BS EN ISO 11073-10419:2016
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Health informatics. Personal health device communication Device specialization. Insulin pump
06-09-2023
05-12-2018
1 Overview
2 Normative references
3 Definitions, acronyms, and abbreviations
4 Introduction to ISO/IEEE 11073 personal health
devices
5 Insulin pump device concepts and modalities
6 Insulin pump domain information model
7 Insulin pump service model
8 Insulin pump communication model
9 Test associations
10 Conformance
Annex A (informative) - Bibliography
Annex B (normative) - Any additional ASN.1 definitions
Annex C (normative) - Allocation of identifiers
Annex D (informative) - Message sequence examples
Annex E (normative) - Schedule-store class
Annex F (normative) - Schedule class ASN.1 definitions
Annex G (informative) - The schedule-store concept
Annex H (informative) - Scedule communication model
Annex I (informative) - Protocol data unit examples
Defines 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.
| Committee |
IST/35
|
| DocumentType |
Standard
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy |
The scope of this standard is to establish 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, 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 the ISO/IEEE 11073-20601 standard, and does not specify the measurement method.
| Standards | Relationship |
| EN ISO 11073-10419:2016 | Identical |
| ISO/IEEE 11073-10419:2016 | Identical |
| IEC 80001-1:2010 | Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities |
| IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| ISO/IEEE 11073-20101:2004 | Health informatics — Point-of-care medical device communication — Part 20101: Application profiles — Base standard |
| IEC 62304:2006+AMD1:2015 CSV | Medical device software - Software life cycle processes |
| IEEE 11073-20601-2014 REDLINE | IEEE Health informatics--Personal health device communication - Part 20601: Application profile- Optimized Exchange Protocol |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| ISO/IEEE 11073-10101:2004 | Health informatics — Point-of-care medical device communication — Part 10101: Nomenclature |
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