LEADER 02063nam 2200337 450 001 996551165303316 005 20231205191927.0 010 $a1-5044-9848-8 035 $a(CKB)28228610900041 035 $a(NjHacI)9928228610900041 035 $a(EXLCZ)9928228610900041 100 $a20231205d2023 uy 0 101 0 $aeng 135 $aur||||||||||| 181 $ctxt$2rdacontent 182 $cc$2rdamedia 183 $acr$2rdacarrier 200 10$a11073-10700-2022 - IEEE Standard -- Health Informatics--Device Interoperability Part 10700 $ePoint?of?Care Medical Device Communication--Standard for Base Requirements for Participants in a Service?Oriented Device Connectivity (SDC) System /$fIEEE 210 1$aNew York :$cIEEE,$d[2023] 210 4$dİ2023 215 $a1 online resource (67 pages) 330 $aMedical 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. 606 $aMedical informatics 615 0$aMedical informatics. 676 $a610.285 801 0$bNjHacI 801 1$bNjHacl 906 $aBOOK 912 $a996551165303316 996 $a11073-10700-2022 - IEEE Standard -- Health Informatics--Device Interoperability Part 10700$93646409 997 $aUNISA