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BS EN ISO/IEEE 11073-10419:2023 – TC

$280.87

Tracked Changes. Health informatics. Personal health device communication – Device specialization. Insulin pump

Published By Publication Date Number of Pages
BSI 2023 350
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This standard establishes a normative definition of communication between personal telehealth insulin pump devices (agents) and managers (e.g., cell phones, personal computers, personal health appliances, set top boxes) in a manner that enables plug-and-play interoperability. It leverages work done in other ISO/IEEE 11073 standards including existing terminology, information profiles, application profile standards, and transport standards. It specifies the use of specific term codes, formats, and behaviors in telehealth environments, restricting optionality in base frameworks in favor of interoperability. This standard defines a common core functionality of personal telehealth insulin pump devices. In the context of personal health devices (PHDs), an insulin pump is a medical device used for the administration of insulin in the treatment of diabetes mellitus, also known as continuous subcutaneous insulin infusion (CSII) therapy. This standard provides the data modeling according to ISO/IEEE 11073-20601 and does not specify the measurement method.

PDF Catalog

PDF Pages PDF Title
1 30479635
215 A-30381271
216 undefined
221 Important Notices and Disclaimers Concerning IEEE Standards Documents
224 Participants
227 Introduction
228 Contents
230 1. Overview
1.1 Scope
1.2 Purpose
1.3 Context
231 2. Normative references
3. Definitions, acronyms, and abbreviations
3.1 Definitions
233 3.2 Acronyms and abbreviations
234 4. Introduction to ISO/IEEE 11073 personal health devices (PHDs)
4.1 General
4.2 Introduction to ISO/IEEE 11073-20601 modeling constructs
235 4.3 Compliance with other standards
5. Insulin pump device concepts and modalities
5.1 General
236 5.2 Device types
237 5.3 Collected data
242 5.4 Stored data
5.5 Scheduled data
6. Insulin pump domain information model (DIM)
6.1 Overview
6.2 Class extensions
243 6.3 Object instance diagram
244 6.4 Types of configuration
245 6.5 Profiles
6.6 MDS object
6.6.1 MDS object attributes
246 6.6.2 MDS object methods
247 6.6.3 MDS object events
248 6.6.4 Other MDS services
6.6.4.1 GET service
6.6.4.2 SET service
6.7 Numeric objects
6.7.1 General
6.7.2 Current bolus setting
250 6.7.3 Pending bolus delay
251 6.7.4 Bolus delivered
254 6.7.5 Current basal rate setting
257 6.7.6 Basal delivered
258 6.7.7 Basal rate schedule setting
259 6.7.8 I:CHO schedule setting
260 6.7.9 ISF schedule setting
261 6.7.10 Insulin reservoir remaining
262 6.7.11 Insulin concentration
263 6.8 Real-time sample array objects
264 6.9 Enumeration objects
6.9.1 General
6.9.2 Operational status
266 6.9.3 PHD DM status
267 6.9.4 Insulin pump status
269 6.10 PM-store objects
6.10.1 General
270 6.10.2 Persistent store model
271 6.10.3 Metric results PM-store object attributes
272 6.10.4 PM-store object methods
6.10.4.1 Clear-Segments
6.10.5 PM-store object events
273 6.10.6 PM-store object services
6.10.6.1 GET service
6.10.6.2 SET service
6.10.7 PM-segment objects
274 6.11 Schedule-store objects
6.11.1 General
6.11.2 Schedule-store model
6.11.3 Basal profile settings schedule-store object attributes
276 6.11.4 I:CHO profile settings schedule-store object attributes
278 6.11.5 ISF profiles schedule-store object attributes
280 6.11.6 Schedule-store object methods
281 6.11.7 Schedule-store object events
6.11.8 Schedule-store object services
6.11.8.1 GET service
282 6.11.8.2 SET service
6.11.9 Schedule-segment objects
283 6.12 Scanner objects
6.13 Class extension objects
6.14 Insulin pump information model extensibility rules
7. Insulin pump service model
7.1 General
7.2 Object access services
287 7.3 Object access event report services
8. Insulin pump communication model
8.1 Overview
8.2 Communications characteristics
288 8.3 Association procedure
289 8.4 Configuring procedure
291 8.5 Operating procedure
292 8.6 Time synchronization
9. Test associations
9.1 Behavior with standard configuration
9.2 Behavior with extended configurations
10. Conformance
10.1 Applicability
293 10.2 Conformance specification
10.3 Levels of conformance
294 10.4 Implementation conformance statements (ICSs)
299 Annex A (informative) Bibliography
300 Annex B (normative) Any additional ASN.1 definitions
B.1 Device status and insulin pump status bit mapping
301 B.2 Capability-mask
302 B.3 State-flag
304 Annex C (normative) Allocation of identifiers
C.1 General
C.2 Definitions of terms and codes
306 C.3 Systematic derivations of terms and codes
315 Annex D (informative) Message sequence examples
317 Annex E (normative) Schedule-store class
E.1 Schedule-store class
321 E.2 Schedule-segment class
325 Annex F (normative) Schedule class ASN.1 definitions
F.1 ACTION-method-related data types
F.2 Data types for new object attributes and object services
328 F.3 Data protocol definitions
329 Annex G (informative) The schedule-store concept
G.1 General
330 G.2 Schedule-store object hierarchy
333 Annex H (informative) Scedule communication model
H.1 Operating procedure
337 Annex I (informative) Protocol data unit (PDU) examples
I.1 General
I.2 Association information exchange
340 I.3 Configuration information exchange
344 I.4 GET MDS attributes service
346 I.5 Data reporting
I.6 Disassociation
347 Annex J (informative) Revision history
BS EN ISO/IEEE 11073-10419:2023 - TC
$280.87