IEEE/ISO 11073-10700-2024

Die Annotation des Normtextes IEEE/ISO 11073-10700-2024 :

Adoption Standard - Active.

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.

ISBN: 979-8-8557-1254-4, 979-8-8557-1255-1

Number of Pages: 58

Product Code: STD27323, STDPD27323

Keywords: base PKP; BICEPS; communication protocol specification; documentation and process responsibilities; dynamic medical device interoperability; IEEE 11073-10700™; integrated clinical environment; participant key purpose; point-of-care medical device communication; risk management; SDC; service-oriented device connectivity; safety, effectiveness, and security; system function; system function contribution; usability engineering

Category: Medical Device Communications