is PD IEC/TR 80001-2-3 - Guidance for wireless networks incorporating medical devices about?  

PD IEC/TR 80001-2-3 is the second subpart of the third part of the multiple series document that supports the HDO in the RISK MANAGEMENT of MEDICAL IT-NETWORKS that incorporate one or more wireless links. The report provides technical background concerning wireless technology and examples of HAZARDS to be considered when wireless technology is used in MEDICAL IT-NETWORKS and suggests RISK CONTROL measures to reduce the probability of UNINTENDED CONSEQUENCES. 

Note 1: PD IEC/TR 80001-2-3 does not focus on a single wireless technology, it is assumed that the attached wired infrastructure is an Ethernet-based IP network. 

Note 2: It is not the intent of PD IEC/TR 80001-2-3 to propose a regimented step-by-step PROCESS for implementing a wireless MEDICAL IT-NETWORK or mitigating the RISK associated with a particular wireless technology. There are many reasons which conspire against such an effort and chief among them are: 

• There are many different wireless technologies available, each with their PHY, MAC and upper layer characteristics with varying degrees of control available to the HDO. 
• Many wireless technologies are in an evolving stage of development and are still subject to frequent and significant changes. 
• HDOs, depending on their needs, might utilize varying combinations of wireless technologies to meet their particular requirements. Each technology should require its own independent RISK ANALYSIS and RISK CONTROL measures that should be reviewed systemically (aggregate RISKS ANALYSIS). 
• Each HDO will have their own unique clinical use cases and network topologies and will perform its own unique RISK ANALYSIS and management that will differ from other HDOs. 

Who is PD IEC/TR 80001-2-3 - Guidance for wireless networks incorporating medical devices for?  

PD IEC/TR 80001-2-3 on wireless networks is useful for: 

• Health care delivery organizations  
• Medical device manufacturers 
• Biomedical and clinical engineering departments 
• Risk managers 
• Software developers/IT engineers  
• Manufacturers and suppliers of alarm systems devices  
• Hospitals  

Why should you use PD IEC/TR 80001-2-3 - Guidance for wireless networks incorporating medical devices? 

Wireless communications have been a key technology enabling the connectivity of MEDICAL DEVICES for decades. RISK MANAGEMENT is the systematic application of management rules, methods, and practices to the activities of risk analysis, evaluation, control, and monitoring. 

PD IEC/TR 80001-2-3 addresses the unique RISK MANAGEMENT requirements of operating wirelessly enabled MEDICAL DEVICES in a safe, secure, and effective manner. It will assist you in dealing with a large number of devices and complex application mixes in both wired and wireless networks. 

Overall, PD IEC/TR 80001-2-3 assists you in reviewing the issues connected with wireless technologies and providing information on how to use MEDICAL DEVICES on a wireless MEDICAL IT NETWORK safely, effectively, and securely.