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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
IEEE Std 11073-10700-2022
Year: 2023
IEEE - The Institute of Electrical and Electronics Engineers, Inc.
Abstract: 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.
Subject: and security; system function; system function contribution; usability engineering
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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
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| contributor author | IEEE - The Institute of Electrical and Electronics Engineers, Inc. | |
| date accessioned | 2024-12-17T08:09:55Z | |
| date available | 2024-12-17T08:09:55Z | |
| date copyright | 15 September 2023 | |
| date issued | 2023 | |
| identifier other | 10253649.pdf | |
| identifier uri | http://yse.yabesh.ir/std;query=autho47037D83FCDCAC4261598F1EFDEC014A/handle/yse/336414 | |
| description abstract | 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. | |
| language | English | |
| publisher | IEEE - The Institute of Electrical and Electronics Engineers, Inc. | |
| title | 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 | en |
| title | IEEE Std 11073-10700-2022 | num |
| type | standard | |
| page | 67 | |
| status | Active | |
| tree | IEEE - The Institute of Electrical and Electronics Engineers, Inc.:;2023 | |
| contenttype | fulltext | |
| subject keywords | and security; system function; system function contribution; usability engineering | |
| subject keywords | effectiveness | |
| subject keywords | base PKP; BICEPS; communication protocol specification; documentation and process responsibilities; dynamic medical device interoperability; IEEE 11073-1070 | |
| identifier DOI | 10.1109/IEEESTD.2023.10253649 |