02063nam 2200337 450 99655116530331620231205191927.01-5044-9848-8(CKB)28228610900041(NjHacI)9928228610900041(EXLCZ)992822861090004120231205d2023 uy 0engur|||||||||||txtrdacontentcrdamediacrrdacarrier11073-10700-2022 - IEEE Standard -- Health Informatics--Device Interoperability Part 10700 Point‐of‐Care Medical Device Communication--Standard for Base Requirements for Participants in a Service‐Oriented Device Connectivity (SDC) System /IEEENew York :IEEE,[2023]©20231 online resource (67 pages)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 allow for manufacturers to have certain expectations about BICEPS participants from other manufacturers. This common understanding enables the manufacturers to perform risk management, verification, validation, and usability engineering for the safe use of system functions. This standard specifies requirements for the allocation of responsibilities to SDC base participants.Medical informaticsMedical informatics.610.285NjHacINjHaclBOOK99655116530331611073-10700-2022 - IEEE Standard -- Health Informatics--Device Interoperability Part 107003646409UNISA