ISO/IEEE 11073-10419:2019
Health informatics — Personal health device communication — Part 10419: Device specialization — Insulin pump
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.
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Important Notices and Disclaimers Concerning IEEE Standards Documents
Participants
Introduction
Contents
1. Overview
1.1 Scope
1.2 Purpose
1.3 Context
2. Normative references
3. Definitions, acronyms, and abbreviations
3.1 Definitions
3.2 Acronyms and abbreviations
4. Introduction to ISO/IEEE 11073 personal health devices (PHDs)
4.1 General
4.2 Introduction to ISO/IEEE 11073-20601 modeling constructs
4.3 Compliance with other standards
5. Insulin pump device concepts and modalities
5.1 General
5.2 Device types
5.3 Collected data
5.4 Stored data
5.5 Scheduled data
6. Insulin pump domain information model (DIM)
6.1 Overview
6.2 Class extensions
6.3 Object instance diagram
6.4 Types of configuration
6.5 Profiles
6.6 MDS object
6.6.1 MDS object attributes
6.6.2 MDS object methods
6.6.3 MDS object events
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
6.7.3 Pending bolus delay
6.7.4 Bolus delivered
6.7.5 Current basal rate setting
6.7.6 Basal delivered
6.7.7 Basal rate schedule setting
6.7.8 I:CHO schedule setting
6.7.9 ISF schedule setting
6.7.10 Insulin reservoir remaining
6.7.11 Insulin concentration
6.8 Real-time sample array objects
6.9 Enumeration objects
6.9.1 General
6.9.2 Operational status
6.9.3 PHD DM status
6.9.4 Insulin pump status
6.10 PM-store objects
6.10.1 General
6.10.2 Persistent store model
6.10.3 Metric results PM-store object attributes
6.10.4 PM-store object methods
6.10.4.1 Clear-Segments
6.10.5 PM-store object events
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
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
6.11.4 I:CHO profile settings schedule-store object attributes
6.11.5 ISF profiles schedule-store object attributes
6.11.6 Schedule-store object methods
6.11.7 Schedule-store object events
6.11.8 Schedule-store object services
6.11.8.1 GET service
6.11.8.2 SET service
6.11.9 Schedule-segment objects
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
7.3 Object access event report services
8. Insulin pump communication model
8.1 Overview
8.2 Communications characteristics
8.3 Association procedure
8.4 Configuring procedure
8.5 Operating procedure
8.6 Time synchronization
9. Test associations
9.1 Behavior with standard configuration
9.2 Behavior with extended configurations
10. Conformance
10.1 Applicability
10.2 Conformance specification
10.3 Levels of conformance
10.4 Implementation conformance statements (ICSs)
Annex A (informative) Bibliography
Annex B (normative) Any additional ASN.1 definitions
B.1 Device status and insulin pump status bit mapping
B.2 Capability-mask
B.3 State-flag
Annex C (normative) Allocation of identifiers
C.1 General
C.2 Definitions of terms and codes
C.3 Systematic derivations of terms and codes
Annex D (informative) Message sequence examples
Annex E (normative) Schedule-store class
E.1 Schedule-store class
E.2 Schedule-segment class
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
F.3 Data protocol definitions
Annex G (informative) The schedule-store concept
G.1 General
G.2 Schedule-store object hierarchy
Annex H (informative) Scedule communication model
H.1 Operating procedure
Annex I (informative) Protocol data unit (PDU) examples
I.1 General
I.2 Association information exchange
I.3 Configuration information exchange
I.4 GET MDS attributes service
I.5 Data reporting
I.6 Disassociation
Annex J (informative) Revision history
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Important Notices and Disclaimers Concerning IEEE Standards Documents
Participants
Introduction
Contents
1. Overview
1.1 Scope
1.2 Purpose
1.3 Context
2. Normative references
3. Definitions, acronyms, and abbreviations
3.1 Definitions
3.2 Acronyms and abbreviations
4. Introduction to ISO/IEEE 11073 personal health devices (PHDs)
4.1 General
4.2 Introduction to ISO/IEEE 11073-20601 modeling constructs
4.3 Compliance with other standards
5. Insulin pump device concepts and modalities
5.1 General
5.2 Device types
5.3 Collected data
5.4 Stored data
5.5 Scheduled data
6. Insulin pump domain information model (DIM)
6.1 Overview
6.2 Class extensions
6.3 Object instance diagram
6.4 Types of configuration
6.5 Profiles
6.6 MDS object
6.6.1 MDS object attributes
6.6.2 MDS object methods
6.6.3 MDS object events
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
6.7.3 Pending bolus delay
6.7.4 Bolus delivered
6.7.5 Current basal rate setting
6.7.6 Basal delivered
6.7.7 Basal rate schedule setting
6.7.8 I:CHO schedule setting
6.7.9 ISF schedule setting
6.7.10 Insulin reservoir remaining
6.7.11 Insulin concentration
6.8 Real-time sample array objects
6.9 Enumeration objects
6.9.1 General
6.9.2 Operational status
6.9.3 PHD DM status
6.9.4 Insulin pump status
6.10 PM-store objects
6.10.1 General
6.10.2 Persistent store model
6.10.3 Metric results PM-store object attributes
6.10.4 PM-store object methods
6.10.4.1 Clear-Segments
6.10.5 PM-store object events
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
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
6.11.4 I:CHO profile settings schedule-store object attributes
6.11.5 ISF profiles schedule-store object attributes
6.11.6 Schedule-store object methods
6.11.7 Schedule-store object events
6.11.8 Schedule-store object services
6.11.8.1 GET service
6.11.8.2 SET service
6.11.9 Schedule-segment objects
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
7.3 Object access event report services
8. Insulin pump communication model
8.1 Overview
8.2 Communications characteristics
8.3 Association procedure
8.4 Configuring procedure
8.5 Operating procedure
8.6 Time synchronization
9. Test associations
9.1 Behavior with standard configuration
9.2 Behavior with extended configurations
10. Conformance
10.1 Applicability
10.2 Conformance specification
10.3 Levels of conformance
10.4 Implementation conformance statements (ICSs)
Annex A (informative) Bibliography
Annex B (normative) Any additional ASN.1 definitions
B.1 Device status and insulin pump status bit mapping
B.2 Capability-mask
B.3 State-flag
Annex C (normative) Allocation of identifiers
C.1 General
C.2 Definitions of terms and codes
C.3 Systematic derivations of terms and codes
Annex D (informative) Message sequence examples
Annex E (normative) Schedule-store class
E.1 Schedule-store class
E.2 Schedule-segment class
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
F.3 Data protocol definitions
Annex G (informative) The schedule-store concept
G.1 General
G.2 Schedule-store object hierarchy
Annex H (informative) Scedule communication model
H.1 Operating procedure
Annex I (informative) Protocol data unit (PDU) examples
I.1 General
I.2 Association information exchange
I.3 Configuration information exchange
I.4 GET MDS attributes service
I.5 Data reporting
I.6 Disassociation
Annex J (informative) Revision history