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BS EN ISO/IEEE 11073-10419:2023

BS EN ISO/IEEE 11073-10419:2023

$215.11

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

Published By Publication Date Number of Pages
BSI 2023 136
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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
2 undefined
7 Important Notices and Disclaimers Concerning IEEE Standards Documents
10 Participants
13 Introduction
14 Contents
16 1. Overview
1.1 Scope
1.2 Purpose
1.3 Context
17 2. Normative references
3. Definitions, acronyms, and abbreviations
3.1 Definitions
19 3.2 Acronyms and abbreviations
20 4. Introduction to ISO/IEEE 11073 personal health devices (PHDs)
4.1 General
4.2 Introduction to ISO/IEEE 11073-20601 modeling constructs
21 4.3 Compliance with other standards
5. Insulin pump device concepts and modalities
5.1 General
22 5.2 Device types
23 5.3 Collected data
28 5.4 Stored data
5.5 Scheduled data
6. Insulin pump domain information model (DIM)
6.1 Overview
6.2 Class extensions
29 6.3 Object instance diagram
30 6.4 Types of configuration
31 6.5 Profiles
6.6 MDS object
6.6.1 MDS object attributes
32 6.6.2 MDS object methods
33 6.6.3 MDS object events
34 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
36 6.7.3 Pending bolus delay
37 6.7.4 Bolus delivered
40 6.7.5 Current basal rate setting
43 6.7.6 Basal delivered
44 6.7.7 Basal rate schedule setting
45 6.7.8 I:CHO schedule setting
46 6.7.9 ISF schedule setting
47 6.7.10 Insulin reservoir remaining
48 6.7.11 Insulin concentration
49 6.8 Real-time sample array objects
50 6.9 Enumeration objects
6.9.1 General
6.9.2 Operational status
52 6.9.3 PHD DM status
53 6.9.4 Insulin pump status
55 6.10 PM-store objects
6.10.1 General
56 6.10.2 Persistent store model
57 6.10.3 Metric results PM-store object attributes
58 6.10.4 PM-store object methods
6.10.4.1 Clear-Segments
6.10.5 PM-store object events
59 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
60 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
62 6.11.4 I:CHO profile settings schedule-store object attributes
64 6.11.5 ISF profiles schedule-store object attributes
66 6.11.6 Schedule-store object methods
67 6.11.7 Schedule-store object events
6.11.8 Schedule-store object services
6.11.8.1 GET service
68 6.11.8.2 SET service
6.11.9 Schedule-segment objects
69 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
73 7.3 Object access event report services
8. Insulin pump communication model
8.1 Overview
8.2 Communications characteristics
74 8.3 Association procedure
75 8.4 Configuring procedure
77 8.5 Operating procedure
78 8.6 Time synchronization
9. Test associations
9.1 Behavior with standard configuration
9.2 Behavior with extended configurations
10. Conformance
10.1 Applicability
79 10.2 Conformance specification
10.3 Levels of conformance
80 10.4 Implementation conformance statements (ICSs)
85 Annex A (informative) Bibliography
86 Annex B (normative) Any additional ASN.1 definitions
B.1 Device status and insulin pump status bit mapping
87 B.2 Capability-mask
88 B.3 State-flag
90 Annex C (normative) Allocation of identifiers
C.1 General
C.2 Definitions of terms and codes
92 C.3 Systematic derivations of terms and codes
101 Annex D (informative) Message sequence examples
103 Annex E (normative) Schedule-store class
E.1 Schedule-store class
107 E.2 Schedule-segment class
111 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
114 F.3 Data protocol definitions
115 Annex G (informative) The schedule-store concept
G.1 General
116 G.2 Schedule-store object hierarchy
119 Annex H (informative) Scedule communication model
H.1 Operating procedure
123 Annex I (informative) Protocol data unit (PDU) examples
I.1 General
I.2 Association information exchange
126 I.3 Configuration information exchange
130 I.4 GET MDS attributes service
132 I.5 Data reporting
I.6 Disassociation
133 Annex J (informative) Revision history

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BS EN ISO/IEEE 11073-10419:2023
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