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Description of P11073-10700 2023New IEEE Standard - Active - Draft. MEDICAL DEVICEs that offer a communication interface as specified by the IEEE 11073 Service-oriented Device Connectivity (SDC) standards can be integrated into a HEALTH IT SYSTEM to jointly execute SYSTEM FUNCTIONs. However, implementing the IEEE 11073 SDC communication protocol is not sufficient to demonstrate safety, effectiveness, and security of SYSTEM FUNCTIONs resulting from the combination of SYSTEM FUNCTION CONTRIBUTIONs from two or more MEDICAL DEVICEs. SDC PARTICIPANT KEY PURPOSEs (PKPs) are sets of requirements that support MANUFACTURERs in making valid assumptions about BICEPS PARTICIPANTs from other MANUFACTURERs. This common understanding allows for the MANUFACTURERs to perform RISK MANAGEMENT, verification, and USABILITY ENGINEERING for the safe use of SYSTEM FUNCTIONs. This standard specifies requirements for the allocation of responsibilities to SDC BASE PARTICIPANTs.Subscription InformationMADCAD.com IEEE Standards subscriptions are annual and access is unlimited concurrency based (number of people that can access the subscription at any given time. Listed IEEE Standards prices are applicaple for US firms whose annual revenue is less than $400 million. All others, please contact us at info@madcad.com or +1 800.798.9296.
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About IEEEIEEE is the world's largest professional association dedicated to advancing technological innovation and excellence for the benefit of humanity. IEEE and its members inspire a global community through IEEE's highly cited publications, conferences, technology standards, and professional and educational activities. IEEE, pronounced "Eye-triple-E," stands for the Institute of Electrical and Electronics Engineers. The association is chartered under this name and it is the full legal name. IEEE creates an environment where members collaborate on world‐changing technologies – from computing and sustainable energy systems, to aerospace, communications, robotics, healthcare, and more. The strategic plan of IEEE is driven by an envisioned future that realizes the full potential of the role IEEE plays in advancing technology for humanity. The IEEE Brand Identity Toolkit explains the basic usage rules for all corporate identity elements and how to utilize them to create a powerful and consistent communications pieces. IEEE is led by a diverse body of elected and appointed volunteer members. The governance structure includes boards for operational areas as well as bodies representing members in the 45 Societies and technical Councils and ten worldwide geographic regions. |
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