IEEE 11073-10700-2022
$44.96
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 (Published)
| Published By | Publication Date | Number of Pages |
| IEEE | 2022 | 67 |
New IEEE 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.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | IEEE Std 11073-10700-2022 Front cover |
| 2 | Title page |
| 4 | Important Notices and Disclaimers Concerning IEEE Standards Documents |
| 8 | Participants |
| 10 | Introduction Acknowledgments |
| 11 | Contents |
| 12 | 1. Overview 1.1 Scope 1.2 Word usage |
| 13 | 1.3 Service-oriented Device Connectivity standards 1.4 Participant key purposes |
| 14 | 2. Normative references 3. Definitions, acronyms, and abbreviations 3.1 Definitions |
| 21 | 3.2 Acronyms and abbreviations |
| 22 | 4. Notational conventions 4.1 Requirement categories and numbering |
| 23 | 4.2 References to IEEE 11073-10207 model elements 4.3 XML Schema namespaces |
| 24 | 4.4 Notation of IEEE 11073 Nomenclature codes 5. Responsibilities 5.1 General responsibilities |
| 27 | 5.2 Intended interoperability |
| 31 | 5.3 System integration |
| 38 | 5.4 System use |
| 41 | 6. Technical design 6.1 SDC PARTICIPANT KEY PURPOSE conformity assurance 6.2 Standards conformity indication in the CONTAINMENT TREE |
| 42 | 6.3 Cybersecurity 6.4 Logging |
| 44 | 6.5 Maximum load conditions 6.6 Participant model |
| 52 | 6.7 Extension model |
| 53 | 6.8 Localization |
| 54 | 6.9 Calibration 7. Conformity |
| 55 | 7.1 Implementation conformity statements |
| 60 | Annex A (normative) Object identifiers |
| 61 | Annex B (informative) Utilized IEEE 11073 Nomenclature |
| 62 | Annex C (informative) SDC PARTICIPANT ENSEMBLE inference |
| 65 | Annex D (informative) Bibliography |
| 67 | Back cover |
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