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BS EN ISO 11073-10425:2019

$215.11

Health informatics. Personal health device communication – Device specialization. Continuous glucose monitor (CGM)

Published By Publication Date Number of Pages
BSI 2019 88
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This standard establishes a normative definition of communication between personal health continuous glucose monitor (CGM) 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 of communication functionality of CGM devices. In this context, CGM refers to the measurement of the level of glucose in the body on a regular (typically 5 minute) basis through a sensor continuously attached to the person.

PDF Catalog

PDF Pages PDF Title
2 undefined
4 European foreword
Endorsement notice
5 Blank Page
8 Important Notices and Disclaimers Concerning IEEE Standards Documents
11 Participants
14 Introduction
15 Contents
17 1. Overview
1.1 Scope
1.2 Purpose
1.3 Context
18 2. Normative references
3. Definitions, acronyms, and abbreviations
3.1 Definitions
19 3.1 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. Glucose monitoring concepts and modalities
5.1 General
22 5.2 Device types
23 5.3 CGM agent-to-manager communication
24 5.4 Collected data
25 5.5 Stored data
6. Continuous glucose monitor (CGM) domain information model (DIM)
6.1 Overview
26 6.2 Class extensions
6.3 Object instance diagram
27 6.4 Types of configuration
28 6.5 Profiles
6.6 MDS object
31 6.7 Numeric objects
41 6.8 Real-time sample array objects
6.9 Enumeration objects
45 6.10 PM-store objects
49 6.11 Scanner objects
6.12 Class extension objects
6.13 CGM information model extensibility rules
50 7. CGM service model
7.1 General
7.2 Object access services
52 7.3 Object access event report services
8. CGM communication model
8.1 Overview
8.2 Communication characteristics
53 8.3 Association procedure
54 8.4 Configuring procedure
56 8.5 Operating procedure
8.6 Time synchronization
9. Test associations
9.1 Behavior with standard configuration
57 9.2 Behavior with extended configurations
10. Conformance
10.1 Applicability
10.2 Conformance specification
58 10.3 Levels of conformance
10.4 Implementation conformance statements (ICSs)
64 Annex A (informative) Bibliography
65 Annex B (normative) Any additional ASN.1 definitions
B.1 PHD DM status, CGM status, and measurement status bit mappings
66 B.2 Numeric extension for measurement confidence
67 B.3 Capability-mask
B.4 State-flag
69 Annex C (normative) Allocation of identifiers
C.1 General
C.2 Definitions of terms and codes
71 C.3 Systematic derivations of terms and codes
74 Annex D (informative) Message sequence examples
76 Annex E (informative) Protocol data unit examples
E.1 General
E.2 Association information exchange
79 E.3 Configuration information exchange
82 E.4 GET MDS attributes service
84 E.5 Data reporting
E.6 Disassociation
85 Annex F (informative) Revision history
BS EN ISO 11073-10425:2019
$215.11