IEEE/ISO 11073-10701-2024

Podrobné informace

Označení: IEEE/ISO 11073-10701-2024

Datum vydání: 13.09.2024

Stran: 44

Země: Mezinárodní technická norma

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Anotace

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 defines requirements for SDC metric participants in an SDC system that comprises an IT network of medical devices to enable safe and secure contribution to system functions based on the exchange of metric information.

ISBN: 979-8-8557-1248-3, 979-8-8557-1249-0
Number of Pages: 44
Product Code: STD27319, STDPD27319
Keywords: base PKP; BICEPS; communication protocol specification; device component; documentation and process responsibilities; dynamic medical device interoperability; IEEE 11073-10701™; integrated clinical environment; medical device communication; metric; metric PKP; participant key purpose; point-of-care service-oriented device connectivity; risk management; safety, effectiveness, and security; SDC; system function; system function contribution; usability engineering
Category: Medical Device Communications